Tamoxifen cancer drug

New way to conduct clinical trials may reduce cost and improve therapy

Judy Keen
Jun 18, 2013

After many years of advocating for a “master protocol” for clinical trials, the Friends of Cancer Research has finally gained the support from pharmaceutical companies and the Food and Drug Administration. This is (potentially) good news.

What is a “master protocol” and why should it be approved? Instead of running independent, separate clinical trials for each new drug, a master protocol would include many different drugs (the first attempt will be to test 6 different drugs in lung cancer patients) and enroll patients in many centers across the country. Since approval time for testing new drugs can take longer than 2 years, approving several drugs together at one time would clearly save time and money. Additionally, approvals for additional drugs could be added at a later time. Together, this approach would increase the number of patients enrolled in any given trial, reduce the approvals required with each trial, and allow for enough statistical power to identify smaller effects – or effects in smaller subsets of patients – that would otherwise go undetected in classically managed clinical trials.

What is the downside? Pharmaceutical companies are on board for early, Phase I trials, but may be reluctant to participate in larger, advanced Phase II or III trials. This may change in the future as issues of sharing data and maintaining proprietary information are addressed, however pharmaceutical buy-in to this process is necessary.

Obviously, this is a first step. It can help control costs and time in advancing drug development, but there are many issues to address along the way. What implications would this have for patients? Are there possibilities to increase participation or the numbers of drugs being tested?

What impact does having a shared database of clinical trial outcomes? What are your thoughts and suggestions about this new “master protocol” approach?

Photo: http://commons.wikimedia.org/wiki/File:Tamoxifen_cancer_drug.jpg

Reviewed by Stephanie Byng.

Judy Keen

Judy is a S&T Alumni Fellow (HEHS, 2012-2014). She blogs about the latest cancer research, increasing the access to the scientific literature, and graduate education. Follow Judy on twitter @judykeenphd or at judykeenphd.com

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Comments (2)

Stephanie Byng (not verified)
June 18, 2013 at 9:07 am
Thanks for sharing this news. I'd like to play devil's advocate for a second. Is there a chance that this "master protocol" could take just as long as independent trials? You say it would be quicker, but wouldn't the coordination of so many drugs, companies, institutions, researchers and patients take some time? How are they planning on streamlining this process so it doesn't get jumbled up in red tape? Who would be in charge of the "big picture"? My worry is that patient care would deteriorate as more patients are included in the studies. There is also the issue of how to manage the big data, which I guess is an issue for every aspect of our lives nowadays.
Judy Keen (not verified)
June 18, 2013 at 9:43 pm
Thank you for your comments! You raise some really good points. Part of the delay now is the time for approvals (IRB etc...), which are needed from each institution for each drug. Since many institutions may be involved in a single trial, there can be significant delays. It will remain to be seen if a master protocol will truly reduce the time for approvals. It should if multiple drugs can be approved at one time and additional drugs can be added as necessary. In terms of who is in charge, it may be left to the institution or group that serves as the Principal Investigator for the trial. Issues like patient confidentiality, patient care, and protection of data (especially when genetic data is collected) is a very big and very important issue. How do you maintain privacy and patient confidentiality in the face of big data and lack of security? Recent studies have shown that it is possible to identify someone using their genetic data alone. What wlll happen when more clinical data is combined with increased amounts of genetic data that is stored per person. How do we make sure that people aren't discrimated against or prevented from obtaining healthcare or health insurance?

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