The policy on “publication of clinical data for medicinal products for human use”, also referred to as the “policy 0070” was launched in 2015 by the European Medicines Agency (EMA), to comply with the growing demand from stakeholders for additional transparency in the clinical data that form the basis of regulatory decisions. (1-3) Policy 0070 […]
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 […]
Systematic reviews (SRs) are the embodiment of the evidence-based approaches, and they have reformed clinical decision-making in almost all therapy areas. The approach of SRs was essentially developed to fulfil the need of the medical practitioners to obtain precise and consistent information about the efficacy and safety of a clinical intervention, diagnostic procedure, or a […]
Systematic reviews (SRs) often face a major challenge while identifying all the relevant research, including randomised controlled trials (RCTs) irrespective of their publication status.(1) Unpublished, selectively reported, or non-reported research can lead to poorer quality clinical trials, thus leading to suboptimal care delivery. It also overlooks the opportunities for potential scientific progress.(2) Such incomplete publication […]
The world today is observing an exponential growth in the volume and variety of the real-world data (RWD). Thanks to the technological advancements and the rise in the use of integrated electronic medical records (EMRs), RWD is ever more accessible and applicable in the regulatory domain as well as outcomes research. The evidence from randomized […]
Clinical practice should ideally rely on robust scientific evidence, the standard for which are systematic reviews and meta-analyses of all randomised controlled trials (RCTs). (1,2) Therapeutic decisions in healthcare must be informed by clinical research findings, and patients and prescribers must be able to trust the presented research evidence. However, this evidence can be considered […]
Systematic reviews (SRs) are crucial in health and scientific research as they offer a thorough understanding of the findings from research. (1) They provide critical information on different aspects of research, such as answers to the questions not often addressed by individual studies, problems in primary research that need to be avoided in future studies, […]
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 […]
