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WEBINAR: Data Transparency in Clinical Research
The obstacles to data transparency and how to overcome them
Data transparency in clinical trials has become an essential requirement for anyone involved in clinical studies. Although many pharmaceutical companies had spontaneously provided the opportunity to access data collected during their clinical trials to anyone who requested it, regulatory agencies and the International Committee of Medical Journal Editors (ICMJE) have made mandatory the effective management and publication of the data collected in clinical trials. The ICMJE and the main medical-scientific congresses require, together with the publications that report the results of each clinical trial, also the protocol, patient’s level data, and the methods used for their analysis or, as a minimum, the strategy to share such data under request.
This new approach makes mandatory to re-defining both the management of the company’s confidential and patient’s personal data by the clinical study sponsor: A challenge to be effectively faced for its translation to effective communication. Furthermore, the alignment of any document (regulatory or publication) belonging to the same study is crucial. Thus, the role of science communicators is becoming every day most important.
The obstacles to data sharing will be examined during this webinar to let scientific communication specialists and medical writers able to act ethically and effectively enhancing clinical studies data transparency.
- The public reputation of pharmaceutical companies
- Patient’s requests
- The information on trials for patients
- The requests of the International Committee of Medical Journal Editors (ICMJE)
- How information is published
- The obstacles to data sharing in clinical trials
- How to enhance data transparency
Webinar language: English
Andrea has a degree in Biology from Florence University. After a brief spell at the University, he started working in the Italian Affiliate of Eli Lilly as a Clinical Research Associate. In the years that followed he was responsible for Statistics, Health Outcomes and Medical Information. Andrea has been working as Medical Writer since 2003 beginning in Italy and, then, becoming responsible of worldwide scientific affairs in a biosimilar company based in Switzerland.
He is author of more than 350 disclosures and acknowledged for his contribution in several others. From 2007 to 2009 he was on the coordination board of BIAS (Biometristi Italiani Associati) and has been a European Medical Writers Association (EMWA) member since 2004. Andrea acts as trainer for statistics and medical writing in some Italian schools for specialisation in medicine and has been a speaker at national and international conferences.
Andrea leads workshops for and is past-president and ambassador of EMWA.
All company figures involved in the development, registration, and reporting of clinical trials on products for medical use.
Participants should be aware of the basic principles governing clinical trials.
Webinar with Q&A
Webinar online: 16 April 2020 at 11.30 am
After the registration you will receive all details about the connection
Wednesday, April 15, 2020
At the end of the training, you will be able to
Understand the importance of data transparency
Evaluate the obstacles to data transparency in clinical trials
Understand how to enhance data transparency