Rescue Studies

Rescuing clinical trials is now a service offered by more and more CROs. In fact sometimes we hear that this is indeed easier than doing a trial right from scratch, as the trial is already set, detecting issues is easier than avoiding them, and – ultimately – the risk of failure is low, as the situation most probably couldn’t get much worse.

Despite all of these arguments are at least partially correct, there are particular challenges with rescue trials which are not too easy to tackle. Ultimately the sponsor desires not only an effective solution, but also requires speed and cost containment, and – most of the times – compromises in terms of quality cannot be made due to regulatory, ethical and systematic reasons.

To satisfy these needs it is necessary to perfectly understand what went wrong, and find ways to address the root causes underlying the current project performance. These causes are so manifold that profound experience in the field of clinical development and with rescuing trials is a mandatory attribute for the organisation and the project team which will be dedicated to the endeavour.

Please see our fact sheet “Rescue Projects” for a real case study.

ProjectPharm conducted a series of further rescue trials, and gained deep insight into the mechanisms and dynamics governing the associated scenarios, which would – at least partially – also be applicable to highly complex clinical trials.

Should you wish to receive further information, or discuss a potential rescue project, please do not hesitate to contact us.