Cancer Drug Shortage May Impede Clinical Research

While ongoing oncology drug shortages may not affect patient outcomes, they could impede the discovery of new therapies to treat cancer, according to a survey conducted by the National Comprehensive Cancer Network (NCCN; an alliance of cancer centers that works to improve the quality of cancer care through research and their NCCN treatment guidelines).

Many cancer clinical trials compare the current standard-of-care therapy with a novel drug or agent, often given alongside the standard therapy. However, some of the drugs that are recommended (such as vinblastine, etoposide, topotecan and 5-fluorauracil) have been reported to be in shortage.

Cancer Centers ‘Doing More With Less’

Among 27 NCCN-designated cancer centers surveyed, 56% said that with mitigation strategies they were able to treat all patients who are receiving a drug in shortage; 37% said that they were able to treat patients without the use of mitigation strategies; and 7% reported that they did not have any drugs in short supply.

“Slightly more than half of these centers have had to implement mitigation strategies to ensure everyone receives treatment, including careful waste management procedures and adjusting timing and dosage within evidence-based expert recommended ranges,” Dr. Crystal S. Denlinger, CEO of the NCCN, said in an interview with CURE®. “They are essentially doing more with less to ensure every person with cancer is still able to achieve their best possible outcome. This places additional administrative burdens on hospitals but should not impact the patient.”

READ MORE: Oncology Drug Shortage May Not Lead to Suboptimal Care

Drug Shortage Impacts Clinical Research

The CEO of the NCCN, Dr. Crystal S. Delinger, spoke with CURE® about the cancer drug shortage and how it may affect clinical trials.

However, 43% of surveyed institutions reported that drug shortages impacted clinical trials at their center. Among these 12 institutions:

• 83% reported a general administrative burden
• 58% reported reduced enrollment in clinical trials
• 17% reported a reduction in open trials
• 25% reported other issues, such as budget changes for trials or hesitation or delays to open trials

“The NCCN survey shows that drug shortages can delay vital clinical trials, through the added administrative burden and potential delays in enrollment to or opening of new trials that include drugs on shortage, which could slow the pace of progress for new cancer therapies,” Denlinger said.

Denlinger also mentioned that the NCCN “strongly encourages” clinical trial participation for people with cancer, “as these trials provide the evidence supporting appropriate care recommendations.”

Dr. Wui-Jin Koh, chief medical officer at the NCCN, echoed Denlinger’s sentiment.
“The inability to offer the patient a chance to participate in a clinical trial where one of these drugs [in shortage] forms the backbone [of therapy] can affect future medical developments,” he said in a separate interview with CURE®. “Many of these drugs are in short supply form the backbone of current treatment and are used to address newer treatment. So, it may delay the discovery of new and more effective agents.”

Discuss Different Treatment Options

Moving forward, Denlinger said there may be more than one treatment strategy for patients’ specific diseases.

“In many situations, the NCCN Clinical Practice Guidelines in Oncology recommend numerous different approaches, so there are often options when one treatment or drug in a treatment is in shortage,” she said.

When this is the case, Denlinger emphasized the importance of patients being educated on their disease and having open communication with their cancer treatment team.

“People with cancer can utilize NCCN’s free patient-facing resources such as the NCCN Guidelines for Patients and other information to be empowered to participate in decision-making for their care,” she said. “They should talk to their care team about what options exist for them, and what the pros and cons are for different approaches. Using NCCN Guidelines can help navigate treatment decision-making in a time of drug shortages and can help people facing cancer have informed conversations with their oncology care teams.”

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