There is nothing more important in clinical research execution than ensuring sites and patients conduct and participate in a clinical trial as intended by the Sponsor. A recent study involving researchers from the Johns Hopkins Bloomberg School of Public Health reveals that the median cost of a single clinical trial for FDA-approved new drugs is $19 million, and can swell up to $100 million. Despite years of planning, millions of dollars spent, and 100’s of people collaborating to make it a success, mistakes and delays will happen, and some can be accounted for. But not all mistakes and delays are created equally, and some of the most critical ones can be controlled for and avoided. For example, did the researcher miss a footnote in a 100-page document? Or what about two researchers reading the same information but interpreting it differently?
Look at this recent example from a study protocol regarding instructions for a Nerve Grading System:
"If subject is a [redacted] transection, randomized in the operating room, the baseline assessment is done at V2 or Week 1."
While more context may help, the fact remains that this instruction still requires a good deal of detective work to understand, and even then, there may still be confusion and variability that lead to costly deviations and amendments. Avoidable errors are becoming the norm as clinical trials continue to increase in complexity.
The root cause of study conduct variability is due to Sponsors failing to provide crystal clear study workflows, leaving study sites to interpret the protocol and supporting documents on their own. Though it could be related nuance in process or approach among sites or the honest misinterpretation of written instructions, in most cases, just the sheer variety of protocols being run at a site, each with a plethora of manuals and instructions to navigate, is the culprit. This variability can have a significant impact on the conduct of the trial, clouding the true efficacy of a treatment, delaying the approval of a potentially life-saving therapy, or jeopardizing patient safety. Not to mention, sites will quiet quit on a study deemed too complex or unfairly compensated.
Moreover, these inconsistencies can have a profound impact on the patient experience as well. Patients who are enrolled in a trial expect that the trial will be conducted in an efficient, consistent and transparent manner, and that the results will be used to inform treatment decisions and improve patient outcomes. However, site guesswork driven by disparate, written instructions artificially lengthens study visits, and inconsistencies within the trial can erode patient trust in the drug development process, making it more challenging to recruit and retain participants for future trials.
Inconsistencies and guesswork are avoidable through the use of technology to create an integrated, digital journey. For example, if you are driving across the country, you might be able get by with an old-school, paper map and a set of written instructions. But you’ll likely make a few wrong turns, engage in several finger-pointing spats, and hit some detours. Inevitably you might get to your destination, but it won’t be pretty, and you’ll likely be late as well. However, today we can plug our destination into Google Maps or Waze and receive turn-by-turn directions – when you need to turn – resulting in a smooth, predictable, easy to follow journey, ensuring you get to your destination in a timely manner MISTAKE FREE. Sponsors now have that same capability for clinical trial execution with ProofPilot.
ProofPilot is purpose-built to address the issue of protocol variability. Our approach in supporting Sponsors to ensure consistent interpretation of the protocol is to distribute a standardized, digitally automated workflow to sites and their patients. We do this by digitalizing the protocol and all the supporting instructions into an integrated experience, automating the sequence of study tasks, technology, communication, and content in real time to ensure flawless execution. Tactically, ProofPilot helps improve the operability of protocols. Strategically ProofPilot reduces protocol deviations and patient drop out which improves quality, time, and cost.