November 21, 2018

Why health systems and other providers are trying to make clinical trial enrollment easier

Daily Briefing

    Health systems, cancer centers, and other providers are collaborating to create networks intended to make it easier for pharmaceutical companies to use their facilities—and patients—to conduct clinical trials, Jared Hopkins reports for Bloomberg

    Drugmakers can spend years seeking patients for trials

    Pharmaceutical companies can spend years recruiting the appropriate patients for clinical trials, which are designed to test the safety and effectiveness of experimental treatments, Bloomberg reports.  

    According to Bloomberg, drugmakers often have difficulty finding patients to participate in clinical trials. The Cancer Research Institute estimates that just 3% to 6% of cancer patients eligible to participate in clinical trials end up enrolling in the studies.

    Before a clinical trial can begin, drugmakers also are required to receive approval an Institutional Review Boards (IRB), which are intended to protect patients' rights and safety. But depending on the design of the trial, a drugmaker might need to get approval from several different IRBs. For instance, if a drugmaker is seeking to perform a clinical trial at 40 hospitals, they could be required to get signoff from as many as 40 different IRBs.

    As such, pharmaceutical companies tend to choose large hospitals to conduct clinical trials because they would be subject to fewer IBR reviews and have access to larger patient bases.

    How providers are trying to ease the process

    But some providers are working to give drugmakers a different option for overcoming clinical trial hurdles.

    Hospitals, health systems, and other providers are beginning to band together to form organizations that can serve as a main point of contact for pharmaceutical companies looking to conduct clinical trials at the group's facilities. Such arrangements, Bloomberg reports, are subject to only one IRB review, as opposed to the standard process of getting one from each participating provider. 

    According to Bloomberg, Geisinger Health and five other health systems in New Jersey and Pennsylvania have established such a consortium.

    James Brazeal, Geisinger's chief administrative research officer, explained, "As a group we're stronger than just one. We're able to leverage that so we have more of an ability to participate [in clinical trials], so that we can attract some of the trials that we couldn't attract before." Geisinger Health's consortium, which will directly negotiate with drugmakers on behalf of the health systems, aims to direct 20% of clinical trials conducted at the health systems over the next year.

    In addition, more than 1,400 cancer physicians came together to create the US Oncology Network, a unit of drug wholesaler McKesson, which helped Johnson & Johnson with the clinical trial enrollment process for the company's myeloma drug Imbruvica.

    Jeff Sharman, a hematologist at Willamette Valley Cancer Institute and a medical director of hematology research for the US Oncology Network, said the network was able to help recruit and enroll patients in the Johnson & Johnson clinical trial in less than half the time it would have taken the drug company on its own.

    In another example, Sanford Health, which operates 45 rural facilities in North Dakota, is partnering with others to host 300 clinical trials. David Pearce, who directs Sanford's research, said Sanford's involvement in clinical trials helps drugmakers and patients.

    Consortiums could help make trials more profitable for providers

    According to Guidestar Research, which helps hospitals conduct clinical trials, centralizing the clinical trial enrollment process across hospitals also can make participating in trials more profitable for smaller providers.

    According to the Halloran Consulting Group, drugmakers can pay hospitals more than $10,000 per participant. Sean Walsh, managing partner at Guidestar Research, said, "We go to the hospital and can say, 'Hey there is a clinical trial sponsored by X pharmaceutical company that can help patients bring a new drug to treatment and can also help you with your bottom line and offset some losses in other areas'" (Hopkins, Bloomberg, 10/29).

    Learn more about why study design matters

    Been awhile since your last statistics class? It can be difficult to judge the quality of studies, the significance of data, or the importance of new findings when you don't know the basics.

    Download our cheat sheets to get a quick, one-page refresher on some of the foundational components of evidence-based medicine.

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