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Background:

Our client was a Clinical Operations team that had encountered a number of challenges during their Phase 2 trials. As their Phase 2 trials neared completion, they wanted to ensure that their Phase 3 trials would be completed on time and within budget.

The challenge: Members of the client’s internal team had differing perspectives on what they believed they needed to modify in order to make the Phase 3 trials run more smoothly

Clinical SCORE Approach:

  • Clinical SCORE met with the clinical team to obtain their thoughts on the challenges that might have hindered the Phase 2 trials.
  • Clinical SCORE drafted a protocol for a “quality improvement project” for IRB review and exemption. A single-blind study, it included informed consent and discussion guides for interviews with participants from the Phase 2 trials, including patients, study coordinators and investigators.
  • Clinical SCORE compliantly interviewed patients, study coordinators and investigators within days of database lock.

Clinical SCORE’s team has extensive experience working with IRBs and can serve as principal investigators.

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Analysis:

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Clinical SCORE’s research identified three major factors that hindered patient recruitment and trial completion in the Phase 2 trials:

  1. Exclusionary criteria eliminated 35% of patients that PIs felt were fully qualified for the trial. Although those criteria were considered necessary to reduce risks, much of the risk was discharged in a 2a dose-ranging trial—but not reflected in revised exclusionary criteria for phase 2b.
  2. The study required patients to return used discreet lab samples to the investigator site at each visit.  Women complained of poor discretion in the return process, causing higher than expected withdrawal.
  3. Both patients and staff reported that site visits were too frequent and lengthy.  Women who worked had to take too much time off from work to participate.

Results:

The client’s Phase 3 protocol addressed all three issues identified by Clinical SCORE:

  • Although still strict, recruiting criteria were relaxed to enable faster recruitment.
  • Patients were given a more discreet, mail-based means of providing the sanitary napkin samples to the lab.
  • The team consolidated the in-person clinical site appointments to complete more during each visit.
    • One-third of the appointments were changed to telephone appointments, eliminating the need for time away from work.

The Phase 3 trial is progressing according to forecast, and faster than the projected timeline based on the Phase 2 trial experience.

Table 4
Get unbiased feedback from trial participants on how to optimize trials