A Seller’s Market: Site budgeting in the time of COVID-19
By: Catherine Click, Greenphire-Director Clinical Pricing & Analysis
We are well into the global pandemic that has disrupted our professional and personal lives. This is a once in a lifetime paradigm shift – we have adjusted much of our day to day BUT where does clinical site contracting and budgeting fall?
This often-beleaguered, tedious process is essential to the launch of a clinical trial and COVID-19 studies are no exception. Sponsors and CROs cultivate a proprietary budgeting approach reliant upon industry benchmarking tools providing an anonymized view of historical industry costs and shaped by each unique Sponsor or CRO’s experience in the field. And then COVID-19 hit.
The industry needs a more agile, of the moment dataset reflective of key disruptions. Pipelines and portfolio planning have had to adjust due to COVID-19, but when will the investigator grant data catch up?
Site budgeting during this pandemic should be reflective of the risk to sites and their staff and patients who volunteer to participate. Risk equates to cost on every level.
Regulatory authorities who enforce standards for Sponsors and CROs to avoid incentivization of sites and participants are now inundated with COVID-19 related activities – and often won’t review anything outside of COVID-19. Sponsors and CROs are competing for a limited number of sites globally to run their COVID-19 research. The risk involved to sites and patients plus the law of supply and demand will drive investigator fees exponentially higher (as they have been) until a vaccine and broad reaching therapy are proven safe, effective, and approved for use. These regulatory authorities will eventually catch up and issue revised guidance (if they haven’t already) along with resuming their watchdog responsibilities to ensure compliance with regulatory standards.
In the interim, how can Sponsors and CROs address the unique nature of site budgeting and start-up in this global pandemic? If they haven’t already done so, I recommend a switch from negotiation via procedure cost to visit-level (which also provides coverage downstream in case of the inevitable protocol amendment), and redefining parameter-setting with a mathematically-driven “upcharge” for COVID-19 to offset the gap between industry benchmarks and current state. This will drastically reduce time to agreement with sites as negotiating individual budget components (i.e. the cost of an ECG) will take less time. Standardization and documentation to support budget defensibility are still key components of site budgeting. Regulatory authorities will resume – perhaps more intensely – their oversight of investigator payments once the initial sprint to Phase 3 research has passed. Ensure your budgeting practices and contracted rates still meet documentation and justification standards to maintain consistent audit readiness in case regulatory authorities pick up oversight activities.
Start-up fees have been trending upward globally for years, however, the data in the current industry benchmarking tools lags behind with low and outdated costs. These fees are a significant cost driver of clinical research because independent of a site’s enrollment or successes post initiation, Sponsors are on the hook to pay these fees. Sponsors and CROs have realized the misalignment of administrative fees in benchmarking tools against real-world experience in fully-executed site contracts. During the current state of the world, sites are pushing for even higher non-refundable start-up fees, driving costs and ensuring that their initial efforts are covered above and beyond what would normally be required.
Elisa Toma, CEO of CTA Focus, an international clinical site contracting company with a global presence, identifies this as a trend in current global contract negotiations. “From the site budget perspective, we note a more focused approach toward the start-up fees; sites make sure they are reimbursed for their start-up activities, regardless if a study is or is not started in their center.” Sites are also using discretion in choosing which study or studies to participate in depending on compound type (novel or otherwise). Studies with novel compounds are more difficult to start-up because the safety of the compound is not proven, adding more risk. Sites have their choice of varying Sponsored trials in which to participate. If you are a Sponsor testing a novel compound in this space, be prepared to offer significant administrative start-up fees, Personal Protective Equipment for site staff, and travel management for at-home patient visits.
The days of only reimbursing for patient travel have gone as most study participants are taking on significant risk to enroll in a COVID-19 study – and I believe regulatory guidance will catch up to this in time. The risk of exposure to COVID-19 has to be considered when defining patient reimbursement and stipend practices for any study independent of Therapy Area – whether enrolling new patients or trying to retain currently enrolled participants. A robust travel plan should also be considered to ensure participants can travel safely to and from a clinical trial site if not participating in a remote study. Patient reimbursement must be adequate to address the risk each participant faces due to increased potential exposure to COVID-19 to ensure ongoing compliance with study requirements.
The list of available clinical research sites and clinicians with a specialty in infectious disease and vaccine research is finite, and sites with these capabilities are in an incredibly powerful position in the current environment. While there are many complexities to study start-up, ensuring that as a Sponsor you are prepared for (and can defend/justify) expansive administrative fees, adjusting budgeting and parameter setting practices with agility due to market trends, covering additional safety measures, and devising a plan for patient reimbursement, you will position your study for a higher likelihood of start-up success.