Drug Shortages Compromise Oncology Research

Alice Goodman, MA

Disclosures

April 25, 2012

In This Article

How Drug Shortages Affect Clinical Trials

The impact of drug shortages on care of patients with cancer has been on the radar for well over a year. Equally important -- especially over the long term -- is the impact of oncology drug shortages on clinical trials.

As of October 2011, 22 of the 267 drugs in shortage in the United States were cancer drugs. Currently, about 400 cooperative cancer group clinical trials are active, and about one half of these trials have at least 1 drug on the shortage list, according to a fact sheet from the Coalition of Cancer Cooperative Groups Website.[1]The shortages extend across the large network of 1800 research sites affiliated with the cooperative groups -- albeit unevenly, depending on region. Thousands of patients who have enrolled in clinical trials are affected, and the shortages slow down progress in identifying new anticancer therapies.

The oncology drugs in short supply are primarily sterile injectable generic drugs that form the backbone of standard therapy for many types of cancer. Some examples are carboplatin, cisplatin, cytarabine, fludarabine, etoposide, vincristine, and paclitaxel. These drugs are typically included in the control arm of clinical trials when a new drug is compared with existing therapy. If 1 or more of the drugs in the control regimen is not available, investigators either have to delay the trial until the drug becomes available or select an alternative. Both of these strategies can have unintended consequences on research.

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