This month, we want to highlight the growing connections between decentralized clinical trials (DCTs) and the critical therapeutic area of oncology.
Because DCTs have been in the news and evolved so quickly over the past year, and because they may require new components, processes, and approaches, it has become common for many in our industry to think of them as their own discrete category, often discussed and conceived separately from therapeutic advances in clinical trials as a whole. However, this was never the intent of the drive toward patient centric models and could even represent a concerning paradigm if carried too far.
Our therapeutic leaders are continuously working intensively with their sponsor counterparts, as well as with our DCT operational team and the data management and regulatory review teams to ensure that progress in our clinical trial models is based upon supporting the specific needs of each therapeutic area, promoting better patient experiences while striving to improve the value of the trial for the sponsor.
Given the key nature of oncology clinical trials to the pharmaceutical industry, this therapeutic area is a hotbed of activity for DCTs. Despite an early industry opinion that the care-intensive nature of these trials would gain little from a DCT approach, we now understand that a shift toward designing the trial around the patient –to the extent possible—has much to offer in improving patient, site, and sponsor experiences. No longer do we frame DCT as an all-or-nothing approach, but instead we recognize that each incremental step we take to help our sponsors minimize patient burden and improve quality of life represents an important advance.
One of the most critical areas that needed to evolve to support the incorporation of a hybrid DCT approach in oncology trials is the Centralized Medical Data Review (CMR) along with monitoring and reporting. To meet the unique needs of oncology, we’ve developed an integrative approach combining elements of our DCT Technology Platform with our Xcellerate® Medical Review Tool, promoting essential collaboration between medical monitoring teams and the medical data reviewers.
Because this process is by its nature a complex one, we’ve created an eBook that walks you through the processes and tools step by step, so that you can see how these elements mesh together for the benefit of all stakeholders. We’ve included an oncology CMR case study, as well as one from the cardiovascular area to showcase the broad applicability of our CMR process. Please click the link to be taken to the site where you can download a copy of our new eBook, Centralized Medical Data Review for Oncology Studies. We hope you will find this informative.
That’s it for this month’s blog, but please join us next month when we will continue the “data” theme by discussing new tools and processes for digitizing DCT workflows.
To learn more about how we can help you build efficiencies into DCTs, please visit our website.
You can also find additional DCT resources like case studies, white papers, scientific articles and more here.
Authors: Ken Morrison, PhD PMP, Vice President, Portfolio Analysis and Growth (Oncology), Ariel E. Aguiló, MD, Senior Medical Director, Oncology Global Clinical Development, and Praveen Kumar, Director, Medical Data Review.