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Appendix D Voluntary Health Agencies and the Clinical Research Enterprise Exploratory Focus Groups BACKGROUND AND PURPOSE It is estimated that in the next 5 years there will be a 6- fold increased need for study participants in clinical research. Understanding how stakeholder and participant groups, such as Voluntary Health Agencies (VHAs), fit into the Clinical Research Enterprise (CRE) and might better fit into it in the future is thus more important than ever. To do that ef- fectively, the Institute of Medicine (IOM) contracted with Balch Associates to conduct exploratory focus group re- search on current perceptions, practices, barriers, benefits, enablers, and needs of VHAs in the CRE, and on ways to improve this role and the CRE. George I. Balch, Ph.D., pre- sented the findings of this report to the Clinical Research Roundtable in December 2001. METHOD We conducted a total of four nationwide computer-as- sisted telephone (CAT) focus groups (see Appendix A) with 29 VHA personnel in 20 VHAs that are members of the National Health Council (NHC) and one VHA that was not a member. These were VHAs that were willing and able to participate in the study in response to inquiries from the NHC. Appendix B lists the VHAs in the study. These VHAs represent a variety of common and rare diseases and conditions, including genetic diseases, auto- immune diseases with no known cause, birth defects, and mental illnesses. Of the 21 VHAs that participated 43 per- cent were membership organizations and 85 percent fund clinical research, with support ranging from $20,000 per year to $1 19.4 million per year. The first focus group was composed mainly of Top Management. The remaining three groups were composed of people who play roles related to clinical research, such as program directors, science and research directors, and direc- tors of patient education and services. In addition, two in- 57 depth interviews were conducted with science and research directors of two other national non-profit organizations that are stakeholders in the clinical research enterprise: Paralyzed Veterans of America and the Society for Women's Health Research.. All focus groups and interviews followed a discussion guide (Appendix C) developed by Balch Associates with input from IOM. Focus group sessions were observed by a staff member of IOM and audio taped (with participants' consent) and transcribed for the sole purpose of writing re- ports. This report is based on analysis of those transcripts. KEY FINDINGS Benefits of Clinical Research All participants noted important benefits of clinical re- search. In view of their willingness to participate in a study about the CRE, one would expect as much. Participants noted benefits to their constituents those who have or might de- velop the disease or condition that their organization deals with and benefits to their organization. Participants expect clinical research to benefit their con- stituents, ultimately, by producing effective treatments, de- lay of onset, prevention, and cure for the disease/condition. More proximal benefits of clinical research include:

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AS Beget treatments; Better care for improved quality of hip; Helping some qualify for insurance benefits and direct care they might not be able to get otherwise, Providing care for those Or whom clinical teals are the standard I care (e.g., kidney cancer parents); Providing improved management of the diseases Condition; Helping to make treatment available to those who are not now treated (~s with many merda1 health problems); A sense of hope; EDA approval for treatments that =e ~QW used ``o[~-l~ne7' [or the disease and not covered by health insur- ~ce; :Early diagnosis of some diseases; and Identifying more of the people W~Q have a ram d~- ease. They consider research fundamentally beneficial to the success of their agencies, exerts to achieve their missions. These organ~z~ons bene0t mom research through: ~ Supporting advocacy ~r v~ious issues, such as rising public awareness ~out the diseaselcond~~on, raising public awareness of rood ~r community services (~0 tn schools, tr=~ortat~on ~r Resoled), rising public arid Novae funding far reweigh and treatment, and removing bathers to pabent access ~ clinics teals? ~ Pmv~ng the bas~s for education of patients Id . . lySICl=S; ~ Showing their organization, $ accou:r~tab~lity tugh chmeal bm~roughs, suit He city of He agency, Encouraging Id rms~, ~ strong appeal ~ do- nQ(S, defog ph~naceut~ co - amen In touch with rare patient Is; HeJL~:,ing the V~ to Men and convene rese~ch- e:rs to ecus on their specific - teems; =d Idendfying new p~entsfto:nshtuems when ~QCtOtS inform the agency of Heir involvement in ~ clinical study. While clinical research is impodant to all of them, their interests gal beyond clinical research. Most commonly Heir other Booties Be education (of physicians, patients Ed the public) and a~acawy. $~e Fancies ~~o place high pnoFtt,7 on dared patient ass~st=ce ~ improve quality of It, such as direct c~e' summon Damps? =d finance re- soumes. Moreover, chmcal re$e=ch is not the only kind of m- se=ch they consider ~mpo~=t. Some kind it di~-~t to sepa- r~;e $?? Id `climcal', research on the grounds ~ re seam th~ cods ~ understanding the disease process can be based on Imps or on humps. Some cor~sider re- se~ch the transitives basic Id clinical research into apph- ENGAGING THE PUBLIC lN THE ~INI=L RESEAR~ F~RPKISE cations that doctors and patients can =d do use (such as using the latest treatments? following recommendations [or self-mon~tonng7 respectively) equally important. And some have particular interest in health policy Ed hearth services research. [finds of Involvement in Clinical Research These agencies ~e involved :in ~ remarkable variety of elbows related {Q 1i~C~ research, open creative and inv~- ably tailored to their respective missions, needs? and capa- hilities. In addition to direct exams such as Ending and, to ~ lesser extent, conducting clinical research, Vitas have found numerous unique ways to ~n/~uene clinical beseech. These effods p=~cul~ly tap their ingenuity, flexibility, and spe- ci~ resources to encourage Id enhance clinical research in the interests of their missions. They collaborate, convene? Consult with other entities in the cacao ente~nse; attract and su~ou researchers' educate clinicians, Orients, and the pubhc; Id recruit patients to chmeal research shoes. FLJO~ Con~ctmg' aodAUrachog Research ~~d Researched Funding ~d conducting clinical research me the most direct and obvious ways in which V~As are involved. The I=gest Fancies And OF co-~und maim clinical Ends. Some of the smilers 'n~he,, or o~han disease agencies provide smut:! number of small research gr=ts to mse~chers. Some of the newest Id smallest agonies fund no beseech ~ this dme. Of course V8As we not the main source of funds for cl~l research. amen the Caged orgam~ns my no) be pr~ncip~ Angers I Urge chock Aims. They may provide `~mpiem&~'7 dollied such as bode grmts. Many Yams tend not to Anal clinical research Ads because of Be I^e cost involved =~' for m~y' the need and ability ~ have greater It in more ~rlnov~ive or ba- StC WAS. ~~f eX~:le7 8$ will be discussed further 50]OW7 they do so by Owning new research and rese=chers to Bract teem Id their Joseph into their own disease area. ~w of these Vitas actually ondlct research themselves, as distin- guished Tom fielding it. One of the major biers and opponunit~es Vitas see to funding high quality research is at~racung begs quiver researchers IO[Q their held. Even the largest research CtS7 such ~ ~e Amenc~ Cmcer Sorely (~ow than $~00~1ye=~, Gel th~ ~~,< lack the funds to compete di- rect:ly for researchers with the massive funding omen by prime ID0US~7 ~~' =6 ~undabon$ (more Can 568-578/ year) They see ~ :~e arid Wowing showed of physician scientists. NI=y fund begging mse~ehers, tn arms to encourage them {Q ends =$~5, (Q conduct beseech in their Gelds and to build up their work Q the point where they can secure

