In a data-driven world, where everything can be digitalized, drug regulators and sponsors are increasingly looking beyond the confines of clinical trials. The use of real-world data (RWD) is becoming common in the clinical development process of a drug. RWD enhances the drug approval process, helps sponsors understand how a particular intervention really performs, and […]
Systematic literature reviews (SLRs) are classically conducted with an aim of mapping the complete evidence base of a particular healthcare intervention, which enables an impartial evaluation of the evidence and lays the foundation for strong recommendations. The initial step in achieving this aim, while carrying out an SLR, is to conduct an extensive literature search […]
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 […]
Real-world evidence (RWE) research is gaining significant importance in biopharmaceutical product development as well as its commercialization. The increasing need of the industry to seek broader information about the safety and effectiveness in the real-world setting, which typically impacts the ensuing reimbursement and utilization of new products, is determined by regulators, public and private payers, […]
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, […]
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 […]
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 for clinical […]
