Of Course Your Clinical Trial is Delayed: Ready for a Divorce?

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By Olga Alfonsova

Global Head, BD

Even if your trial wasn’t already delayed before COVID-19, it probably is now. And although the world is slowly going back to “normal”, it’s going to take a new kind of resilience to catch up and get back on an acceptable track.

In light of the pandemic and looming revenue plunges, many CROs started reduced their workforces early on, making steep cutbacks, and introducing hiring freezes.  With so many CRO folks laid off or fearing for their jobs, who and how is going to step up and to take care of the enormous backlog?

The authorities did their best to jump in and ease up the stringency on protocol deviations during the pandemic. Tech providers came up with a few on-line solutions to substitute physical presence. And yet the bulk of the make-or-break work to spike up that patient enrollment graph is in the hands of CRO clinical teams and their tenacity and result-oriented style of working with the sites.

All this is to say, it’s the perfect time to question whether your CRO has the grit, the stable study team, and a trust-worthy plan to transition from a delay to a more-or-less timely LPI without sending the cost of your trial through the roof.

No surprise that these days we are seeing a considerable uptick in requests to transition or rescue entire pivotal studies and phase III programs away from former CROs. And there is a lot more observable agility about making CRO transition decisions.  Just like divorce rates spiked after the weeks of lock-down, sponsors have become much more resolute about making CRO changes here and now.

It’s hard, but not as hard as you might think

Just like a divorce, it can be an emotionally draining experience, though it doesn’t have to be. If your new CRO has well-established transition processes, checklists, per-country requirements, ample support from in-house regulatory and legal staff savvy in CRO transition particularities in each of the involved countries, and a good plan for how to communicate with the sponsor and former CRO for the next few months, you’ll be fine.

Having taken part in hundreds of rescues and dozens of major full-service take-overs we have established SOPs, detailed processes and smooth communication techniques to facilitate the transition. Our 7-Step CRO Transition Program has been run and tested on several pivotal transitions just in the last few years, resulting in increased enrollment rates and reduction of the overall study timeline every single time.

Your CRO keeps changing people?

Great enrollment should be largely attributed to great site relationships – specific people at the CRO having built trust and rapport with specific people at the trial site, and these specific CRO people being available to work on your study.

No amount of expensive technology or promised access to patient banks can replace the good old power of a strong human connection. If the investigators are not excited about working with your CRO (meaning CRO’s specific people visiting, calling on, talking to their site staff), chances are they may not be that excited about enrolling patients in your study.

When we are asked to assess the enrollment potential of a lagging study, we would always take into account whether the right sites had been chosen to begin with and, if so, have they been nurtured enough to produce results.

You’ll be surprised how easy it is to tell after a careful glance at the site list and a few conversations with the site staff why enrollment hasn’t been quite happening. Often, just like Sponsors, the sites point at the unfortunately high turnover of people they are dealing with on the CRO side.

It doesn’t have to be the lasting fate of your study. And if it is, come talk to CROs who are known for exactly the opposite: very low staff turnover rates and top investigator ratings. I bet these two are somehow connected.

Where does one find a stable CRO these days?

In Switzerland… Just kidding. Well, maybe not. Everything is stable in Switzerland, they might as well have stable CROs!

Look for someone who’s privately owned by management and doesn’t have to report to anyone but themselves, never borrowed a dollar, has always been fully self-financed through clinical project work, has grown into a global organization by meticulous hiring, training, and cultivation of company culture, has a great reputation (you find that out by talking to their clients) and are known for uncompromised focused on delivery and service.

If you find them, chances are you are finding a partner for life.

About the author: Olga Alfonsova has been with PSI from day one and has overseen launches of dozens of CRO transitions. If you’re a sponsoring company considering a CRO change, you can reach out to her for a free consultation by leaving a comment here or through her LinkedIn page.