The start up phase of any clinical trial is critically important. It is during this stage where many questions need to be asked and (hopefully) answered. This is a time for full project team collaboration. Gaining alignment on the systems, processes, plans, tools, and vendors to be utilized is crucial. By spending time discussing these items and documenting plans, the project, and the project team, is best set up for success.
Complementing that, the start up phase is the right time to embrace a holistic risk management approach. Each project team member can play a valuable role in identifying and assessing risks, as well as developing mitigation strategies for those risks. Will this trial be challenging to enroll on time? If so, a project team might consider a centralized recruitment campaign or another kind of supplemental support for sites. Will protocol compliance be difficult to achieve given the nature of the study design? An enhanced training plan for both site staff and potential study participants may prove to be a worthy investment.
When we look specifically at the process and timelines for site activation, planning is similarly important. I firmly believe that no factor has a greater influence on trial enrolment than how quickly selected sites are activated. Maximizing each site’s opportunity to enroll in a trial is the key to on-time delivery of every successive trial milestone. Of course, it is not just about speed. Site activation must be approached with a high standard of quality, with a focus on ensuring each site is ready and motivated.
Site Activation Strategy
What should be considered when planning a successful site activation strategy? All the following should be assessed:
- Ethics committee / Institutional Review Board (EC/IRB) and regulatory authority (RA) requirements, including submission deadlines, meeting dates, and expected feedback timelines
- Requirements and timelines for other committee reviews, whether at a country or site level
- Customization of a study-specific Informed Consent Form (ICF)
- Essential document requirements
- Site contract and budget requirements, including negotiation and agreement execution timelines
- Availability of study-required equipment and/or supplies
- Site staff training
- Site staff system access, as applicable
- If applicable, investigational product (IP) availability and shipment expectations
- Site staff availability for a Site Initiation Visit (SIV)
Planning for Success
At Linical, the development of a Site Activation Plan is an important step to outline how the above considerations will be handled. This includes how to process changes to key study documents (e.g. ICF, site contract, budget).
While such a plan provides a roadmap for approaching the site activation process, things won’t always go as planned. Even though issues may arise, and delays incurred, planning creates a better foundation for a trial and puts a project team in the best position possible to adapt when something changes. The more a team has considered what could happen, they can prepare for how they would respond, and, in many instances, mitigate the risk up front. As Benjamin Franklin once said, “If you fail to plan, you are planning to fail.”
At a site level, motivation for participation in a trial remains highest when expected timelines are achieved. When sites are asked to wait on something outside of their control, they are left trying to fill an unexpected gap in demand for their time and resources. Often, sites will pivot to other study opportunities, depending on the length of the delay. When a study can be started as close as possible to the predicted timeline, sites are best positioned to be successful and thus more likely to enroll and deliver as expected.
An experienced CRO partner will have the skills required to map out an effective strategy for study start up and deliver on that project plan. Linical helps clients position their clinical trials for success from inception to completion, enabling clients to overcome obstacles, save valuable time and money, and reach their goals.
Author:
Aaron Sanford
Senior Director, Study Start Up