Best Practices for Investigator Site Support

Any clinical research professional will tell you there’s no silver bullet for ensuring clinical trial patient recruitment success. As with so many things, it takes a mix of operational elements and execution know-how. At Clariness, we refer to these fundamental elements as the “three pillars:”

  • Robust technology to automate and streamline the moving parts of patient outreach, pre-qualification and site referral
  • Digital patient outreach, supported by in-depth profiling and targeted media
  • Investigator site support, to help reduce the labor burden on sites and promote enrollment and patient retention efforts

Most patient engagement and recruitment efforts get 1 or 2 of these right, but enrollment success is critically dependent on the integration of all 3 pillars. Below are some of our best practices for investigator site support:

  • Feasibility

More often than not, armed with the right data, you can predict the chance of success at any given site before the study starts. Advanced feasibility tools confirm site-level patient populations, verify enrollment projects and help determine the best mix of sites and countries. At the patient level, you can identify your population, determine their eligibility for a specific trial and explore their willingness to participate.

  • Refer Only the Most Qualified and Motivated Patients to Relevant Sites

A targeted campaign can be customized to site-specific levels. The conventional method of churning high volumes of patient referrals to sites is likely to only increase their workloads. A focus on the most qualified patients, filtered through a two-step screening process, minimizes site staff labor burden, reduces the screen failure rate and increases the chance of completion for each of these patients. (Not to mention, in-depth screening goes hand in glove with today’s complex protocols.)

  • Robust Technology

Investigator portals provide the connectivity to enable site staff to coordinate and efficiently manage all of the moving parts of clinical trial patient recruitment. Our ClinLife® platform model connects every stage recruitment and enrollment, beginning with a potential participant’s response to an outreach campaign through patient randomization. This system provides the step-wise ability to track enrollment progress, and provide detailed reporting to sponsors.

  • Engage Sites

The low-tech side of site support involves regular phone calls to each site. Spend some time upfront to determine communication preferences, and follow up with 1:1 communication. Weekly check-ins not only keep a trial top of mind; anticipated status updates also tend to bring a higher degree of accountability. If it’s a global study, make the environment more welcoming by assigning a dedicated site support staff who speaks the same native tongue of the participating site.

Individual site support needs will vary significantly depending on their staffing resources, experience levels with clinical research, types of studies conducted in addition to many other factor. Ad hoc support can take the form of helping with screening, scheduling appointments or other forms of patient outreach.