Security has become increasingly important in all aspects of modern life, and clinical trials are no exception. In addition to close monitoring by investigators and pharmaceutical company sponsors, clinical trials are autonomously reviewed by Independent Review Boards (IRBs), Ethics Committees (ECs), and drug safety firms. This is where pharmacovigilance fits into the drug development process: to provide an extra level of security to ensure safe and effective products reach patients.
Pharmacovigilance, simply put, is drug safety. It is the science of understanding the adverse effects caused by a drug and assessing whether the drug benefits outweigh the risk. This includes detecting adverse events (AEs) during the clinical trial and post-marketing, monitoring and updating the risk-benefit ratio based on relevant findings, preventing and/or minimizing AEs, and, most importantly, harmonizing, and communicating findings to the relevant regulatory authorities in a timely way.
If at any time during the clinical development process the drug developer decides the risks associated with a compound outweigh its benefits, development may be discontinued altogether. By detecting safety signals early in the process, a strong pharmacovigilance system can help minimize the costs of discontinuing clinical development at a later phase.
The principle of vigilant pharmacovigilance in a clinical trial is well served by the establishment of strict eligibility criteria, which can help target the effect of a drug on a disease process with minimal interaction from comorbidities or concomitant medications. Such criteria can produce highly focused data that can be extrapolated to cover larger patient populations with a vast array of medical conditions. If the product receives marketing approval, it will be used in a far less controlled environment. One serious AE may not be statistically important in an arena with 8000 patients, but in a clinical trial of 150, it can change the course of the drug’s future.
Another benefit of pharmacovigilance is enhanced communication with IRBs, ECs, and regulatory authorities around the world. In addition to decreasing the potential for bias, global communication allows the results of a limited trial to be collated and compared to similar trials or similar drugs. Massive computer databases can be used to monitor safety signals that may not be apparent within the pharmaceutical company’s own database. As a result, the company gets a broader picture of a drug’s potential than that provided by a single trial. Such information also allows the company to lay the groundwork for a new trial without duplicating efforts from previous trials, thereby saving costs as well as time.
In today’s pharmaceutical marketplace, patients expect a medication’s benefits to outweigh its risks. Pharmacovigilance can help ensure that those expectations are met. Indeed, a robust, well-defined pharmacovigilance system, actively employed throughout the clinical development process, is the single most important process available to provide safe and effective drugs to patients around the world.
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