In 2014, we wrote a popular post about deciding between a large CRO and a boutique CRO for your oncology study.
There are many situations where the large CRO is the obvious choice. Selecting one of the global CROs that dominate the top-end of the market is the obvious choice if you are running a global trial in multiple continents, need a lot of project managers and CRAs quickly, want a multi-year contract with a single provider for multiple studies or are looking for a strategic partner who will take equity participation.
However, for certain types of sponsors and studies, choosing a boutique CRO can be the best choice when running a phase I or phase II and need the following:
The pandemic has added some new wrinkles to this selection criteria; it has amplified some of the challenges with both large CROs and certain boutique CROs.
For every oncology study launched during the pandemic, we recommend that sponsors include the following additional components during your CRO evaluations.
During these chaotic times, the biggest challenge is with timely and effective communication. With different states having different rules about whether patients can visit a site (which can change on a weekly basis), evolving COVID-19 screening criteria, protocol changes, and changes in site operating hours, excellent communication skills are paramount for navigating a study through 2020 in the United States. Having a PM or CRO with average or poor communication skills – with sites and with your team – could cause significant delays in your study.
The next biggest challenge is with changing processes. The FDA guidance during COVID-19 discusses contingency measures to manage study conduct. Thus, the need to adapt to changing processes for site visits, protocols, product availability and monitoring is critical. Some larger CROs might be able to adapt quickly, but a boutique CRO should be able to adapt quicker. Ask specific questions about their ability to adapt and ask about recent examples that demonstrate this ability.
Does the CRO already have a working relationship with the sites? If so, how strong is it? This is important because it can affect the timing of the communication, which can affect timelines with process changes and patient visits. A strong relationship between the people at the site and the CRO’s team can minimize additional delays due to unanticipated COVID-19 changes.
The final additional consideration is about your study’s priority to the CRO. In such uncertain times, will the CRO have enough bandwidth to give you the undivided attention you need and expect? Some large CROs may have extra bandwidth. Others may not. And some boutique CROs may have reduced staff and not be able to respond quickly to changes. You can ask during the evaluation process, but few are going to tell you that you’re not their top priority; you need to decide where you stand with your internal team.
One evaluation criteria element that hasn’t changed is the importance of the team assigned to your study. While large CROs may present you with an “A” team in the bid defense, the people who start your study aren’t always the ones who deliver the final results. This can tie into your study priority; if you’re not at the top of their priority list, you might end up with the “C” team with little experience or the requisite skills to navigate your study through these uncertain times.
If you desire to have the same people working on your trial from start to finish, choose the boutique CRO (and confirm who will be working on your trial).
Connect with us to learn more about how we handle complex oncology studies during the COVID-19 pandemic.