Real-world evidence (RWE) is derived from real-world data (RWD) sources, such as electronic health records (EHRs), claims data, data from product/disease registries, pharmacy data, social media, and pragmatic trials. RWE provides essential insights into the clinical experience, thereby complementing the information obtained from traditional randomized controlled trials (RCTs).(1) RWE has been extensively used for post-marketing […]
The role of the medical affairs (MA) professional is constantly evolving, thanks to ever-increasing advancements and broadening scope of work in the pharmaceutical and healthcare domain. Of late, MA professionals are seen to increasingly get involved in the drug development process in order to manage market access and reimbursement challenges while also facilitating drug discovery, […]
Results from over half of all conducted randomized controlled trials (RCTs), especially those with negative or unfavorable results, never get published. This means, searching only electronic databases that index published literature does not provide the entire spectrum of information; additionally, a bias is induced, since most trials having negative results get omitted. This is extremely […]
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 […]
