Helping Specialty Practices Bridge the Clinical Research Gap

Participating in clinical research offers several important benefits for specialty provider practices. It can generate new revenue opportunities, expand the potential patient pool and even help to ensure compliance with new and evolving regulatory mandates. Clinical research can also play a key role in helping practices maintain competitive differentiation. And in today’s complicated marketplace, any opportunity to stand apart is an important one.  

Yet while many practices have recognized the advantages of participating in clinical research, there are inherent challenges that can undermine the feasibility of doing so. In one survey, physicians cited several reasons for not taking part in more research endeavors, including:

• A lack of opportunities
• The inability to meet the required time commitment 
• Inadequate personnel support and resources
• Administrative burden[i]

Specialty practices must also contend with consistently low patient participation in clinical research. For example, one study found that only three percent of adults with cancer enter clinical trials[ii] — a figure that has remained steady for two decades. In recent years, this has been exacerbated by a continued reduction in the size of the targeted patient population resulting from a focus on niche and/or rare conditions, requiring increased use of biomarkers and companion diagnostics to qualify patients.

Low participation rates and increased potential indications have helped to evolve the research continuum itself, i.e., the shift from traditional randomized clinical trials to pragmatic clinical trials conducted in real-world settings. There has also been an increase in prospective patient registries and the extended monitoring of trial patients, along with an increased focus on patient-reported outcomes. These have become critical inputs for the quality and value assessments associated with shifting reimbursement methodologies such as the Medicare Access and CHIP Reauthorization Act.

But the news isn’t all bleak for provider practices seeking to become more involved in clinical research. Applying a little of the same innovative spirit and forward thinking that has propelled advancements in other areas of healthcare can also help cure what ails existing research study processes.

As a result, at least one coordinated initiative has been introduced to help bridge the gap between aspiring clinical investigators and the opportunities that may be eluding them. It does so by focusing on five key areas:

• Identifying qualified research sites based on existing patient populations, not just research expertise.
• Implementing technology that enables patient identification and selection at the point of care, including integration with electronic medical records and pre-identification of patients already being treated by the practice.
• Enrolling patients from a broader network than just those participating in trials to enable practices to compete against large academic and hospital institutions.
• Leveraging technology to facilitate patient and caregiver participation. (As patient-reported outcomes become a bigger component of all research activities, it is increasingly important to implement technology to facilitate collaboration with patients and/or their caregivers).
• Enabling monitoring of patients’ post-study participation and helping them understand how their participation supported the approval and/or expanded access of that medication.

Based on these tenets, the program is designed to simplify and streamline the process of helping practices identify, qualify for and enroll in sponsored clinical trials. It establishes a non-exclusive network that allows practices to join other specialty providers to locate the research opportunities that best suit their needs, including clinical trials, investigator research, prospective patient registries, retrospective outcomes research studies and panel studies. Practices provide access to de-identified patient information which is then made available for site feasibility analyses based on specific study criteria.

This centralized approach, which is fully regulation-compliant and driven by cutting edge technology, is designed to allow patients most in need of study participation to gain access to it as efficiently and affordably as possible. It also seeks to remove the obstacles practices face by significantly lowering administrative overhead, time commitment and associated costs. As part of the program, participating practices and their physicians will receive support such as contract management resources, ongoing research education and training and grant submission coaching.

Perhaps most importantly, the program helps both practices and life science organizations gain insight into opportunities and patients, respectively, that they would otherwise be unaware of.

Given the increased prevalence of specialty care, it is critical to find ways to match patients to the innovative therapies found in clinical trials, and to connect provider practices with key research opportunities. In a way, it’s about access and a program that can provide that to patients and providers who otherwise don’t have it is both timely and necessary.

At the same time, as healthcare continues its trajectory toward eliminating siloes and facilitating collaboration among otherwise disparate entities, a program of this nature goes a long way toward aligning stakeholders and incentives. It is something of a healthcare holy grail in that each participant stands to gain with little or no compromise or downside; a true and rare win-win all around.

_References:

_{[i] Taylor, H. 2004. Most physicians do not participate in clinical trials because of lack of opportunity, time, personnel support and resources. Harris Interactive: Health Care News 4(9):1–8.}