To continue operating throughout the pandemic, research sites quickly implemented a variety of measures and procedures (i.e., PPE requirements, increased sanitation, COVID screening, IP handling systems, patient transportation systems, limitations on number of people on site, etc.). While these measures continue to be necessary, they have increased site workload and consequently led to an unprecedented level of financial strain. As a result, sponsors and sites have found themselves renegotiating clinical trial budgets to reach new terms appropriate for study conduct during the ongoing global crisis.
WCG clinical compiled information across multiple sponsors and groups like SCRS, and found that the cost per site has been steadily increasing throughout the pandemic. In an analysis by Brook Millman, Vice President of Site Contracts and Budgets at WCG, site cost is broken down into three categories:
- Overhead Rates, which have increased by roughly 5-10%.
- Personnel Costs, which is expected to have an overall increase of 20% (an average of 10% for study coordinators and an average of 10% for principal investigators).
- Invoiced Items (e.g., patient travel reimbursement and lodging), which are expected to double in cost.
Millman’s analysis also shows that the average per patient total has increased from approximately $35K-$39K to $50K per patient. This represents a 28% increase.
In addition to amending budgets for overhead rates, personnel costs and invoiceables, other common areas of negotiation have included:
- Reimbursement for PPE
- Access to electronic medical records
- Remote monitoring costs (i.e., visit costs, technology set up)
- Release of holdback fees
- COVID testing
On the subject of reimbursement for remote monitoring, the three experts explain that the associated costs are likely the most challenging for sites to receive. Clinical trial agreements (CTAs) usually include onsite monitoring as it is considered the traditional method for study monitoring. According to George Kourtsounis, Director of Clinical Trial Contracts and Grants at Bristol-Myers Squibb (BMS), sponsors may find it difficult to reimburse sites for remote monitoring if this methodology is considered to be less invasive and less time consuming.
Jeannie Gatewood, Vice President of Clinical Research Strategy at Temple Health Fox Chase Cancer Center, explains that holdback fees are another challenging area for negotiation. Holdback fees are usually added to contracts to ensure timely data entry and query resolution. While several research companies have agreed to release holdback fees, other sponsors have expressed concern that release of holdback fees will lead to a reduction in data entry and missed deadlines for datalock.
As the industry continues to navigate through this unprecedented time, sponsors will need to continue revamping the routine contract processes and principles so that they are applicable during and after the COVID era.
As Millman says, sponsors need to “ensure that the solutions put in place to triage needed changes in contracts and budgets are specifically tailored to meet the evolving needs of sites.”
Going forwards, sponsors should:
- Look at what each site needs individually
- When writing up a new contract, make sure to account for some level of change (e.g., new procedures, remote monitoring)
- Be flexible
- Over communicate with sites to understand their evolving needs
- Allocate time and effort to clarify site asks
- Look for opportunities to standardize contracts, or create master CTAs
- Maintain channels of communication and transparency between sites and sponsors
- Brook Millman, JD, Vice President of Site Contracts & Budgets at WCG
- Jeannie Gatewood, RN, MBA, Vice President of Clinical Research Strategy at Temple Health Fox Chase Cancer Center
- George Kourtsounis, JD, Director of Clinical Trial Contacts & Grants at Bristol-Myers Squibb
- Lindsay McNair, MD, MPH, MSB, Chief Medical Officer at WCG (Moderator)