Clinical research brings new treatments to patients. New treatments can be new medicines, new cell therapies and other forms of advanced therapies, new surgical procedures or other new approaches to managing a patient. Randomised controlled prospective clinical trials are generally agreed to be the gold-standard for clinical research. A randomised controlled trial compares two or more treatments or approaches in a controlled setting.
A prospective clinical trial is required if the trial protocol includes an intervention that is outside of the patient’s routine medical care such as an unlicensed medicine. All prospective clinical trials must follow a protocol that has prior ethics committee and competent authority approval and must be conducted in compliance with the EU Clinical Trials Directive (2001/20/EC) and the EU Good Clinical Practice directive (2005/28/EC). From late 2011, all EBMT sponsored prospective clinical trials will be approved by the EBMT-CT2 committee.
EBMT sponsored prospective clinical trials are run by the EBMT Clinical Trials Offices in Leiden, often in conjunction with a CRO. The CTOs support multinational, multicentre trials. The services that the CTOs provide vary between trials and include study design and operational feasibility (through the CT2 committee), protocol and patient information leaflet writing, ethics committee and competent authority submissions, insurance, site selection and set up, monitoring and/or auditing, pharmacovigilance, data management, and day-to-day project management and documentation. The services that the CTO will provide for an individual study will be agreed with the Chief Investigator.
Patients who are interested in participating in an EBMT prospective clinical trial should first speak to their personal physician. Patients may find information about current EBMT prospective clinical trials by clicking on the relevant disease on the left hand side. Further general information on clinical trials can be found at the UK’s Medical Research Council website .
If you would like to know more about the EBMT Clinical Trials Offices, please contact Marianne Mol, Clinical Studies Operations Manager: firstname.lastname@example.org