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GlobalData Release: Oncology Clinical Trials Plagued by Low Enrollment


7/23/2012 11:55:11 AM

LONDON, UK (GlobalData), 23 July 2012 - The lengthy oncology drug development process frustrates both cancer patients and pharmaceutical companies. Drug developer inefficiencies and regulatory delays are commonly blamed, but there’s another culprit that is often overlooked: the difficulty in recruiting patients for clinical trials. According to the National Cancer Institute, an estimated 2–4% of adults with newly diagnosed cancer participate in clinical trials. This staggeringly low percentage limits the patient pool, and makes trial recruitment difficult and highly competitive for sponsors and contract research organizations (CROs) in the oncology space.

The increasing difficulty of meeting enrollment goals was a major topic of discussion at the 2012 Clinical Operations in Oncology Trials conference held July 18-19 in Boston, MA. Despite the fact that delegates hailed from competing pharmaceutical companies and CROs, the overall atmosphere was one of mutual frustration and a collective desire to increase patient enrollment rates. The low percentage of cancer patients involved with clinical trials was attributed to a number of factors, including patients’ fear of randomization to placebo rather than experimental treatment, patients’ fear of increased adverse events, overall discomfort with the lack of transparency in the clinical trial process, and reluctance to receive treatment from comprehensive cancer centers rather than the patient’s own physician.

Oncology clinical trial designs are growing more and more complex, often targeting small subsets of patients with rare mutations or those who have been treated with a very specific therapeutic regime. More companies target these narrow patient pools, and competition to recruit these patients has become fierce. Trial sponsors must be increasingly aware of where their competitors are operating trials, and often avoid operating their trials at individual sites and even entire countries due to market saturation. Sponsors’ attempts at patient recruitment can also be thwarted by the entry of a new drug to market during the enrollment period, as patients who otherwise might have participated in clinical trials opt in favor of the newly approved product.

To overcome these barriers, pharmaceutical companies and CROs must be more creative than ever in their recruitment efforts. There is a general consensus that physician education and support is critical to patient accrual, as the treatment of cancer patients is directed by shared patient-physician decision making. Sponsors increasingly employ companies like Dava Oncology, which hosts workshops for small groups of physicians that encourage investigators to discuss case studies related to the trial. Dava and its clients believe that these peer-peer interactions promote physicians’ interest in enrolling patients in a given trial, which helps sponsors stick to their timelines and meet their enrollment goals. GlobalData expects sponsors to more frequently utilize this model, although it is unlikely to replace the lavish but minimally effective large investor meetings currently in use. Sponsors also emphasized the importance of continued contact with investigators through the course of the study, in order to maintain interest and confirm that eligible patients are not inappropriately excluded.

In addition to efforts geared towards investigators, it will be critical for sponsors to increase patient education and awareness. The role of social media as a tool to educate and recruit patients was often mentioned and intensely debated. Delegates agreed that on premise, using social media like Facebook or Twitter seemed like it would provide patients and their families with better exposure to quality information about clinical trials. There was hope that this strategy would raise awareness among previously inaccessible patient groups, while requiring minimal expense from the sponsors. However, there was concern that social media would not effectively reach cancer patients; delegates feared that the older demographics rarely use social media, and that sponsors would fail to receive a return on their investment.

In addition to questioning the success rate, delegates were clearly concerned about the current lack of guidance from the food and drug administration (FDA) on social media recruitment strategies. The FDA held hearings on the use of social media in 2009, and touched on the topic when it later issued limited draft guidance on “responding to unsolicited requests for off-label information about prescription drugs and medical devices.” Due to the lack of thorough regulatory guidance on this issue, sponsors and CROs have been hesitant to risk implementing social media-based recruitment. Inappropriate wording could easily result in claims of coercion, and few companies are currently willing to take that risk. As the FDA waits longer and longer to issue guidance on this topic, however, GlobalData expects more and more sponsors and CROs to lose patience and brave these murky waters in order to supplement their recruitment efforts.

It is apparent that personalized medicine will continue to rise in popularity, and that recruiting cancer patients for clinical trials will become increasingly difficult. Delegates at Clinical Operations in Oncology Trials recognized this, and shelved their personal agendas to genuinely share their successes and failures with their peers. GlobalData hopes that this collaborative spirit persists, as an industry-wide effort to raise patient and physician awareness of oncology clinical trials will bring the greatest mutual benefit to cancer patients and individual companies.

*Oncology Clinical Trials Plagued by Low Enrolment

This expert insight was written by Dr. Cheryl Strelko, Oncology and Infectious Diseases Analyst for GlobalData. If you would like an analyst comment or to arrange an interview, please contact us on the details below.

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