Tips to Rescue a Clinical Trial Before It’s Too Late

Elizabeth Kelchner is the Associate Director of Data Management at Rho

Sometimes relationships can continue even when things aren’t working out. However, when it comes to the partnership between a sponsor and its contract research organization (CRO), there isn’t any time to waste. Failing to address issues quickly during a clinical trial can cause issues.

Some red flags are obvious, like if a CRO doesn’t return calls in a timely fashion or starts missing deadlines. However, there are other indications that a clinical trial is going in the wrong direction that sponsors should consider. The following are some potential warning signs to keep in mind and tips to help stay proactive in collaborations for a successful clinical trial.

The ‘bait and switch’
The team that a sponsor meets in an introductory meeting isn’t always the exact team they will work with long-term. While some personnel shifts are inevitable given the length of time it can take to move from proposal to award, sponsors should be wary if their CRO starts assigning new team members without relevant experience or changes the team often without a compelling reason.

Undefined roles for data management

Data management can be a challenging area for sponsors to oversee, as they may not be intimately familiar with all the processes that their CRO is executing behind the scenes. For example, Interactive Response Technology (IRT) integration is crucial to align correctly, as it sets the stage for everything from supply management and randomization to accurate data reporting during the trial. If a sponsor doesn’t employ a dedicated data manager who understands the ins and outs of IRT, they should strike a close collaboration with the right counterpart at their CRO who is managing that process. Failure to do so could lead to a situation where a required data point is not included during the initial IRT integration process. Missteps like this can lead to big problems.

Infrequent or incomplete status updates
As clinical studies get underway, it can be tempting to accept statements like “everything is good” or “we’re on track” at face value. However, sponsors should be comfortable digging deeper into the details, as the ability to ask the right questions can help teams avoid potential pitfalls. If a sponsor has doubts about something, or if they simply feel their understanding is lacking on a certain piece, those are good signals to raise a hand.
CROs should be providing regular access to status reports, project management plans, data management plans, and updates on activities like data cleaning. If a CRO isn’t regularly monitoring data and, when applicable, flagging issues for further exploration, this itself should be a signal for the sponsor to raise concerns. It could simply be that there is a misunderstanding, or a sign that teams need to come together to better define the areas of special interest that will require deeper investigation. If the study team is waiting until the end of the study to review and specify inconsistencies, it may be too late to course correct.

Absence of checks and balances
For data collection, the glass-half-full view for sponsors is that there are built-in processes to help facilitate and filter information during a trial. When a CRF is created, for example, there are often several check points established to help direct study participants when more context is necessary. In response to questions where a patient checks “other” with no explanation – it will prompt the responder that they “need to specify.” This action allows for a lot of data cleaning to occur at the point of entry.
Other information, such as clarification on adverse events, may require more nuanced investigation. Symptoms like headaches can sometimes go unreported during a trial – or conversely, they could be inaccurately labeled as migraines. It’s important for sponsors and CROs to be aligned on how granular the study needs to be with this type of data. There should also be a data review tracker that notes scenarios where the CRO is digging deeper to confirm details outside of the automated system.

To the rescue

At the end of the day, relationships don’t always work out. If a sponsor decides it’s time to make a change, they should ensure their new CRO can implement a tailored rescue plan that meets requirements and minimizes process changes for clinical sites.

Whether facing a rescue trial scenario or planning a new trial, sponsors should establish a consistent communication cadence up front to help ensure transparency between teams and keep things running on track. Drilling down on protocols, such as what to do about missing or incomplete data, can help to reduce the number of speed bumps along the way. Having a transparent view of what’s happening with the study, sponsors can rest easier knowing their trial is the best shape for successful execution.

Elizabeth Kelchner is the Associate Director of Data Management at Rho