What is a Clinical Trial?
A clinical trial is any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
What is the Lebanon Clinical Trials Registry (LBCTR)?
The Lebanon Clinical Trials Registry (LBCTR) is an online registry of clinical trials being undertaken in Lebanon. The LBCTR includes trials that target humans; from the full spectrum of therapeutic areas of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies and complementary therapies. The LBCTR will allow registration for investigational (mandatory for some types of interventional studies) as well as observational studies (optional).
What is the purpose of the LBCTR and why it is important?
The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research effort, to help patients and the public know what trials are planned or ongoing into which they might want to enrol, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering. Thus, prospective registration is a must and should be done before the first patient enrolment. In addition, Clinical Trial registration is needed to fulfil ethical obligations to participants and the research community, help editors and others understand the context of study results, facilitate systematic reviews and other analyses of the research literature and promote more efficient allocation of research funds and aids the Ministry of Health to regulate clinical trials done in the country.
Why Do I Need to Register My Trial and Submit Results to Lebanese Clinical Trials Registry?
It will be required by a Ministerial Decree that will be issued by the Minister of Public Health: It will require (obligatory) responsible parties to register and submit summary results of investigational clinical trials conducted in Lebanon that involve pharmaceutical products (Phase II to IV), medical devices and genetic testing with Lebanese Clinical Trials Registry. Phase I studies will not be allowed in Lebanon. Some studies might be considered if the product will be locally manufactured (to support innovation) or if proven safety in humans (used in other diseases/conditions).
Observational studies are optional (on a voluntary basis) to be registered, but highly recommended/encouraged.
Registration of clinical trials is also required for Journal Publication: The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. The ICMJE requires and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrolment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s trial registration policy. The ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP).
The Lebanese Clinical Trials Registry (LBCTR) is officially a primary registry where organizations and individuals can register their trials that are conducted in Lebanon and LBCTR in turn will serve as a data provider to the WHO ICTRP.
Who funds the LBCTR?
The Lebanese Ministry of Public Health.
Is there a charge for registering studies with the LBCTR?
My study is not yet approved by a human-subjects review board (ethics review committee, institutional review board). Can I register it with the LBCTR?
When will the registration Number for my study be assigned?
After being approved for publication.
Can I register a study after it has started, has been closed to recruitment, or has been completed? (Retrospectively)
No, it has to be registered before the recruitment of the first patient/subject. (Prospective registration).
Some retrospective registrations will be acceptable given a reasonable justification is provided.
How do I contact the LBCTR if I have a question about my study record?
Refer to contact us section on the main page
What is the time needed for a study to be reviewed and published at LBCTR?
Maximum of 2 weeks