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Todd Johnson, MD, senior vice president, Optum® clinical research, offers perspective into the benefits provider organizations gain from participating in clinical research. The barriers that inhibit many provider organizations’ increased involvement are also detailed.
 

Participating in clinical research is readily acknowledged as important to most providers’ patient health-focused mission. As physicians, nurses and pharmacists, we are taught early on the importance of advancing the science of our chosen field. 

However, many provider organizations face a number of pain points in doing so. This is particularly true when it comes to the disruption clinical studies can cause when inserted on top of the fast-paced environment of care delivery, which needs to function as a well-oiled machine.

And yet, we need more providers — and patients — to participate in clinical studies. 

As publicized widely in the popular press, we are woefully under-resourced in both numbers of physicians and numbers of patients to pursue the research required to develop new treatments. We are seeing this especially in areas like cancer and Alzheimer’s disease.

Furthermore, we face a dangerous homogeneity in the patient populations that participate in research today. It begs the question as to whether the results of many clinical trials are relevant to underrepresented populations.

Understanding the reasons why some provider organizations frequently engage in clinical research and the challenges that may limit others from participating is the key to expanding involvement. And, ultimately, enhancing patient care.

Optum recently ran a major market research study to assess providers’ primary motivators — and their key detractors — from participating in clinical research. This market research identified opportunities to use data and technology to increase participation rates across the United States.

 

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Identifying providers’ primary motivators for involvement in clinical research

It shouldn’t surprise us that providers express both patient-centric and business-oriented motives for participating in clinical research.

These include internal and external benefits to the organization and quality of care benefits for both patients and participating physicians. The four most often cited reasons for participating in clinical research studies were:

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  • Reputation. Providers want to be known — by patients, by payers and by other providers — for their knowledge of, and ability to deliver, cutting-edge treatment. Reputation impacts patients’ decisions on where they seek care.
    Payers will route patients toward provider organizations known for delivering better care, enhanced by reputation for experience and access to innovative approaches. The same is true of other providers. Simply put, reputation drives referrals.
  • Access to new therapeutics. By participating in clinical trials, providers are able to offer their patients access to new therapeutics. This expands their care options and in some trials, enables a greater level of personalized attention, particularly in important disease areas such as cancer.
  • Physician engagement and retention. Clinical research essentially puts an organization “on the map” for various types of care and can help enhance the perceived prestige of participating physicians.
    This can be especially important for recruiting new talent to provider organizations that want to be known for and protect their reputation as cutting-edge innovators.
  • Downstream revenue. Industry-sponsored trials are typically well reimbursed and promoted. Participation has been shown to help support and sustain patient care infrastructures, as well as attract foundations and other philanthropic funding.
    Organizations also clearly see enhanced reputation and physician engagement and retention, as important drivers of revenue, likely at levels higher than the direct financial impact from trials themselves.
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Understanding the key barriers to clinical trial participation

While there are data-related, political and strategic reasons that affect participation in clinical research, two key pain points have emerged as the most significant barriers: disruption in the traditional practice at the point-of-care and technical challenges related to patient recruitment.

Pain point #1: Clinical practice disruption

Historically, randomized controlled trials have been designed to create evidence using the most scientifically robust markers of efficacy and safety.

Some of those markers are simple, everyday values also used in a typical patient encounter, such as blood pressure and heart rate. 

Others, especially for diseases that are currently in a high innovation cycle, are not routinely used at the point of care, such as detection of minimal residual disease in cancer. 

Performing unusual testing is just one example of the challenges faced within the clinical practice setting when trying to overlay clinical research on top of day-to-day clinical practice. The most commonly expressed challenges were:

  • Extra time and effort. Trials do not readily fit into the normal course of care. They require extra time and work for physicians and staff, which interferes with their primary focus on providing day-to-day patient care.
  • Duplication of data. Data is already entered into the electronic medical record (EMR) through the regular course of patient care, but physicians, nurses and other care professionals must re-enter that data in electronic data capture (EDC) systems and/or case report forms (CRFs) as part of the clinical trial.

Pain point #2: Patient recruitment

Currently, most organizations face challenges enrolling the number of patients needed per trial. 

In fact, 11 percent of sites never enroll a single patient. Up to 40 percent of sites in any multi-center study under-enroll, and most trials end up needing to double the enrollment period to reach the recruitment target. There are multiple factors at play:

  • Planning and trial selection. Organizations do not have an efficient way to determine how many patients in their population would be eligible for a trial under consideration.
  • Patient identification. There are challenges in being able to efficiently identify specific patients who would be eligible for an active trial.
  • Awareness. Providers need better ways to make patients aware of a trial for which they may be eligible.
  • Screening and consenting. Issues effectively gaining patient agreement and consent need to be addressed to help providers more readily participate in trials.

Additionally, the issues with practice disruption and poor recruiting may have major organizational implications that affect participation in research:

  • Hard-to-meet accrual quotas. Each trial site may only have one or two patients, leading to high carrying costs.
  • Extended trial timelines. Recruitment issues cause extended trial timelines, adding costs and potential friction in the provider/sponsor relationship.
  • Credibility loss. Difficulty in recruitment may make sponsors more likely to look at other sites that can reliably recruit for a new clinical trial.

Summary: Address the challenges and encourage greater participation

Clinical research is an essential element of our health care system — without it, we cannot ensure the safety and efficacy of new therapies and major advances in health care technology.

For example, the therapies and advancements we’ve seen in hepatitis C virus (HCV) infection would come to a screeching halt.

Provider organizations recognize the many important altruistic and organizational benefits that result from participating in clinical research. 

Our market research suggests that, in order to meaningfully increase their numbers, we must find new and creative ways to reduce the disruption that trials cause in clinical practice. We need to find new ways to make it easier for sites to perform trial feasibility and patient recruitment.