New way to conduct clinical trials may reduce cost and improve therapy
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?
Reviewed by Stephanie Byng.
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