'The Past, the Present, and the Future … Clinical Trials and the Contract Research Organisation (CRO)'

Helen Fovargue, Senior Legal Director, Quintiles

In 2016, Clinical Trials globally are performed to ensure safe and efficacious treatment which meet ethical principles, but will these principles meet the challenges of the future? To understand how and why clinical trials are performed today and will be in the future it is essential to understand the past and the thorny path trodden in the performance of clinical trials. Overarching any clinical trial is a person’s right and ability to consent. The issues surrounding the urgent need for effective efficient treatments balanced by the risk/benefit analysis of the efficacy and efficient treatments is a universal global concern. The ultimate goal of any successful treatment belies a history of divergent checks and balances to reach the constant moving pyramidal spike of success and each end point creates a giant leap forward to the benefit of mankind. But the rapidly escalating cost of clinical trials has caused the pharmaceutical and biotech industry to seek new ways to off-set the burgeoning costs to reap financial reward and fund future trials of new innovative medicine, and the introduction of outsourcing through Contract Research Organisations (CROs). All of these factors in the past have created a plethora of legal and industry challenges. The law is always one step behind the advance of science, and ultimately the industry and the law must partner together to meet these challenges to strive forwards. The focus of this paper primarily pertains to events affecting the UK and USA.