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Compliance In Focus
Posted by John Lehmann on Thu, Jun 21, 2012

Four Points to Consider in Global Clinical Trials

I came across a recently published article, “Clinical Trials Have Gone Global: Is This a Good Thing?”Going Global with Clinical Trials (2) published by Lang and Siribaddana. The title immediately caught my attention and begs the question: why is there a trend of clinical trials going over seas, and what are the possible consequences? The paper is divided sub-headings that pose the following enquiries:

  • Why Do We Need Trials and What Makes a Trial a Trial?
    Clinical research is simply put as any research that involves human subjects. Clinical investigations rely on patients to volunteer in order to capture the data required to ensure safety and effectiveness.
  • Why Go Global?
    The global trend in clinical research has been credited to decreases in cost and time for approval. Other reasons are tied to patient recruitment, or a specific health event is the focus of the research.
  • What Are the Ethical, Scientific, and Operational Challenges of Running Trials across the Globe?
    A Table in the paper “provides examples of steps and issues in clinical trial conduct that could be adversely impacted by inappropriate interpretation of guidelines or overly keen CROs and sponsors. These steps are important for optimum trial conduct and should be carefully considered for each trial and its specific risks and complexity.”
  • What Do We Need to Do Differently?
    As pointed out in the paper, “Clinical trials operations should be specific to the risk and complexity of each trial and not governed by one-size-fits-all requirements of sponsors and their contracted organizations. Overly burdening trials with too-rigorous requirements is pushing up costs and putting off investigators to undertake research.”

Some critics suggest that the global push is too rapid and lacks the individual attention the countries need for proper regulatory oversight.

Last year the FDA launched a Pathway to Global Product Safety and Quality to help build a more global reach and develop a model to ensure global product safety and equality. To find out more information about this program, check out our blog on the global push.

What are your thoughts on globalization of clinical trials? Do you have any other points for consideration when going global? Add them below!

Photo Credit: Judy **

 

Topics: Global Clinical Trials, FDA, Clinical Research

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