My Clinical Trials Diary

After more than two years since the registration of clinical trials was made mandatory in the country, the Union health ministry will soon make the registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI). According to sources, the Union health ministry has already taken the decision in-principle to make the registration of BA/BE studies mandatory, on the same lines of the other clinical trials in the country. The drugs controller general of India (DCGI) Dr Surinder Singh has already directed the senior officials in the CTRI to make the necessary changes in its web network to incorporate the BA/BE features, sources said. According to sources, just like the clinical trials, the DCGI wanted to streamline the BA/BE studies in the country. So far, registration of BA/BE studies with the CTRI was optional. Once the DCGI makes it mandatory, all the BA/BE studies have to be registered with the CRTI without which the DC...

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization? G Praveen Kumar. If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below: Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the defin...