Key Clinical Trial Industry Themes Post-COVID

The clinical trial landscape has changed significantly post-pandemic, and many industry experiences and strategies emerged at DIA 2022. in this interview, Barbara Lopez Kunz, president, and global chief executive at DIA, discusses key themes on the current state of the clinical trials industry and its future.

Moe Alsumidaie: Post-pandemic, what are the most significant changes in drug and clinical development?

Barbara Lopez Kunz: We've all seen drug development evolve over the past few years, but the pandemic catalyzed some of the things we've discussed. It turned our talk into action, which we love, and hope will continue.

As the pandemic spread, we all faced the same challenge. As a result, international collaboration increased, and as part of this international exchange, formal work-sharing initiatives and dialogue emerged, and there is a strong desire to use the pandemic response's flexibility and innovation to address unmet needs in other disease areas. This has been DIA's mission for nearly 60 years.

We’ve seen a few emerging trends. First, we see a sharper focus on including diverse patient populations in clinical research and development so that the solutions are effective for those who need them most. Pandemic urgency helped integrate clinical research into communities that may not have felt welcome or understood how to participate. While diversity inclusion has made strides, we still need to improve our outreach and integration of all communities.

Second, there is expanded collaboration; since it doesn't matter how effective therapies are if patients can't access them, DIA has brought in new players. Pharmacy benefits, reimbursement, health technology assessment, and other experts engage earlier in the drug development lifecycle so all perspectives work together.

Last, decentralized clinical trials have emerged quickly and are here to stay. Tufts University's Center for the Study of Drug Development showed that decentralized processes increase drug development efficiency. Our DIA Global Annual Meeting 2022 program included many DCT themes.

MA: What are some companies' DCT implementation challenges?

BLK: DCT adoption is a significant change, requiring the proper methods, tools, and training. DCTs will bring new challenges, such as ensuring appropriate training and delivery across sites and improving data collection and management. Until new approaches are solidified, drug development will use proven methods. As in change processes, some companies will move forward with decentralized trials while others wait for a larger mandate, monitoring understanding, process, training, and regulatory guidance. Clinical trials are the most time-consuming and expensive part of drug development, so process changes should reduce risk.

MA: Post-pandemic, what regulatory changes have you seen?

BLK: Regulators want to keep pandemic-era flexibilities. Regulators are accelerating changes in structures and processes to be more patient-focused. I'm seeing more patient engagement and patient-centric drug development now.

In the US, the FDA published guidance on patient-focused drug development, including collecting patient input, identifying patient priorities, and developing meaningful outcome assessments. In Europe, the EMA endorsed the PREFER initiative's patient preference, integration, and drug development framework. The ICH is working to harmonize data submission requirements for patient experience. Patient-centricity is entering countries' regulatory agendas. Asia, the Middle East, and elsewhere are seeing new patient engagement communities. DIA has long supported these efforts, and we're actively generating new patient engagement knowledge and learning opportunities for our community.

New data collection and analysis pose challenges throughout the drug development pipeline. Patient privacy, data ownership, and data integration will determine how we use these data to drive R&D efficiency now and in the future. The EMA and HMA (Heads of Medicine Agencies across Europe) maintain a collaborative data steering group to easily integrate big data and advanced analytics into their regulatory assessments. Signal detection uses analytics to automate case adjudication and identify false claims, adverse events, and illegal marketing. Darwin-EU enables real-world data analysis and post-market surveillance and decisions. The FDA has seen a rise in AI/ML-related submissions in the US.

MA: Where do you see clinical development headed in an uncertain world?

BLK: We're all in transition. New covid variants are emerging, and we're preparing a response. In addition to the pandemic, geopolitical issues, war, and unusual weather are causing health-related crises. We've made great strides in healthcare, and I'm proud of that, but we must continue collaborating and sharing our findings. We must create clinical trial designs that address our challenges. We must better prepare for collateral challenges, such as supply chain issues. Many companies and regulatory agencies must stabilize their supply chains to meet demand and launch new products. Global crises will persist. As a neutral convener, DIA will continue to address these issues. And we'll keep putting patients first as a healthcare community. DIA's sharing and learning environment fosters ideas and creates momentum and practical ways to implement them. As new knowledge emerges, we revise and refine our learning offerings to ensure they offer the latest regulatory, clinical, and data science content our community needs.

MA: How is DIA supporting clinical trials' future?

BLK: One DIA board member said years ago that we’d create it if DIA didn’t exist. I couldn’t agree more. In 1964, our founders couldn't have imagined how important a trusted, neutral, global platform would be for therapeutic development today. We knew years ago that we needed to improve access to DIA's knowledge, so we digitized all of our content and created a multi-year archive that we updated with new information. Creating a digital DIA was unrelated to recent crises. This work was done so that life science professionals worldwide could access the latest knowledge of science and policy. All stakeholders developing new therapies should use the latest information.

We've created a digital platform to keep clinical development experts like you informed and educated and to share what you've learned. In the early days of SARS-CoV-2, we launched the DIA Direct series to share China's experiences with healthcare delivery, drug use and repurposing, and clinical trials. This helped us engage thousands of members and stakeholders in knowledge exchange, accelerating the response to covid. Today, we're publishing a new DIA Direct series on clinical trials and the Ukraine war. This series has helped clinical research, and care communities in Ukraine share their experiences so others can learn and support them.

DIA offers regulators and the healthcare community a global, digital, virtual, and in-person neutral platform. We'll keep building strategies to prepare for the next disruption. You may remember that we presented a snapshot of the future of healthcare at DIA 2022. Next year's DIA Global Annual Meeting 2023 (in Boston) will focus on clinical research and healthcare challenges. This meeting's theme, Illuminate, aims to highlight the latest in drug development and our global collaborative network, which can transform individual professional expertise into actionable progress that benefits everyone. The DIA 2023 Call for Abstracts is open until October 6.