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APPENDIX D funding from NIH. They provide funds to help beginning researchers, particularly physicians, overcome the great ob- stacles that they face in entering and remaining in a career in clinical research. These obstacles include the need to pay off education loans from medical school, the need to get research training, and the need for enough protected time to produce research results that enable them to compete effectively in "the larger environment" for greater funding. These VHAs tailor their grants to address these obstacles. Collaborating and Consulting/Acivocating with Other CRE Entities Collaborating with other CRE entities is a major way in which VHAs leverage their expertise, their commitment, and their resources. Several collaborate with NIH in various ways. Some also collaborate with the pharmaceutical indus- try, biotechnology companies, and the FDA. They do so to educate, stimulate and enable these organizations to conduct research in their field, as well as to identify and address spe- cific problems in the disease, treatment, research design, and approval process. VHAs have, for example: . Developed and funded a "clinical trials network" of academic and industry partners for phase 1 and 2 research, together with the VHA' s "care network" to access patients. Invited biotechnology and pharmaceutical compa- nies to join a VHA "Industry Liaison Council" to interest the pharmaceuticals in their disease, provide peer coaching to help biotechnology companies navigate the difficult FDA approval process, work with insurance companies to change the reimbursement process for clinical research, develop educational materials for constituents, and provide a patient population for research. Created a liaison group endorsed by NIH that in- cludes several of its Institutes, FDA, biotechnology compa- nies, pharmaceutical companies, and their own medical and scientific leadership, as well as one or two consumers. They confer quarterly to discuss issues of clinical trial design and identify areas that industry could not discuss amongst them- selves (because of competitive secrecy and federal regula- tion). The resulting cross-fertilization is used to develop fo- cused workshops designed to resolve issues and develop consensus. They have also designed clinical trials together. Used their patient registry to enroll patients for clinical trials conducted by industry. Has clinical trials reviewed by the VHA's standing ELSI committee before committing patients from their registry. Worked with multiple institutes at NIH to establish criteria by which to offer investigators whose meritorious pro- posals fell below the pay line competitive bridge grant oppor- tunities to improve their research and re-apply to NIH; some 80 percent of their grantees have succeeded with full grants of $20M-$22M that would not have otherwise been made. Convened regularly international research confer- . 59 ences among leading researchers to inform one another and VHA constituents of current research activity: and a, Convened industry and physicians who are inter- ested in pre-clinical and clinical trials to encourage combi- nation therapy and encourage communication and encour- age more clinical trials. VHAs also influence other CRE entities through con- sultation and advocacy on issues and policies. For example, VHAs have: Developed a data safety monitoring board, includ- ing outside experts and experts on research and care in a disease, that has been helpful in identifying and monitoring the patient's safety; they have brought their work before Congress; Influenced standards for clinical trial protocols in a particular disease about what happens to patients at the end of the trial, e.g., patients are informed of the results of the trial, are usually told what their particular status was in the trials are rolled over into therapy; - . ~ ~, Advocated successfully for more/particular kinds of research and guidelines for protection of patients in re- search; and Had a major role in setting and monitoring compli- ance with new FDA and NIH guidelines on inclusion of women in federally funded research. Recruiting or Informing Patients About the Availability of Clinical Trials Many VHAs both inform patients about the availability of clinical trials and recruit patients to trials. Many do not. Why and What They Do or Do Not Recruit Those who recruit do it because of patient demand for better treatment than otherwise available to them, as well as to learn more about the disorder. Many do not recruit pa- tients at all, and provide only links to websites and advise patients to participate at their own discretion. They are con- cerned primarily with the responsibility and potential liabil- ity of connecting people to trials whose safety they have not been able to assure or control. Those that recruit patients select the trials in a variety of ways in order to address this concern. Most will refer to NIH trials, some exclusively so. Many agree that neither industry nor NIH makes it easy for their VHAs to be informed and to disseminate information. They would like speakers and writ- ten education materials in lay terms; finding, translating, and disseminating the information makes great demands of their limited time, money, and labor. Some recruit only for trials whose researchers or re- search centers they support or whose protocols they have reviewed. Others also rely on third party sources of indepen-

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deftly reviewed teals (e.g., Center Watch =d Hopel~nk). They we p~~cul~ly leery of industry sponsored teals with- out independent review. Several operate reg~stnes~abases of patients who have expressed interest ire pari~cip~ng in conical trials' Id may have even provided blood or other samples. Rese~ch- ers can then apply to the registry to use the patients or mate- H~ (Q conduct shades. The V~As review the protocols as condition of granting access to the registry, and may enroll the poems directly' providing ~ buffer Mom the C(3~&S =d researchers that wish access to them. A related ethical policy concern is the reposed absence of guidelines for genetic registries amortg small, new Vitas. These V~As He not aware of the specific needs and tech- niques for protection of confidentiality of these sensitive data. The National Organization of Rue Disorders, the Ge- netic Alliance, and the Nations :Heal~ Council provide such Norton to members. The small? new Y:HAs He unlikely to be aware of these org~zat~ons. Ir~format~io'7 tf~h~c~s dewy all of He Vows re~esen~d ill our focus groups provide ~nfo~on about clinical trials, both about results of Finis and about ongoing Aims. They use newspapers' door Webster, =d ehatrooms? call centers to respond to questions' patient magazines, and even (~or the American Diabetes Assoc~i~r~) ~ monthly magazine on newsstands that has a monthly eimul~io:n of TOO'000. Hey use their local ch~- ters to put on health fairs and hold copy forums. Usu- ~ly, these vehicles He available to non-members as well as members. Some reemit far edn~e~ Onals through their local chapters, ~~h the Ares that they fund' ~d, as previously mentioned, through their registries. Some YHAs also inform ~:~ss~on~s (phys~ci~s and :~restig~ors) through pubheation in jounces' magazines scienDOc medians ~~t they convene. They do t~$ SO t5~ these As wall ~s~bute the ~:~rm~on {o their patients =d publics. Some V~As reach out to Yes: translate monads into Spanish, place stones In women magazines. (for ex- ' multiple scieros~s is Ye common among women3. Severa1 engage in outreach directly [Q codes, for ex- le, via Lass roots Yes with Native America tubes =d with Abicm American and ~sp~c church-haled pro- gFamS. Some do so indirectly' - ~~h ion with canons haul th Cal o~zations, su`; h as He Na- tiona:l Black N=~s Associ~io~n and the Naiona:l ~~c Medical Assoc~on. Amens to Was Getting Info~at'~n aod Same As They Cope All Y - s have Cat ~~ficul~ find~n.g out and Bering updated Boat the full He of chme~ ~~s available, espe- THE PUBLIC IN THE Cr~INIC:~. RESEARCH ^TERPR~E civilly because of the reluctance of pharmaceutical compa- n~es and in~vidua1 investigates and institutions ~ pm with the IH[QRmatIOO. They Ond it hard to get relevant intimation about research that is ongoing or even about research that is completed. They see no comprehensive, up-to-date source of informa:~;~or~ about trials. All agree that there is no single comprehensive, up-to-date source of independently F0ViOWC cacao [nals. They would love to see a compreher~s~vc, up- to-~ate database on chn~c~ tows, such as the nat~ ctim- cal teals database that they had expected to be in place some time Ad. Co~n~eti~ve commercial and publication pressures keep researchers =d research organizatiorls (both co~er- cial and governmental) from sharing unit! they have been pubUshed. And, some believe, some of these orgaruz~ons cider do ram think A sharing ~nto~ion with YHAs very e=ly or ohen, if at all, even when the inforn:~ation is not In usable for for VIAL ~ pass on to their lay constituents. (They also note that some of the government organizations are reluctant to include VITA supported climca1 Bats on their websites.) In addition to the d:~ficu1~es A getting' sh~ng? d~gest- ~ng' =d transIatWing existing information, several Vitas ~e f~stmted by the Iack of basic Notion collected about their miser, such as prevalence, co-morbid~es, and basic disease management needs, as well as ~nformabon Bout the substantial indirect costs O~ the disease to society. Some V~As with Are d~so~ers have great by identifying Events? since there are no professionally recognized and distributed sods far detection of their Crease to income physicians of what to look for. These YHAs beheve that the lack of this In~iLon :Is ~ ~~6vant~* for public fundil3Lg r beseech Ed se - ices for these diseases. The ti~r7el~ness of the ~nfo~at~on Hat Hey get ~s some- times =other bier {Q their effectiveness. Severe Ond themselves uncomfortably surprised when ~ reporter or constituent cans them ~r comment Boat beseech recoded n the mass mesa. Among m~ research jouma1s ~at get substantial} mass memo coverage, only JAMA provides clec- nic Few ~ week in advance of pubbcadon to those who register for their expert test. Some YHAs rely on ~ web-based semice th~ deliverers mass media sines by science ~ health writers. Two factor both related to their own efforts and re- sources heel some V:HAs to get access to relevant, timely ~;on about chnical sages: the OC~Q~S =4 the reg- istries that they have bu~t and Anew. VRAs the have committed subst=ti~ times enemy, and resources to develop md maintain contact networks with researchers, comedies' and gov~men:t agencies have Bond those emus necessary Ed thee results A. His is ~ moor source of their best, most timely in~ation~ It does not come easily, espe- c~ly ~r VUAs that address ~~' 7~0~-eo~mme:rcially-~rom- . . . using c Users Lers. For YHAs wall ~ disorder that; has commercial promise and that `own,, ~ patient base in the [Qua Oi ~ regi$t~, re-

