Clinical Research

29Mar 2018

Every country exercises strict control on medicines’ market access. Typically, this requires successful completion and adequate presentation of results from phase I through phase III clinical trials, bringing forward the findings of medicine’s safety and efficacy. The USFDA approves approximately 40 new medicines for the US market each year through this process. (1) In India, […]

25Oct 2017

Clinical trials are instrumental for health science community to test and evaluate interventions. Trials can be broadly categorized in two classes, i.e. pragmatic and explanatory; where the former are designed to evaluate the efficacy of interventions in real-life routine practice conditions, whereas the latter aim to test whether an intervention works under optimal situations. Outcomes […]

14Sep 2017

A recently published study by Dyer O (2017) exposed major drawbacks in the accelerated approval process of some drugs available to the American patients without any stringent clinical evidence of their benefits. (1) Drugs receiving fast track approvals from the US Food and Drug Administration (FDA) often rest on a weak evidence base, says research that […]

11Aug 2017

Ethics are the moral principles that distinguish between right and wrong. In research, they differentiate between acceptable and unacceptable behaviours on the part of the researcher. Ethical considerations in research form the basis of adherence for the integrity, reliability and validity of the research findings. Some form of ethical review of human research is prevalent […]