Despite all the technology in place which should contribute to have more effective clinical trials, sponsors are still facing delays in the overall conduct of their clinical studies. 80% of clinical trials fail enrolment timelines and 50% of investigators never enrol any patient or just one. As a result, delays in regulatory filing, market entry, finally the delivery of new therapies to patients are still a common aspect, one month delay in market approval can lead to 6 Mio USD in loss.
The majority of sponsors outsource their clinical trials, more than 70% of all clinical trials are outsourced to Contract Research Organisations (CROs) and other vendors. Delays in the conduct of clinical trials is extremely costly, especially when sponsors decide to change the CROs while conducting the clinical trial. These decisions can delay further the trial results at least for 6 months to get the new CRO onboard and to organize a smooth (if possible) handover between the parties and to align new teams and the investigators.
Considering the already high costs involved in conducting clinical trials, the complex regulatory environment, expectations of investors and other stakeholders, the lack of early warning systems of potential clinical trail failures is surprising.
Possible reasons for failure
One failure reason we have seen is a too short planning of the clinical trial. Time spent on the design of the clinical trial and the alignment with state of the art treatment option is without doubt a key task. But it should not be forgotten that the selection of the best fit CRO and other vendors for the purpose of the clinical trial needs at least the same attention, detailed preparation and a clear strategy which activities to outsource and how the remaining work can be covered in house.
As a rule of thumb, the more people involved in an endeavor, the more time the leaders must spend putting together the project plans and aligning the people towards a common goal.
Organise the necessary structures early
Since clinical trials are an extraordinary leadership and management exercise, setting up the necessary structures early on is key to success.
Thinking in structures helps to reduce the complexity of project organisations. During all these plans in excel sheets and describing reality in aggregates, nobody should forget that on the execution side always humans conduct the work.
Oversight Management is Key to Success in Clinical Trials
Proper planning, setting up the necessary structures early, and ensuring good communication and expectation management at all stages of a trial should be a continuous effort at all levels of the organisations involved. Sponsors have clearly defined duties to oversee the proper conduct of the clinical trial as they have the final responsibility for the safety of the patients, the quality and integrity of the clinical trial data.
For oversight management it is our rule of thumb: when you outsource a clinical trial, for every five to seven people working in a CRO on your clinical trial, you should have one person in your company conducting risk based oversight of the activities. A fact that is often underestimated at sponsors which leads to inefficient use of resources and overworked teams.
How to keep Studies on Track
Basically, it is all about pro-active communication, cross functional team motivation, transparent management of expectations and risk awareness.
The development and use of good business intelligence (dashboard) should become a standard with Key Performance Indicators (KPIs) in place to measure study performance and having mitigation strategies in place to manage risks.
Be prepared for the unexpected not everything can be covered in risk management plans. A well thought through governance charter, agreed with all parties involved, defining responsibilities and escalation procedures will set the ground to solve problems mutually.
In the case that activities in a clinical trial go wrong you should always do a very good root cause analysis and move forward with the lessons learned.
(First appeared in Clinical Trials Insight June 2022 edition)
This post was written by Heike Schön. Heike is the Managing Director of Lumis and has worked in management positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post‑marketing activities. She had positions within contract research organisations (CROs) and in the biotechnology industry.
Heike holds a master’s degree in psychology from Freie Universität Berlin and a master’s degree in business administration from Schiller International University. Since 2002, she has been active in the Association of Clinical Research Professionals (ACRP) where she also served as a member of the Board of Trustees and as its Chair in 2010. Heike is a regular speaker at international conferences and publishes within clinical research and medical device magazines.