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APPENDIX D searchers inevitably come to them to recruit patients for tri- als. Because of this ownership, they also get early needed information about the trials for dissemination to patients and . . physlclans. Information Gaps for Patients Despite their best efforts to inform, VHAs often find substantial information gaps and misconceptions in the minds of their patient publics. Some of these gaps and mis- conceptions result from "media hype" about the promises and risks of clinical trials, and some of them result from the desperation of those in need of treatment. Several partici- pants would welcome a general public education campaign about clinical trials to raise awareness, dispel common mis- conceptions, and immunize against "media hype." These VHA representatives find that patients need help in recognizing that: Not all clinical trials result in proven therapies Some research requires a placebo control arm Clinical trials have high quality of care and prepa- ration, and are not "guinea pig" treatment. Patients also need to be informed of the results of the trial in which they participate, which apparently does not always happen. They often need more help than is provided in understanding the informed consent process, so they have overlooked neither real risks nor benefits and have a realistic sense of the ratio. Barriers to Patient Participation in Clinical Trials These VHAs often found their efforts to recruit patients to clinical trials thwarted by a variety of important barriers that many are engaged in advocacy to relieve: . Availability of trials for some disorders that are less commercially appealing; 61 Perceived inadequacy of health surveillance of pa- tients in trials so one could "jump in early"; Clinician reluctance to refer patients to clinical tri- als (and, in some cases, reluctance to apply the latest tested treatments). Some VHAs are also concerned that more trials might be designed for the welfare of patients. For example: Fund some more innovative research, rather than. spreading the money around universities and relying exclu- sively on the inherently conservative peer review process; More trials with closer end points so that fewer re- cruits are needed and results can come earlier; and More research on the realities of those who live with the medical conditions, such as research on how to manage flaccid bladders for people with spinal injuries and research on the cost-effectiveness of power wheelchairs (to avoid ro- tator cuff problems) vs. manual wheelchairs. APPENDIX A: COMPUTER ASSISTED TELEPHONE (CAT) FOCUS GROUPS1 Availability of trials for some groups for whom it is hard to design or deliver ethical trials, such as children, people over 72 years old, people who live far from tertiary health care institutions; Insurance coverage of the ancillary costs for clini- cians, such as costs of enrolling patients, time needed to dis- cuss participation in trials, and time needed to administer some treatments; Patient concerns about trust in the system, such as fears of discrimination based on information about their genes; Non-responsiveness of the CRE to outcomes that patients and some VHAs value, such as ability to function with the disorder (instead of "symptom reduction" or more distal outcomes); Telephone focus groups have been in use for over 30 years, and have been enhanced by computer technology in- vented in the past five years. Organizations are increasingly finding it valuable for reaching people from all over the United States (and even internationally), going beyond the usual less-than-a-handful of large cities to represent many locations and kinds of participants that could not otherwise be considered. It is especially useful where participants are geographically dispersed, relatively rare, reluctant or unable to travel to a central facility, or in need of anonymity. People participate from the comfort of their home, of- fice, or other private place where they have access to a phone. This permits people to participate with equal ease across lo- cations. Participants may also feel more candid than in face- to-face groups because there is less opportunity for facial "intimidation." All are equal on the phone. There are fewer distractions, less silence, less formality and posturing, and a greater sense of privacy. Everyone can hear everyone else very clearly. Because everything is said directly into their ears, participants are all psychologically closer than in face-to-face groups. No side conversations are possible. Interaction starts fast and is often more natural and intense than in face-to-face groups. The fact that participants cannot see each other is not unusual or problematic. People use the phone to communicate all the time. Participants use complete sentences and nonverbal re- marks, like "uh-huh" to substitute for the nonverbal head ~ For further detail, see Silverman, George (1996) Introduction to Tele- phone Focus Groups. www.mnav.com/phonefoc.htm. Orangeburg, NY: Market Navigation, Inc.

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62 nods, They Me encouraged to "chorus,, Chit agreement or disa~eemerd. Pauses become much more obvious and mean- ing~. Many other nonverbal auditory cues supplement Me conversation, such as participants using ~~r name each time they spew. Products' concepts, ads' and other`'hands-~n'' adrenals can be sent in advance Id expenenced in the pri- vacy of padicip=ts' home or ofOce~ither during the ses- port or before it. The computer technology provides several unique ad- vantages, such as: (13 the tnoder~or can identify who is t~k- ing~n a computer screens (2) client observers can call in Mom anywhere Id listen without being beam and can even pass notes to the moderator- (~n the moderators computer screen)2 without inter the group session, (33 partic~- pmrs can be separated into subgroups (separate lines) wale the moderator travels between them and then reputes them; (~) groups can he polled anonymously on specific iss~}es- and results punted out. Compared to face-~-~ce focus groups, telephone focus groups we more representative, easier to recoin, c~ be set up more quickly, and elf the costs, time, and ~ncor~veY nience of ~~l for chent observers R$ well as ~r p~ic~- pants. They ~~t involvement across morel clients as well as p~icip~ts. OlK Be VHAS IN FOCUS GROUP STUDY Alpha-) :~ur~on Alzb~me:~'s Assoc~n Amenc~ Cancer Society American Metes Association Ardency Away Fund Amyotr~c La~ Sclerosis Association Asthma ~ Allege Foun~don of Amenca Epilepsy :Foundat~on The ~ou~ion ~ighi~n,~ 8jir~dness Kidney Cancer Associatior~ The Leukemia and LymphoTna Society The Na:nona:l Pcmphigus ;Foun~ion Lupus Foundation of Amenca March of Dimes Birth Deflects Foundation Myasthenia Gravis Foundation National Down Syndrome Society Nations Mends depth Association N~tior~] Multiple S~OSiS Socked National Sleep Con S~e-~Teber ion: Cystic Floss F~ndan~ (~HA not ~ member of Radons He~h Council) 2 Observers need no computer ~ do His., they use their telephone touchpad to contact a techrucal assets - t who transmits the note. END GING THE PlJ~Ll F IN the C.L.IN. IDOL RE7SFaRCH ^~PR~ 0bje-~:hte$: to explorc;~currc~nt perceptions, practices' barr~rs7 ~~ ::::::: : : :: benefits, ens? and nods e! llamas in the conical fired ells terpr~se in erder to ~dentify~rea~st~c~ - s tc supreme this Me a Introduction Telephone Introduction (5-IQ minutes) Welcome, th~s for p~cip~ing Introduce topic, moderator' participants first name, V~A' pan of country Describe process Benefits (~-15 m~nutesJ What benefits, ~f any, do your V~As expect mom clinical research for members? :For the YHA? In what ways are these benefits important ~ your Vitas? What's more implant to them than clinical re- search~ Less? Current Clinton} Research Involvement General Perceptions (30 m~tes3 Let's thin h~t about how, if ~ all, your VIIAs now get involved in clinch r:esearch: Informing members, f~rt~C-~Dg, funding, over- seeing resewed, recanting p~tic~p=s~ What kinds of beset (~lin~a1 teals, ~~de- miolo~ca:~' sads~ction...?3 - Ming ~out ~l of the things that you now do related to Chtl~l research? w-hM Ages ~t h~ to have ~ m?m ~ffech~e roles What helps make it Amp? What MIGHT helps Which componentts3 of the CRE would do th~? What contnbunons might Vitas themselves Amp? Are there any other ways in wash you think your VHAs could Ad should be involved in the Cow? Who is the Il3EAL cow th~ you might have? Who, if ~yth:ing9 keCp?S your VITA from doing some of ~e things you might w=t to A about cI~mc~ reteach? Specific. Roles, Pracdces, B,armem, Enablers, NTeed~an~ (20 mmu~) Now let's look at some of these in more depth, st=- . ~ . ~ sing wall To: What in~rm~ion do you provide members? (specific ~nform~ion about available research? msuts, just a hnk, ...?3 Why that?

