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Drug makers usually put in rigorous efforts to fast-track and reduce the cost burden of regulatory decision-making by regulatory authorities like USFDA and EMA. As a part of these efforts, the interest in utilizing real-world evidence (RWE) for the approval process has considerably increased in the past few years.(1) Even though data from randomized controlled […]

Real-world evidence (RWE) has been used extensively for satisfying post-launch regulatory requirements, mainly about drug safety. Of late, it has been realized that RWE has a wide range of applications across various phases of a product lifecycle, starting from the pre- to post-launch phases. These applications aim to address the particular needs of different healthcare […]

Artificial Intelligence (AI) refers to a computerized system that performs physical tasks, cognitive functions, solves problems, and/ or makes decisions without overt human instructions.[1] First proposed by McCarthy in 1955, the concept of AI has been applied in many health-related areas, including clinical research, hospital care, drug development, disease diagnosis, prognosis, and treatment monitoring. Advancement […]

A patient registry has been defined as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves a predetermined scientific, clinical or policy purpose.”(1) Patient registries provide an infrastructure for the standardized […]

Patients with serious, life-threatening health conditions and who have no available treatment alternatives, often want to know if and how they can receive early access to investigational products, sometimes even before they are approved by the regulatory agencies. “Expanded access programme” (EAP), also referred to as “compassionate use programme” or “managed access programme”, is a […]

Economic evaluations of health interventions focus on comparative analysis of alternative approaches concerning their costs and outcomes. These help healthcare decision-makers to take informed decisions about appropriate resource allocation for healthcare, such as the approval of new drugs, devices, or procedures. However, economic evaluations often face reporting challenges because of the enormous amount of information […]

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 […]