Rescue Studies

ARG’s goal is not to start from scratch but instead to continue the study forward with minimal disruptions.

Identifying Critical Factors in Changing CROs Mid-Project

Sponsors sometimes face the very difficult decision to replace CROs mid-study. The reasons to consider changing CROs during a project are wide-ranging, from a lack of a dedicated team to sub-par deliverables. Over time, the sponsor realizes that the existing study team is not invested in the success of the study. Or maybe the CRO simply does not have the experience to be successful. 

This is made plain by a lack of accurate and timely communication. The overall lack of buy-in or expertise ultimately impacts the performance and results of the study team, resulting in missed milestones, poor quality management of sites and vendors, and unmet goals. 

Simply Making a Change does not Guarantee Successes in Rescue Studies

Although it would appear to be a relief for the sponsor to make a change in CRO, in reality it is very challenging to execute. The first consideration is to select a CRO that provides direct antidotes to the project’s current set of problems. 

For example, if the core issue for the existing CRO is communication, the sponsor should seek a replacement team that is structured in such a way that facilitates accountability and predictable reporting. One specific issue to probe during the vetting process could be to determine if the CRO team is supported by their senior management.

Communication and Continuation are Keys to Rescue Studies

If the issue involves data quality and deliverables, it is important for the sponsor to ascertain whether or not they will have complete data transparency with the rescuing CRO. Specifically, this means sponsor access to reports and dashboards, not just verbal updates. This sort of collaboration will in turn lead to comfort and rapport in the sponsor-CRO relationship.

For the CRO, a rescue involves a holistic approach highlighted by up-front frank conversations that serve to make corrections and set expectations. The only way this is possible is for the rescue team to know what to look for and know what to ask. 

At ARG, when faced with rescuing a study, our goal is not to start from scratch but rather continue to move the project forward with minimal disruption. Therefore, it is vital to know the history of the project–namely the risks, processes and decisions to date–in order to develop and create a successful plan moving forward. All factors need to be considered from the sponsor, site, and vendor perspectives in order for a study to be rescued effectively.

A Gap Analysis and Thorough Review of Clinical Data are Essential in Rescue Studies 

A rescued project should be subject to a comprehensive gap analysis. The protocol is reconciled with the existing database to confirm forms, edits, eCRF completion guidelines, skip logic, form rules and ranges are accurate. Existing SOPs, processes and tools utilized are reviewed, then ARG addresses any major inconsistencies or non-compliance concerns through an SOP deviation or updated plan. In the end, a clean rescue generates a plan to re-establish how to run the trial to meet expectations.  

A comprehensive review of the clinical data, coding, queries, external data vendors, site relations, amendments, protocol deviations, project plans and documentation are gathered and reported. Our DM Leads meet with study biostaticians, determining the best way forward to produce compliant datasets. In addition, an assessment must be made regarding how much biostatistical work has been completed, how much can be retained and how much must be discarded.

Experience in Parallel Operations Leads to a Smooth CRO Transition

It is compulsory to have experience understanding and running parallel operations. In other words, in a well-executed rescue, the new project team gets up and running while the other is temporarily maintained. Sites are often up and running under contract with another CRO; in that case, we execute a carbon copy of the same agreement. With data in the database, ARG requests a URL transfer to take over the DM oversight.

ARG has also been involved in changing central lab vendors mid-study. The lab piece can be especially challenging, and the sponsor can save time  and money with a clean transition. The key is to get one up and going in parallel as you work to close out the other. This is done by planning out the switch-over tasks and timelines with the key team members that will be impacted.

In the end, by selecting a well-suited and experienced rescue CRO, a complete adoption of the study emerges in terms of both commitment of the team and quality of the deliverables.