Clinical trials lay the foundation for the biomedical research enterprise. They not only assess the applicability of innovative laboratory findings in humans, but also generate robust evidence on treatments and/or preventive interventions in routine clinical care. Clinical trials also directly engage human participants, who trust the investigators to maintain utmost scientific as well as ethical […]
The most recent evidence shows patient recruitment and retention issues to be a persistent problem in clinical trials. Also, it is almost certain that this problem will only continue to grow as the years go on. (1,2) Missing data is often due to patients being lost to follow-up or withdrawing before data collection time points, […]
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, […]
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 […]
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 […]
According to the data from clinicaltrials.gov, 1.4% of global clinical trials are done in India, when the country has 16% of the world’s population and carries 20% disease burden in the world. However, the number of clinical trials in India is expected to rise by 2018-19 as a result of more stable and predictable regulations […]
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 […]