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dS Boa do you act the in~adon? (PROBE: spe- ciDc sources, ch~ncls, ...) How do you pet the iron 10 members? (PROBE: modes, messes, and cb~ncls) How, if it all, do you reach non-mombers? ~i- n-~cs? How wolf do your members undor~=d chnical Such? (What do they need 10 Cow? Whams . . ~` ~SS1Dg a) What ad~1iona1 iron Could help? (OD ~- subs OD how to and thus on how 10 volunteer .~) ~h) specific 1001s {\uld you new 10 prod S # vice that invasion? Iffy of p~icip~ts Ovc~ie~ of V8As included: 49 Voluntary HeaRb Apcncies, a] mcmb~rs o{ the MOODY Hale Council. Rich, Stocky ad chucking ace tic common gods. 51 pcrccn1 (25) ~c membership opinions. e ol stiles ~ SuppoM Wreath Why ~ you Wool do it? (PROBE: perceived need ~ mambos ~ ~HA, bard Boa? (PROBE: 1n~edals, mess~es, and cb~- ncls) What bract ~ mc~itmcn1 do you oncuun~r? (WEBB: inert, earn What helps you overcome these back? Wbut s~ciAc tools Brat help even mooch ~~ ~ Types of Researob funding llanalog the Bent Three Croups (10 minus As you know, we wiU be conduchng 1broc focus groups with noD-CEOsto underhand morouboulthe det~lcd procossesth~ they do or nb~blin~p~ moat about chnlcalrosc~ch. We ncod your helpin plan- ning Case. W ha kinds of positions or roksin VHAs He most likely to have this kind ofin ~ mason? (PROBE: padcnteduc~ion,caN cc ~ r,n~hon~ Booms, ..) ~ ~ ~ ~~ ~~ ~ vats _ that they can discuss those 10~CS most com~- ~ Aim one Honor? ADOBE: vows of Mass mvonue, Wave proportion of minobties who have the disease, role-speciAc divisions [cab?], . . . ?) @ Check Observer tar Obtests True Po~cip~ CHnical Trials Consider: Hal the Wings we've considered 1~lEW LIST], war fit hag ~ ~ ad wN~ ~- mr musics it o~icsl? Pup Cur) yt~n~ chic we should know Put Ems 10 im- ~ve ~o Cat ~ VH^s ad was ~~ Vans can egg? T~K P^~llClP^~IS 88 percon1~43)fundrcse~ch. 82 pc~cnt<40)fund chnica) Sch. 76 pe~eDt(37)fund othcrlypesotrcscarcb. 8 percent(4)conductclinicalrose~ch. agony ~soin~c~cd1h~ pan ofthoirrole wasload- voc~e far uddhionu1 funding, m Aching funds or bdd~cgrmtshom govcnnnentoro~cro~g ~ zillions (biotechnology and pb _ accubcalcomp ~ ask 82 Icons (40) find Orals aced age, mincing grants, l~gc Patsy. 49 gnu (24) find Ups (in Edition lo ~F lordship Ink them acre cancer ~vOlopmCDt pro- gr~s, scholarships at di^mnl disciplines, invesh- g~r Ems). 26 pc~ont (13) have ~o~ssion~ mo~caUscicndOc . . . advisory orpocrnevle~ conl~u~oes. 25percen1~12)f~ndapadentd~arog~1 OCR for page 57
64 Eclucation . ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE 92 percent (45) communicate with members and/or interested people who have requested information via newsletters, magazines or updates (e-mail and hard copy). Some organizations have separate periodicals for professionals. Some publications were listed as appropriate for both public and professional. 69 percent (34) have professional conferences (some are research symposiums, some educational). 67 percent (33) have conference for public regarding current findings. Education was generally listed as a goal or part of the mission statement with a dedicated budget. Some of the education activities are through the local chap- ters. The public education campaigns included help lines (86 percent), fundraisers, booths at health fairs, educational programs, resource centers, printed and web information. Many also used the print media to educate the public. A few of the larger, well estab- lished VHAs also had PSAs for radio and TV (occa- sionally with celebrity endorsement). 59 percent (29) VHAs have local chapters or affili- ates where public education offered to communities or regions. It was not always clear if or how much financial support the local affiliates received from the national organization. Outreach to Minorities Not always apparent on the national VHA website. 63 percent (31) had Spanish language information or links. Many offered links to other foreign language information. Review of several local chapters or affiliates indicated that cultural diversity and minority outreach was often addressed through the local chapter and was specific to their communities. (However, many local affiliates do not have websites and it is difficult to determine the extent of their outreach to minorities.)

