February 4, 2021 is World Cancer Day, an annual global observance designed to raise people’s awareness of cancer and how to prevent, detect, or treat it. Cancer has a major impact on society and across the world. In the United States alone, approximately 2 million new cases of cancer are diagnosed each year.
The clinical studies our customers and other research organizations conduct are critical to better understanding cancer – how to prevent it, how to detect it early, how to treat it, and ultimately, identifying cures. The Mednet team is proud of our extensive experience working in oncology studies, and we commend our CRO partners and clinical research sponsors for the exciting and innovative work they are doing to discover new therapies, treatments and cures.
Over the years, our team has supported hundreds of cancer research studies around the world. The types of oncology studies conducted on the iMednet platform are broad, ranging from small, early stage biotech studies to large and complex late phase pharmaceutical trials.
Oncology studies bring unique challenges that require flexible technology solutions. For example, oncology registries can be especially challenging because there are many different types of treatment – chemo, radiation, surgery, hormone therapy, etc. – that can change at any point during the study due to a patient response and NOT a study protocol. Treatment cycles in oncology research can also complicate the study, as many times it is not known how many cycles a patient will undergo. For example, if they are having only partial response to treatment, but they are tolerating it well, it may be continued for a long time. However, in other instances, if “progressive disease” is indicated or they are experiencing an adverse event from treatment, treatment may need to be changed or even halted for a short time.
To address these complicated challenges and study designs, it’s critical to have a flexible and responsive technology solution. For example, iMednet’s dynamic grids are uniquely designed to address these complex study dynamics. Among other things, individual case report forms (CRFs) can be hidden in the grid, while treatment CRFs can also be hidden, with the exception of the actual treatment given.
Adaptive designs, common in oncology studies, represent a new level of complexity in clinical trials. Simultaneously, they demand a new level of flexibility that is required throughout study conduct. Mid-study modifications are typically based on rather complex computational algorithms. As designed, the changes must be implemented quickly, efficiently and accurately. Response adaptive randomization (RAR) or a sample size reassessment (SSR) are commonly used adaptive designs that require the research team to be able to assess data and formally implement mid-study changes. This new requirement has heightened the tug of war between the need to support greater trial complexity and the need for simultaneously greater user flexibility. Flexible and dynamic technology is critical to addressing these evolving needs.
Understanding the unique demands of oncology study designs is key to success. While many Mednet customers choose to use iMednet in more of a ‘self-service’ mode, our experienced team brings decades of experience conducting and managing oncology research projects. Individual team members also have experience working in clinical settings in oncology and even as a participant in an oncology research study. Given the unique considerations of oncology studies, this experience helps us support research teams most effectively, whether it is helping with a study build, training designers or simply providing end-user support. For example, a recent Mednet customer was running an oncology trial and requested additional study support. Having worked as a registered radiation therapist earlier in her career, Sally Huebner, project manager, was able to leverage her experience to help them create contracts and hire pathologists to perform independent biomarker reviews. She was also able to support them by reviewing biostats’ data and abstracts.
Having the right technology and experience can significantly streamline processes and improve efficiency in all studies, but particularly in complex oncology studies given their unique considerations. Mednet is proud to have conducted hundreds of cancer-related studies on its platform, and several of our team members have deep experience in oncology. To learn more about Mednet’s flexible platform or our therapeutic expertise, contact us.