One of the most important aspects of clinical research is ensuring the safety of new drugs, treatments, etc on patients. This is called pharmacovigilance or drug safety compliance. This safety aspect is monitored, implemented, and complied with in two ways. Firstly, the sponsor of the clinical research, usually a pharmaceutical organization, conducts drug safety tests at all the stages of the clinical trials they conduct wherever it is required by law. They also implement drug safety protocols at stages of the clinical research study voluntarily too. The other way in which pharmacovigilance compliance is ensured is by the laws and guidelines given by the regulatory authorities like the Food and Drugs Administration (FDA) in the US.
SPONSOR’S PHARMACOVIGILANCE COMPLIANCE
The sponsor of a clinical research study or trial has his major aim as the determination of the efficacy of a new drug on a human condition by experimenting on patients diagnosed with the condition. It is the legal, moral, and ethical responsibility of the sponsor to also ensure the experimentation is conducted in a safe manner and does not cause any adverse or fatal consequences to the patients’ lives.
In order to do this, the sponsor initially starts a clinical research study/trial by designing a research protocol. This protocol is designed according to the guidelines provided by the regulatory authority. The guidelines describe in detail how sponsors can ensure that their trials or studies comply with the required pharmacovigilance regulations. Since reporting of adverse events is considered to be the most common activity performed by sponsors with respect to pharmacovigilance in clinical trials, the guidelines also explain how the reports of adverse events during the trial are to be provided by the sponsor to the regulatory agency.
COMPLIANCE THROUGH REGULATORY NEEDS
In the US, the FDA released a guideline document in 2005 titled the “Good pharmacovigilance practices and pharmacoepidemiologic assessment – Guidelines for Industry”. This document contains inputs from the US department of health and human services, along with the FDA’s two sister organizations – Center for Drug Evaluation and Research (CDER) and The Center for Biologics Evaluation and Research (CBER). This document helps prepare a pharmacovigilance plan and provide guidelines for actions to be taken when adverse events are reported.
The FDA compliance program guidance manual is another document that is used by FDA staffers. They used it to file investigational reports about various stages of the trials as well as adverse events in the field.
The 2005 guidance for industry document in E2E Pharmacovigilance planning is another regulatory document that details the steps to be taken by sponsors to formulate a pharmacovigilance plan for their study/trial. It also details the various pharmacovigilance methods that can be used.
The FDA’s “Introduction to Post-marketing drug safety surveillance: pharmacovigilance in FDA/CDER” provides inputs for sponsors on pharmacovigilance guidelines to be complied with after the approval for a new drug is granted.
Individual case safety reports (ICSR) are another layer of compliance that regulatory authorities demand from sponsors. Sponsors need to report on the effects of the new drug or treatment of every participating patient and file them. They need to provide this to the FDA in order for the FDA to assess if the new drug has caused adverse events, whether it is effective or not, etc.