Clinical trials are a gold-standard tool for driving evidence-based medical research today. With the benefits they can present to patients, trials should be considered a viable healthcare option, particularly in oncology. Cancer trials can potentially reduce treatment cost burdens for patients and advance our grasp of how cancer develops. In this next installment of Vial CRO’s Oncology Trial Management series, we discuss how sponsors can increase their chances of success when running a lymphoma clinical trial.
1 | Understanding Lymphoma
Lymphoma is a general type of blood cancer that originates in the lymphatic system, which drives our immune system by producing and promoting the activity of white blood cells against infections. Patients may be diagnosed with one of two major types of lymphoma. Hodgkin lymphoma (HL), which spreads to each lymph node in an organized manner, or non-Hodgkin lymphoma (NHL), which moves more disorderly through the whole lymphatic system. NHL makes up nearly 4% of all cancer cases and is the more prevalent type of lymphoma, as it can affect anyone from young children to older adults. HL is one of the most common cancers diagnosed in adolescents, but individuals aged up to 39 years are also at a greater risk. As of 2022, the estimated 5-year relative survival rates for patients fighting HL and NHL were 89.1% and 73.8%, respectively.
2 | Overcoming Oncology Recruitment Challenges
Only about 5% of cancer drugs in Phase I will end up receiving approval from the Food and Drug Administration (FDA). Therefore, sponsors can secure a greater chance of success by focusing on the most significant challenge facing clinical trials: patient recruitment. One lymphoma clinical trial conducted back in 2016 was terminated in 2018 due to randomizing only 7 patients from 43 screened participants, among other notable difficulties. The study cited the burden of undergoing regular diagnostic procedures as being a contributor to enrollment delays. The disease burden of cancer patients makes frequent clinic visits physically, economically, and emotionally challenging; as a result, lymphoma studies which may not account for these limitations are less likely to be appealing to potential participants. To reach success more easily, lymphoma clinical trials should have an enrollment playbook thoughtfully designed with the patient in mind long before activation; read more here to follow 5 easy steps to developing an ideal recruitment plan for your study.
3 | Optimizing Protocol Designs for Lymphoma Trials
Another factor that can contribute to low enrollment numbers is the inherent uncertainty associated with lymphoma and other cancers. The limited availability of preclinical and post-marketing data on a drug’s safety and efficacy can make patients hesitant to participate in clinical trials. Because lymphoma is still not fully understood today, sponsors may find traditional study designs aren’t as well-suited for testing oncology therapies as adaptive designs, where there are calculated opportunities for protocol updates as new information is gathered.
Like with any clinical trial, highly qualified sites are a key part of successfully managing a lymphoma study. However, site selection must be done carefully and thoroughly. Although a site may be experienced with oncology trials, they should also have the capacity to support the specialized procedures required routinely by lymphoma patients. This includes either having on-site access to necessary equipment and staff to perform procedures or being affiliated with a local vendor who can supply these resources.
Likewise, participating countries should also be chosen by the sponsor after extensive review of regulatory standards. As reported by Strother et al. (2020), one significant reason for trial initiation delays was conflicting consensus between approving bodies regarding the definition of minimum standard of care requirements for the trial. Depending on the location chosen, the overseeing regulatory body may have additional criteria that must be met before the trial can adhere to local standards. If these criteria are too heterogeneous across a global multi-center program, sponsors could run into issues with maintaining consistency between sites across different countries.
Lymphoma causes thousands of deaths across the United States and the world every year. Clinical trials dedicated to developing more novel therapies allow clinicians to offer more variety in treatment options for lymphoma patients, which drives our understanding of the disease. Ensuring success at the marketing stage begins right from the start when sponsors choose their protocol design. By leveraging the resources for patient recruitment, utilizing the flexibility of adaptive designs, and carefully considering different sites and participating countries, the retention rates and site compliance for your lymphoma clinical trial will become noticeably easier to manage.
Vial is building towards a more efficient future for clinical trials using its digital innovations. Visit https://vial.com/cro/oncology/ to learn how our products deliver faster and more efficient cancer trials for sponsors. Connect with a team member today!