corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 2921

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Dixon RB.
The current status of guidelines for clinical research from the viewpoint of the pharmaceutical industry.
J Clin Pharmacol 1977 Nov-Dec; 17:(11-12):691-6
http://jcp.sagepub.com/cgi/reprint/17/11/691


Abstract:

The guidelines for clinical research are here to stay. Even if they could, itis unlikely that industry sponsors would abolish them. Industry should heed the regulatory description of the guidelines as illustrations of acceptable standards, not as minimal requirements. In some cases, more than just the studies suggested in the guidelines may be required for an approvable new drug application. Hopefully, the Food and Drug Administration will continue to discuss with industry guidelines interpretations with respect ot individual drugs and to refer disputes to the advisory panels and not to adhere rigidly to the strictest interpretation.

Keywords:
*analysis/United States/trial design/ regulatory authorities/ new drugs/ drug company sponsored research/INFORMATION FROM INDUSTRY: REGULATORY AUTHORITIES/SPONSORSHIP: RESEARCH Drug Evaluation*/standards Drug Industry* Drug Therapy/adverse effects Humans United States United States Food and Drug Administration

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend








As an advertising man, I can assure you that advertising which does not work does not continue to run. If experience did not show beyond doubt that the great majority of doctors are splendidly responsive to current [prescription drug] advertising, new techniques would be devised in short order. And if, indeed, candor, accuracy, scientific completeness, and a permanent ban on cartoons came to be essential for the successful promotion of [prescription] drugs, advertising would have no choice but to comply.
- Pierre R. Garai (advertising executive) 1963