Anybody who understands Clinical Trials does know that pharmacovigilance is a critical part of any trial as it deals with the safety of humans. However, there are many questions pertaining to pharmacovigilance. Like:
- Is pharmacovigilance limited to any particular phase of study?
- What are the strategies involved in having a good pharmacovigilance plan?
- What are the key considerations required by regulatory authorities globally? And lastly, what is the ultimate aim of all these?
The World Health Organization (WHO) defines pharma-covigilance as “the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications and biologics.” Also, according to WHO, pv has four principal aims, they are, improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions; improve public health and safety in relation to the use of medicines; contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use; and promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public.
Pharmacovigilance plays a critical in every phase of the study, and most importantly, in the post-marketing phase. Once the product enters the market, the intake of an investigational product cannot be controlled by the sponsor. However, it is very important for the sponsor to monitor and assess data on its safety aspects. This can be done by a robust pharmacovigilance strategy that is technology-driven and harmonizes with the medicine and regulatory aspects as well. The basic elements of a pharmacovigilance-strategy are strong SOPs, accurate case study report capturing, updated safety database, speedy signal detection, expedited reporting to regulatory authorities, and lastly, risk management.
However, any strategy will work only if it complies with regulatory authorities. With tragedies that have taken hundreds of lives, the regulatory authorities have made submission of expedited reports for serious and unexpected adverse events mandatory along with confirmed signals occurring in association with the investigational product. Additionally, a working risk management plan along with qualified professionals who follow all the regulatory guidelines, especially the timelines.
Therefore, with the changing trends in clinical trials and changing demographics of the patients taking the medicines, outsourcing pharma-covigilance has been the preferred as they have the expertise to centralize data and hence, early identification of risks; ensuring that the ultimate aim, that is, the safety of human health is fulfilled.