Optimizing Clinical Trial Management: Enrollment, Administration and Participant Experience

Highlights from the May 2020 SRAI International Webinar

I recently gave an exclusive presentation for members of the Society for Research Administrators International highlighting clinical trial processes related to participant enrollment, study administration and the research participant’s experience.  Having been involved with academic medicine for 27 years, I shared process improvement activities I’ve personally been involved with as well as novel trial management trends we’re seeing, especially in response to COVID-19.

The overarching theme of the webinar was “the imperative to think differently” and covered new ways for managing trials to optimize efficiency, which of course are needed now more than ever.  Just a few months ago, many of us had no idea the preeminence the clinical trial industry would assume as a result of COVID-19.  But suddenly, solutions to support remote work structures while maintaining study operations as fully as possible became critical.  In addition, emphasis on “speed and efficiency” in the drug development and evaluation process became magnified.

The webinar began with a fundamental question that I also ask of you: “How does an organization adapt to reengineering and process improvement in general and in what areas should they focus?”  

Below are a few areas discussed:

“Create a Structure” for Process Improvement Within your Organization

A successful approach for process improvement, begins with “an assembled team,” a dedicated group that meets on a continuous schedule (at least monthly) with a clear purpose and focus on process improvements. We asked the webinar attendees if they had a clinical research improvement group and a staggering 60% said that they didn’t have one or weren’t aware of one at their research institution.

Process Mapping to Support a Comprehensive Digital Strategy and Identification of Improvement Areas

Once the team is established, completing a workflow “process map” of the sequential steps in conducting a clinical trial at your organization can be illuminating.  Of particular importance is identifying “bottleneck steps” – steps that are manual, paper-based, or generally problematic.  This “process assessment” allows the team to develop a comprehensive digital strategy to assess technology gaps and manual areas to potentially make digital. We also conducted a live poll regarding process mapping and just 20% of attendees have an overall digital plan.

Once you’ve put a team and process in place, it’s essential to understand what you’re solving for – before introducing any type of technology to your organization. Common clinical trial challenge areas applicable to all organizations include:

Participant Recruitment

A basic question facing all studies is “how to make potential participants aware of a trial?”  In my opinion, the most important factor whether an individual decides to participate in a study is whether their doctor communicates the study opportunity. I encourage you to assess whether or not you have a good process in place for this communication or to identify ways to hardwire that process.

A second, recruitment-related best practice at large institutions is leveraging the electronic medical record (EMR) for participant recruitment.  Many EMRs have an “Opt-In for Research Identifier” to identify individuals who consented for research participation opportunities who meet the inclusion criteria.   Using the EMR is a great, new best practice to leverage.

General Research Administration Efficiency Opportunity Areas

Additional areas of efficiency include optimizing trial feasibility assessment, managing study coordinator workloads, IRB efficiency and commercial IRB consideration, and Medicare Coverage Analysis streamlining.  These are all process improvement areas that may be uncovered during the process mapping activity.

A final area that can potentially improve accrual, retention, and efficiency and becoming increasingly common, is hybrid or decentralized trials.  This involves participant study visits conducted through remote video or telemedicine technology, electronic device and data capture systems, and remote informed consent and digital signature systems.   Remote technology offers great flexibility and convenience for both study participants and staff and is clearly the wave of the future.

Participant Experience

The most important person of all in a clinical study is of course the research participant. We need to think about their needs and their experience when they participate in a trial.

On the webinar, I suggested that listeners think about the participant and their needs “like family.” What are important areas to support when their participating in a trial? Here are a few to consider:

• Understanding the Study and Medications – At the top of the support list is assuring a clear understanding of their illness, what the study treatment is intended to do, how the treatment might make them feel, and possible side or adverse events.
• Participant Communication – Systems for ongoing communication (to reinforce medication adherence, reporting adverse events, and providing upcoming study visit reminders) can be useful in staying in touch with patients during a trial.  Leveraging the EMR for these communications and text or email reminders (e.g., available thru the ClinCard platform) are best practice technologies that exist to support this.
• Transportation Challenges – Can participants get themselves to study visits independently? Or are there rideshare services that make it easy so participants don’t have to navigate traffic, hospital parking, public transportation, and “way-finding” on campus. The single greatest reason why a participant chooses not to enroll in a study is convenience.   You must make it easy!
• Expense Reimbursement and Participation Payments – At completion of a study visit, what is the method to reimburse the participant for out-of-pocket expenses for: gas, parking, tolls, bus, subway, hotel, air, etc., how long does this process take, and in what form is the payment? Also, if the next appointment is a remote, virtual visit, what system will be used for payment?  Do you have a technology in place, such as ClinCard, to enable remote payments?

These are some of the possible areas to consider when managing the participant experience and clinical trial management overall in recognition of the critical imperative to think differently.