Since the drug approval process involves phase I, II, and III trials, post-marketing trials are sometimes referred to as phase IV trials. PMS involves systematic monitoring of medications as they are used in real-life scenarios, as opposed to the controlled settings of pre-marketing trials, where study conditions are tightly controlled. Although randomized, RT clinical trials, which minimize variability, are useful in assessing the efficacy of one drug versus another, they do not provide adequate information on a drug’s effects after it is released for general use.
PMS provides valuable information on the use of drugs in special patient populations, which is information not easily obtainable from pre-marketing studies. Randomized clinical trials conducted before marketing include only subjects who meet defined inclusion and exclusion criteria, thus creating a homogenous study population. The population of potential users after the drug is released is very different from the population studied in the pre-marketing phase. For example, randomized clinical trials typically exclude from study participation women who are pregnant or breastfeeding; therefore, PMS is the only means of obtaining information on mutagenic and teratogenic effects of drugs in humans. Other special populations that benefit from PMS include the elderly and patients with multiple comorbidities. Like pregnant women, patients who are very old or very sick are excluded from premarketing trials.
A drug may exhibit different effects when administered to a healthy 30-year-old patient versus an 85-year-old patient who has multiple health problems and is taking multiple medications.
PMS also allows for long-term monitoring of the effects of drugs. Due to cost and feasibility issues, randomized clinical trials conducted before marketing are short in duration. Thus, Medycal research has developed strategic partnerships with patient databank providers to asserts its market presence in a niche fashion that enables Medycal to provide data for post marketing surveillance studies to its partners.
Yasir Butt B.S, M.T
Dr. Sohaib Abbas Malik FCPS, FRCS
At Medycal, we aim to speed up the development of novel therapies having significant potential to improve patient lives.