FDA Changes Website for clinical trial information

July 29, 2009

The FDA announced that it has changed its website and that links for GCP documents might no longer work. That is really unfortunate because many of us have included those links in articles or powerpoint presentations over the years. I have included a link on the Blogroll as 111 FDA Changes Website for your reference. Here is part of what FDA has to say:
The U.S. Food & Drug Administration (FDA) recently redesigned the FDA Web site. As a result, the Good Clinical Practice Program was moved.
Additionally, some Web links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA
We apologize for any inconvenience this redesign might have caused.


Life after the Coast IRB sting: What should we do about IRBs?

July 21, 2009

I was discussing the Coast IRB sting operation by the Government Accountability Office (GAO) with some quality assurance colleagues the other day. Quality Assurance departments at biopharmaceutical and medical device companies are starting to scrutinize the institutional review boards (IRBs) that they contract with or that clinical sites use to review research. FDA requires sponsors to obtain assurances from clinical investigators (on the Form FDA 1572 or Investigator’s Agreement) that they will obtain approval from an IRB that meets the requirements of 21 CFR Part 56 (the IRB regulations).

The closure of Coast IRB impacted approximately 300 clinical trials and 3,000 clinical sites conducting the studies. Coast had approved a phony study submitted to them by the GAO. Two other IRBs refused to approve the study but Coast did. They are now out of business and a lot of people are scrambling to make sure their studies and their data aren’t negatively impacted by the closure. It is understandable that there is considerable concern. However, there will be a lot of false assumptions made by the Coast sting and a lot of wrong conclusions drawn from the case. Here are some of my preliminary thoughts:

1. The IRB regulations are hopelessly outdated. When they were written commercial IRBs like Coast weren’t really imagined, let alone accounted for. IRBs were supposed to be ethics committees for a specific institution at a specific location, such as an academic medical center. They were led by volunteers and there frequently wasn’t even an administrative fee for submission of a protocol. They were also slow and cumbersome. That’s one of the reasons commercial IRBs came into existence.

To make matters worse, IRBs are regulated both by FDA and the Office of Human Research Protection (OHRP), in the Department of Health and Human Services for NIH and other government funded research. Although the regulations are very similar, there are some differences and OHRP regulates IRBs much differently than FDA. Most academic medical centers depend on NIH funding so they follow the OHRP regulations very closely.

2. The regulatory relationship is between the investigator and the IRB, not between the sponsor and IRB. Many of the traditional institution based IRBs won’t even talk to the sponsor. However, things have changed. Many studies are conducted outside of the traditional institutional setting and many sponsors prefer to work with a commercial IRB because they are faster and, in the opinion of many, more efficient. Clinical trials are expensive and the ability to work directly with an IRB on informed consent forms and protocol amendments is very appealing to sponsors and investigators alike.

3. IRBs aren’t supposed to monitor clinical trials, sponsors are. However, many are suggesting more and more responsibilities be assigned to the IRB. This can be a problem for a variety of reasons. An academic IRB may be slower if OHRP decides to enforce regulations in a strict manner. Their funding depends on it. NIH can put stricter enforcement standards in their proposals. For FDA to require commercial IRBs to do more supervision there would need to be a revision of the regulations. That can take a lot of time.

In the mean time, sponsors are wondering how they qualify and supervise their contract IRBs. There is only one place that gives them any clout in FDA guidance documents and regulations. The very last sentence of Section 3 in E6, Combined Guidance for Good Clinical Practice states the following:

“The IRB/IEC may be asked by investigators, sponsors, or regulatory authorities to provide copies of its written procedures and membership lists.”

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The Blog goes to RAPS in Philadelphia

July 16, 2009

The Blog will be speaking at the upcoming Annual Meeting of the Regulatory Affairs Professional Society in Philadelphia this September. The session will be chaired by Michael Marcarelli, Director of the Division of Bioresearch Monitoring at the Center for Devices and Radiological Health (CDRH) from 10:30 till Noon on Wednesday 16 September. The topic is, “An Insider’s View of Outsourcing in Clinical Trials” and deals with clinical trial vendors such as contract research organizations, clinical laboratories, and ECG core laboratories.


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