Globalization of Clinical Research

Over the last 3 decades, clinical trials have become increasingly globalized. This has especially been the case for cardiovascular outcomes trials. There are many reasons for this phenomenon, but foremost is the growing size and length of clinical heart failure trials. For example, the modern era of heart failure therapy with neurohormonal antagonists was ushered in by the Captopril Multicenter Trial published in 1983, in which 92 patients with refractory heart failure were randomized to captopril or placebo with a primary endpoint of improvement in treadmill exercise time after 3 months of treatment. Surprisingly, even with this small number of patients, a subsequent post-hoc analysis showed a significantly lower mortality rate in the clinical deterioration, and improved symptoms and quality of life. Demonstrating meaningful benefit with an additional agent on current guideline-recommended therapies has become increasingly difficult. Mortality reductions rarely approach the 20% to 30% range over a 1- to 3-year period, necessitating larger and longer trials that can detect much more modest, albeit clinically meaningful, improvements. Given advances in therapy, it has become increasing difficult to include placebo groups, so often an active comparator with known efficacy is utilized, making it more difficult to show an incremental benefit. Alternatively, a noninferiority design may be utilized to ensure that the new therapy is at least as good as another therapy with proven efficacy. This type of trial requires even larger numbers of patients depending on the noninferiority margin selected. With the current focus on drug safety, even larger trials may be required to exclude unexpected safety problems when a novel agent is studied.

Related Conferences:

8th Pharmacovigilance & Drug Safety Summit, July 10-11, 2017 Jakarta, Indonesia; 11th Pharmacoepidemiology Conference, July 06-08, 2017 Kuala Lumpur, Malaysia; 10th Pharmacovigilance Congress September 21-22, 2017 Charlotte, USA; 8th Molecular Pathology Congress, June 26-27, 2017 San Diego, USA; Managing Outsourced Clinical Trials Conference, January 25-26, 2017 Miami, USA; Leveraging Real World Data for Clinical and Observational Research Conference, January 25-26, 2017, Miami, USA; Clinical Trial Forecasting and Budgeting Conference, January 24-25, 2017 Miami, USA; Clinical Technology and Innovation Conference, January 25-26, 2017 Miami, USA; American Society of Clinical OncologyLeukemia & Lymphoma SocietyCentral Society for Clinical and Translational ResearchECFS-Clinical Trial Network- EuropeAustralasian Kidney Trials Network

  • Trends in the globalization of clinical research
  • Ethical and scientific questions raised by globalization
  • The importance and challenges of considering multinational trials
  • CRO/Sponsor
  • Clinical investigation plans
  • Global regulatory plans

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