Resources for Clinical Investigation Report of a Study (1988) / Chapter Skim
Currently Skimming:
Position Papers on Issue 3: Organizational Structure of Clinical Investigation in the Future
Position Papers on Issue 3: Organizational Structure of Clinical Investigation in the Future
Pages 69-80
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 69... ...
ISSUE # 3: OE=NIZP~IC~PL Si^JClURE OF CLINICAL IN~G~CN IN quite: W; 1 lion N Halley 70 Elaine L
|
From page 70... ...
Research grants which represent studies ready for patient application should be reviewed by study sections set up entirely for this purpc set The number of study sections, as well as the qualification of the members of these study sections would be determined over time by the number and orientation of the grants submitted, but in any romp, shall not be less than one study section committed to this purpose for the entire NIH. Since the studies under review would be only those which are ready for patient application, the basic bench research leading up to the proposal would have to be supported by other mechanisms and, if such research was incomplete, the studies would have to be completed by other mechanisms.
|
From page 71... ...
, it is difficult to envision how such an advance could be able to generate a return on investment to even recover develcpment costs. On the other hand, it is quite easy to recognize how such an advance Night be preventative or curative for literally millions of patients, thus reducing dramatically the di=~hility and death from a specific disea e, and perhaps saving countless billions of dollars, in addition to untold human despair.
|
From page 72... ...
In summary, it Is quite clear that the most rapid and appropriate application of advances in basic bicmedic~1 investigation win 1 be realized when support is combined four the NIH, the pharmaceutical industry, the Insurers of health care and of life. We would summarize our concept as follows: Melanism: Nordic adva~lini~a1 R - l~lin.Trials Implantation Source: NIH NIH NIH Industry Ir~stry NIH Health Care H - filth Care Payors Payors Wile the NIH aced continue to provide the major support in ~ of these stops, critical support four other saris as appropriate wed insure final sup at a maxim rate.
|
From page 73... ...
Consider the su~-cc of the CRC in supporting medical student research as an important factor in competitive renewals (eg. number of students supported, number of protocols involving serpents, number of abstracts and publications involving students, and, in the long run, number of students pursuing a ~r~ |
From page 74... ...
~ ~ ~ of ~~ _ ~~ ~ a _ Of 150 ~ ~ ~ 40 ~ e ~ ~ 1~ ~ 3 ~ ~ ~~ ~ ~ ~ a ~ of 3 ~ a of 5~ =1~ ~ too ~ $20~000 ~ at, 74
|
From page 75... ...
In addition, certain types of arch are not appropriate within those settings where funding has been traditionally allocated. Examples include evaluation of alternative therapeutic modalities or systems of care delivery, aE~#R;ment of pro grams for disease prevention and health prc motion (e.g., AIDS education for high risk populations, smoking lion pro grams, prenat~l care deigned to reduce low birth weight)
|
From page 76... ...
On the research spectrum NIH funding has placed emphasis on basic science whereas the focus of industrial research and development is on technology and product development. There are currently no adequate mechanisms in place to assure smooth flow of scientific research to technologic innovation, nor to facilitate joint sponsorship of clinical investigation by industry and government.
|
From page 77... ...
In KL. rim pains of biblical r~r~ furring: me impact on ~ clinical investigator.
|
From page 78... ...
in their support for academic units of this type. The reasons for this parlous state are multiple: The failure of clinical pharmacology to achieve a clear image in academia of its potential value and the absence of academic support for such individuals once past their training, the "taint" of "applied" research in academia, and the recent worship of molecular biology as if somehow all scientific progress could be achieved by focusing on molecular level research.
|
From page 79... ...
Tinge scale, lengthy, expensive controlled trials Cannot possibly be done for every new drug marketed in such areas as lipid-lowering, blood pr o reduction, or thrcmbDlysis. Can we assess the putative long term benefits by epidemiologic data: (It seems paradoxical that those who answer "no" to this question are willing to concede that the pressure to develop broad pressure lowering drugs or cholesterol-lowering drugs comes preccminantly from epidemiologic evidence.)
|
From page 80... ...
A new drug is like a new surgical procedure; with time' the choice of target population and the skill with which therapy is applied change, as they should. "Fine-tuning" of treatment for individuals, hand on data suggesting dine variables that predict response, is the goal, not treatment of the "average person.!
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.