In 2024, roughly 2 million people in the United States will be diagnosed with cancer, per the National Cancer Institute. Given that stark statistic, oncology clinical trials are more urgent than ever before. Characterized by their intricate design, highly targeted therapies, and relatively restrictive participant eligibility criteria, oncology clinical trials involve a number of unique challenges. Fortunately, as the research community continues its tireless work in oncology, these trials will continue to evolve, improving the lives of the countless people impacted by this devastating disease. Read on to learn more about the unique challenges found within oncology clinical trials.
Working Through Challenges in Oncology Clinical Trials
Oncology clinical trials involve a host of challenges, including the need for highly targeted therapies designed to treat specific tumor types. While these advanced precision treatments have lifesaving potential, they can also make matters difficult for clinical research sites, limiting participant eligibility and increasing dropout rates and protocol deviations. Other challenges with oncology trials include enrollment barriers and clinical trial outcome assessment, both of which are explained in more detail below.
Enrollment Barriers in Oncology Trials
Recent research shows that fewer than one in 20 adult cancer patients enroll in clinical trials. Barriers to enrollment pose a significant challenge within oncology research, limiting the number of sites that can conduct important research around the globe. After all, fewer participants mean fewer studies. Overall, oncology trial enrollment barriers may be linked to the following:
- Highly targeted oncology trial protocol: As mentioned above, oncology trials often involve complex trial designs due to the need for advanced precision medicine. With this in mind, trial enrollment can be highly competitive, with more participants choosing sites that offer advanced technology and facilities.
- Participant barriers: As with any clinical trial, participants face unique barriers that may prevent them from enrolling in or completing a trial. For example, if potential participants have to travel significant distances to a clinical trial site, they may be less likely to participate. They may also be wary of joining an experimental trial, opting instead for approved therapies already circulating within the oncology space.
- Staffing limitations: Oncology trials involve a number of complex processes, often requiring specially trained staff. This adds a layer of difficulty in terms of finding, training, and retaining oncology trial specialists.
- Meeting global standards: Many oncology clinical trials take place internationally. That can mean juggling multiple regulatory agencies and review boards, potentially postponing the onset of a trial.
Difficulties Assessing Oncology Trial Outcomes
Clinical trial endpoints are a key part of evaluating a new treatment’s efficacy. Endpoints include patient survival rates, symptom management, functional capacity restoration, and reduced rates of chronic conditions. In many cases, collecting clinical endpoint data can take years, which has recently driven researchers to explore surrogate endpoints to reduce the length of a study and speed up a treatment’s approval process. These endpoints can have merit in a clinical setting; however, they may not offer the level of substantial data that real patients seek when deciding on their course of treatment. The predicted surrogate endpoints also may not perfectly match actual patients’ overall survival rates or quality of life. This challenge has led oncology researchers to explore alternate endpoints, many of which are still being discovered.
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The unique challenges within oncology clinical trials also speak to the urgency of this kind of research. Fortunately, researchers continue to devote countless hours to addressing these challenges, ensuring that progress is made. Strategic partners well-versed in the regulatory landscape can also prove hugely beneficial when embarking on an oncology trial. Experienced Regulatory Affairs professionals can engage the various review and approval agencies early and often, helping to reduce any friction throughout the trial lifecycle.
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