GenePredit is another example of a Portuguese start-up that successfully took its R&D project from bench to clinical trials. GPD-01-01 clinical trials is the first trial that uses a genotyping based therapy based on a genetic predictive biomarker of body weight and fat mass reduction in obese patients treated with perindopril.
Blueclinical has been supporting GenePredit in this project, and is involved in several steps of the way from its Conception to its execution. Namely, medical writing activities, statistics, project management, submissions, data management, site selection and initiation, study conduction and monitoring. Archive and final report preparation will also be performed by Blueclinical.
This is a Phase II exploratory multicentric therapeutic trial, implemented in 12 national study sites. The participating sites are hospitals and primary health care units throughout Portugal’s territory. Working with primary care health units allowed the development and implementation of clinical research training to the clinical teams and implementation of clinical research activities.
Blueclinical took advantage of its Blueclinical CRP network which comprises institutions of the national health service. Thus, 11 out of the 12 study sites where GPD-01-01 has been implemented are institutions belonging to Blueclinical CRP network.
The first patient was recruited on the 2nd of March 2016 and, since then recruitment rate has been outstanding, allowing the inclusion of 177 patients in 6 months. The first patients already finished their trial participation on June 2016.
Clinical research teams have been developing an excellent work for the sake of national research!
GPD-01-01 implementation has also enabled the dissemination of training actions such as, the CLIC program for clinical research teams, which were provided access to an online platform with all documents, courses and updated study information and experience sharing between clinical teams through monthly study Newsletters.
According to GenePreDiT “this clinical trial GOD-01-01 represents the output of 8 years of work, involving the optimization of an entire companys development strategy, with validation in getting the results that formed the basis of assumptions for this study kick-off. Currently company’s activity is centered in this trial. If results are promising, GPD-01-01 will be the starting point in the clinical development chain as a therapy for obesity. This is a particularly important study on the national scene as it is the first clinical trial to be held in Portugal by 100% national researchers, promoted by a biotech company. "For more information please visit https://clinicaltrials.gov/ct2/show/NCT02777489?term=gpd-01-01&rank=1