No More Secrets

Mark Twain once said, “The secret to getting ahead is getting started.” In reality, it’s not much of a secret. All of us have experienced the frustration of falling behind because we may not have started either properly or according to plan.

Now imagine you face daily frustration in your job where you are falling behind, not because of your own abilities but because the systems and tools you’re armed with can’t keep pace.

Welcome to the world of study start-up.

Trial delays are one of the biggest challenges clinical operations executives face today. It is widely recognized that delayed trials contribute to some of the largest costs in drug development, with the average global trial taking a year to move from pre-visit to site initiation.

Despite advancements in clinical trial technology, opportunities for improving study start-up activities remain overlooked by the industry, resulting in pervasive, costly trial delays.

Most sponsors and CROs surveyed report challenges with study start-up processes, according to the Veeva 2017 Clinical Operations Survey. And almost all (85%) are still using spreadsheets to manage study start-up activities, with roughly one-third or less using CTMS, eTMF, or other internally developed applications.

Consistent with this research, the Tufts Center for the Study of Drug Development found it takes on average one year to identify and activate a site to conduct research. Additionally, Tufts also found that study start-up time is no faster today than it was nearly 10 years ago.

That’s right, we see that the industry is no faster at starting clinical trials than a decade ago! A new and better way is needed to transform study start-up. And here are the not-so-secret ways how:

• Execute all core study start-up processes within a unified single system that is connected with other clinical processes.
• Eliminate system and functional silos.
• Automate and streamline study start-up activities.
• Provide sponsor and CRO stakeholders the visibility to proactively manage a trial, rather than reacting to critical bottlenecks and risks that significantly delay site initiation.

Some organizations are getting ahead because of how they are getting started. It is a choice between a unified clinical environment with a seamless flow of content and data versus a web of integrated point solutions. Dedicated study start-up functionality as part of the unified clinical environment further ensures that the clinical development process moves ahead. And there will be no secret about its success.

Chris McSpiritt, Clinical Practice Lead at Paragon Solutions, and I discussed the role of data, content, and workflow when selecting study sites in a recent webinar.

References:

1. Lamberti, MJ, Chakravarthy, r, Getz, KA. Assessing Practices & Inefficiencies with Site Selection, Study Start-Up, and Site Activation. Applied Clinical Trials. Link accessed December 13, 2017.
2. A new start for study start-up, Clinical Informatics News. Link accessed December 13, 2017.