FDA Initiative Spearheaded By University Of Rochester to Develop New Pain Reducing Products

  • Date: November 08, 2010
  • Source: Admin
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The U.S. Food and Drug Administration (FDA) and the University of Rochester have formed a partnership to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.
FDA recently launched the Initiative for the Advancement of Regulatory Science. ACTION is aligned to the same. The goal is to align the procedure for the invention and development of new analgesic (pain-relieving) drug products.
The ACTION initiative is phased through several years. It will identify the main gaps in scientific information that may delay clinical trials and drug development.
Key objectives include:
  • Establishing a scientific and administrative infrastructure to support a series of projects;
  • Establishing relationships with key expert stakeholders, industry, professional organizations, academia and government agencies;
  • Coordinating scientific workshops with key experts in the field of anesthesia and analgesia;
  • Conducting in-depth and wide-ranging data analyses of analgesic clinical trial data to determine the effects of specific research designs and analysis methods.
What triggered this partnership?
The past few decades has witnessed the phenomenal advancements in drug development, e.g. cancer, rheumatoid arthritis, etc. However, new analgesic products have sadly seen few or no innovations. The analgesic products used extensively have serious levels of toxins in them, even when used in mild dosages. The pharmaceutical industry is reluctant to develop new products largely due to the overwhelming task of demonstrating the efficiency of analgesics in clinical trials. In other words, many trials fail. There are contradictory thoughts about analgesic drug development, with several experts of the mind that the fault lies in the design of clinical trials. The current method of clinical trials may hinder or limit their ability to distinguish the effective pain treatments from less effective treatments. Further studies, therefore, may yield a solution.
ACTION will analyze several different clinical trials of treatments for acute and chronic pain. It will examine the trails’ approach and procedures. Researchers will then identify the gaps in trial design and implementation, and come up with solutions to bridge these gaps. This will in turn lead to the speed the development of new safe and effective medications.
The program
The contract awarded to Rochester is for $1 million. The partnership has public and private organizations, including professional societies, patient advocacy groups, industry and government. They will collaborate on multiple projects to help bring more treatment options to patients.


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