Meeting planned enrollment timelines is a challenge in many clinical trials. Studies of novel products for treatment and diagnosis of women’s health conditions are no exception. Based on years of experience in women’s health clinical trials, the Health Decisions Clinical Affairs group has developed a methodology that has successfully accelerated start-up in studies in a variety of women’s health indications. In brief, key elements of the methodology include:
- Simultaneous activation of all or almost all investigational sites
- Performing limited feasibility with Key Opinion Leaders and high-enrollers
- Streamlining full feasibility
- Establishing timelines and expectations early [e.g. at the Investigator Meeting (IM) and the release of the Investigational Product (IP)]
- Utilizing sites that can use a central Institutional Review Board (IRB) wherever possible
- Developing a Clinical Trial Agreement Negotiation “Playbook”
- Waiving Site Initiation Visits (SIVs) for IM attendees.
The Benefits of Simultaneous Site Activation
Achieving simultaneous activation of a high percentage of sites requires careful planning. However, the benefits justify the effort:
- Maximizing the effectiveness of the IM
- Increasing the flow of early feedback from sites
- Enabling deployment of lessons learned to actively enrolling sites
- Leveraging competitive enrollment
- Collecting meaningful early data on site performance.
Health Decisions’ Head of Clinical Services Kevin Bickford says, “The time and resource investment during start-up to bring up as many sites as possible on Day 1 is worth it.” Bickford also emphasizes the value of having early data on site performance. “Carefully selected site metrics provide the greatest benefit in studies that succeed in activating most sites simultaneously because the project team has an early understanding of potential performance issues across the study,” Bickford says.
Which Techniques for Accelerated Start-Up Will Benefit Your Study?
Techniques for accelerated start-up are not suitable for all studies but deliver substantial benefits in many trials, especially those that involve relatively common indications, a large number of sites and large patient populations. The scale of the benefits can be so substantial that Health Decisions recommends consideration of such techniques during the planning of almost all studies.