Clinical Research

Protocol writing in Clinical Research

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A clinical trial protocol is a legal document which outlines the study plan of the clinical trial in a detailed, yet comprehensive and concise manner. The protocol must provide a valid scientific rationale for the conduct of the clinical trial as well as make sure that the rights of the patient is safeguarded, maintaining the […]

Clinical Research

Self Help Groups / Patient Support Groups – Role in Clinical Research and Epidemiology

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A patient support group is constituted as a common forum or locus where patients with common diseases or interests can obtain information about their condition, share feelings and experiences and attain a sense of belonging and acceptance. Even though not being fully representative of the disease population, the pharmaceutical industry has long recognised the marketing […]

Translational Medicine

Clinical Translational Research

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A micro-segmentation of the research enterprise along with drying up drug pipelines and piling up of un-translated basic science discoveries has prompted all the stakeholders of innovation towards development of translational medicine tools for efficacious and expedited entry of products to the market. Clinical trials are important and have lately come under scrutiny for their […]

Medical & Scientific Writing

Consolidated Standards of Reporting Trials (CONSORT)

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CONSORT (Consolidated Standards of Reporting Trials) includes various initiatives formulated by the CONSORT Group to identify and rectify the effects arising from inadequate reporting of randomized controlled trials. Deficient design and reporting of randomized controlled trials is widely acknowledged and the issues are addressed in the CONSORT statement. CONSORT Statement: The main document of the […]

Translational Medicine

Systems Biology – Virtual Patients

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Systems biology can describe intricate responses to therapeutic interventions in pre-clinical studies and also provide predictive models for drug safety and efficacy before going for the clinical phases. Systems biology can potentially reduce the R&D expenditure and time by improving target identification and lead quality, better description of pharmacokinetic and toxicity profiles, as well as […]