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Mask Off: Being in the Business of Breakthroughs and Study Rescues


Adam Hartzell

Things we learned from industry-leading clinical development programs

Clinical research discoveries and studies all follow different trajectories in terms of their potential approvals.  Successes and failures will occur at every phase of research, and overcoming hurdles in a timely fashion is at the utmost importance.  With competing drug approval timelines, it is important to maintain focus, composure, and organization to ensure the quality of the trial.

Rescue studies are becoming more prevalent in the industry.  With many studies suffering budgetary and tight timelines due to the pandemic, Sponsor's and Clinical Research Organizations had the challenge of finding ways to navigate the rough waters.  Through decentralization, risk based monitoring, remote consenting and home nursing visits, research studies attempted to catch up to their original projections, bringing drugs to market through optimizaton and remote quality oversight.

Trial design solutions do not come easy.  The turnover rate of employees in Clinical Operations is approximately 25 percent.  Consistency and clear communication in a team is paramount to success, and most of the industry works on multiple projects with different Sponsors.  New changes to vendors, CROs, technology, and employees all create learning curves and new challenges to implement without losing track of timelines to complete a trial.  

There are no simple solutions to the vast amount of issues that occur during the lifespan of a trial.  Expecting changes will often help pivoting when necessary.  Standard Operating Procedures, standardizing documents and flow, open communication and transparency will shape the team in a positive manner, ensuring quality.

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