• Brooke Millman, JD | Vice President, Site Contracts & Budgets
  • Russell John | Global Director of Grants Management and Institution Benchmarking
  • Tia Allison | Global Contracts Manager

As we emerge from crisis-response mode and embark on the path to recovery, we find ourselves—as a world, a country and an industry—in a period of transition and uncertainty.

While much remains unresolved, we do know this: Sites and sponsors will be recalibrating everything,  especially budgets for either new components of trials or changes to clinical trials. We anticipate that many site budgets will need to be recalculated, amended and renegotiated. We expect an increase in amendment requests across ongoing studies to modify site budgets beginning now and running through the fall.

At WCG Clintrax, we’ve outlined the 5 critical changes sites and sponsors should be considering to best plan for the future:

1: Protocol changes trigger new contracts and budgets

We foresee an influx in the volume of upcoming protocol amendments affecting trials that span multiple therapeutic areas and phases. Sponsors conducting non-COVID-related trials have already started to amend study protocols to update inclusion and exclusion criteria requirements. Patients suspected of having—or having had—COVID-19 must undergo additional testing or be excluded from the studies. The financial impact of these new considerations has yet to be assessed fully, but we expect the trend of new steps in the process and new considerations for participation to continue in the weeks and months to come. 

We’re already witnessing an enormous volume of changes in research—in particular, protocol changes to allow for virtual visits and remote monitoring. Adding virtual components may not prove difficult for concept studies or, at the other end, late phase 4 trials. But to insert those changes directly into current phase 2, phase 3 trials? That’s quite an undertaking.

From documenting and justifying protocol deviations due to COVID-19 to handling sample collection, questions abound.

2: New site requirements will likely require revisiting reimbursement practices and rates

And then there are safety considerations. What new measures will sites have to take to prepare the facility? We anticipate seeing a whole new layer of work on top of a site’s normal activities: Screening employees, testing for COVID-19, managing the need for personal protective equipment.  These factors could result in additional overhead expenses for sites, which could dramatically change existing budgets.

As sites begin to adopt necessary changes, how will sponsors reimburse them? What are the benchmark rates for these added measures? Sites don’t yet know how much time and effort may be required or how long these additional steps will be expected to remain in place.

Getting started can be as simple as creating a basic framework that accounts for additional staffing and additional time. For instance:

  • How much additional time are the new operating procedures taking?
  • What are the typical reimbursement rates for the types of staff who will complete these procedures?
  • What will it cost to train staff on new SOPs, technologies and/or processes related to changes in research? This may require working with new vendors or even outsourcing tasks that were previously completed internally, which affects the costs incurred by sites.

3: Staffing shortages may hinder the anticipated wave of starts and restarts

In the time since this pandemic began, we have to consider how sites overhead structures for staffing may have changed. Many may still be struggling with pandemic-related staff shortages

Some sites will continue to limit the number of employees they allow into the building at any one time. Some may need to outsource some of staff to cover essential duties. The costs for those additional requirements will need to be accounted for in investigator budgets or in overtime pay planning.

And this may be particularly acute in the essential services around recruitment –  data entry or other administrative elements that fall outside of patient care.  It remains to be determined how widely sponsors will support these additional services financially or if sites will have to adapt and refocus their efforts to participate in clinical trials.

4: Taking a cue from global learnings

Many countries are limiting or restricting trials. We recently encountered an example of this with a global, non-COVID-related trial: the designated central lab reached full capacity and was only processing COVID-related samples.

We noted another limitation that recently surfaced in the United Kingdom. Though it is usually a straightforward process to set up a study in the UK, everything has currently come to a halt. The National Institute for Health Research is reviewing only academic research launched within the UK–and only those deemed as essential COVID-related studies. That means NIHR is not reviewing or accepting any regulatory or contractor budget submissions for non-COVID trials.

We see this happening on a global scale, as regulatory bodies are prioritizing work within the country, and COVID-specific studies. Sponsors are responding by rethinking portfolios, and determining what to launch, what not to launch, and ultimately where to launch. The 2020 pipeline only vaguely resembles what many sponsors had planned.

Sponsors may need to establish relationships with new sites to effectively launch trials in the near term.

5: Critical lessons are driving new behaviors and new innovation

The pandemic has forced all of us in the clinical trials arena to become more efficient. Here are just a few examples:

  • Enhanced communication: Social distancing seems to have improved communication. Sponsors and sites are more likely to pick up a phone and have conversations about budgets, rather than send countless emails. Planning efficiency has increased dramatically. All parties involved appear to be much more focused on arriving at a speedy resolution to finalize a budget.  Parties are far more prepared in how they approach those discussions. Emails are fewer, but more substantive.
  • A move toward digital: How many sponsors and sites, previously dependent on paper records, will continue to avail themselves of digital solutions? Although many sponsors had already moved in that direction, others have yet to catch up. We’re seeing this have particular impact in terms of contract execution. Many countries that previously required wet signature are adapting to use of an electronic or digital signature.
  • Greater agility: Sponsors and sites had to pivot quickly as the world changed. Prior to 2020, virtual trials were rare, but many sponsors and sites have started to make the transition. Sponsors who had little experience with virtual trials or remote monitoring have found that in many cases, it’s often the only way to keep a trial going. Those adaptations will certainly inform future best practices.
  •  New routines, recalibrated expectations: Many sponsors that have worked with the same sites and investigators for years now need to find alternatives, quickly. They may need to turn to new sites, but they have fewer from which to choose. We’re working with clients to limit the number of sites required for activation to achieve the target patient enrollment. We’re partnering with a client on a COVID-19 study where we initially anticipated contracting with 50 to 100 research sites, but have since refined our focus to approximately 20 sites, shifting our attention to maximizing the number of identified and enrolled patients per activated site.
  • Faster contracting: In the COVID-19 trials we support, we’ve been able to finalize and execute contracts and budgets at an accelerated rate as compared to other therapeutic areas. Everyone is motivated. Now, sponsors are looking to replicate the expedited pace of COVID-19 trials across other trials.

Everything we’ve learned during this turbulent time will increase efficiency and accelerate adoption of more effective ways to conduct the budgeting process, as well as many other research-operation innovations that have long been on the periphery.

WCG Clintrax can help

By staying abreast of new country requirements, site considerations and overall financial implications, WCG Clintrax has been able to present clients with key insights that have helped aid in their determination of the best path forward. During a time of uncertainty, it will remain our focal point to stay vigilant in observing trends and impacts that could present barriers, risks or limitations to our clients.

To learn more about WCG’s expert team of budget and contract negotiators and how we can help during this unprecedented time, contact our Contracting & Budgeting experts. One of our team members will follow-up with you directly.