A complete folder that clearly explains the aims and the methodology of SHERPAM clinical trials will be submitted to the “Ouest V” committee to Protect People and accepted before starting the trials. This folder also presents the letter that informs each participant about the protocol and about his rights. Another folder must be sent to our National Health Authority in order to register each participant to a research study (Agence Nationale de Sécurité du Médicament et des Produits de Santé) and to our National Authority regarding personal data use (Commission Nationale Informatique et Libertés). All this information is available on our SHERPAM internal exchanges platform. An assistant of editing project from the Clinical Research Management Office will be dedicated in order to verify that our folder is accurate and convenient, and to submit it to our French Authorities.
Clinical trials will be separated into 2 steps:
- First step, the first clinical trial that mainly aims to validate the estimation of energetic expenditure issued from our primary SHERPAM device.
- Second step: the second clinical trial testing the final SHERPAM device on healthy but also cardiovascular disease patients. Each subject will use SHERPAM device for one month. The consortium have started to work on the methodology of this trial . Such collective forward-thinking allows to better identfy the needs and improve SHERPAM device (related to smartphone autonomy for example). The first draft file of the CPP folder and clinical trial protocol can be sent on request for project evaluation (confidential French written file). It is worthwhile to specify this protocol will evolve certainly with SHERPAM device development..
The following table specifies the important deadline for protocol submission and beginning.
|
Dead-lines 1rst clinical trial |
Steps |
Dead-lines 2nd clinical trial Touring cyclists + cardiovascular patients |
|
January 2016 |
CPP folder submission, ANSM, CNIL |
Early January 2017 |
|
March 2016 |
Start of the trial |
Early July 2017 |
|
August 2016 |
End of the trial |
End March 2018 |
