It wouldn’t surprise anyone to hear that conducting clinical trials is a complex, and at times, challenging business operation as much as it is a scientific practice. That’s why this week on his Research Confidential podcast, ProofPilot Chief of Strategy Joseph Kim was interested to speak to Rochester Clinical Research President, Adam Larrabee, about just what some of those challenges are, and how he balances the science with the business.
Early Impressions - the Sales Funnel
Adam actually started out at Rochester in 2008 doing business development (he was still in college, and needed credit for one of his programs), which is selling his site capabilities to Sponsors looking to hire sites to conduct research. He says that the first thing that surprised him about trying to get sponsors to come to his site for trials was the complexity, length, and uncertainty of the sales cycle. In other words, he found that the amount of time needed to initiate a trial meant that a lot of opportunities would never materialize into actual trials, so he had to make sure he always had a lot of sponsor opportunities lined up. This has changed little to this day.
Investing in Skills
As the president of Rochester since 2016, Adam now sees everything that happens “on the ground” at his sites, and he has noticed a few opportunities for improvement. Firstly, Adam became acutely aware recently of the investments made when hiring and onboarding new staff, while dealing with the rise in demand for Covid-19-related trials. Once hired, staff also need continued training and development, and together these represent a significant investment for sites that needs to be recouped. In the world of fair market value constraints and tight budgets, this continues to be challenging.
Yet, he did not see the same level of investment in Sponsor or CRO personnel, which created a ton of friction and confusion - questions couldn’t be answered quickly or sometimes the wrong answers were given. Training and development of Sponsor and CRO staff would lead to more effective partnering with sites, and therefore lead to better-run clinical trials, likely improving the patient experience, and ultimately generating better-quality data.
Scientific Training on Protocols
In terms of training sites on the study protocol - a crucial aspect of trial execution - Adam gave Sponsors about a 6 or 7 out of 10. Going into further detail, Adam explained that trial execution really starts when sponsors or CROs are assessing potential sites for their trials, and sites are assessing their ability to perform a trial (a.k.a pre-study visits, or site qualification visits). The issue is, sites will often only have a brief trial synopsis to go off, with limited information about trial procedures and a number of patients needing to be enrolled. However, as soon as sites do get the go-ahead for a trial, they are surprised with a great number of additions and changes, yet expected to start immediately. These kinds of challenges can affect how well a site is able to perform a trial. It’s a bit like being interviewed for a job, without a complete job description, and then being expected to start the following day and being handed 80% of the requirements when you walk through the door. ProofPilot’s Digital Protocol Platform can provide unprecedented clarity on the tasks required to execute a protocol and offers hope in closing this knowledge gap at scale.
Poor Communication Leads to Gaps in Information
The core of trial execution, however, comes down to how well sponsors or CROs communicate with sites during trials to ensure sites are fully informed, prepared, and supplied so they can carry out the protocol.
It’s no secret that sites may have upwards of 20 portals needed to conduct a study. If sites aren’t informed when, or how, they will be trained and certified, or if sponsor clinical team members don’t have the required access to provide training to sites when needed, things can begin to get very challenging. Not to mention accessing each portal in the right sequence during the conduct of a visit.
From a clinical supply perspective, sites may have been informed that they need to enroll 20 patients, but if they aren’t informed by sponsors when to expect delivery of all the lab kits needed to carry out study procedures on the 20 patients, if at all. This unpredictability can grind enrollment to a halt.
These “little” things that are poorly communicated, or even just left to slip through the gaps, can make the difference between a well-run trial and a poorly run trial. Adam was on board with that assessment, even going as far as to say that he would rate communication around these types of issues as low as a 2 or 3 out of 10!
When you throw in the fact that sites are typically running multiple different trials at the same time and usually have packed schedules (research staff shortage, anyone?), it’s easy to understand how even small delays caused by unclear or insufficient communication can have disruptive knock-on effects.
The Solution
A tightly orchestrated trial, ideally with automation, therefore becomes pivotal for efficient, effective, high-quality trial conduct, as it allows things to run themselves to an extent, with processes and communication being automatically triggered at the right time, as opposed to site staff having to do a lot of “chasing” of tasks. Joe recalled a recent personal experience of poor trial orchestration when he had to go onto site as a participant in a Covid vaccine trial. After a nurse had taken his vital signs, he was kept waiting around 45 minutes before receiving the vaccine dose due to staff having to chase the pharmacist, locate the study drug, take it out of refrigeration, let it come up to room temperature, and any number of other tasks that could have been performed in a much more well-organized way if automated.
Adapting to Reality
Finally, Adam reflected on his current workload at Rochester Clinical Research and shared that RCR is currently running about 40 - 50 trials, and expects that to rise to about 50 - 60 trials next year, with all of this supported by a staff of 70 people. Adam explained that one way that sites try to manage the workload is to organize “bulk days”, where sites are only seeing patients from one study on a particular day, so that all the staff, equipment, and labs can be set up for the one study. This is why an unexpected supply, access, or training issue can really disrupt trial execution for sites, leaving them having to switch between multiple studies, systems, and even investigational products, in one day.
If this week’s episode highlighted anything, it is that the challenge of conducting highly complex, scientific studies, written by one set of clinical scientists, and executed by another set of researchers with only a few written documents to go off, is one that has definitely not yet been fully conquered. And that certain critical skills - mastery of the supply chain, excellence in communication, training, and planning - are just as important to the science business, as they would be to any business.