Insight is critical to improvement — it goes without saying. Without new information, nothing changes. The pharmaceutical industry has come to understand that, when it comes to improving the clinical trials process, it’s not enough to learn through trial and error, hoping that eventually you’ll stumble upon information that we may or may not recognize as the clues you need to solve the puzzle. That leaves only one solution: Ask experts for the answers you need to move forward in a timely manner with confidence.
When it comes to clinical operations, the experts are the principal investigators and study coordinators. They have boots on the ground — and all the answers as to what’s working and what’s not. Whether you are concerned with an individual study that is behind schedule or you’re managing a portfolio of studies, we know that the sites themselves are the best source of information.
Here’s the rub: As a sponsor, you cannot ask the questions and expect candid answers. Conducting your own quality survey isn’t going to extract anything useful. The CRO has a vested interest in telling you “everything’s OK,” even when it’s not. And since sites rely on studies as a source of revenue, they are apt to minimize problems rather than jeopardize the relationship with you or the CRO.
As in clinical research, blinded studies are the gold standard in this type of surveying research. Anonymous input can reveal detailed issues that support concrete recommendations for changes that make a real difference to the study timeline. What’s more, a firm like Clinical SCORE, with deep experience in polling investigators and trial sites around the world, has procedures and protocols in place to provide rapid turnaround.
Some of the roadblocks our research has uncovered include:
- Payment problems, including slow payments and inadequate compensation
- Monitoring issues, including inconsistency among different monitors, lack of direction and the perception that the CRA did not understand the protocol
- Slow patient enrollment due to a variety of issues, including insufficient recruitment outreach by specific medical specialties
Without anonymous, third-party research, none of these issues would have come to light. It gets to the heart of whatever obstacle is slowing the trial and provides actionable information to get back on track.
For more information on how to apply this approach to your trials, look here or call Ross Weaver (484) 202-6630.