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APPENDIX D 65 TABLE D. ~ Website Survey of Selected Voluntary Health Agencies, follows

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66 TABLE D. 1 Website Survey of Selected Voluntary Health Agencies ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE Kinds of clinical Recruitment info Voluntary Health Research funded Do they fund Do they fund Do they conduct research on specific clinical Agency $$ clinical research? non-clinical? research? activities? trials? TOTAL (49) 88% (43) 82% (40) 76% (37) 8% (4) Grants 82% (40) 49% (24) Fellowship 49% (24) Pt. Registry 25% (12) Alpha-1 $1.8 M Y2000 Yes (also have Yes Yes (At University -Registry + online Yes Foundation * > $7 M since 1995 consumer of FL Gainesville) consent (genetic disease- participation in -Tissue + Antitrypsin clinical trial DNA bank deficiency is a lack design) -Grants of blood proteins -Medical + that protect tissue scientific advisory in lungs from committee being destroyed by -Clinical resource enzymes released centers by own white -Fellowships blood cells) -Alpha -1 Research Network -Conferences Alzheimer's $19.3 M Y2000 Yes Yes No Grants Yes Association * >$100 M since Conferences 1980 American $106,412 Y2000 No Yes No Most research is No Autoimmune disease-specific Related Diseases and not done Association through AARDA American Cancer $119.4 M Y2000 Yes Yes Yes (Ca prevention Grants,Fellowships, Yes (for Ca Society * $2.3 billion since studies) Professorship, prevention studies) 1946 Masters and Doctoral programs for SWs, RNs American Diabetes $31.6 M Y2000 Yes Yes No Grants, Physician- No Association * >$175 M since scientist training, 1940 Medical scholarships, Conferences American $175 M since 1985 Yes Yes Unclear think not Grants, Peer Foundation for Review, Scientific AIDS Research Advisory, Fellowships American Heart $133.6 M Y2000 Yes Yes No Grants Pre No Association > $1.9 B since and Postdoctoral 1949 Fellowships, Physician-Scientist Fellowship Research Review Program American Kidney $96,825 Y2000 Unknown Unknown No Clinical Scientist No Fund * Fellowship

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APPENDIX D 67 E-mail/listserv Links to open clinicaltrial Clinicalresearch Clinicalresearch How do they do Membership newsletter/maga- Efforttoreach recruitment? info for public? results for pros? public education? organization? zinc? minorities Spanish language 69% (34) 88% (43) 65% (32) Local chapter 51% (25) 92% (45) info 63% (31) Help line 86% Yes Yes Yes. Medical/ Regional No Yes Foreignlanguage research extranet, education days No links Conferences Yes Yes Yes Local chapters, No Yes Race specific media studies, Foreign language info Yes Yes Yes Disease-specific No Yes Gender specific organizations, studies Media, Celebrity spokes-person Yes Yes Yes Local chapters No Yes Race specific studies, Foreign language info Yes Yes Yes Local chapters Membership for Yes Community based public and pros diversity programs Church, Tribes Yes Yes Yes Unknown No Yes Race and gender specific No on web Yes Yes Yes Local chapters, For Professionals Yes Spanishinfo avail Media, PSAs on Webster No No No -can subscribe Health fairs, No (membership No (Baxter does) Materials in to a clinical brochures, help in Discount Spanish. AA strategies line, financial Pharmacy outreach, newsletter \assist program) Screening program continued

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68 TABLE D. 1 Continued ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE Voluntary Health Research funded Agency $$ Do they fund clinical research? Kinds of clinical Recruitment info research on specific clinical activities? trials? Do they fund Do they conduct non-clinical ? research American Liver $4.6 M since 1980 Yes Yes No Liver Scholar, Yes Foundation Pre + Post doctoral (website under Fellowships construction) American Lung Yes. Details not on Yes Association website Grants, Donor program Yes No Grants, No Fellowships, Investigator awards American Tinnitus $1.3 M since 1980 Yes No No Data registry, No Association Grants Amyotrophic New grants for Yes Yes No Database (registry), Yes Lateral Sclerosis Y2001 $1M, Grants Association * plus ongoing grants w/ orig. commitment of $6.7M Arthritis $30 M Y2000 Yes Yes No Fellowship, No Foundation Physician-Scientist Development Dissertation awards. Investigator awards, Grants Asthma& Allergy Approx. Yes Yes No Seed Grants No Foundation of $20,000/yr (details ($20,000 ea.), America * not on website) Scholarships, Trending + data application w/ EPA Cancer Research >$50 M since 1985 Yes Foundation of America Yes No Grants No ($40,000 ea), Fellowships CHADD Unknown Unknown No No Conferences, Yes (Children + Adults "Promotes" Clearing house for w/ Attention- "supports" research info, Deficit/ Research awards Hyperactivity Disorder) Christopher $5 M Y2000 Yes Yes No (they do lab Grants, Consortium No Reeve ($2.5 M in grants) research) labs + Advisory Paralysis since 1982 $22 M panel, National Foundation survey (formerly APA) Crohn's & Colitis $5.4 M Y2001 Yes Foundation of America Yes No DNA and Cell Yes Line Bank, Prof. Research Workshops and Conferences, Grants

