Outsourcing
Rescue clinical trials D
espite 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 patients, 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 $6m 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 for at least six months to get the new CRO on-board and to organise 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 trial failures is surprising.
trial need the same level of attention and detailed preparation, as well as a clear strategy. This helps realise which activities need to be outsourced and how the remaining work can be covered in-house.
As a rule of thumb, the more people involved, the more time leaders should spend putting together the project plans and aligning everyone towards a common goal. Another reason for failure is poor organisation of the necessary structures. Since clinical trials are an extraordinary leadership and management exercise, setting up the necessary structures early on is key to success. It helps to think in structures to keep projects simple. This can include keeping plans in spreadsheets and working together to solve issues – the human side of work is crucial too.
Oversight is key
When proper planning, setting up the necessary structures early, and ensuring good communication and expectation management at all stages of a trial are in place, there 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.
“As a rule of thumb, the more people involved, the more time leaders should spend putting together the project plans.”
Possible reasons for failure One reason for failure is insufficient clinical trial planning. The time spent on the design of the trial and its alignment with state of the art treatment options is key. But it must be remembered that the selection of the best fit CRO and other vendors for the purpose of the clinical
Clinical Trials Insight /
www.worldpharmaceuticals.net
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. This is a fact that is often underestimated by sponsors and
Lumis specialises in providing consulting and solutions for clinical trials, and offers advice on how best to avoid failure.
leads to inefficient use of resources and overworked teams. To keep studies on track, 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. Not forgetting mitigation strategies to manage risks. Finally, 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, companies should always do a thorough root cause analysis and move forward with the lessons learned.
Expert support
The experts at Lumis support clinical teams in implementing and maintaining an oversight management system. It defines and integrates an effective and risk-based study oversight plan to manage the quality, patient safety and data integrity during the different stages of a clinical trial.
Lumis Life Science Consulting has the focus to provide consulting and solutions to biopharmaceutical and medical device companies. Its customers are mainly small to mid-size companies.
The services the company offers cover the whole spectrum of vendor selection and management, clinical trial oversight management and training. Lumis develops tailored solutions to optimise drug development programmes. The company cooperates with a network of experts, partners and consultants. ●
www.lumisinternational.com 35
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