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  • Writer's pictureDr. Robert A. Nagourney, MD

The Cancer Clinical Trial Process is in Need of Revision

Patients with advanced malignancies often seek the expertise of physicians at major institutions. Centers such as the MD Anderson, Dana Farber, UCLA, City of Hope and others have access to novel compounds and combinations. Patients whose diseases progress following standard treatments are referred with the hope that these new drugs and novel combinations will provide a benefit.

But what the patients actually encounter is a maze of clinical regulatory oversight, protocol inclusionary and exclusionary criteria, repeat biopsies, repeat staging (PET/CT, MRI, blood tests, etc.) and molecular profiling.

All of which cause delays and hardship for these desperately ill patients – and it is only patients with the best performance status that can qualify.

A recent experience was emblematic of the problem.

This 74-year-old gentleman had a rare form of lung cancer. After he had shown disease progression, despite multiple prior lines of therapy under the care of his physicians in LA, we used our laboratory platform to identify a drug combination that worked perfectly.

The dilemma: he had failed numerous prior therapies before we met, and we believed – rightly or wrongly – that he needed something better, something newer, something different... something experimental.

Despite his positive response, there was concern that our therapy would ultimately stop working. We made the decision to move to an experimental trial with the hope of consolidating his positive response.

That is when things unraveled. First, he needed a four-week wash-out period. Second, he needed repeat biopsies and scans. Third, the consent forms and accrual process dragged on interminably as his condition deteriorated.

By the time the experimental treatment actually started, he was once again in poor condition.

We communicated regularly with the patient, but it was still too early to know whether the first weeks of therapy would provide any benefit. By the time we realized it was not working, it was difficult to unwind him from the trial and move onto other treatments.

We made every effort to reinstitute the same laboratory-based therapy that had previously worked so well, but by then he was just too ill and succumbed to complications of his illness shortly thereafter.

This is an unfortunate reminder that clinical trials are not user-friendly. The accrual process, time to activate, and requirements for participation can be so onerous as to prevent patients in need from availing themselves of these treatments.

It is said that “banks only lend money to those who do not need it”, meaning that you have to be a perfect credit risk to borrow the money you need to improve your credit. Similarly, one must be in stellar clinical condition to qualify for many cancer clinical trials. Yet it is rarely Olympic tri-athletes who need cancer clinical trials.

We need to re-examine the availability of experimental drugs and make it easier for patients to gain access to these potentially life-saving drugs and combinations, and we must remember that it is the patient’s outcome and well-being that drives oncology care.


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