Dr Markman on Pragmatic Clinical Trial Designs in Ovarian Cancer

Maurie Markman, MD, president, Medicine & Science, City of Hope Atlanta, Chicago, and Phoenix, discusses the importance of designing clinical trials for patients with ovarian cancer that are based on real-world data and consider the increasing complexity of treatment sequencing in this disease, which he presented on at the 41st Annual CFS^® Meeting.

Numerous uncertainties surround the optimal sequencing of available ovarian cancer therapies, and the treatment paradigm is becoming increasingly complex, Markman says. Additional considerations include identifying the most effective ways to administer certain agents, the optimal doses of those agents, and their synergy when used in combination with other therapies, Markman explains. Other nuances to be elucidated through further research include the optimal use of molecular testing to determine optimal therapies, Markman emphasizes. Even if only 1% to 2% of the ovarian cancer population has a certain targetable mutation, the true prevalence of these mutations remains unknown unless widespread testing strategies are adopted, Markman notes.

Although drug approvals are often supported by data from 1 or 2 pivotal clinical trials, such a small number of trials does not provide comprehensive guidance to oncologists and patients about optimal therapies, according to Markman. The array of available therapies for patients with ovarian cancer lacks a well-defined road map for their optimal use in sequence or in combination with each other, Markman says. Moreover, researchers need to determine the most effective applications for information regarding molecular abnormalities, Markman notes.

To tackle these complexities, the oncology field must learn how to conduct clinical trials that incorporate real-world data, Markman emphasizes. A collaborative approach involving heath-care professionals, patient advocacy groups, regulatory bodies, and pharmaceutical companies is imperative, according to Markman. Furthermore, statisticians play a key role in using real-world data to discern optimal treatment strategies for patients, Markman says. As the intricacy of the ovarian cancer treatment landscape escalates, data-driven insights are imperative, Markman concludes.