Featured Research

from universities, journals, and other organizations

Ethical, scientific issues related to 'post-market' clinical trials

Date:
July 13, 2010
Source:
Johns Hopkins Medical Institutions
Summary:
Amid growing concerns about clinical trials for drugs that have been approved by the FDA but are later linked to serious health risks, an independent committee at the Institute of Medicine has developed a conceptual framework to guide the agency through the tough decision of ordering such controversial "post-market" drug-safety trials.

Amid growing concerns about clinical trials for drugs that have been approved by the F.D.A. but are later linked to serious health risks, an independent committee at the Institute of Medicine led by two professors from Johns Hopkins University has developed a conceptual framework to guide the agency through the tough decision of ordering such controversial "post-market" drug-safety trials.

Related Articles


The recommendations of the committee, requested by the Food and Drug Administration, lay out a set of considerations that the F.D.A. can reference to ensure that clinical trials uphold ethical duties to trial participants. The committee also stresses that the agency be accountable to the public in its decision-making processes.

Presented on July 9 in a letter report to the F.D.A., the framework is organized around these recommendations:

  • The F.D.A. should determine if questions about possible risks or the risk-benefit balance of a drug or vaccine already on the market are serious enough to justify a policy decision, such as whether to revise the product's label.
  • A randomized, controlled trial of a drug linked to serious side effects should be conducted only when the existing scientific evidence and any evidence from new observational studies still do not supply the F.D.A. with enough data to make responsible policy decisions.
  • The agency should use "regulatory-science" principles and practices that emphasize public accountability and transparency when determining the need for a policy decision -- or the need for new knowledge to support a policy decision.
  • Such post-marketing trials to assess the safety and efficacy of approved drugs should be properly designed so that they minimize risk to patients and monitor risks on an ongoing basis. Any risks should first be judged as "acceptable" by appropriate oversight bodies.
  • Lastly, the F.D.A. and relevant oversight agencies should ensure that such trials have a comprehensive and meaningful informed-consent process in place, and one that continues over the course of the trials. Specifically, participants should be promptly advised of developments such as new research findings or changes in clinical practice that could affect their willingness to continue to accept the risks associated with a trial.

"The letter report was designed to provide general, broad guidance about some of the ethical issues that need to be taken into account by the F.D.A. in requiring post-market safety studies," says Ruth Faden, Ph.D., M.P.H., the committee's co-chair and the director of the Johns Hopkins Berman Institute of Bioethics.

The other co-chair is Steven Goodman, M.D., Ph.D., a professor of oncology in the Division of Biostatistics at the Johns Hopkins Kimmel Cancer Center and a core member of the Berman Institute faculty as well. Goodman is editor-in-chief of Clinical Trials: Journal of the Society for Clinical Trials and serves on the society's board of directors.

"The post-marketing context poses more difficult ethical and design challenges than we could address in this letter report," says Faden, a member of the Institute of Medicine (IOM). "We plan to take on these challenges in more detail in our full report."

The more immediate report responds to one of several questions that the F.D.A. asked IOM to explore in a review of ethical and scientific issues related to studying the safety of drugs on the market. The agency requested an initial report on the ethical issues in advance of a meeting it will hold July 13 and 14 to discuss the case of the diabetes drug Avandia.

The report covers some of the issues at play in the case but does address the specific controversies surrounding a large-scale clinical trial launched by the drug's maker, GlaxoSmithKline PLC.

A more detailed analysis of the issues discussed in the report, as well as their implications and effects, will be presented in the committee's final report, which is expected to be complete in the spring of 2011.


Story Source:

The above story is based on materials provided by Johns Hopkins Medical Institutions. Note: Materials may be edited for content and length.


Cite This Page:

Johns Hopkins Medical Institutions. "Ethical, scientific issues related to 'post-market' clinical trials." ScienceDaily. ScienceDaily, 13 July 2010. <www.sciencedaily.com/releases/2010/07/100712154436.htm>.
Johns Hopkins Medical Institutions. (2010, July 13). Ethical, scientific issues related to 'post-market' clinical trials. ScienceDaily. Retrieved October 23, 2014 from www.sciencedaily.com/releases/2010/07/100712154436.htm
Johns Hopkins Medical Institutions. "Ethical, scientific issues related to 'post-market' clinical trials." ScienceDaily. www.sciencedaily.com/releases/2010/07/100712154436.htm (accessed October 23, 2014).

Share This



More Science & Society News

Thursday, October 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Fears Keep Guinea Hospitals Empty

Ebola Fears Keep Guinea Hospitals Empty

AP (Oct. 23, 2014) Fears of Ebola are keeping doctors and patients alike away from hospitals in the West African nation of Guinea. (Oct. 23) Video provided by AP
Powered by NewsLook.com
Academic Scandal Shocks UNC

Academic Scandal Shocks UNC

AP (Oct. 23, 2014) A scandal involving bogus classes and inflated grades at the University of North Carolina was bigger than previously reported, a new investigation found. (Oct. 23) Video provided by AP
Powered by NewsLook.com
Chameleon Camouflage to Give Tanks Cloaking Capabilities

Chameleon Camouflage to Give Tanks Cloaking Capabilities

Reuters - Innovations Video Online (Oct. 22, 2014) Inspired by the way a chameleon changes its colour to disguise itself; scientists in Poland want to replace traditional camouflage paint with thousands of electrochromic plates that will continuously change colour to blend with its surroundings. The first PL-01 concept tank prototype will be tested within a few years, with scientists predicting that a similar technology could even be woven into the fabric of a soldiers' clothing making them virtually invisible to the naked eye. Matthew Stock reports. Video provided by Reuters
Powered by NewsLook.com
Jet Sales Lift Boeing Profit 18 Pct.

Jet Sales Lift Boeing Profit 18 Pct.

Reuters - Business Video Online (Oct. 22, 2014) Strong jet demand has pushed Boeing to raise its profit forecast for the third time, but analysts were disappointed by its small cash flow. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Science & Society

Business & Industry

Education & Learning

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins