hile discussions among representatives from industry and regulatory agencies often stress the importance of patient stories, only a few of these discussions give insights into how to elicit these perspectives, identify patients, and empower them to share their experiences. Further, industry requires a level of change management to convert these insights into meaningful changes in drug development structures and processes geared to improving patient experiences and outcomes. The live panel discussion “Telling Health Stories for Drug Development” at the DIA 2020 Virtual Global Annual Meeting  revealed the considerations and steps to take when integrating patient stories and experiences into drug development activities.

Key Takeaways

• Plan ahead to identify “representative” populations and individual patients.
• Stigma may silence the very patient voices that are most necessary for relevant drug development. Methods from the arts, such as drama, and behavioral sciences can provide safe ways for people to share their experiences and insights with researchers.
• Change management techniques are needed to get beyond an individual protocol and fully integrate patients into drug development programs. Consider changes to program-level eligibility criteria, endpoints, terminology, and even to internal organizational structures and processes.
• The urgency of the COVID-19 pandemic and the Black Lives Matter movements shine a light on populations whose voices must be heard while potential vaccines and treatments are fast-tracked into development.

his past June, Australian Federal Health Minister Greg Hunt announced that the Commonwealth of Australia will join with all our States and Territories to achieve a “one-stop shop” for enhanced clinical trial approvals in Australia. Speaking at the annual State of the Nation Forum, run for the last forty years in our national capital by the highly regarded Committee for Economic Development of Australia (CEDA), Hunt provided an update on the COVID-19 crisis and how Australia has managed so far.

stablished and organized by the Committee for Drug Clinical Evaluation Research (CDCER) of the Chinese Pharmaceutical Association (CPA), the China Forums of Clinical Research Capacity Building and Human Research Participants Protection known as CCHRPP brought together a majority of representatives from hospital clinical research centers, the R&D-based Pharmaceutical Association Committee (RDPAC), research sponsors, contract research organizations (CROs), and site management organizations (SMOs), to share clinical resources and improve communication efficiency, especially during the current pandemic. More than 120 facilities throughout China have become CCHRPP members since 2017.

his article reviews several barriers to implementation of clinical studies involving COVID-19 patients in India and attempts to address possible solutions for rapid clinical trial deployment and implementation in line with Good Clinical Practice (GCP) guidelines and regulatory requirements.