Translation of "Signal de recherche d'essai " (French → English) :

It is appropriate that universities and other research institutions, under certain circumstances that are in accordance with the applicable law on data protection, be able to collect data from clinical trials to be used for future scientific research, for example for medical, natural or social sciences research purposes.

Question No. 53 Ms. Kirsty Duncan: With respect to the chronic cerebrospinal venous insufficiency (CCSVI) clinical trial being undertaken by Dr. Traboulse: (a) what milestones are reportable to the government, (i) on what date(s) is reporting expected to occur, (ii) how will this information be communicated to patients, the medical community, and the general public; (b) on what date did each of the trial sites pass ethical review; (c) on what date did recruitment of patients begin for each of the trial sites; (d) how many patients with multiple sclerosis (MS) are being recruited for each site, and how is consistency in diagnosis and t ...[+++]reatment being ensured across sites; (e) who is performing the diagnoses for CCSVI for each site, (i) how is the diagnosis being performed, including, but not limited to, ultrasound and venogram, (ii) how many diagnoses has each person undertaking the diagnosis at each site performed prior to the study, and by whom was each person trained; (f) who is performing the procedures for each site, (i) how is the procedure being performed, including, but not limited to, anesthetic, balloon size, (ii) how many procedures has each person undertaking the procedure at each site performed prior to the study, and by whom was each person trained; (g) what are the selection criteria for the trial, including, but not limited to, type of MS, Expanded Disability Status Scale (EDSS) score, venous abnormality/malformed valve/stenosis, mobility, (i) how do these criteria compare with the international literature, (ii) with how many international studies to date will the selection criteria be analytically comparable; (h) if both progressive and relapsing-remitting forms of MS are to be examined in the trial, how will statistical significance be ensured given that 50 of 100 patients will undergo a “sham” procedure, 25 patients will have a progressive form of the disease, and 25 will have a relapsing-remitting form of the disease, and will people with bo ...

Research will focus on: developing promising candidate interventions (vaccines, therapies and HIV microbicides) against the target diseases by sponsoring research over the full spectrum from basic molecular research, taking advantage of microbial genomics, through to pre-clinical testing and proof-of-principle; establishing a clinical trials programme to unite and support Europe's clinical trial activities specifically targeted at interventions for use in developing countries; establishing an AIDS Therapy Trials Network in Europe to improve the coherence and complementarity of clinical trials of AIDS therapies for European use.

(i) description of the control testing methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and the finished product, specific tests e.g. sterility tests, test for the presence of pyrogens, for the presence of heavy metals, stability tests, biological and toxicity tests, tests on intermediate products).

(h) Description of the control methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and of the finished product, special tests, e.g. sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests, controls carried out at an intermediate stage of the manufacturing process).

(e) some direct benefit for the group of patients is obtained from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods; additionally, such research should either relate directly to a clinical condition from which the minor concerned suffers or be of such a nature that it can only be carried out on minors.