“We’re worried that the service providers working on our study are causing it to fall behind. Timelines are being missed due to slow enrollment and data quality is poor. Do we need a clinical trial study rescue?”
Missed timelines, poor communications, and poor data quality are all common indicators that a study is headed for trouble.
Meeting planned study timelines is essential for successful, on-budget trials–and unfortunately, an estimated 85% of trials experience delays. Aside from the immediate impact on study budgets, major delays can also impact the long-term profitability of a new therapy by reducing the patent window.
Patient enrollment and retention is often one of the biggest culprits in study delays. According to a whitepaper by Clinical Leader, approximately 85% of trials fail to retain enough patients, with the average drop-out rate across all clinical trials is around 30%.
Fortunately, if you see that your study is enrolling slower than expected, there are steps you can take. Strategies to increase enrollment include increasing advertising, opening additional sites, or even amending the protocol to adjust inclusion/exclusion criteria.
At PharPoint, our project managers proactively monitor enrollment and provide sponsors with the support they need to meet tight study deadlines. Open communication between all parties involved is key. A quality service provider will stay on top of any issues – including slow enrollment and poor data quality – that might derail your study and proactively problem solve to ensure adherence to timelines.
Work with a study consultant
Even with all of the troubles you may be facing, a sponsor can still turn their study around via a rescue effort.
As soon as a sponsor begins to have doubts about their service providers, they should first investigate your concerns. A clinical trial consultant or consulting service provider can help you look into current and potential issues and come up with an action plan. If the issues are caught early, you may be able to continue to use the contracted service providers and simply add additional consulting support. A consultant can help provide functional oversight, ensure adherence to study timelines, and manage data quality. Adding a functional expert is a very cost effective option to keeping your study on track for success.
Consider a full clinical trial study rescue
Some troubled studies need a full rescue or study takeover. In these instances, the sponsor will need to pull the contracted services from one provider and transfer them to a different provider.
Completing a full clinical trial study rescue will require a lot of planning and communication. First, you will want to make sure that you hold all key documentation and communications for the study. Then, you will want to contract an organization that is experienced in rescues to take over the study. A full study rescue can be quite costly, but can often be far less expensive and time consuming than dealing with timeline delays, after-the-fact data cleaning and a difficult service provider.
Don’t wait until it’s too late to ask for help
PharPoint Research is an award-winning, client-focused CRO that offers clinical operations, project management, biostatistics and statistical programming, and data management services. PharPoint has provided both rescue consulting as well as full study rescues to many different sponsors across a variety of therapeutic areas.
With an experienced leadership team averaging over 22 years of industry experience, we’ve seen nearly everything that can go wrong in a study and can help your trial get back on track.