Rescuing a clinical study that has lost one or more of its wheels

An over 30-year long career within clinical research and development from both big pharma and international CROs has taught me that many clinical trials suffer from delays. An estimated 85% of all clinical trials will experience delays, with 94% being delayed by over a month.1 Thus, the financial impact can be significant, e.g. the long-term profitability of a drug may be impacted by reducing its patent window.

The increasing complexity of study protocols as well as the significant increase of trial endpoints, including many “nice to have” parameters, will potentially cause an overall constraint on resources needed.

During the trial conduct, the most common reason for delay is the complex and challenging area of patient retention and recruitment, meaning that many studies fail to recruit adequate numbers. It is not uncommon that the number of patients that fails pre-screening exceeds the initially calculated number. Moreover, it is also not uncommon that unrealistic overall goals are set at the beginning of a clinical project, which are not in accordance with what to expect based on the experience of previously executed trials.

However, measures taken early on to counteract unnecessary delays should optimize procedures into being sensitive to detect risks before they become an issue during trial conduct. Close communication, interaction and effective procedures at sites are also important to sustain site alertness all the way through the project’s lifetime. Other factors which play a crucial role in a successful trial are; site selection, finding the right clinics and investigators, having the right patients, having the expertise, functional and suitable equipment, and resources delivering with quality. When these are not optimal or even not in place, a trial is doomed to be faced with delays and needs to be rescued.

Thus, an upfront feasibility process is crucial. It is important to keep in mind that feasibility is a “fresh product” that needs to be performed in close proximity to the project’s start (e.g. a historically good site can change with regard to available resources since the last feasibility assessment). Furthermore, based on my own experience, a realistic interpretation of the collected feasibility data is paramount.

Hence, if delays and quality issues still occur and endure, e.g. because of not having patients, lousy data quality, lack of team members and milestones running away faster than the team, etc, an efficient and well proven rescue process is warranted. Crown CRO’s study rescue process is all about offering a special solution designed for a situation when a clinical trial is facing difficulties and getting it back on track is needed.

The aim of Crown CRO’s rescue project team is to improve overall study quality, and to secure patient enrollment and timelines, e.g. by re-evaluating sites in use, adjusting study design as needed, improving monitoring quality, solidifying project management and improving data quality.

Therefore, I am happy to be part of a CRO organization such as Crown CRO that can offer such a service to those who would need and benefit from it. By offering and executing study rescuing, our organization makes an important impact on, and contribution to, delivering treatments on time to patients with different unmet medical needs.

All in all, the goal is to achieve and work Together for a healthier future!

Claes-Göran Brobäck PhD

Director Commercial Innovations

  1. Facts about clinical trials. (Online) Available at: http://www.arena-international.com/clinicaltrials/facts-about-clinical-trials/1063.article (Accessed 12.09.17)