As a member of the Leuconnect e-cohort, you can easily access clinical trials and play a key role in research.
Accelerating research in the field of leukodystrophy is one of the major challenges facing the ELA association and the main objective of Leuconnect. Leuconnect supports the implementation of clinical trials by facilitating patient recruitment and providing access to open clinical trials on the platform. The patients registered in the cohort form a community that is available and motivated to participate in online studies.
A clinical trial is a medical study performed on humans. It can be either interventional or observational. Interventional trials allow for the evaluation of the safety and effectiveness of a drug or molecule for a given disease. In this kind of trial patients receive treatment. An observational trial is an epidemiological and statistical study that contributes to improving knowledge of the disease and understanding its evolution. The inclusion process is carried out after the patient has been informed about the trial and signed a consent form during a visit to the doctor.
The sponsor: This is the director of the trial. Along with his/her associates, he/she analyses the trial data, but does not know the names of the patients.
The investigator: He/she directs and supervises the execution of the trial at a hospital site. He/she is the consultant doctor at the trial site. He/she knows the patients and includes them in the trial. He/she is responsible for the proper conduct of the trial regarding his/her patients and has access to all of their data.
Many other professionals are involved in trials such as trial technicians, clinical research associates, statisticians and data managers. They have access to the data but can only find out the names of patients if they are authorised to do so.
Before being formally included in a trial, patients must follow the selection process. Inclusion and exclusion criteria are used to determine eligibility for the trial. If the patient's criteria meet the trial requirements, he/she is invited to take part. During the patient’s consultation with his/her doctor (the trial investigator) the doctor will inform him/her about the protocol of the trial and its objectives. All procedures of the trial, as well as the potential risks and benefits, will be communicated so that the patient can decide whether to participate with full knowledge of the facts. If the patient wishes to formally validate his/her participation in the trial, he/she must sign a consent form.
A trial may be conducted at several sites at once, but each patient is assigned to only one site per trial. The site chosen by the patient is generally based on his/her place of residence or consultation. Each trial site is supervised by an investigator, a doctor responsible for managing the research on the site.
Thanks to your registration in the Leuconnect e-cohort, you and other patients will be able to register more easily for clinical leukodystrophy trials or be contacted by a healthcare professional requesting your participation.
Now that you are a member of the e-cohort, you will be informed about ongoing or upcoming trials on Leuconnect. They will be listed in your personal space on your dashboard.
From your dashboard, you can find information about different trials and select the one in which you would like to participate. If the trials allow it, you can apply for several trials at the same time. Once the trial has been selected, you will find a summary on the right-hand side of the screen stating its purpose, status, duration, start and end date, recruitment closing date, inclusion and/or exclusion criteria and the location of the trial.
On Leuconnect, the pre-screening step takes place before the patient can be enrolled on the trial. It involves patients being pre-screened according to three criteria: gender, age and medical condition. If you meet these pre-selection criteria, they will be displayed preceded by a small green check mark.
When applying for a Leuconnect trial, you must select the site at which you want to be based.
For observational trials conducted exclusively online, there is no "physical" site allocated to the trial. In this case, the trial will be linked to a virtual site that must be selected automatically.
Once you have selected a site, you can finish your application, which will then be reviewed by the investigating doctor. Leuconnect will forward all of your data to your investigating doctor for evaluation. You will then receive a notification informing you that your application is under consideration.
If your application is approved by the investigating doctor, you must sign the Leuconnect agreement. If applying for an observational trial, this agreement will be taken as your consent to take part. For interventional trials, you must sign the trial participation consent form during the appointment with your investigating doctor after you have read the conditions of the trial. Following this appointment, you will be asked to validate your agreement on Leuconnect.
To sign the Leuconnect Online Agreement, you must first read and accept the consent document, then accept the terms and conditions of use of the online signature system and finally sign the trial participation consent form. This three-step process is exactly the same as the one followed when you registered to join the e-cohort, except this time it concerns the trial itself (see article in ELA Info review n°104 dec.2018 "Registering on Leuconnect / Signing the form electronically").
Once you have signed the Leuconnect agreement, the trial will appear in the "My Clinical Trials" section on the left of your dashboard and a notification will inform you that new items concerning the trial will soon be available on your dashboard. These items may consist of medical appointments or questionnaires that you must complete as part of your participation in the trial.
Following the examination of your medical file, provided that all the inclusion and/or exclusion criteria are met, your investigating site doctor will be able to include you in the trial, and you will then receive a notification.
It is only once you have been accepted for the trial that the actual research-related activities and the monitoring of them can begin. Your trial's investigating doctor will have access to your data.
On your dashboard you will find your online schedule which gives details about events relating to the protocol of the trial in which you are taking part. You will be able to view medical appointments that you need to make, questionnaires or forms that you must complete as part of the trial as well as instructions indicating how to complete them on time. This tool is only available for those participating in a trial. It does not allow you to arrange appointments, but you can view and track them.
Your dashboard also gives you access to questionnaires. You will be notified when a new questionnaire is available to you. You may also be asked to complete pre-selection questionnaires before being accepted for the trial. As part of the trial, you may be requested to complete questionnaires related to your medical condition.
As a member of the Leuconnect community, you can access online clinical trials and can easily apply to them or be asked to participate. You are, therefore, helping to accelerate research on leukodystrophy.
A preliminary epidemiological trial on leukodystrophy is being prepared and will soon be opened on Leuconnect. The clinical trials to be conducted on Leuconnect will provide a wealth of information on the history of the disease and the biology of leukodystrophy and should also make it possible to explore other forms of therapy, providing treatment opportunities to many patients.