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Data Transparency: Its Impact on Clinical Trials
Effectively facing with the new environment of clinical studies
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, policy 0070 of the European regulatory agency (EMA), section 801 of the Food and Drug Administration’s Act (FDAAA), the initiative Restoring Invisible and Abandoned Trials (RIAT), the requests by the International Committee of Medical Journal Editors (ICMJE) and the European regulation on clinical studies (536/2014), have made mandatory the effective management and publication of the data collected in clinical trials. The policy 0070 “on publication of clinical data for medicinal products for human use” has made the publication of the main documents sustaining the registration dossier of new products mandatory; its final goal is making publicly available the data collected during each clinical trial which was used for registration purposes.
An analogous approach is the one followed by the FDA, other regulatory authorities, the ICMJE and the main medical-scientific congresses that 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. This new approach makes mandatory to redefine both the management of company’s confidential data and patient’s personal by the clinical study sponsor. A challenge to be effectively faced for its translation to communication effectiveness.
This course aims to provide practical tools to manage the new clinical trial environment in a proactive and effective way.
Collection of expectations
Individual questionnaire compilation
The principles of clinical research
Public reputation of pharmaceutical companies
- The informed consent
- All trials
Analysis of the individual questionnaire and discussion
The requests of the International Committee of Medical Journal Editors (ICMJE)
Registration of study protocols
- Clinical studies registries
- Publication of clinical trials results
- Non-interventional studies
The regulations on the publication of the results of clinical trials through the world and their implications
Data sharing initiatives
- The RIAT
The EMA approach
- EMA Policy 0070
The FDA approaches
- Section 801 of the FDAAA
Clinical study reports and clinical investigation reports
Individual patient’s data
The statistical implications
- The SAP
The companies' point of view
How information is published
Establish Strategic Timelines for Publications Development and Publishing
- Understand Quantified Risk Assessments
- Create Data Anonymisation Strategies
- Manage the EMA Timeline
Verification of expectations and conclusions
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 including:
- Clinical Operations
- Medical Affairs
- Clinical data registration
- Scientific Communications
- Medical Information
- Clinical Information
- Quality assurance
- Data management
- Real World Data
Participants should be aware of the basic principles governing clinical trials and the regulations to be used for the approval of new medical products in Europe.
Interactive workshop with on-train exercises and application to participant’s daily activities.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.570,00* (until 17 August 2020)
Ordinary: € 1.780,00*
Freelance - Academy - Public Administration**: € 890,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Monday, August 17, 2020
At the end of the training, you will be able to
Manage the principles of clinical data sharing
Evaluate the implications for ensuring resources needed to effectively and efficiently address data transparency needs
Transform new legislative requirements into an opportunity to improve image and company’s productivity