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Pre-marketing drug studies vs Post- Marketing research
Pre-marketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.
Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA). Other regulatory agencies, such as the European Medicines Agency (EMA), use the term post-authorization studies instead of post-marketing studies.
Post-marketing studies concentrate mainly on safety and effectiveness. FDA uses post-marketing study commitments to gather additional information about a product’s safety, efficacy, or optimal use. Agreements with sponsors to conduct post-marketing studies can be reached either before or after FDA has granted approval to a sponsor to market a product.
Post- Authorization Safety Studies (PASS)
Post-authorization studies that are focused on safety are known as post- authorization safety studies (PASS), and these can be interventional or non-interventional. According to the EMA, a PASS refers to “any study relating to any authorized medicinal product conducted with the aim of identifying or quantifying a safety hazard, confirming the safety profile of the medicinal product, or measuring the effectiveness of risk management.”
Post market research for monitoring drug safety
The most used approaches for monitoring drug safety in humans are based on spontaneous reporting systems, automated linkage data, patient registries, case series and case reports, case control studies, and data obtained directly from an interventional study. Since there are major limitations to relying on case reports or on voluntary reporting, post-marketing research has become an integral part of the drug evaluation process for assessing adverse events.
In the past, post-marketing research, post-marketing surveillance and pharmacovigilance were synonymous with phase IV studies because the main activities of the regulatory agencies were focused on the monitoring of adverse drug events and inspections of drug manufacturing facilities and products. However, the fact is that not all FDA mandated (classical phase IV trials) research consists of randomized controlled trials and not all post-marketing activities are limited to safety issues (pharmacovigilance).
Why are Post- Marketing studies conducted
There are several initiating mechanisms for post-marketing studies:
(1) Those required by a regulatory agency as a condition of the drug’s approval
(2) Those that are initiated by the pharmaceutical company to support various aspects of the development of that drug
(3) Investigator-initiated trials that may be as scientifically rigorous as phase III RCTs, but occur after drug approval
(4) Investigator-initiated observational studies.
FDA mandated studies vs Non-FDA mandated postmarketing studies
Any type of study may be requested or mandated by the FDA upon New Drug Application (NDA approval) and these are bucketed under postmarketing requirements (PMRs) and postmarketing commitments (PMCs). PMRs/PMCs are studies or clinical trials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. These studies or clinical trials can be required either by regulation or statute (PMR), or by a written agreement, between FDA and the applicant (PMC).
Non-FDA mandated postmarketing studies may utilize a wide array of research designs with various objectives. Examples of these studies include superiority testing, equivalence and non-inferiority trials, surveillance studies such as effectiveness studies, epidemiologic observational studies etc. Health services research, and health outcomes research are other types of studies that are conducted for marketed drugs.
Recently, the FDA has increasingly approved new drugs and biologics based on shorter, smaller, and fewer trials. This shift corresponds with the FDA’s adoption of a life cycle evaluation process, which emphasizes the importance of continued evaluation and monitoring of safety and effectiveness in the post-market period.
Conclusion
Post-marketing or phase IV clinical trials usually include a larger and more heterogeneous population than phase III trials with emphasis on reproducing usual clinical care conditions. For some special populations such as pediatrics, phase IV commitment trials represent a unique opportunity to determine the safety and efficacy of a drug because only a small fraction of all drugs approved are studied in pediatric patients.
In conclusion, post market research answers all the important questions about the benefits, harms, and optimal uses of new drugs, devices and biologics post approval and are essential to ensure that the treatments stay safe and effective when applied to larger populations.
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Reference
- Post-marketing observational studies: my experience in the drug industry BMJ 2012; 344 :e3990 doi:10.1136/bmj.e3990
- Glasser, S. P. (2014). Essentials of Clinical Research. Springer.
- Research, C. f. (2022, February 27). Postmarketing Requirement/Commitment Related Submissions – Administrative Handling, Review, and CBER Reporting . Retrieved from https://www.fda.gov/media/90205/download
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