Year-over-year, SCOPE is both comprehensive and intimate, offering a one-stop-shop to assess the landscape of clinical trial innovations and technologies. The only downside is too many compelling sessions at the same time; actually, a nice problem to have.
A most welcome SCOPE trend is the increase of speakers and attendees from trial sites. Many conversations with site coordinators and PIs reveal the desire for sponsors and CROs to recognize the amount of site skin-in-the-game and to increase the inclusion and communication as innovations roll out in RBM, eTMF, eISF and portal. Sites want to understand the changes at hand, help support new efficiencies, and have site requirements acknowledged and taken into account. Leave the sites on the sidelines, and risk project success.
The risk theme resonated in the plenary session and quite a few of the tracks. With Risk-Based Monitoring gaining traction, many are grappling with the impacts, struggling to smartly leverage industry tools and the wisely manage the role changes, especially for monitors and data managers. Unfortunately, many are not driving the risk assessment up to the development program and protocol level, instead starting with the end in mind, and focusing on reduction of trial effort and costs. While efficiencies should be realized from RBM, the efforts are hampered if risk is not holistically assessed and managed first at the program and then at the protocol level. Starting a risk-based monitoring project without full product program risk planning and action is getting the cart before the horse, and certainly not the direction expected by the health authorities. The RBM tools, industry accelerators and guidances are ready (of course, using the tools implies your Clinical Architecture is sound). What’s lagging are the risk-assessment clarity, the risk-reduction process rigor, and solid RBM change management practices encompassing all impacted roles at sponsor, CRO and site.
The other resounding theme was the frustrating pace of innovation in clinical trials. Many presentations referenced the lackluster performance speed and the head scratching delay in leveraging today’s technology capabilities. We continually hear “can’t” in our projects, and dig in to find it is all too often based on a perception of GCP and legal requirements. Life science executive management needs to push the “can” expectations, and support the innovators taking risks in leveraging new capabilities. Fully electronic clinical trials are happening, and have made it through health authority marketing approval. Innovative biopharm and device companies are managing without paper, reducing protocol complexity, realizing efficiencies and ensuring all stakeholders have a voice at the table, including trial participants and sites.
Want to move faster? Pay the upfront price for change. Make the time. Ask the “why not” questions. Get insight from all stakeholders, communicate the plans and results to them, and take action. Repeat.
If you struggle to innovate, we want to hear from you. We turn insights into action, and support new programs with continuous improvement. Our accelerators, expertise and methods get the job done across the innovation landscape - eTMF, RBM, eISF, Portal, Clinical Architecture, Site Activation to name a few – the same principles apply in our process optimization projects. Paragon is solutions, delivered.
What roadblocks are holding back your innovations? Want keeps you from achieving an advanced maturity state in your trial advancements? Drop me a line at firstname.lastname@example.org.
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Fran joined Paragon Solutions in April 2012, and is currently Associate Director in the Clinical and Regulatory Optimization practice. She previously worked at Genzyme / Sanofi for more than a decade, and has more than 20 years of academic and industry clinical and process expertise. She presents frequently at industry conferences, and is a member of several industry initiatives, including TMF Reference Model, OASIS eTMF Interoperability, and ACRES.