Leuconnect: an online clinical research support platform
Clinical trials concerning leukodystrophies come up against the issue of too few patients included, which results in statistical weakness and a low level of proof of efficacy of therapy. To overcome this, the ELA International association is creating an online platform to support clinical research to expand the international recruitment of patients in studies and clinical trials. Si Leuconnect is an innovative tool for medical investigators and paramedics, this platform will also revolutionise access to clinical studies for patients and their families by simplifying administrative procedures, offering patients the possibility of choosing themselves the study in which they would like to be included and by expanding this involvement of patients from several countries.
Leuconnect: the patient actor in research
• The public space is intended to offer relevant and updated information on the understanding of the mechanisms of the disease, symptoms, diagnosis innovation, ongoing studies and clinical trials and improvements in the management of leukodystrophies.
It is from the public page that the patient can join the community of Leuconnect and the cohort and from his private space that he can be recruited and followed for several years in order to accumulate knowledge on the evolution of the disease.
• By registering in the e-cohort, the patient creates an account, allowing them to access their private space. From his private space, the e-cohort subject, after completing his medical file, can apply on his own for the clinical studies listed on the site or be easily contacted by a health professional to participate. From their account they can also manage their personal administrative and medical information, be informed of their inclusion in a study for which they have applied (if the inclusion or exclusion criteria defined in the study protocol are completed), sign the regulatory documents online and complete the questionnaires relating to the study. This private space also offers the possibility of accessing a secure messaging system allowing e-cohort subjects to be put in touch with each other after having accepted this principle, and discuss common issues related to the disease. They may also be contacted by health professionals to monitor their inclusion and their medical history in relation to their participation in the study. Through this private space, the e-cohort subject will also be able to learn about the results at the end of the study in which they’ve participated.
From e-cohort to clinical study: a highly secure journey.
Access to the Leuconnect platform is highly secure. All personal data is stored with a host approved by the Ministry of Health (Almerys) guaranteeing their complete confidentiality. Only investigators of clinical studies will have access to all personal data, other medical actors will only have access to anonymised data, as provided for by regulations.
All of these healthcare professionals must also use a strong authentication mechanism.
When the statistical analysis phase is completed and the results of the study are published, a summary sheet of the personal situation of each e-cohort subject is made available to them in their private online space.
With Leuconnect, ELA confirms its commitment to promoting research against leukodystrophies, by enabling the patient to be a real player in research, and by expanding clinical research internationally. In addition to facilitating the performance of clinical studies, the platform is set to become a valuable database for research on leukodystrophies. With Leuconnect, ELA brings real progress for families and a promising prospect for research.
Schematic representation of the public and private spaces of Leuconnect