Health Policy

New software to provide data on deaths during clinical trials

eHEALTH Bureau To make the country’s clinical trial registry more transparent and user-friendly, the ministry of health and family welfare has proposed that a new software to be launched in November provide details on deaths during trials and hospital-wise data on ongoing studies.The clinical trial registry-India, run by the Indian Council of Medical Research, has seen an overwhelming response since registration was made mandatory in June 2009. But the existing software has not been able to handle all the information, reports Live Mint.”With the new software, we want to make the clinical trial scenario even more transparent and at the same time put pressure on the industry. We will devise the software in such a way that one can get hospital-wise information on ongoing clinical trials,” said a senior health ministry official on condition of anonymity.The number and nature of the trials will also be made public. “A lot of questions have come up about trials, adverse events and deaths during trials. We want to put all this information on the website so that every detail is available immediately,” said an ICMR official who, too, didn’t want to be identified.In India, adverse events or deaths during clinical trials are reported directly to the Drug Controller General of India (DCGI) and usually do not become public.People interested in participating in clinical trials have little or no access to information on the studies.”The hospital-wise search will certainly reduce the number of trials one doctor undertakes and also the outsourcing of trials in the industry,” said the health ministry official quoted earlier. “Today, in some cases, if one hospital takes approval for a trial, it outsources it to another hospital without taking approval. This new software will decrease the chances of such a thing happening as people will know exactly which hospital has received approval to conduct which trial.”A recent study by the health ministry shows that nearly 80% of the deaths during clinical trials occur in terminally ill people and not due to the drugs administered.”We intend to put all these deaths, their causes and the pattern of deaths on the website so there is no misrepresentation of facts,” said the ministry official.India’s clinical trial registry is already more advanced by way of information when compared with the US registry, said CM Gulhati, editor of Monthly Index of Medical Specialities, a medical journal. “But this kind of a search which will enable people to search for trials by the hospital is needed in India. It is a good move…as it enables greater clarity for the general public.”

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