Finalizing protocols, aligning teams, and staying engaged headline best practices.
Too often, clinical trials are delayed while waiting for technology implementations, which can significantly increase cost, timelines, and frustration for study teams, sites. And the stakes are high: in the US alone, biopharmaceutical companies spent about $1 billion to bring each of their new drugs to market between 2009 and 2018, according to a 2020 JAMA report 2020.1
Sponsors and CROs can help their clinical trial technology providers improve study delivery times if they adopt the following three best practices.
Technology providers always want to be brought into the protocol drafting process early. This is especially the case when the provider has scientific and clinical experts who can advise on best practices for the patient experience, quality of life possibilities, and sometimes even recommend specific scales. That said, all work on actually configuring the systems should be held until after the protocol is finalized. Too often, technology providers are asked to program their systems on a draft version of the protocol, ostensibly to save time; unfortunately, the opposite can happen.
When implementation work begins early, each inevitable change to the protocol may require performing duplicate work and can create significant downstream effects. Whatever the task is—programming an eDiary, writing informed consent, or creating source documents—it will mean extra time repeating processes, potential re-validation exercises, and re-submitting to the IRB for approval. It also drains resources and keeps the technology team doing redundant work instead of moving on to other strategic items.
One of the most important success factors is to make sure the sponsor’s procurement team and study team are in sync from the beginning.
Studies go sideways because the procurement team decides to proceed with the technology provider, but they don’t bring in the study team until the 11th hour. Maybe the study team lost the questionnaires, or they're not ready to proceed because another project is pending. Or they're just not clear on exactly what type of services the technology provider offers. These issues slow the process and can derail timelines.
Sponsors should bring their project team into procurement discussions very early in the process. This sets the expectation that there will be one checklist of questions the study team needs to be prepared to answer, and that checklist will be shared with the procurement team as part of that process.
Having an engaged team on the sponsor side is critically important. At each kickoff meeting, technology providers should include a slide which presents a clear and concise list of what they will commit to in their timelines, and also what they need the customer to commit to for shared success.
This level of transparency and accountability establishes a partnership up front. It can help ensure teams to stay on track not just because people show up to meetings, but because they’re achieving their own milestones. When one team hits the tennis ball onto the other side of the net, the other team hits it right back.
The end goal is to determine how to best capture the data for the trial—for example, with electronic diaries—and then get that data back to inform the study’s endpoints.
It doesn't matter if the customer is a Top 10 pharma or a bootstrap startup, a sponsor or a CRO. If they adopt these three best practices, they can make higher on-time trial delivery a reality.
Kristopher Sarajian, Vice President of Marketing, ClinOne