Bridging Research and Clinical Care

This past March, our survey partner SCORR Marketing launched its first conference called Bridging Clinical Research & Clinical Health Care (

https://www.bridgingclinical.com/

). The event highlighted the need, as well as the avenues taken by the presenters, on clinical research as a care option, which brings research closer to patients in the care continuum. The event broke down sessions into Technology, Regulatory, Patients, and Processes, and covered the myriad of challenges and opportunities for organizations to start thinking outside the box in each of these areas to meet this greater need in the overall healthcare system.

Over the summer, Applied Clinical Trials and SCORR Marketing took the core focus of the event closer to our audience with the Bridging Clinical Research and Clinical Health Care survey. The response to the topic was very positive, and top top-level insights on the respondent data are shared ahead. The full report is downloadable here.

The inherent flaw with this survey, of course, is that it was only distributed to a clinical trials audience. Therefore, there would be a bias toward the interests and ideas related to this industry vs. healthcare. If we were to poll a healthcare audience, we may have received a different perspective. Suffice to say, most respondents are aware that both clinical research and healthcare are very entrenched in their procedures and ways of operating. In addition, the clinical trials arena has a higher-level of regulatory scrutiny in regard to pharmaceutical drug development.

Almost half of the survey respondents were director level and above, and the other half manager and below, so

there was a balanced representation between the decision-makers and those executing at the day-to-day functional level.

Moving to the Process piece, respondents felt that the greatest challenge in strengthening the connection between clinical research and care lay with gaining buy-in from healthcare providers, with 30% believing so. This is echoed in the chart to the right, which found hospitals and physician practices/networks the top two least likely organizations to work on integrating care. The outlier would be integrated delivery networks, which are larger regional health systems that incorporate hospitals, practices, and community health services. The next two leading challenges cited by respondents in strengthening the connection between clinical research and care were improved integration between the clinical research and clinical care groups, at 28%, and developing patient-centric practices, at 18%.

There are potentially many avenues to address these challenges, through formal for-profit collaborations, or informal one-off collaborations, for example. Though we didn’t inqure about profit motive in the survey question, 42% of respondents said their organization has an initiative to increase collaboration between research and care. Another 14% are in the planning stages, 32% are not planning at all, and the remainder are unsure of their company’s plans.

However, if industrywide incentives were offered in certain areas, respondents said on a scale of 1-10-most scored at an 8-9 or almost equally-that the following would encourage the integration of clinical research and clinical care:

• Data sharing

• eConsent simplification

• Education and training for physicians and patients

• Multisite institutional review boards (IRBs)

• Patient participation in clinical trials

• Physicians referring patients into clinical trials

• Stakeholder collaboration

The first two choices above are related to technology, so how did respondents rate technology required or used to bridge clinical research and clinical care? On a scale of 1-10, respondents rated that their company’s investment in IT infrastructure to achieve healthcare interoperability at a 6. And while much is made of mHealth to improve patient engagement, facilitate remote data collection in trials, and enable more patients to participate in research for less on-site visits, only 26% of the respondents said their trials incorporated wearables or devices. The majority (58%) said their studies did not include those technologies, and the remainder were not sure.

To the question, “How does your organization currently use digital technology and data in clinical trials?” respondents answered:

• To coordinate source documentation for regulatory

• body compliance; 47%

• To identify eligible patients for studies; 45%

• To reduce time from data acquisition to data reporting; 44%

• To monitor real-time performance of sites; 36%

• To make it easier for patients to participate; 32%

• To design studies for patients; 25%

• To simplify physician referrals; 21%

• None of the above; 14%

• To leverage artificial intelligence; 13%

Clearly, the winner in a more integrated clinical research and clinical care ideal would be to simplify physician referrals, make it easier for patients to participate, and to more easily identify the right patients for studies.

Finally, much also is made of integrating electronic health record (EHR) data into the electronic data capture (EDC) record or vise versa. That area, in our survey, represented the biggest challenge in strengthening the connection between clinical research and clinical healthcare data. Developing standards for EHRs and EDC came in at 28%, ensuring data security at 23%, and developing data mapping tools for EHRs and EDCs at 22%. You can view more regarding the EHR and EDC topic here.

The survey also included information regarding protocol design, degree of involvement and progress on education and initiatives around research and care integration, and the benefits of increasing collaboration, so we encourage you to download the survey.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline