Experts in academia, cancer research and the pharmaceutical industry have been voicing concerns over the spike of clinical trials for cancer immunotherapies, believing that many of the trials will not be completed due to a lack of participants. The increase in trials has resulted in duplicate trials being conducted, which are using up resources that could go to novel drugs.

Many combination studies with checkpoint inhibitor drugs have also been on the rise. Checkpoint inhibitors prevent a cancer to conceal itself from the patient’s T cells by blocking cell-surface proteins. Since 2011, 6 checkpoint inhibitors have been approved by the FDA for cancers including melanoma and lung cancer; however, approximately only 20% of patients respond to the drugs. Despite this, the hype over the health and commercial potentials of checkpoint inhibitor drugs has skyrocketed their growth in clinical trials. At a minimum, 1105 combination studies are currently testing drugs using these approved checkpoint inhibitors, according to the Cancer Research Institute (CRI).

The FDA lacks the authority to provide oversight to immunotherapy trials so long as they are passing the Administrator’s standards. Because of this, cancer research institutions such as the CRI, as well as experts in the industry, are calling for improved coordination in the execution of clinical trials involving checkpoint inhibitors, such as eliminating single site trials in exchange for multicenter clinical trial designs.


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