The business of medical writing enables pharma and healthcare industry to access validated scientific documentation. The field of medical writing is an area of specialization which allows maximizing the commercial potential of pharmaceutical products as they enter the market. It is also a reliable quality evidence for healthcare providers for effective decision making during administration of treatment protocol.
According to a panel of experts who deliberated at the recently concluded DIA event on Medical Writing, the capability in medical writing is an integral part of the biopharma and healthcare landscape. This was because it is seen as an expertise to help industry navigate from the complicated world of medicine.
“The industry business strategy is changing from a dichotomous model to a flexible form of adaptive pathways. This is where the systematic literature review is used to identify and assess high-quality studies which is gaining significance,” said Dr Sunita R Nair, head, Knowledge Services, Capita India Pvt. Ltd.
Availability of data on products' efficacy, safety and quality are pre-requisites in the medical writing. Systematic reviews involving high-quality studies are considered the best available evidence. However, the review should involve well-established, comprehensive methodology and accurate interpretation of results. Good writing is manifested through simplicity, clarity and accuracy. Therefore, data has to be acceptable by regulators, both for marketing authorization and for reimbursement purposes, she added.
Nandini K Kumar, former deputy director general senior grade (ICMR) and adjunct visiting professor, Kasturba Medical College, Manipal, pointed out that publication in peer reviewed journals is validation and acceptance of that research as quality work. Published research is considered as good conduct of research.
Airing similar views was Dr Nimita Limaye, VP Risk Based Monitoring, CDM and Medical Writing, Tata Consultancy Services and programme chair for the DIA conference who stated that it was critical to ensure transparency in information to drive patient safety.
Good quality evidence is key to effective decision making. Systematic reviews involving high-quality studies are considered the best available evidence. However, the review should involve well-established, comprehensive methodology and accurate interpretation of results, stated Dr Nair.
The need for health technology appraisal is now an unavoidable part of a new product launch. This is also calls for expertise in economics to evaluate cost and consequences of healthcare interventions, such as drugs, devices, procedures and services. Specific specialisation in health economics will help to devise a robust strategy to determine the comparative effectiveness of medical interventions. Further adoption of health economics is also needed to formulate efficacy-based decisions, useful in developing clinical practice guidelines, stated Dr Nair.
Delving into data transparency initiative, Dr Limaye said that while responsible conduct of research is paramount, this was possible only with integrity and transparency.
Medical writing is indispensable as it provides not just deployment of a secure data repository but an explicit framework for making decisions, said the experts.