Outsourcing

Rescue CRO: Thoughts for Taking the Ultimate Step to Save the Study

Outsourcing

07:00, October 27 2017

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Jacquie Mardell, Sr Director of Clinical Operations, Ascendis Pharma, explores the challenges of changing CROs in the middle of a study

Last February, I wrote in these pages some thoughts about when sponsor/CRO relationships go off the rails: what can cause it and strategies for repairing it. In this article, let’s go a step further and map out a strategy for the ultimate step: employing a rescue CRO for some or all of an ongoing study.

Generally, we consider bringing in a rescue CRO for all or part of a troubled study for one of two reasons: 1) the study is falling behind in enrollment, or 2) the CRO has failed to deliver results in some other, irreparable way, such as submissions not done (or of poor quality), sites not initiated, monitoring visit reports not done, poor quality data in the database, or other significant quality issues. These two are not mutually exclusive, as slow startup will almost certainly result in slow enrollment.

Choose a Companion CRO or Total Replacement

The sponsor may be able to address slow enrollment by bringing in a rescue CRO alongside the incumbent CRO, instead of a total replacement, and this may be enough to solve the problem. Some CROs specialize in rapid deployment in regions with ready populations to bridge an enrollment gap and recapture or at least minimize lost time. For this strategy to work, the rescue CRO must have a track record of success in the region(s) and therapeutic area of the study: it helps no one if the rescue CRO is great at enrolling cardiovascular studies in Eastern Europe when the troubled trial is in diabetes.

The second reason a sponsor may implement are placement CRO strategy indicates a more systemic problem. It may have been a wrong fit from the start, such as when a sponsor chooses a CRO that is the wrong size or lacks expertise in the study’s therapeutic areas or geographic regions. Perhaps the team that was so impressive at bid defense is nowhere in sight now that the study is in full swing. Or the sponsor audit identified areas of quality concern not adequately addressed. Either way, whatever happened to the study has the sponsor so concerned that she determines it may be worth the effort, cost, and potential other problems to replace the existing CRO completely with a new one.

Identify Root Cause and Rank Interventions

No one enters into the decision to change CROs lightly: strained relationships will almost certainly be further harmed, important tasks risk slipping through, and the sponsor may become a full-time referee between CROs, one of whom is extremely unhappy. To mitigate these really bad outcomes, it is vital that the sponsor’s team first go through a structured and detailed process to identify the root cause of the failure. Beth Harper, president of Clinical Performance Partners, explained in an interview with Clinical Leader that only after the root cause(s) are identified can the sponsor determine the types of interventions in rank order that are likely to effect change, and then use that list to inform the rescue CRO selection process.

Brook White, writing in the Rho World blog, offers some thoughts for choosing a rescue CRO. Of paramount importance is that the CRO must have previous rescue experience and a documented process, including managing the transition at the sites. This is no time for aspirational goals. Many CROs incorporate rescue work into their business plan and have thought through the challenges. They will have the resources available to handle the transition and the full workload. It was oddly comforting to me that one CRO owner initially responded “no” when asked about a rescue opportunity; he did not want to overtax his resources and potentially harm the other work he was doing with us.

White also offers sponsors some tips for prepare for and manage the transition: Make sure you have copies of all important documentation, including data build specifications, in case your rescue CRO has to recreate the study database; rigorously follow a communication plan and have regular meetings, if possible with both CROs together. This task requires extraordinary sensitivity to manage, but if done right will help the new CRO get their hands around the activities during and post-transition, and minimize the delays that may accompany the switch.

The Most Important Stakeholder

In all the flurry of transition activity, give investigator and site management the highest priority. The new CRO must have a plan for managing the transition in monitoring personnel, study practices and procedures for the sites. The transition can tax the investigators and their staffs and cut into their enthusiasm for putting subjects in the study, so the site-level transition plan must be solid and well thought out to mitigate the inevitable confusion and stress for the site personnel.

 

References:

1) Harper, B. (2016 July 13). Study Rescue: How To Get Your Clinical Trial Back On Track (E. Miseta, Interviewer) Clinical Leader. Retrieved from https://www.clinicalleader.com/doc/study-rescue-how-to-get-your-clinical-trial-back-on-track-0001

2) White, B. (2014 Mar 10). 5 Red flags your CRO is putting your trial at risk-and what to do about it RhoWorld. Retrieved from http://resources.rhoworld.com/blog/bid/338615/5-Red-flags-your-CRO-is-putting-your-clinical-trial-at-risk-and-what-to-do-about-it

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