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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.
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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.
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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
Representative terms from entire chapter:
clinical trials
