Thursday, March 25, 2010

Responsibility to Disseminate Clinical Research and Educate Key Target Groups

Questions often asked - Can clinical research be used to disseminate and educate key target groups? Who is responsible for the dissemination of product information once the drug is approved by FDA? The answers are yes and the responsibility of pharma primarily as per post-marketing commitment plans with FDA, respectively.

It is the responsibility of pharma to continue to investigate, elucidate and clarify safety and efficacy benefits and risks for the life cycle of the drug once approved by FDA. Clinical research provides the most up to date scientific intelligence pertaining to drug mechanism of action, safety, tolerability and effectiveness. Clinical research assists key target groups and decision-makers, physicians, health care agencies, health care providers, health care payers, patients, buyers, M&A, key and expert opinion leaders, shareholders, stockholders, sales and marketing, FDA and regulatory agencies worldwide and otherwise to make clinically and meaningful decisions.

It is essential for the pharma industry to educate and disseminate, well monitored, well audited, integrated, summarized quality data and documentation to relevant and appropriate communities and interested parties.
  • Physicians - It is ideal, especially for pharma companies that health care professionals base their prescribing decisions on supporting evidence provided by quality clinical submission, regulatory approved data, statements and documentation. Prescribing code reinforces that professional exchanges with the medical community are designed to benefit patients and medical practice. The more robust the clinical evidence, data and documentation, the better the case for that drug to be prescribed. Now more than ever, during the post approval period and life cycle of the drug, there is, as well, a good opportunity to more define the product's ROI - return on investment, with continued clinical research.

More to come...

  • Health Care
  • Health Care Payers
  • Key Opinion Leaders
  • Sales and Marketing
  • Buyers, Patients, Distributors, Consumers
  • FDA.

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