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FDA: Technology’s Value in a World of Precision Medicine and Research

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Over the course of the past 10 years, significant advancements have been made in clinical research. Personalized medicine, immunotherapies and genomic testing have equipped researchers with the tools necessary to identify the biological causation of diseases and to target treatments accordingly.

Yet in the face of therapeutic innovation, clinical trial operations have remained old fashioned. So, the question is, how do sites, CROs and sponsors catch up? Recent FDA Commissioner Scott Gottlieb, M.D. released some guidance in early 2019:

Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations. In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable. We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise.” (Our emphasis)

From an agency with a history of belabored approval processes, Dr. Gottleib’s statement is very promising. The FDA is taking a stand in support of utilizing best-of-breed technologies to facilitate stakeholder collaboration and communication.

The ready access to and sharing of data is essential to faster approvals.

Understanding this, sponsors and CROs are taking steps in the right direction. Monitoring visit schedules of q4-8 weeks are of a bygone era. One hundred percent (100%) source document verification (SDV) may soon be too, as it is not only very expensive but also inefficient and offers no guarantee of quality.

Remote/centralized monitoring is becoming more and more prevalent as technology solutions allow for Sponsors and CROs to monitor a trial’s progress and associated data from wherever, whenever. The success of this model hinges largely on sites’ willingness to adopt technologies to enhance their internal operations.

Technological advances result in operational efficiencies that ultimately lead to patients receiving safe, proven treatment options faster than ever before.

With this objective in mind, the FDA, Sponsors, CROs, and sites have 2 options:

  • Continue to conduct business as usual (process heavy, paper documentation, manual data collection),
  • or, disrupt the legacy approach by adopting technology solutions to enhance your collaborations, data quality and speed of delivery.

Our recommendations:

  • CROs and sponsors should continue a path toward risk-based monitoring, but add remote monitoring workflows in order to make up for reduced time on site,
  • CROs, with the right site-oriented technology partner, can transition monitoring to technical platforms, increase their differentiation and support higher margin monitoring processes as a result,
  • Create relationships with sites that have committed to technological progress. Sites that have adopted eRegulatory and eSource workflows can be easily identified as part of this group,
  • Furthermore, sites can take a proactive approach. The best sites are marketing themselves as technologically advanced and can win more business as a result of this differentiation.

The choice is clear.

Florence Healthcare is a software firm committed to advancing clinical trials through document management and data flow between research sites and CROs / Sponsors. Florence eBinders is trusted by over 4500 Investigators globally to manage the eRegulatory/eSource for over 600 active protocols. Florence eTMF is the most flexible eTMF on the market designed for the Sponsor/CRO team wearing “multiple hats.”​ Florence SiteLink is revolutionizing site-CRO/Sponsor connectivity in a virtual site workspace for site inspection readiness oversight, monitoring, start-up, and quality control.