Clinical Trials In Medicine

It is perhaps a fundamental truth in medicine that there is no intervention – be it a drug, medical device or a procedure – that is without risks. It is a high obstacle to develop safe drugs because every drug carries potential to harm. Drug safety is usually assessed comparing to drug’s benefits and cannot be merely considered an absolute. The safety and efficacy of drugs or medical devices are demonstrated in a sequence of clinical trials which are conducted prior to the approval. Considering the rigorous process with which a drug is approved by the regulatory bodies, it can be said that there is no drug which is completely safe.

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications,

For registration purposes, World Health Organisation states clinical trials as ‘any research study that prospectively assigns human participants or groups of human to one or more health related interventions to evaluate the effects on health outcomes?’ (WHO) Clinical trials play an important role in the improvement of the quality of medical practice. Clinical trials have predominant in approval of many drugs and medical devices. Depending upon the ‘product’ and ‘the stage of the clinical trial’ to be investigated, investigators generally enrol patients and volunteers in the trials and consequently conduct progressive comparative studies. A paramount condition for the

These alterations can be ‘change in dose, population, needed monitoring, consent forms, etc.’; these modifications are done because the reactions in their most severe forms threaten life. Either due to the nature (seriousness) or due to their significance of the adverse events (adverse reactions) and the unexpected information they provide, accelerated reporting along with special medical or administrative criteria’s were needed to define the reaction. These reactions should be promptly reported to the regulators. The seriousness of the adverse events depends upon the patient outcome or action criteria usually associated with events that pose a threat to a patient’s life or functioning. For the timely update of this crucial information, serious adverse events (SAEs) have to be reported according to the International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines. As defined by ICH-GCP, a Serious adverse event or reaction is defined as “any untoward medical occurrence that at any