Clinical trials finally public!
The World Health Organization announced that it was creating an internet portal on which would be available all the clinical trials taking place around the world.
The interest of such a centralization (which had already been undertaken by some pharmaceutical laboratories)is that of avoiding duplications and unnecessary repetitions. It would also provide scientists with the possibility of checking for negative results (which are seldom published).
On the plane of bioethics, it is certain that this tool also has its importance as it would allow specialized associations and interested individuals to check out for clinical trials being conducted on human patients. The lack of transparency on clinical trials has often been incriminated, especially when these trials are conducted in third world countries.
However, that transparency seems to be quite far away for the time being. One can recall clinical trials being conducted on AIDS in some African countries without real information being given to the patients. On the other hand, clinical trials being conducted on patients in end of life have also to undergo scrutiny (cfr. for instance one of the clinical trials available on the WHO site which talks about tests on cancer patients of which the benefits are clearly not evident compared to the secondary effects:
Evidently, rules of bioethics request that the physician compares the potential benefits to the inconvenience resulting from the trial for the patient. However, who can really say that the patients have made a sufficiently informed consent to this trial, especially when being at the end of their life?
Hence, the main interest of publishing online all clinical trials being held, is mainly to favour a control by the citizen or pressure groups on these trials.
The interest of such a centralization (which had already been undertaken by some pharmaceutical laboratories)is that of avoiding duplications and unnecessary repetitions. It would also provide scientists with the possibility of checking for negative results (which are seldom published).
On the plane of bioethics, it is certain that this tool also has its importance as it would allow specialized associations and interested individuals to check out for clinical trials being conducted on human patients. The lack of transparency on clinical trials has often been incriminated, especially when these trials are conducted in third world countries.
However, that transparency seems to be quite far away for the time being. One can recall clinical trials being conducted on AIDS in some African countries without real information being given to the patients. On the other hand, clinical trials being conducted on patients in end of life have also to undergo scrutiny (cfr. for instance one of the clinical trials available on the WHO site which talks about tests on cancer patients of which the benefits are clearly not evident compared to the secondary effects:
Palliation of thoracic symptoms measured over 52 weeks after randomization. The data collection schedule for follow-up is presented in table 2. A maximum of 33 questionnaires per patient would be sent in case follow-up could be completed. The first questionnaire was given before randomization, the last questionnaire in the 52nd week after randomization. Data about effectiveness of the treatment and QOL were based on the Rotterdam Symptom Checklist (10). Seven symptoms could be scored each on a four point validated scale from 1 (no complaints) to 4 (severe complaints) (10). The baseline total symptom score had to be 8 indicating that the patient had at least one tumor related complaint. The maximum total symptom score could be 28 indicating the patient had all seven complaints in the worst degree. After response the lowest total symptom score could be 7, having no complaints at all. Palliation was defined as a average total score below the baseline score.
Secondary Outcome(s)
1. Toxicity, Quality of Life (QOL), and survival. 2. Quality of life was measured using the EuroQol classification system (EQ-5D), consisting of five questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression 3. In addition, information about acute toxicity as nausea, vomiting, and radiation esophagitis induced dysphagia was collected, based on the NCIC CTG Expanded Common Toxicity Criteria 4. Patients were also asked to provide information about costs. Together with quality of life data, these data will be published separately in a cost-utility analysis. 5. Follow up after 52 weeks was continued by the data manager, who made 3-monthly inquiries after survival of the patient.
Evidently, rules of bioethics request that the physician compares the potential benefits to the inconvenience resulting from the trial for the patient. However, who can really say that the patients have made a sufficiently informed consent to this trial, especially when being at the end of their life?
Hence, the main interest of publishing online all clinical trials being held, is mainly to favour a control by the citizen or pressure groups on these trials.
posted by dawnofeurope | 8:47 am
