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The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately…
In the second part of the review on ‘English for Medical Purposes’, I present the main results of the research conducted on spoken interaction in medical settings. I start with those EMP studies that have a clear pedagogical goal, followed by EMP…
With increasing transparency demands andthe new legal requirements for providingclinical trial information to lay readers, clinicaltrials need to be given titles that patients canunderstand and recognise. Trial titles informthe readers what the…
There seems to be a move towards ‘patient-centred’ health care as part of an overall effort to improve the quality of health care and to reduce costs. Individual patients and providers have to work together to ensure effective communication.…
AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
In this data-driven era, the type and format of publicly available medical and scientific information is significantly changing. Medical writers can serve as guardians of the information entering the public domain by ensuring accuracy and…
Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…
Members of the social web are increasingly banding together and using web 2.0 technologies to actively participate in their own healthcare (‘health 2.0’). This article gives an overview of how ‘crowdpower’ is impacting the field of healthcare, above…
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