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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:
OCR for page 58
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—
t—ugh 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/~uen£e 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 £ondl£ct 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
OCR for page 59
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-
OCR for page 60
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 Na£iona: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-
OCR for page 61
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.
OCR for page 62
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?
msut£s, just a hnk, ...?3 Why that?
OCR for page 63
OCR for page 65
OCR for page 66
OCR for page 67
OCR for page 68
OCR for page 69
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OCR for page 71
OCR for page 72
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Representative terms from entire chapter:
local chapters
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
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.)
APPENDIX D
65
TABLE D. ~ Website Survey of Selected Voluntary Health Agencies, follows
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
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
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
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
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
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
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-cllni£al~ 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
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
:~ :~ ~~
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)
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
ha—Ogre
Yes Yes Yes Day of Aw=eness Yes Yes Unknown
continued
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 $1M Y2000 Yes Yes Yes Professional Yes
Advisory Board,
Alliance (a genetic
Tissue donations,
disorder tnat
Grants
causes benign ,
Fellowships,
tumors to form In
Investigator
many different
awards
organs)
United Ostomy No No No No None No
Association
TOTAL (49) 88% (43) 82% (40) 76% (37) 8% (4) Grants 82% (40) 49% (24)
Fellowship 49%
(24)
Pt. Registry 25%
(12)
Links to open E-mm~istserv
clini$~ial f:lin~calmsearch Clinical research How Whey do Membership newsletter/maga- Effortto reach
recruitments ink for public? results for pros? public e£luc~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~)
