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Ask a Clinical Trial Expert: Study Rescues

Courtesy of http://www.flickr.com/photos/joaoism/ Question: 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. What are our options?

 Answer: Sounds like you’re in a tough spot! While the majority of outsourced clinical trials are adequately managed and delivered on-time and within budget, there are some situations where studies need to be rescued. 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. Slow enrollment can often put a study behind, costing the Sponsor time and money. 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.

Here 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.

Even with all of the troubles you’re facing, you can still turn the study around via a rescue effort. When you begin to have doubts about your service providers, you should first investigate your concerns. A 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.

Some troubled studies need a full rescue. 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 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.

PharPoint has provided both rescue consulting as well as full study rescues to many different Sponsors in a variety of phases and therapeutic areas. Contact us today to discuss how our experienced team can help you with your clinical programs.

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