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APPENDIX D 69 Links to open E-mail/listserv clinicaltrial Clinicalresearch Clinicalresearch How do they do Membership newsletter/maga- Efforttoreach recruitment? info for public? results for pros? public education? organization? zinc? minorities Yes Yes Yes Celebrity PSAs, No Yes Spanishlanguage Local chapters info, Hispanic, AA and gender specific info. No Yes Yes Local chapters, Yes Yes Multicultural + Spanish language info No Yes Yes Local chapters Yes Yes Unknown Yes Yes Yes Local chapters, Yes "Member" of Yes Multicultural info Public awareness database and through local campaign chapters No Yes No Local chapters, Yes Yes Ethnicity trials Fund raisers, PSAs No Yes No Coolio talks to Yes Yes Spanishlanguage teens, Local info chapters, health fairs, community forums Yes Yes No Ed materials No No Spanish language Prevention info Yes Yes Yes Local chapters, Yes Yes Spanish language Media, Experts on info chat calls Yes Yes Yes Celebrity PSAs + No Yes Gender specific Media research, work w/ Amer. w/ Disabili- ties Yes Yes Yes Local Chapters Yes Yes Links to foreign Celebrity speakers language sites bureau continued

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70 TABLE D. 1 Continued ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE Kinds of clinical Recruitment info Voluntary Health Research funded Do they fund Do they fund Do they conduct research on specific clinical Agency $$ clinical research? non-clinical? research activities? trials? Easter Seals No No No No None (Advocacy + No (People w/ direct rehab disabilities) services) Epilepsy Yes. Details not on Yes Yes No Grants, Yes Foundation * website Since 1968 Fellowships, Conferences, Professional Advisory Board The Foundation $12 M Y2000 Yes Yes No Registry, Coop w/ Yes Fighting $150 M since 1971 Research Centers, Blindness * Career development, Grants Glaucoma $8 M overlast Yes Yes No Grants, Scientific No Research 5 yrs Advisory Foundation Committee, Eye Donor Network Huntington's Last 3 yrs $3.3 M Yes Yes No Grants, Yes Disease Society of since 1967 Fellowships, America Coalition for Cure (alliance of 17 labs) Kidney Cancer Yes. Details not on Yes Yes No Grants, Clinical No Association * website Conferences The LAM $2.2 M Y2000 Yes Yes No Nationalregistry, Yes Foundation $5.7 M since 1995 Patient Directory, (Lymphangioleio- Patient protocols, myomatosis- Grants muscle cell that invades lung tissue, including the airways, + blood + lymph vessels causing obstruction) The Leukemia and $32 M Y2000 Yes Yes No 129 Fellows Yes Lymphoma > $200M since 153 Special fellows Society * 1949 88 Scholars, Grants, Institutional program support The National Yes. Details not on Yes Unknown Unknown Medical Advisory Yes Pemphigus website Board, Foundation Conferences, * Grants (rare autoimmune blistering disorders of the skin multi-lingual links

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APPENDIX D 71 Links to open E-mail/listserv clinicaltrial Clinicalresearch Clinicalresearch How do they do Membership newsletter/maga- Efforttoreach recruitment? info for public? results for pros? public education? organization? zinc? minorities No No No Easter Seals sales, Only as a donor No ADA media Yes Yes Yes "E-communities," No Yes Gender specific Teen awareness studies, some campaign Spanish Yes Yes Yes Media, Brochures/ No Yes Unknown info in retina + vitreous physicians Yes Yes Yes Unknown No Yes Spanish language info Yes Yes Yes Media No Yes Links to Spanish info Yes No (links toinfo) No (links toinfo) Publications Yes Yes Unknown Fundraising Mail campaign Yes Yes Yes Unknown No Yes Unknown Yes Yes Yes Media No Yes Infoin41anguage Yes Yes Yes Unknown No Yes Spanish language+ multilingual links continued

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72 TABLE D. ~ ~nt~nued OWING THE PUBLIC IN THE CONICAL RICH EN^RPRI Kinds of clinical Recruitment ink Voluntary B;e~th Research funded Do they And Do they And Do they conduct research on specific clinical Agency $S clinical research? non-cllnial~ research? activities? trials? Lupus Fotandation Yes. Details not on Yes Yes No Fellowships, No of America* website Grmts, Liaison council of researchers March of Dimes S44 2 :M 1999 Yes Yes No Grar~:s No :Defects Foundation ~ MyasthemaGravis Yes. Deters not on Yes Yes Yes Conferences' pro Foundation * website Scientific =d ~, Advisory Boards, Fellowships, Patient registry' PhD scientist, Med student? ~ RN research supports Grants Myos~t~s No No ~o No Patient whisky, No ~ A Ass=~at:ton of Patient survey America (muscle diseases involving me inO~t~on and degeneration of skeletal muscle tissues) National Alopecia $200,~Y2~0 Yes Yes No GFaD[~? Yes Areata Foundation Con:~wnces Capons Down Yes. ~tail~nmon Yes Yes NTo Post doctoral Yes Syndrome websim fellowships, Society * Sym~3s~ums, Scholl awards, Grants Nations $~.3 ~ Y2~ Yes Yes No C=eer devel. Lo . ~ into :Hemophilia Since 1948 Awards, Foundation Fellowships, Medical and SciendOc Advisory board, Lab mats National Meant Pro No No No :t~otI~s~d No Health Associatton * Nat:tonalP4~:~le ~ $25 M Y2~Q Yes 5cT=os~s Moiety ~ Since 1946 I) ~ Yes No NARCOMS Yes registry, Pre and st doctors Asps, Faculty awards7 MS gene ~ tissue Arks, Its

