The Clinical Trial Diary

Case Study: Scientific Leadership in complex, multi-regional trials boosts recruitment across the board

Georger
Posted: 10/04/2016

The scientific leadership model for conducting clinical trials is relatively new. Despite its novelty, scientific leadership continues to prove its worth when comparing recruitment metrics both before and after the addition of scientific leadership into some of the world’s most complex, multi-regional trials. The implementation of scientific leadership into any clinical trial has shown to motivate and engage investigators, many of whom maintain their connection with the scientific leader (and their affiliate CRO), long after any one trial finishes. As such, the scientific leadership model illustrates its utility through its capacity to develop (and maintain) robust, engaged clinical networks from which to draw data of the highest scientific standards.

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This year’s event will continue to look at in an interactive manner how we can effectively manage the supply chain and reduce wastage, with topics of discussion to include: improvements in temperature controlled logistics;forecasting and investigator initiator studies.

The conference will also look into more detail the impact that the EMA’s CTR356/2014 regulation will have on the supply chain from a packaging stand point,with various European regulators due to provide their input into the flexibility they can offer.

So what is scientific leadership? To put it simply, scientific leadership is where distinguished researchers and clinicians, from a highly respected, impactful health research institute avail themselves to lead a clinical trial. Due to their high-level academic position they already possess an impressive reputation in their therapeutic area. In addition, their affiliation with said high-impact research institute bestows on them a level of influence that has the potential to incentivise investigators.

George Clinical, a leading CRO in Asia, has taken a principal role in the robust and systematic implementation of scientific leadership in the sector. Across a variety of clinical trial phases and therapeutic areas, including: renal, cardiovascular, endocrinology and respiratory, to name a few, George Clinical engages leading researchers from their parent organisation, The George Institute for Global Health, to apply their expertise to the oversight of clinical trial implementation.

A large scale diabetes trial led by George Clinical’s scientific leadership and conducted over four continents provides an example of the impact scientific leadership can have on patient recruitment. George Clinical implemented their scientific leadership model into the trial design and through delivery. The scientific leaders were integral in cultivating the required clinical networks and to assuage any concerns investigators had about the complex screening requirements. This ongoing high-level scientific oversight was also highly regarded by the sponsor, a large, multi-national pharmaceutical company.

Following a series of scientific leader-led investigator meetings held in multiple countries, investigators were asked to rate their experiences engaging with the scientific leader. Of all those who attended 97% found the meetings to be useful, engaging, well organized and informative, and expressed their interest in participating in similar meetings in the future. Congruently, screening rates for all sites that participated in the scientific leader-led investigator meetings increased significantly? Following the meeting. These persuasive recruitment and investigator satisfaction metrics provide just a glimpse of some of the benefits that scientific leadership can bring to a trial.

 

Scientific leadership in clinical trials is a new model that has the potential to significantly improve the way clinical trials are conducted. As with any shift from the traditional modus operandi, the champions of this new model must find ways to effectively demonstrate the model’s benefits. In the current clinical trials environment, where the cost and complexity of running a clinical trial continues to escalate, the running of a clinical trial to the highest scientific standards and with a minimal drain on resources is paramount. 

By Michael Sydes – George Clinical 

Georger
Posted: 10/04/2016

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