From winning SCOPE's Site Innovation Award to patient engagement and tech advancement, a Q&A with Medidata

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Medidata Clinical research Clinical trials Patient recruitment Data management

A Q&A session was held at SCOPE 2024 in Orlando, Outsourcing Pharma speaks with Kelly McKee, VP of decentralized clinical trials and patient registries, and Daniel Braga, VP of EHR and healthcare solutions.

They discuss their roles and experiences and how Medidata handles clinical research. The conversation covers topics ranging from patient engagement to technological advancements, highlighting the importance of human touch in clinical trials and the integration of data-driven solutions to enhance patient experiences.

LL: Just to kick things off, could you both introduce yourselves and explain your roles at Medidata?

KM:​ Certainly. I'm Kelly McKee, VP of Decentralized Clinical Trials, and Patient Registries at Medidata. My focus is on optimizing site, patient, and sponsor experiences through technology solutions. I have more than 20 years of experience working with major pharmaceutical companies before joining Medidata.

DB:​ Hi, I'm Daniel Braga, VP of EHR and healthcare solutions at Medidata. My role revolves around bridging the gap between the healthcare industry and clinical research, leveraging metadata to connect these previously disparate areas. Before Medidata, I founded a startup in medical imaging interoperability.

LL:Let's continue by discussing your recent achievements. Dan, congratulations on winning the Site Innovation Award. Could you tell us more about the technology behind it and how it's revolutionizing data entry in clinical trials?

DB:​ Sure. Last year, we embarked on a mission to connect the healthcare industry to clinical research, aiming to eliminate redundant data entry by leveraging EHR data. We've made significant strides in this area, reducing data entry time by up to 93% and winning the Site Innovation Award.

The technology we developed focuses on bridging the gap between healthcare and clinical research by enabling the seamless integration of electronic health record (EHR) data into clinical trials. Historically, this data entry process has been time-consuming and prone to errors. Our solution eliminates manual data entry by providing sites with access to EHR data, allowing them to simply click on relevant data points to populate the required forms. This not only saves time but also improves data quality and reduces query rates.

LL:That truly is remarkable. Kelly, could you elaborate on how this innovation contributes to patient engagement and retention in clinical trials?

KM:​ Absolutely, Liza. By streamlining the data entry process for sites, we're ultimately enhancing the overall patient experience in clinical trials. Patients are no longer just subjects providing data; they're active participants in the research process. We've also implemented initiatives like live video visits to maintain that personal touch, especially during challenging times like the COVID-19 pandemic. Our goal is to foster a supportive and engaging environment for patients throughout their trial journey.

Our focus remains on making clinical trials easier for patients to find and enroll in, enhancing diversity in trial populations, reducing site burden, and expediting drug development timelines.

LL​: What are some common frustrations in the industry, and how is Medidata addressing them?

KM:​ Key frustrations include difficulty in finding and enrolling in trials, lack of diversity in trial populations, and lengthy drug development timelines. We're tackling these challenges by leveraging real-world data to model patient populations, enhance patient engagement, and streamline trial processes.

DB:​ Human touch is essential in clinical trials, and we're committed to treating patients as individuals, not just data points. Our focus on patient feedback and engagement drives our efforts to improve trial experiences.

LL: Can you elaborate on the role of technology in enhancing patient experiences?

KM:​ Technology can be a powerful tool to enhance patient experiences in clinical trials. By combining high-touch interactions with high-tech solutions, we can provide personalized, user-friendly experiences for participants.

DB:​ For example, our live video visits initiative during the COVID-19 pandemic allowed patients to maintain personal connections with trial staff, demonstrating the importance of human interaction alongside technological innovations.

LL: What are some future directions for Medidata  in revolutionizing clinical trials?

DB:​ We're exploring innovative uses of data, such as synthetic control arms, to improve patient experiences and trial outcomes. Our focus remains on leveraging technology to make clinical trials more accessible, diverse, and patient-centric.

KM:​ Ultimately, clinical research is the future of medicine, and we're dedicated to ensuring that patients have access to cutting-edge treatments through seamless, engaging trial experiences.

LL:Dan, you mentioned the importance of scalability in your solutions. How do you ensure that your technologies are adaptable across various clinical trial settings?

DB:​ Scalability is key to our approach. We've designed our solutions to be flexible and compatible with different healthcare systems and trial protocols. This allows us to serve a wide range of clients and accommodate diverse patient populations. Additionally, our deep understanding of regulatory requirements ensures that our technologies comply with industry standards while driving efficiency and innovation.

LL:That's certainly a testament to your dedication to advancing the field of clinical research. Kelly, you touched on the importance of diversity in patient recruitment. How does Medidata address this challenge?

KM:​ Diversity in clinical trials is crucial for ensuring that treatments are effective across diverse populations. We employ a multifaceted approach, leveraging our capabilities to help sponsors and CROs design inclusive recruitment strategies. This includes identifying sites with a history of diverse patient enrollment, engaging patients through education and empowerment initiatives, and partnering with organizations like Circuit Clinical to expand access to underrepresented communities.

LL:Do you have any other thoughts or messages for aspiring professionals entering the clinical research industry?

DB:​ I'd like to encourage young professionals to embrace innovation and think big. The field of clinical research offers unparalleled opportunities to make a meaningful impact on global health. Don't be afraid to challenge the status quo and pursue ambitious solutions to complex problems.

KM:​ I echo Dan's sentiments. Clinical research is a dynamic and rewarding field that requires both passion and expertise. Aspiring professionals should strive to blend innovation with a deep understanding of regulatory requirements and patient needs. Together, we can drive positive change and improve healthcare outcomes for all.

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