"Rescue" studies: The importance of getting clinical trials off to a good start

Every clinical trial is a monumental task. Many questions can negatively affect a study timeline, which in turn delays regulatory filing, and can eventually delay market entry.

Every year a large number of clinical trials are outsourced to Contract Research Organizations (CROs). Approximately 70% of all clinical trials will be outsourced to CROs by 2020. But it can happen when the study is not adequately managed by the CRO and the study must be “rescued”.

Why do studies need rescuing?

A study most often needs rescuing when it is in danger of not being completed on time, its quality is suspect or it has lost access to resources. Also unexpected results have caused a regulatory agency to halt the trial.

The scope and type of study management deficiency needs to be assessed by the sponsor to determine the type of remediation required. Simple rescue support may be as adding third-party function experts to the sponsor project team to aid in the management and control of the CRO. As for complex supporting, it is choosing a new CRO to assume all responsibility for the study.

Rescues are on the rise…

We cannot ignore the fact that 80% of clinical trials fail to meet enrollment timelines and up to 50% of research trial sites enroll one or no patients, and according to Cutting Edge Information, 72% of studies run more than one month behind schedule, with sponsors standing to lose between $660,000 - $8 million for each day that the trial delays a product's development and launch.

Intervention before a rescue is required

Clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data. Sponsors/CROs are looking for ways to incorporate business intelligence into the eClinical systems. They are already using to strengthen control — turning raw trial data into useful information. Traditional eClinical systems didn’t justify delivering rapid analytics and insights. Because they do not provide self-service business intelligence — powerful visualizations that empower business decisions, offering customizable reports, drag and drop visualizations, and interactive dashboards.

With the availability of real-time data, the project management team can focus on issues and bottlenecks affecting the clinical study. This is crucial, that intervention usually happens after an issue has occurred, when it's too late to proactively avoid the problem. As a result, true business intelligence — the ability to proactively identify and resolve bottlenecks in real-time, instantly view statuses, quantify your team's performance, and discover meaningful patterns in your clinical study startup data. Today's industry leaders in clinical trials recognize that good data increasingly translates to a competitive advantage.

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