Out-thinking industry

How FDA, ASCO are leading the adoption of clinical trial innovations

Some of the most innovative thinking on display at this year’s American Society of Clinical Oncology meeting came not from cancer companies, but from FDA and groups of oncologists and patient advocates who are busy rethinking how cancer drugs should be developed.

The meeting was chock-a-block with data readouts showing impressive response rates to innovative new therapies, and even included reports from one company taking an unquestionably novel tissue-agnostic approach to designing a clinical development program (see “Big Results in Small Cancers”).

But apart from a couple of brave explorers on the margins, biopharma companies have been slow to innovate in the way that clinical trials are done, preferring to tread well-worn pathways -- even though most stakeholders agree the familiar approaches take too long, leave out too many patients and, as a result, fail to provide the information patients, physicians and payers need to make decisions.

FDA, ASCO and Friends of Cancer Research are among the groups leading industry down a path toward better data and better decision making, by using real-world evidence and expanding access to clinical trials to more patients.

FDA kicked the meeting off with an announcement that it would partner with ASCO to use its CancerLinQ database to track real-world outcomes for melanoma patients taking new drugs. The agency said information from the database could lead to label expansions.

In addition, during a session at ASCO that focused on looking at ways to supplement data from traditional randomized controlled trials, the agency encouraged companies to adopt the use of electronic medical records as a platform from which to conduct studies. FDA expects doing so would yield results that are more interpretable for patients and physicians in the real world, and could speed the enrollment and conduct of trials.

In a second session, the agency, ASCO and Friends of Cancer Research unveiled a set of recommendations for expanding enrollment in cancer trials to four populations who are usually excluded, including patients with brain metastases or HIV, children aged 12 and up, and patients with prior malignancies or organ damage. The hope is doing so would speed accrual of patients in trials while producing data that better reflect individuals who would actually take the drug.

While a small number of companies are leading the way in using basket trials to support approvals of drugs for molecularly defined cancers, FDA took the opportunity in a

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