The unprecedented rapid development of effective vaccines and therapeutic solutions for COVID-19 - reducing the median development time from nine years to seven months - has sparked general interest in what can be learned from these trials that is applicable to clinical development beyond COVID-19. The IQVIA Institute for Human Data Science conducted a webinar on June 7, 2022, with leading experts to discuss this topic, referencing the recent study on Lessons Learned from COVID-19 Vaccine Trials – A CRO Perspective on Accelerating Clinical Development.

Highlights of key themes during the webinar discussion:

• Assessing impact from environmental factors: While there were many important operational and organizational changes that accelerated the clinical development of COVID-19 vaccines and therapeutics, the impact from environmental factors can’t be underestimated. The public health urgency to respond forcefully to the pandemic drove the development of unprecedented partnerships among many parties across government institutions and triggered new public-private partnerships. There were many noteworthy changes in behaviors that helped create a favorable environment for accelerating clinical development timelines, such as the FDA turnaround time, the ability to recruit thousands of patients in just one day, and the readiness of the armed services to engage in clinical trials. Overall, this dramatic level of urgency and responsiveness will be difficult to replicate for other disease areas, even though public health emergencies may call for a similar approach, such as the challenges with  anti-microbial resistance and unmet needs in Alzheimer’s disease. The financial support from governments also helped to de-risk investment in COVID-19 vaccine trials.
• Linking clinical trial design and execution: One of the positive lessons about operational efficiency in the development of the COVID-19 vaccine trials was the linkage between clinical trial design and execution. Connecting clinical operations teams with design teams early in development was an important learning. As an example, there were distinct savings in time through engaging operations teams in the review of and rationalizing/streamlining of the many test kits that were important for the design of clinical trial testing procedures.
• Ensuring patient safety during accelerated clinical development: One of the disadvantages from accelerated clinical development has been the potential perception that patient safety was compromised. The question was also asked whether the timelines were too short, potentially fueling hesitancy toward vaccination in parts of the population; however, the scale of vaccine trials and the large number of patients receiving the vaccine have created comfort about safety issues. Furthermore, regulators have been very proactive in ensuring safety through intensive monitoring of patient health records. Suggestions were made that public concerns about safety can be alleviated through educational efforts.
• Changing role of regulators: During COVID-19 vaccine trials, regulators in general changed their traditional role from operating as gatekeepers to enablers of efficiency. This was demonstrated in multiple ways: through rolling reviews, support for novel and innovative trial designs, and more flexibility in communications with industry sponsors.
• Addressing all trial inefficiencies simultaneously: Many of the inefficiencies in clinical trials that were overcome during COVID-19 vaccine development have been recognized previously, but they have typically been addressed in isolation. During the clinical development of solutions for the pandemic, these inefficiencies were tackled simultaneously as part of an integrated eco-system of change. This holistic approach was instrumental in reducing the “white space” in clinical development.
• Enhancing decision-making: Overall, sponsor company decision-making processes were disrupted and changed during COVID-19 vaccine trials. More efforts were devoted to planning and design early on to ensure the right decisions and resourcing of teams. There was also more flexibility in pushing decisions down to people at the bench-level while at the same time making sure that there was quick access to decisions at the senior level when required. Greater leadership focus and availability was also acknowledged as being critical to faster turnaround times.
• Prioritizing minority populations: Community engagement was pursued systematically to prioritize minority populations that were disproportionately affected by the pandemic. Utilizing social-behavioral approaches, efforts were made successfully to enroll Black, Hispanic, Native-American, older, and veteran populations in Phase III trials. These efforts were based on lessons from the HIV-vaccine trials that had demonstrated the importance of building transparent and trusting relationships with community organizations; for example, engagement with faith-based organizations, historically Black colleges and universities, and tribal organizations. Interestingly, while HIV-research may have generated important learnings for the development of vaccines for COVID-19 – for example, the application of mRNA-technology – learnings from the pandemic can now help reinvigorate research in HIV and TB.
• Coordinating efforts between CROs and sponsor companies: One of the most fascinating aspects of the pandemic has been changes in the dynamic collaboration between Contract Research Organizations (CROs) and sponsor companies. The clinical trial landscape is traditionally highly fragmented, with many players addressing specific tasks in the complex clinical trial process in isolation – sponsor companies, CROs, device and tech-providers, laboratories, etc. The pandemic has seen the dawn of new, more integrated, open, and agile models of collaboration that have contributed to acceleration of timelines.
• Looking ahead two to three years:  The question was raised about the outlook for clinical trials over the next two to three years based on lessons from the pandemic, and whether an acceleration in timelines could be expected for clinical development beyond infectious diseases and vaccines. Panelists were optimistic about positive changes, but also reluctant to predict that the median time for new drug development and approvals would be reduced. While many positive lessons from the pandemic will likely be adopted in clinical development moving forward, as in the use of novel and innovative trials design and in remote and digital patient engagement, as examples, there is also an enhanced recognition of the complexity of clinical trials and the urgency to address issues around inclusion of minority populations. Furthermore, there is an increased appreciation for the importance of proactively engaging the public and communities in clinical trials. Ultimately, while the timelines for clinical development may not necessarily be shorter overall, the quality of clinical trials may be enhanced.

Panelists in the webinar were:

• Simon Collins - Portfolio, Transformation & Insights, AstraZeneca
• Ken Getz - Executive Director, Tufts Center for the Study of Drug Development
• Jim Kublin - Executive Director, Fred Hutch; HIV Vaccine Trials Network
• Peter Ronco - Head of Global Development, Janssen R&D
• Vicky Leamey - Vice President, Therapeutic Strategy, IQVIA
• Keith McDonald - Senior Director, Global Regulatory Affairs, IQVIA and Former Deputy Director, Licensing Division, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

To access the full recording of the webinar, click here.