Accelerating Study Start-up: It’s More than Saving Time and Money
It is a bold statement to say starting a clinical trial today is no faster than a decade ago. And I firmly believe this is a true statement. With trials still taking on average five to six months to start1 I don’t see the life sciences industry making progress to speed study start-up.
Without relying on regulatory authorities to force the issue, how can the industry look at this through a different lens in order to gain a sense of urgency?
Rather than equating delays to figures such as cost and time, let’s relate delays to actual patients. A patient-centric approach is being adopted in areas such as protocol design or patient recruitment, so why not apply this thinking to study start-up?
The number one trial delay is contract negotiation. Once a trial is confirmed, it takes time for sponsors and CROs to negotiate with sites before they are activated. A fully executed site contract not only has the most communications back and forth, but it is typically managed separately from other core site activation processes.
While the negotiation process is a business transaction, let’s look at it from the patient’s perspective. Imagine you are a patient who wants to enroll in a trial because your life depends on it. This is where T.J. Sharpe found himself.
After being diagnosed with multiple melanoma tumours in 2012, T.J.’s oncologist broke the news that he may not live longer than two more years. Using his inside industry knowledge, T.J. sought out clinical trials for new and innovative cures for his disease.
T.J. located an appropriate clinical trial, but found there was a delay because of outstanding paperwork. He discovered a contract was sitting on someone’s desk waiting for a signature. Frustration is an understatement and in T.J.’s words: “For you it’s a wet signature. For me it’s my life!”
Now that is a sense of urgency.
This isn’t about delayed paperwork. It’s about barriers to saving a life. From this lens, the industry must look to accelerate site selection and activation.
The reasons starting trials are no faster than a decade ago is because processes are still managed manually, on paper, and in siloes. Documents are downloaded, signed, scanned, uploaded, and distributed to recipients via email. Each step is in a different system, and therefore it’s no surprise paperwork gets lost.
Moving these processes to a dedicated study start-up application would identify bottlenecks, such as the example of a study stalled because of an outstanding signature. Automated workflows guide users through each process, and interactive dashboards provide oversight into where a contract is at any point.
All stakeholders have the same visibility into progress and status due to shared reporting capabilities across different functional areas. Therefore, if one person misses an alert, other stakeholders can catch it.
Thanks to T.J. chasing a signature, the contract was signed. He enrolled in the trial and benefited from the new drug that saved his life. However, not every potential patient has the knowledge and drive that T.J. has; nor should it be expected that patients go to this length to solve administrative issues with studies.
On a positive note, six years later T.J. is now a patient advocate educating others on his ongoing journey as a melanoma survivor.
1 Lamberti MJ, Wilkinson M, Harper B, Morgan C, Getz KA. Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations, Therapeutic Innovation & Regulatory Science, DOI: 10.1177/2168479017751403 tirs. sagepub.com