Dec 18, 2019
There aren’t enough physicians in the world taking part in clinical trials. But what’s more troubling is that a large percentage of doctors who run their first clinical trial say they wouldn’t run a second one.
Physicians are the trusted advisor to patients. Without increased participation from them, it limits access to clinical trials for patients. Rather than trying to skirt the problem, we need to address core issues that limit why doctors don’t want to run clinical trials.
Doctors generally have just a few minutes with each patient. This means they have a very short window to make critical decisions about the patient’s eligibility for a clinical trial. For larger research centers, this decision can be even more difficult if they are running several trials for different sponsors in the same disease area.
Given time pressures, logically speaking, it would make sense that doctors have quick and easy access to the information they need when they are with the patient.
Yet, access to the clinical trial protocol and other study documents today is primarily through binders of paper documents that are nowhere near the patient. Or, there may be electronic versions of the same documents that are hosted on a secure password-protected portal.
Neither approach is ideal for busy, time crunched research staff on the go. The reality is that high interaction costs – the time and effort to find answers – can limit trial success if it’s just too hard to find the information to make the right decisions.
Whether clarifying inclusion/exclusion criteria, managing a toxicity, or confirming the next steps from an adverse event, research staff will have questions that require input from experts. Sometimes the answers are time sensitive.
With so many channels – email, phone, text, chat – it’s hard to keep track for both CRAs and research staff. Email still seems to be the dominant channel, but it lacks any urgency for immediate questions.
Additionally, informing research staff of study or document changes is not straightforward as different sites may be on different versions of the protocol and located around the world. Newsletters are an effort to tackle some of the challenges, but that is still a generic, one-way broadcast.
It is no surprise that communication is a common complaint among research staff. Without timely, accurate answers, sites are blocked. If sites are blocked, trials are blocked.
Research staff have the best insights when it comes to patients. It is a wasted opportunity not giving them a voice with regards to things such as whether a trial should progress to the next phase or the viability of finding patients for a given study.
By asking for research site feedback, sponsors can gain valuable field-level intelligence that can influence trial success and future study design. Who better to give input than those who know the patients best?
Let’s not forget that investigators and research nurses are human. Asking for feedback has the potential for sponsors to foster better relationships with research staff. This in turn could make them the sponsor of choice and ensure that clinics want to manage their trials.
It all comes down to confidence. Research staff need to have confidence they are making the best choices for their patients.
As the front line in any clinical trial, we need more doctors engaged. Giving them the tools they need to make informed decisions at each step could reduce friction for sites. And with more doctors participating, more patients will have the opportunity to participate in clinical trials.