Study Startup Process Map Helps Sites Align with Sponsor Expectations
Best practices for avoiding trial startup delays are available in a new publication from the Association of American Cancer Institutes (AACI) that offers a process map intended to improve alignment between sites, sponsors and CROs on study startup expectations.
The AACI white paper details multiple recommendations of the association’s 33-member Corporate Roundtable Trial Activation Task Force, which included cancer center personnel involved in trial activation, trial activation leaders from the sponsor side and a National Cancer Institute representative.
The task force highlighted communication as a main hurdle to study activation due to sponsors’ and sites’ conflicting expectations about timelines.
“There was a disconnect between when sponsors started the activation timeline internally versus when sites started the activation timeline,” the task force reported.
For example, while sponsors considered the time it takes to discuss and review protocols before submission to an institution’s review and monitoring committee, an often months-long endeavor, site timelines did not factor this in, AACI found. In addition, new policies enacted in response to the COVID-19 pandemic and workforce shortages have added additional delays to the time between a protocol’s arrival at a site and its addition into the site’s startup process.
To align expectations, the task force recommends sites provide sponsors with a process map detailing the site’s specific startup workflows and timelines.
The process starts during the site qualification visit or shortly after site selection, with the site, sponsor, CRO and all other relevant stakeholders participating in a multidisciplinary “kickoff” meeting to develop site-specific startup plans and decide on proposed completion dates, walking through the roadmap’s four critical activation areas: regulatory, contracts, budgets and clinical operations.
For example, a site would go through the budget section and enter its anticipated times for receiving the budget template, building study calendars, conducting the Medicare coverage analysis, sending the first draft site budget to the sponsor/CRO and finally reaching full agreement on the budget for the trial.
Once this process is complete, the site should share this completed roadmap with the sponsor.
“This permits sites to determine if their startup process allows adequate time for enrollment and the sponsor’s ability to proactively address obstacles to provide for efficient startup timelines,” the white paper reads. “Transparency in the necessary steps allows teams to focus on rate-limiting steps along the timeline and aim to complete as many steps as possible in parallel.”
The white paper also includes best practice recommendations on contract negotiations and trial budget development.
On budget development, for instance, the task force sought ways for cancer centers and sponsors to streamline the process of hammering out a trial budget to take less than a month. Multiple recommendations were put forth to achieve this, including:
- Have study packages include, at a minimum, the final protocol, lab manuals, an investigator brochure and a budget shell;
- Establish a 25-business-day goal for completing budget negotiations, which can be cut down by an estimated five to 10 days if the sponsor provides a trial-specific national coverage analysis that specifies all procedures that are research and not standard of care;
- Identify a key member at the site and the sponsor to serve as decisionmakers on budgets;
- Use existing performance measurement tools to track and improve efficiency of the budget process;
- Map out the site’s specific budget approval process as organizational structures vary and identify all hindering and/or unnecessary steps to be addressed;
- Set expectations with sponsors on realistic budget turnaround times;
- Work to prepopulate the sites’ study budgets as much as possible, such as by providing sites with a packet of known and fixed costs; and
- Consider standardizing fees, which is likely unrealistic but could accelerate budgeting timelines by 50 percent or more.
Read the full white paper here: https://bit.ly/440gXjf.
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