TKL Research - A weight off your mind

Milena Reckseit, global director, patient recruitment at TKL Research, discusses how recruitment management plans ease the pain for clinical trial companies attempting to meet patient enrolment goals.

Patient recruitment advertising for clinical trials is often viewed as a last resort, after sites have combed databases, study coordinator incentive programmes have stopped working, and panic has set in among the project management and sponsor teams. The difference between successful, on-time enrolment and missed deadlines is comprehensive planning. Here is how TKL's comprehensive recruitment management plan (RMP) - in which advertising is a component - helps to mitigate risk and increase the likelihood of meeting patient enrolment goals.

TKL Research starts with a thorough vetting of site feasibilities to determine whether:

  • inclusion/exclusion criteria may be difficult to accomplish
  • the target patient demographic may be difficult to reach enrolment metrics indicate that site-only initiated activities may be insufficient
  • high screen failure rate may necessitate a larger pool of potential patients
  • sponsors require a shortened enrolment timeline

TKL has successfully managed dozens of RMPs for multicentre clinical trials using the following comprehensive model.

Define target enrolment projections

Building on historical reference points including screen failure rates, similar inclusion/exclusion criteria, previous recruitment metrics, time of year and media conversion rates, target enrolment projections are developed along with a media budget. With TKL's approach, the projected media budget is solidly linked to the study criteria and the number of projected, randomised subjects to be supported from the RMP.

Identify target subject and media audience

There must be a differentiation between the broad patient population noted in a protocol and the target media audience for which advertising efforts will be geared. A profile is developed for the patient who is most likely to respond to advertising efforts and qualify for the study. By creating a media strategy that targets a subset of the patient population based on gender, age, media usage habits,and geographic considerations, recruitment risk is mitigated.

Create direct response objectives

Using principles of direct response, a site-specific media mix is formulated to ensure the most efficient coverage of a site's geographic area. Additional techniques target specific days of the week, times of day, type of programming and frequency of message. With this approach, a customised, spot market media plan for each site reaches the target audience.

Manage performance

In order to maintain the most cost-effective RMP and deliver the highest performance results, performance metrics are analysed against projected metrics using a behind-thescenes, dynamic electronic tracking system. Because the data is gathered and available in real time, this provides the ability to make timely, impactful decisions to redirect media resources, close media campaigns and project enrolment completion, thus promptly mitigating risk. Individual sites benefit as well, as their performance metrics are also analysed, and site enrolment forecasts help to drive them to enrolment completion.

Build relationships

Recruitment and project management team members must establish good working relationships with the study coordinators. Timely communications and ongoing support are essential to accomplishing this. The teams are responsible for eliciting and developing a site's involvement as well as engaging the study coordinator and creating a sense of shared responsibility.

Manage budgets

The RMP budget is most effectively managed by purchasing media within a specific contractual framework and ongoing analysis of its performance metrics. Combined with relevant feedback and timely communications with sites, this approach allows real-time decisions and efficient use of the budget.

TKL's recruitment management team uses this RMP model that is clinically grounded in protocol criteria. It helps mitigate risk and meet enrolment goals through solid linkage to study criteria, long history of recruitment success, defined target audiences, and closely tracked performance metrics. The goal of any RMP should be to effectively forecast a study's enrolment needs and then develop comprehensive, cost effective recruitment and advertising strategies and tactics to support performance analysis, manage the budget and timelines, and meet enrolment objectives.

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