The Fondation René Touraine (FRT) has organized a training session in medical research that took place on the 12th and 13th of october, in Hammamet, Tunisia. It was organized in collaboration with The Tunisian society of dermatology and venerology, The College of Dermatology, The public hospitals of Paris (clinical research department) and The PIERRE FABRE laboratories.
Please find below the programme of the training session:
WEDNESDAY THE 12TH OF OCTOBER
8am to 9pm - Registration
9pm - Clinical research: what for? Pr Louis Dubertret
9:30pm to 12:30pm - Prs Olivier Chassany and Patrice Debré
— > Evaluation of professional practice (pre test)
— > Principles and methodology of medical trial
Why do we still have to practice random, comparative and double-blinded trials?
To what extent do we have to include the patients?
How can we analyze the data?
12:30am to 5:30pm - Prs Olivier Chassany and Patrice Debré
— > Regulation and good clinical and ethical practice in clinical trials
Why is the technical framework of clinical research that complicated?
How and why do we have to inform the patient and seek his approval?
What are the responsabilities of the promoter and of the investigator?
THURSDAY THE 13TH OF OCTOBER
9am to 12:30 am - Prs Olivier Chassany and Patrice Debré
— > Practical realization and feasability of the trial
What pitfalls should be avoided for a feasible study?
What is the action to be taken if unexpected events occur during the study?
How and why do we have to respect the protocol and collect good quality data?
2:30pm to 5pm - Dr Anna Beatris Rossi
— > Clinical trials in dermatology
Pharmaceutical clinical trials: study of phase 1 to 4 and regulatory framework
Cosmetic clinical trials: what robustness?
The methodology of clinical trials in aesthetic dermatology: differences amongst the medical devices in Europe and in the United States
Example of a critical evaluation of pharmaceutical, cosmetic and aesthetic publications: therapy of melasma
Factors to consider in order to realize and publish a study on clinical research in dermatology: definition of the objectives of the research, assesment methods and calculating of the samples
Pr Hamida TURKI, president of The Tunisian society of dermatology
Pr Louis DUBERTRET, president of The Fobdation René Tourain (FRT)
Dr Florence Veber, Delegation of International Relations, Public hospitals of Paris