Leading pharmaceutical companies are expending more resources than ever to identify study subjects and to select investigator sites that have superior access to patients for their clinical trials. But even if a sponsor does an effective job of identifying high-potential patients and study sites, they are faced with another major hurdle: having the study site assign eligible patients to their trial and not a competing trial at the site.

The competition for patients at the site level is very real, and further, sponsors also compete for limited staff and resources at study sites. Successfully competing within sites can make the difference between success and failure in patient enrollment, and there are many actions sponsors can and should take to win that competition.

Prepare the study team well.

Study sites are more likely to enroll patients into a trial when they feel confident and ready to commence trial activities. This is in large part a product of how well a sponsor trains the various role players at each site. Every study and its profile of sites is different, and studies are generally becoming more complex. Despite this, few studies benefit from an individualized and comprehensive training plan.

Instead, most sponsors still take a “check the box” approach to site training, in which they complete training as quickly as possible to meet minimal training standards. Typically, little training is performed beyond a front-loaded “data dump” of training that violates numerous well-established rules of Adult Learning 101. The list of best practices a sponsor can apply to better prepare sites is too long for this article, but they are well known and proven to improve performance.

Rapid answers for study professionals.

Clinical trials are inherently challenging, and sites routinely have questions about how to best conduct study procedures. Typically, sites direct questions to CRAs, who respond within 24 hours and sometimes longer. The problem with this approach is that when a site member has a question, they almost always need the answer right away, so they can complete the task at hand.

A better solution is to provide sites with fast, easy access to the information they need. This should take the form of an information access platform that consolidates the most relevant and updated documents and information on a web-based platform that’s conducive to quick searches. This is not to be confused with an eRegulatory binder or an eTMF platform, and unfortunately, few sponsors deploy a true information access platform.

As Artificial Intelligence becomes mainstream, it’s possible to deploy an AI platform that is specially built to provide fast, accurate answers to study-specific questions. There are many provisions that must be built into this solution so that accuracy is closely monitored and strictly reinforced. Also, the possibility of “AI hallucinations” and other creeping dysfunctions must clearly be eliminated from any AI solution. But the potential of providing study sites with immediate answers has tremendous value, and as AI technology rapidly evolves into a reliable tool, the time has arrived to deploy an AI solution.

Empower sites via technology.

The history of eClinical technology had been double-edged, with many platforms adding to site burden rather than reducing it. Clearly, the challenge is to provide sites with digital tools that are intuitive and easy, while still harnessing the many advantages of information technology.

Unfortunately, too many eClinical platforms are designed to meet the needs of sponsors, with much less thought given to sites. Many platforms are powerful, versatile and massively functional, but they are also dense and complex, requiring hours of training just to use. This has resulted in frustration and resistance among site users.

A better approach is to deploy eClinical platforms designed to meet the needs of sites. A “site-first” approach means every platform should make work faster, easier and more productive for sites, with a zero-training design goal. If this can be done, improvements in work quality and data capture are practically guaranteed given the nature of digital platforms.

There are many opportunities to innovate even further in the use of eClinical platforms, but too often such innovation adds to trial complexity, whereas the over-riding goal should be to streamline workflows and lower the burden placed on sites. Site-first eClinical platforms, as friendly as they are powerful, are an important win-win in the competition for site preference and patient enrollment.

Motivation is foundational.

Study sites are comprised of people, not machines, and it’s critical to win their hearts as well as their minds. Sponsors must appeal to the scientific curiosity of medical professionals and stress the altruistic human health mission of each trial. Sponsors also need to continually impress sites with their commitment to deploying reasonable study designs, to providing the resources necessary for sites to succeed, and to feedback mechanisms that make it clear that sponsors listen to sites.

It stands to reason that sites will develop a strong preference for sponsors who understand the challenges that sites face, and who demonstrate that they are a committed partner. Through effective communications and practical support, sponsors can become preferred partners, and this is a sure path to winning the competition for patients.

 

About MedPoint Digital, Inc.

MedPoint Digital, Inc. partners with biopharma companies to deploy virtual pharmaceutical meetings and advanced portals that produce unique value. Our goals are to lower costs, improve quality and expedite timelines with digital platforms that transform key areas of clinical operations, commercial objectives, and study site tasks.