13Oct 2017

The term real-world evidence (RWE) is commonly used to refer to non-randomized clinical trial (RCT) data generated in a healthcare setting, which sometimes extends to cover patient socio-economic data and environmental data. Irrespective of the definition, RWE is seen to offer significant advantages over randomized controlled trials (RCTs), which despite being recognized as the gold […]

04Oct 2017

There’s a huge load on both pharmaceutical industry and academia in terms of data and information that is circulated through documents such as study protocols, reports, investigator brochures, manuscripts, and several other regulatory and marketing publications. Both writers and reviewers of these documents are overwhelmed with data and information overload, more so while adhering to […]

21Sep 2017

Missing data are a big concern in any research project; however, despite investigators’ best efforts they are often unavoidable. Missing outcomes have two effects: they reduce precision and power, and they may introduce bias. The statistician can’t do much about the loss of precision, except to make best use of the data that are available; […]

14Sep 2017

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

06Sep 2017

Health informatics systems are evolving with an aim to revolutionize health and healthcare programs worldwide. However, turning this hope-filled vision into a reality will take enormous effort from thousands of designers, analysts, software engineers, usability specialists, and medical professionals. Albeit challenging, the role of information visualization and visual analytics processes is gaining importance. These algorithms, […]

26Aug 2017

                Workshop title – “R WE Ready?” – “Real World Evidence” Methods! Organisers – Co-organised by Organisation of Pharmaceutical Producers of India (OPPI) and ISPOR India-Mumbai Chapter Objectives – To enhance skill set of the professionals of the medical affairs community in area of real world evidence generation to […]

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 […]

10Jul 2017

Scoping reviews are exploratory projects that systematically map the literature on a topic, identifying key concepts, theories and sources of evidence. Scoping reviews are often conducted before full syntheses, and undertaken when feasibility of the research is considered to be a challenge, either because the relevant literature is thought to be vast and diverse (varying […]