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ISSUE: 3: ~ CX~;IDE~CNS AND N~A~ ~NIZAUm AND - ~C~E OF CLINICAL INV~G~- lhe - ;m~1 organization and struc~ of ~at a~ of clini~al investigation as defined by me Unit, i.e. patient relay clinical rater=, requites a prearm which ~ creative, coordinate and s ~ rtive of ye clinical iTnrestigator. Such a pry ran must maximize the likelihood that important advances will be translated appropriately fr~the research laboratory to the level of effective . . _ . . . . patient care and disease prevention. In consider mg the organization of clinical investigation, the rammit*ee reconsidered concerns that have been voiced both within and outside the academic radical community with respect to issues of conflict of interest, such as those that might be perceived or, On fact, a consequence of personal economic relationships between clinical investigators and companies with whom they are collaborating in clinical research. For example, this relationship may include owning stock, receiving consulting fees, and serving on Boards of Directors. Recommendations 1. Data Collection on Funding for Clinical Investigation NIH grants supporting patient related clinical research should be specifically tracked. -these Chard be spark from studies which, for example, use human tissue, but do not specifically involve subject-illvestigator contact. Currently, it is not possible to distinguish between these ok; of hen investigations because all of the applications are categorized only as to whether or not human subjects are involved. 2. R - 1 paganism to Fund Clinical investigation Deve~qp an RO-1 mechanism d~;cat=d to patient related clinical studies. NIH research grants that represent studies ready for patient application should be reviewed by scaly sections set up for this purpose. m e number of study sections, as well as the qualification of the members of th^ study sections, would be determined aver time by the number and orientation of the grants submitted. Since the studies under review would be only those that are ready for patient application, the hectic research leading up to the proposal would be supported primarily by other mechanisms. All such studies would continue to be funded by the relevant Institutes following current Advisory Council/Board procedures. 5See Appendix B: Galley, p. 70; Larson, p. 7S; and gnu, p. 78. 12

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3. Furring of Gent Clinics Arch Centers Expand the f~ and Off 1ni~cion of Germ C3ini~1 lineal ~5 (Got). Ibe general clinics Inseam cam has proven ~ be s~=ful ~ me application of basic rem affrays to Me bedside (23, 24~. mile the mat rime Aim for swore corsair to be ~ N:IH, mews DUSt be er~raged to allay sort f~ air sales sum as the phannao~ticm1 industry. me GCK: program dhalld be ~ to involve r~h=;pit=1 settings such as Pursing was, ~ care sites, and our non-Lruditional semis;. In addition, ~ ~ponsibi~iicies of the Directors and offer profit staff of the Gem; Chard be eked to include r~xuit~nt of the best ~alifieds~ler*s, postdoctoral trains, and face y to a career in patient relate clinical irnrestigation. Finally, fuming of GC~ Phalli be ideal to swore Muse ex~ed risibilities (Gil Mix B: Alley, A. 73-74). 4. New for Conflict- of Ink Guidelines e NIH is Stan ngly encouraged to add t guidelines to prevent conflict of interest. Such guidelines should include rules for full disclosure (26). 5. Role of Fun in Determining Clinical Investigation Agenda A large portion of United Seats= clinical research resources, particularly from the pharmaceutical industry, relate to drug evaluation (27). a) The NIH and FD~ should examine why much larger numbers of large-scale clinical trials are or can be carried out Europe than In the U.S. It seems evident that additional studies carried out in the U.S. population could provide additional knowledge critical to the public health. 6It Hal been possible ~ recent years to carry out large-scale intervention trials (of beta-blockers, adjutant therapy in breast cancer, acute effects of thrombolysis) in Europe in great numbers. While there have been excellent trials in the U.S. of a similar kind (beta-blocker heart attack trial (BH~r)' AMIS, persantine-asp~r~n re-infarction study (PARIS), trials of adjutant therapy of breast cancer), there have been many fewer trials than in Europe. 13

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b) We urge closer liaison bet For at NTH to He Knin to redone delay and imbrue relax of clinics trials associate with ~ evaluation. 6. Exclusion of Patina or - ?6 fmn China Investigation He remittee ~ that for unclear ark often ina~r~riate rams, children are ~cll~ fmn participation in clinical trials of inrxwative therapies Iffy the exaction of cytologic drugs ark ~ anti-infecti~~= agents. In ?dx;lition~ there is a motion Mat User specific gram such as In, Priorities awl the elderly may be ireful - viably Alto frog Exrticipati~ ~ clinical trials. ] - remittee r~nr~ that the NO ermine this issue in detail. 7. Pa; for Tim;tatianof Patient Manual Clinic investigation Idols A say mold be c~orxtucted cuff Me extent ~ which patient a~1 1im,ts clinical investigation and the masons for limited patient accrual such as marble exclusion By Medicare and Nedi~id nines of rei~r~ent for wary patient care (14), and reluctance of Ehysiciarm to refer patients. 14