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APPENDIX D 73 LE-mail/listserv Inks to open clinicaltrial Clinicalresearch Clinicalresearch How do they do Membership newsletter/maga- Efforttoreach recruitment? info for public? results for pros? public education? organization? zinc? minorities Yes Yes No Health fairs Yes Yes Infoin Spanish, Black RN Assoc. Hispanic Med Assoc. No Yes Yes Media No Yes Infoin Spanish Yes Yes Yes Local Chapters No Yes Unknown Celebrity spokes- person(s) No No No Unknown Yes Yes Unknown Yes Yes National No Yes Infoin 5 language campaign, Celebrity PSAs Yes Yes No Help line Yes Yes Info in Spanish No Yes Yes Help line, No Yes Spanishlanguage Publications No No No Local chapters Yes Yes Latino stories, info in Spanish Yes Yes Yes Media Yes Yes Info in multiple language, Gender specific info continued

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:~ :~ ~~ 74 TABLE f). ~ Continued EWING THE PUBLIC IN ME ~ - ICAL RESTAMP SPRY Kinds A clinical Rec-rui~ent info Voluntary Heath Research Ended Do Hey fund Do Hey fund Do they conduct research on specific cI~n;`eal Agency $$ 11 research? non-cl~M'cal? researched activities? tritest Nations DetmIs not on Yes Yes No Grants, Con~mnce, ITS Osteoporosis website Fellowships, Foundation Appn}x $~8S,Q~ Pro~ssiona~ Y2~t Partner network :National Psoriasis $2~,~ Y2~1 Yes Yes No Grants Fellowships' Yes Foundation [issue registry Anions Sleep Yes, Trough CFnkn~n Unk;nQwn I'm Lion No Foundation * PickwictCInb. Narcolepsy Details not on Registry' website :Fellowships, Osteogenesis Yes, since 197~3 Yes Yes :No Medical Advisor Yes Impe~eeta >51 :M conferences, Foundation, Inc. Grants The Paget Founda- Yes. t:ktaiTs not on Yes L'nkr~own No Patient registry Yes tion (~nic website Grants, C<3n~wnce safety disorder may result in enlarged or deformed bones in one or more regions of He skeleton. Bone is dense but fragile. Pan is the most =~non s~) Prevent; :~:lin~ess 1997 $5~Q Yes Yes No ~ants, No Africa Fellowships, :Detec:~on ~0~ No No No No None Yes (onions city Ass - .) ~og-mn,~ Yes, details not on Yes Syndrome website Foundation (Autoimmune disorder of mois- t~Tre plug gifts) Yes Yes Grafts, Yes |:~liows~ps ? Medical + scientific advisory bond Spma Bifida Yes' debris not on Yes Unknown No Professions Nc' Association of Webster advisor council' Bertha Conferences, Grants Sturge-~= Yes. Details noon Yes Yes No Re~s - ' Edict No Pound~on * website Advisors, Grants (c,+~ - vasc~= rr~ions)

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Apply ~ Links to open E-mailLfistserv clinical tnal Chnical research Clinical research How do -they do Membership newslet~r/maga- Fenton to reach recruitments ink fur publics remits for pros? public educations organization? zinc? m~nonties No Yes Yes TY program on Yes Yes Spanish language :PAX ~1 and ink ongoing web cast Yes Yes Yes PSAs Yes Yes Unkr~owr~ Plo No - public :~o Local chapters ~ Yes Links to foreign survey info language web- sites, gender- spec~fic studies Yes Yes Yes Unkr~vwn Yes Yes Larks {Q foreign language websites Yes Yes Yes Unmown Yes Yes Unmown No :~o No Scho~+ No Yes Media community screenings Yes Yes No L=al Chapter Yes Yes Unmown Yes Yes No Unknown Yes Approx. 7,5~ Yes Foreign language members links NO Yes No Loc~ch~pte~, Yes Yes Fore~gnianguage public awareness links haOgre Yes Yes Yes Day of Aw=eness Yes Yes Unknown continued

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76 TABLE D. 1 Continued ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE Kinds of clinical Recruitment info Voluntary Health Research funded Do they fund Do dley fund Do they conduct research on specific clinical Agency $$ clinical research? non-clinical? research? activities? trials? Tourette Syndrome $370,169 Y2001 Yes Yes No Grants, Scientific Yes Association since 1984 > $5 M Advisory Board Tuberous Sclerosis $1M Y2000 Yes Yes Yes Professional Yes Advisory Board, Alliance (a genetic Tissue donations, disorder tnat Grants causes benign , Fellowships, tumors to form In Investigator many different awards organs) United Ostomy No No No No None No Association TOTAL (49) 88% (43) 82% (40) 76% (37) 8% (4) Grants 82% (40) 49% (24) Fellowship 49% (24) Pt. Registry 25% (12)

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Links to open E-mm~istserv clini$~ial f:lin~calmsearch Clinical research How Whey do Membership newsletter/maga- Effortto reach recruitments ink for public? results for pros? public eluc~ion~ organ~zadon~ zinc? n~noni~es I'm Yes Yes Loc~ters' Yes Yes Spanish PSAs - TV * print T=guage End Yes Yes No Unmown Yes Yes F=nchianguage ink bank Yes No No ~~lic~ty efforts Yes Yes Sp~ish language ink ~: ~~ : ~ 69% (~) ~% (~) ~~ (32) 77 L=al chapter 59% SI% (25) 92~- (45) Help line 86% : :~ Spanish language ink 63% t3~)