Numerous factors contribute to the overall success of a clinical trial. The measurement of what constitutes success is also very dependent on the clinical trial itself, however, a significant component as part of any trial’s success is time.
From the start of protocol design, planning visits and procedures, defining the effort of the site staff and the duration of a participants visit, time plays a critical role. As the trial progresses, timing required to complete regulatory and budget/contract requirements at the site level during the start-up phase can impact the targeted start date of screening participants.
Budget and contract negotiation is often considered a “bottle neck” in the timing of site activation. Over the last few years, costs have risen significantly due to supply chain issues during the pandemic and followed by rising inflation rates. This rapid adjustment has created a spotlight on the challenges that come out of budget negotiation and then downflow impacts it has in the timing of a trial. When budgets are created based on rates that are no longer considered representative of current fair market value it essentially moves the starting line back. It creates a situation where there are more rounds of negotiation. Sponsors are having to assess their study budget holistically to manage expected spend based on the response of those negotiations, all while assessing and ensuring what they are agreeing to in terms of cost is in no way incentivizing or coercive. These delays cause sites to become frustrated, and at risk of losing possible screening opportunities.
A robust budget representing current fair market value, accounting for all protocol requirements, time and effort, fosters a clear understanding of the cost required for the sites to conduct the trial. Furthermore, sponsors benefit from a realistic planning study budget in relation to investigator grants, negotiation teams are prepared to negotiate in good faith in a timely manner, and sites are confident that their costs align optimally to the operating costs to conduct the trial on site. Once screening begins, achieving enrollment goals impacts the timing and ability to review data and analyze the safety and effectiveness of the investigational product.
Trial enrollment and retention has proved to be challenging.
Time and financial burdens can impact a participant’s willingness to join or remain in a trial, and by default, these burdens can have a disproportionate impact to primary caregivers and individuals within certain socioeconomic demographics. Protocols have notoriously become more complex, with direct impact to the participants where their time spent at the site increases, they must consider time away from work, from family and any caregiver support required to attend the trial visits. Participants are key stakeholders to the overall outcome of clinical trials and should be considered as such, their time spent, and expectation of travel should not be an afterthought.
This time and financial burden should be considered early on by the sponsor and CRO. Accounting for ways to limit and mitigate some of this burden by leveraging tools and services to support participants can contribute to the overall trial success, broaden the diversity of the participant population, and assist in eventually bringing investigational products to market. Understanding and accounting for travel costs, services to reduce the burden on both the participant and the site to manage, and differing modalities to provide flat rate payments or reimbursements allowing for a reduced time to payment all effect the adoption and success of a trial.
Taking these things into consideration coupled with the rate at which the volume of clinical trials is outpacing population growth (2012 to 2022, the global population increased by roughly 11% whereas the volume of clinical trials during that same time period increased by approximately 70%), it would be advantageous if sponsors and CROs work early on to help address, plan for, and mitigate the issues they can control. Having investigator budgets that are closely aligned with current costs, accounting for the complexities of the protocol both from a cost and timing perspective, plan for the ways in which they can support participation by helping to reduce burden while remaining compliant will prepare the trial for optimal success.
Let Greenphire Help.
Greenphire isn’t just the market leader when it comes to participant convenience, but also in optimizing clinical trial start-up. Through our investigator budget negotiation and fair market value solution, EnvisiXTM, industry sponsors and CROs can eliminate the guesswork from the budgeting process.
Learn more about our suite of patient engagement and financial automation solutions for clinical research, or request a demo today.
