The Differences Between Clinical and Post Market Medical Reviews

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Wednesday, March 30, 2016

Choosing the most suitable physician as medical reviewer for safety monitoring is always an important part of any company’s pharmacovigilance responsibilities. Yet, it is important to keep in mind that the qualities and expertise that this key safety team member will be called upon to provide will differ depending on the particular safety scenario the company is facing. Knowing what is required and expected of the safety medical reviewer in these differing circumstances, and what factors determine the best choice, is integral to the overall smooth performance of the safety team.

There are two major categories of safety monitoring: “Clinical” which refers to safety monitoring of clinical trials and “Post-marketing”, safety monitoring of situations following approval and marketing, other than directly associated with clinical trials.

For both scenarios, monitoring consists of four basic elements: receiving safety information; processing and recording information; reviewing and analysing information; and, lastly, acting upon information. The good safety medical reviewer is involved in all aspects of the safety cycle, although the level of involvement, and the specific tasks, may vary, depending on whether the scenario is clinical or post-marketing.

How do these scenarios differ?

Safety monitoring in the clinical scenario is tightly controlled, restricted, closely monitored, highly accountable, demanding in terms of time, money and expertise, and integral to the success (or failure) of the drug. Safety information from clinical trials is generally complete, accurate, medically confirmed and relevant, all of which helps with medical review and assessment. The clinical medical reviewer should be experienced in safety monitoring for clinical trial. They are typically assigned to and deeply engaged in the project, experienced in the therapeutic area, and are called upon to exhibit solid and consistent medical judgment. They have achieved familiarity with the study drug, the trial and the safety information to date, and have the ability to forge and maintain the strong working relationships required with both internal and external colleagues. Case review may be time-consuming and complex, with access to little or no safety profile, and demanding a high index of suspicion and finely-tuned medical judgment.

Turning to the world of post-marketing pharmacovigilance, this presents a different scenario. It is generally uncontrolled and much less restricted, and without any patient or health care professional obligations to report safety information. Post-marketing safety information is often incomplete, inaccurate, not medically confirmed and not relevant, all of which hinders medical review and meaningful risk assessment. The post-marketing medical reviewer is assigned most likely to multiple drugs and may have experience across multiple therapeutic areas. They should be experienced in post-marketing safety, able to access and understand each drug’s safety profile, and have the ability to communicate effectively, mainly with safety colleagues internally, but externally when required. Cases are often less complex than in the clinical scenario, although case and aggregate report volume may be much higher, and the post-marketing medical reviewer must exhibit solid and consistent medical judgment and, in particular, a strong ability to appropriately assess less than optimal safety data.

As can be seen, the nature of safety monitoring and the qualities and expertise required for medical reviewers differ in the clinical and post-marketing scenarios, and it is important to consider these multiple, relevant factors when making a choice of medical reviewer. One last factor is worthy of consideration: it is also important to choose a medical reviewer who feels an affinity with, and a preference for the safety scenario in question.

Despite their differences, the aim for all safety medical reviewers is the same: to help gather as much information about a drug as possible, in order to administer it to patients as safely as possible. This task is helped considerably by choosing the most suitable medical reviewer.


Margaret McCulloch, M.D., Medical Director, Ashfield Pharmacovigilance

Margaret McCulloch completed her medical studies in the late 1970’s at Glasgow University in her native Scotland and earned her post-graduate qualifications in anesthesiology from the Royal College of Anaesthetists in London. She practiced clinical medicine in Scotland, England and Sweden prior to her move to the US 26 years ago.

She has been involved in pharmaceutical medicine, working particularly in the field of pharmacovigilance, since 2002, at which time she co-founded her consulting company, Alba BioPharm Advisors. Dr. Margaret McCulloch joined Ashfield Pharmacovigilance as consultant and Medical Director in 2003. For the past 24 years she has resided in north Raleigh with her husband and business partner, Bill.

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