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This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…
The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…
The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…
Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…
To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…
With scientific advances during the COVID- 19 pandemic and expansion of artificial intelligence (AI) in research, there has been a simultaneous increase in misinformation about data collection, privacy, and sharing in clinical trials. This increase h…
Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…
The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…
Unsung heroes: The medical writer’s role in clinical trials The medical writer is heavily involved in clinical trials from A to Z and even beyond. Although we are not in the frontline, our role is nevertheless crucial as we develop most of the…
The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…
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