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EthicsCaseStudyForm edit

Title Expediting Approval
Long Title Expediting Approval
Contributor/Contact John Banja, PhD? (jbanja@emory.edu)
Contributor Details John Banja, PhD?
Director, Section on Ethics in Research
Atlanta Clinical and Translational Science Institute
Emory University
Atlanta, GA 30322
CTSA Emory
Case Study Provided This dilemma, which is a not uncommon one, involves the risks and benefits of expediting approval for a promising drug.

Some years ago, I worked at a pharmaceutical company and was involved in Phase III cancer trials among patients whose disease had returned. These patients had a poor prognosis, but a drug we were working on showed that the median survival rate among the (small group of) patients on the new drug was increased by 5 months. A press release and journal article were prepared and, very rapidly, patient advocacy groups began demanding access to the drug prior to FDA approval.

Once a Phase III trial is completed with results that show sufficient efficacy for FDA approval, it often takes 6 months to 1 year to complete a filing package for the FDA to review, followed by a year before the FDA rules on the drug. So, at a minimum it would take 18 months for approval, meaning that patients who were currently being diagnosed with cancer relapse would probably not be alive when or if the drug appeared. The question therefore was: Could this process be expedited without the loss of data integrity?

While the consequence of routine filing time to desperate patients is obvious, a shortened filing for the pharmaceutical company can mean the loss of data that might be necessary for approval and that could bolster (or diminish) the validity of the efficacy claims. The consequences to the FDA were that taking too long to have the drug approved can look very unsympathetic to the patients who need it, while taking too short a time could potentially put an unsafe drug on the market.

Obviously, both the FDA and the pharmaceutical company have legal obligations to ensure that the drug was reasonably safe and effective. But they also have a moral obligation to provide the medication as rapidly as possible to patients. What kinds of considerations, therefore, need to occur in order to achieve the best of both ethical obligations?
Data Acquisition, Management, Sharing and Ownership Topics No Data acquisition_management_sharing and ownership Topics
Mentor and Trainee Responsibilities Topics No mentor and trainee responsibilities topics
Publication Practices and Responsible Authorship Topics No publication practices and responsible authorship topics
Peer Review Topics No peer review topics
Collaborative Science Topics No collaborative science topics
Research Misconduct Topics No research misconduct topics
Conflicts of Interest, Law and Policy Topics No conflicts of interest_law_and policy topics
Human Subjects Human subjects research

URL http://www.actsi.org/areas/erks/ethics/index.html
RCR Keyword

Other RCR Keywords Data Integrity; Demanding Access; Expediting Approval; FDA Approval; Journal Article; Market; Patient Advocacy Group; Pharmaceutical Company; Phase III Cancer Trials; Poor Prognosis; Press Release; Promising Drug; Risks and Benefits
Type of Case

Source for Topic Areas Du Bois, J., & Dueker, J. (2009). Teaching and Assessing the Responsible Conduct of Research: A Delphi Consensus Panel Report. Journal of Research Administration, 40(1), 49-70.


Topic revision: r1 - 28 Oct 2011 - 15:43:00 - DebieSchilling
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