Today, we delve into an enriching conversation with Kelly McKee, the Vice President of Decentralized Clinical Trials and Patient Registries at Medidata Solutions. Kelly opens up about Medidata’s intricate workings and dedicated efforts in enhancing inclusivity in clinical trials, offering a firsthand look at the initiatives, challenges, and the path ahead in ensuring inclusivity in clinical research.

Moe Alsumidaie: Kelly, can you provide insights into Medidata’s alignment with the FDA’s diversity recommendations?

Kelly McKee: At Medidata, we recognize the immense importance of reflecting the diversity of the patient population in clinical trials – that’s why we’ve launched the Medidata Diversity Program, the industry’s most comprehensive solution to enabling greater inclusivity in clinical trials. The Medidata Diversity program helps sponsors and CROs engage and enroll more diverse patient populations in line with the FDA’s new guidance, highlighting the need for greater diversity to ensure the safety and effectiveness of therapies across various demographic groups. While clinical trials have historically enrolled predominantly Caucasian individuals, Medidata is actively working to bridge this gap and ensure that trials are as diverse as the population that will eventually benefit from the therapies.

Moe Alsumidaie: Can you share the initiatives Medidata is undertaking to enhance inclusivity in clinical trials?

Kelly McKee: We’re leveraging technology to foster inclusivity across the board. Our platforms and focus on decentralized clinical trials enable broader participation by eliminating geographical barriers, allowing individuals from diverse backgrounds to more conveniently participate in clinical trials. We’re also focusing on community engagement and education, reaching out to undersupported communities to increase awareness of the clinical trial process and overall trial participation.

Moe Alsumidaie: How does Medidata prioritize the patient perspective in clinical trials?

Kelly McKee VP of DCT and Patient Registries Medidata

Kelly McKee: We are committed to ensuring transparency and trust with our trial participants. Our myMedidata patient platform offers a comprehensive, single-patient portal designed to easily capture the patient experience in clinical trials regardless of location, reinforcing patients’ confidence and trust in the trial process. This approach acknowledges the participants’ invaluable contribution and underscores our commitment to transparency and prioritizing their welfare and rights in the clinical trial process.

Moe Alsumidaie: How is the impact of Medidata’s diversity programs measured?

Kelly McKee: Measurement is crucial in assessing and enhancing the impact of any diversity initiative. Our extensive and detailed data framework and the largest data set in the industry provide us with critical insights into historical and current enrollment patterns. By continuously analyzing this data, we can ensure our strategies effectively contribute to increasing inclusivity in clinical trial enrollment, with a vision for a positive progression in the representation of various demographic groups in clinical trials.

Moe Alsumidaie: Could you elaborate on post-trial engagement and its significance?

Kelly McKee: Post-trial engagement is a vital aspect of our approach to clinical trials. We facilitate a comprehensive platform for patients to provide feedback throughout the clinical trial process, including post-trial, helping sponsors and Medidata optimize trial design and execution. Additionally, sponsors are utilizing the Medidata platform to communicate and update patients post-trial, such as patient data returns and notifications of new studies, ensuring participants are acknowledged and informed about the trial outcomes, and fostering long-term positive relationships and engagement.

Moe Alsumidaie: Kelly, looking ahead, what are the expectations and future directions for diversity in clinical trials at Medidata?

Kelly McKee: Looking ahead, we are optimistic and committed to continuously advancing inclusivity in clinical trials. Our ongoing initiatives, centered on community engagement, technology utilization, and continuous feedback and assessment, will be augmented with innovative strategies to ensure even broader representation in clinical trials. The ultimate goal is to ensure that clinical research is as diverse as our world, leading to the development of universally effective and beneficial therapies.

Moe Alsumidaie: Any final thoughts you’d like to share, Kelly?

Kelly McKee: I’m profoundly grateful for the opportunity to talk about the Medidata Diversity Program and share insights into the crucial work happening at Medidata. Our commitment to enhancing diversity in clinical trials is unwavering, and our collaborative efforts with sponsors, CROs, sites, and patients are central to this mission. Together, we are shaping the future of clinical trials and, by extension, the future of medicine, ensuring it’s inclusive, representative, and equitable.

In summary, the extensive conversation with Kelly McKee unravels the depth of commitment and the multifaceted efforts by Medidata Solutions to ensure diversity in clinical trials. The initiatives, from leveraging technology for more involvement to prioritizing post-trial engagement, highlight Medidata’s holistic and patient-centric approach to clinical research. As we move forward, the insights shared by Kelly underscore the significance of continuous effort, innovation, and collaboration in achieving a diverse and inclusive landscape in clinical trials, ultimately leading to more effective and universally beneficial therapeutic solutions.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.