We know clinical trials are vital for developing new medicines, medical devices, and diagnostic procedures. That’s why it’s so important to keep improving the way we conduct studies; for patients especially, but also for physicians and for sites.
On this theme, ProofPilot Chief of Strategy Joseph Kim recently spoke to Brad Hightower, CEO of Hightower Clinical as part of his new Research Confidential podcast that goes out on the Outcomes Rocket Network, to find out where he thought improvements could be made to produce more successful clinical trials.
Lower barriers to entry for physicians
Brad started off by explaining that physician education – about the process of conducting clinical trials – can be very important in driving up the number of physicians participating in research. While doing research has become something of a mark of quality for clinics today (think of websites and commercials for clinics that advertise how they are ‘research-focused’, or ‘actively involved in research’), it hasn’t always been that way.
For many physicians, their only perceptions of clinical research come from isolated instances during medical school, leaving them with the impression that clinical trials are too time-consuming, too expensive, and too complicated for them.
This creates a high barrier to entry for physicians, as, while many may still have an interest in getting involved in clinical trials, they may simply not know how to get started, or they may feel that it’s too much trouble. It’s important therefore to engage with physicians appropriately to increase awareness and understanding of the process, because ultimately, the easier we make it for physicians to participate in clinical trials, the greater their involvement will be.
Include more patients (or don’t exclude so many!)
The next issue that came up was overly restrictive inclusion and exclusion criteria for clinical trials. Eligibility criteria are in place primarily to protect patients’ safety, but also to define a study population that will produce reliable and reproducible results. Therefore, a balance always needs to be struck, as overly permissive criteria could put patients at risk, and compromise data integrity as well. Excessively strict eligibility criteria however can end up hindering recruitment, preventing patients from receiving investigational interventions that may benefit them, and also limiting the generalizability of trial results.
The trend does seem to be that eligibility criteria are increasing and becoming more rigid though – an observation that is backed up by a recent analysis that found that between 1986 and 2016, exclusion criteria in oncology trials increased by nearly 60%1. If trials are becoming more and more restrictive, and allowing fewer and fewer patients to receive the latest medications, then, as Brad puts it, “who are the drugs for, if we’re excluding so many patients from trials?”.
One idea as to why sites are seeing more and more eligibility criteria in study protocols is that investigators often use eligibility criteria from previous studies as a template for the next study, and simply add on new criteria without removing older exclusion requirements that may no longer apply to modern therapies. Whatever the reason for overly strict criteria, it’s clear that modernizing, simplifying, and broadening eligibility criteria would provide significant benefits. Brad even suggests that addressing the eligibility criteria issue could have as much of a beneficial impact on enrollment as the use of DCT enrollment strategies.
More clarity and standardization, please!
The third pain point that Brad reports experiencing is about the information that sites don’t receive before a trial is awarded to them. Information about eligibility criteria, about a study drug’s mechanism of action, or about the schedule of assessments required during a trial are all important points to consider for sites when planning and budgeting for a trial. However, site staff may only have a study title and a limited synopsis to go off when deciding if a trial is feasible for them.
When this happens, a site may end up offering to run a trial that from the first appearance seemed to fit with their facilities and capacity, but in fact turns out to require much more complex, frequent, and time-consuming procedures. This also affects the patient experience because, as Brad puts it, “it’s what we're asking the patient to deal with by being in the trial”. Other trials may turn out to have very narrow eligibility criteria, reducing the site’s ability to reach proposed recruitment targets.
The solution? Greater standardization of what information sponsors should provide to sites during the site selection process.
Consolidated workflows for the win win win
The theme of clarity leads us nicely to the next opportunity for improvement identified by Brad: the need to provide clear, simply laid out, and user-friendly operations manuals for site staff. Workflows and procedure manuals, if provided at all, are often hard to understand, and may come as multiple, disparate sets, with one instruction manual for each different vendor-provided system.
Brad estimates that only about 10% of sponsors actually provide these kinds of resources that help site staff to work efficiently, and notes that, ironically, it can be the smaller companies that do better on this front, with larger companies often providing less support. “Having even broad instructions or operations manuals is incredibly useful”, explains Brad, as it helps site staff to know where to get started, to answer basic questions like “which system do I need to be using now?”, or “where do I get a subject number?”
Brad and Joseph both agreed that the best solution is some kind of consolidated, cohesive, and chronologically-ordered procedure manual. With these kinds of resources and support, the site benefits as study conduct become easier, the patient benefits as visits get completed more quickly, and the sponsor benefits from fewer errors and therefore likely better quality data, therefore everybody wins.
The power of the personal touch
Brad’s final point was on the value of personalizing the service and support provided to physicians. He reflected that physicians may come into clinical research for a range of motivations; for example, some may merely be interested in the financial gain, others driven more by altruistic reasons, and yet others can be looking for greater recognition within the medical community (e.g., as a KOL). As such, understanding what drives a physician to get into clinical research in the first place, and using that information to tailor your offering as a provider, can ultimately increase the number of physicians who come into, and stay in, clinical research.