Merkel cell carcinoma (MCC) is an uncommon type of skin cancer, occurring when Merkel skin cells begin to grow out of control. So what role do these cells normally play in our skin? Merkel cells are located near nerve endings in the uppermost layer of the skin, and they allow us to perceive fine details on objects through our sense of touch. Although the incidence of MCC isn’t as high as other types of skin cancer, it has a more aggressive disease progression, with an overall 5-year survival rate of about 64%.
First-line therapies include surgical procedures, radiation therapy, chemotherapy drugs, and clinical trials. Biopharma sponsors are currently bringing much-needed treatment options into the market, which can be especially life-changing for oncology patients. Although there will be inevitable obstacles faced by any study team, awareness is the first step to resolving them. Read on to find out the top five challenges to expect with MCC clinical trials and how to overcome them.
1 | Overcoming Recruitment Obstacles Within MCC Clinical Trials
Less than 5% of oncology patients end up opting to enroll in a clinical trial. This can be attributed to a number of common recruitment obstacles, including trial availability, site access, the willingness of clinicians to recommend enrollment, and patient concerns. Because MCC clinical trials are notoriously complex, sponsors should take care to select only the most well-equipped sites with adequately trained staff. Providing external resources can also help patients facilitate travel arrangements to overcome issues with distance, cost, or visit frequency. Lastly, study materials should address any concerns oncologists or patients may have in order to assuage their reservations about investigational treatments.
2 | Managing Daily Trial Workload
As our understanding of cancer and medical technology both grow in tandem, clinical trial protocols will only become more intensive for sponsors, sites, and patients. Contract research organizations (CROs) are third-party companies that provide services and resources to support the oversight of a study and manage its day-to-day workload under contract. By outsourcing, sponsors free up their time to focus on research and development outcomes. With this recent rise in CRO demand, there are now a wide variety of options available, from those with broad indication portfolios to ones with more narrow specializations. Oncology-specific CROs are in shorter supply, but we’ve compiled our top five picks for your convenience here.
3 | Pressures of Disease Unknowns
Currently, the medications available for MCC patients include avelumab and pembrolizumab, but the most optimal treatment overall still has yet to be agreed upon. There are still so many questions as to the cellular changes underlying MCC, which leaves largely untapped potential to discover new therapeutic targets. This naturally makes oncology drug research very time-sensitive. As a result, sponsors can often incur overwhelming costs to bring a potential drug candidate to market as efficiently as possible. To streamline this process, sponsors can seek out the expertise of CROs well-equipped to provide key resources. Vial CRO optimizes oncology trials, like MCC clinical trials, by offering an experienced medical executive team, a curated network of highly sought-after investigators, and real-time integrated EDC, ePRO, and eSource software.
4 | Investing in Protocol Flexibility
It’s no secret that sponsors can rapidly run up expenses when conducting a study like an MCC clinical trial. One option for effectively managing their time, resources, and participants is to adopt an adaptive trial design for their study. These have become more popular in clinical research, and they allow trials to accommodate expected protocol changes while it is still ongoing. By assessing participant data at interim analysis points, these pre-planned changes can help reduce sample size and determine whether a treatment arm should be dropped due to lack of efficacy. Click here to learn more about the benefits of adaptive study designs.
5 | Partnering with the Right Sites
This last challenge isn’t an insignificant one. Clinical research sites can make or break a new trial. The site selection process should be started as early as possible to ensure sponsors are choosing to partner with the most experienced investigators. To determine whether a potential site is a good fit for your MCC clinical trial, sponsors should look at the staff’s experience with MCC, the investigator’s track record, whether the site is well-equipped with necessary resources, and if the site has access to the right patient candidate pool. For more details on finding sites that are a good fit for your study, visit our article here.
Partner with Vial for Your MCC Clinical Trials
Vial CRO’s mission as a modern, next-generation CRO is to support sponsors around the globe with our innovative tech-enabled study services. To learn more about how our expert executive can help your oncology clinical trials reach its full potential, connect with a team member today!