Claiming that rights and safety of patients are of top priority for the sponsors of the clinical trial and their investigators also, the Indian Society for Clinical Research (ISCR) representing the clinical trial industry has taken exception to projecting all serious adverse events (SAEs) reported of patients in clinical trials as necessarily study-drug related cases at various forums.

Responding to the recent controversies regarding the deaths of patients under trials, the ISCR said that they are committed to ensuring that the rights and safety of patients in clinical trials are safeguarded.

“While reporting of SAEs is done in compliance with regulatory guidelines, it must be highlighted that all unexpected SAEs must be reported, whether they are study related or not. For instance, if a patient in a clinical trial trips and falls in his house and fractures his leg or if he meets with an accident on his way to work or requires an unrelated surgery and any of these require hospitalisation, they have to be reported as an SAE to the regulatory body even though they have no connection with the clinical trial. Therefore, all SAEs reported of patients in clinical trials are not necessarily study-drug related,” a spokesman of the ISCR said.

Patients who participate in a clinical trial already have an underlying disease which could be mild or serious. The death of a patient in a clinical trial could be due to various reasons, including a natural progression of the disease, a new illness he or she may develop, age related disorders, or a complication totally unrelated like an accident.  “Most patients who die in a clinical trial do so because of causes unrelated to the medicine being tested. In reality, patients who participate in a clinical trial receive a greater degree of medical care and attention than they would get under regular treatment because of the high level of investigation and patient management that a clinical study protocol requires,” he said.

In addition, reporting of an SAE begins immediately after a patient signs an Informed Consent Form and even before the first dose of a trial drug is administered. “We would also like to highlight that reporting procedures for SAEs are different in India as compared to other parts of the globe. Whereas in India, any Unexpected Serious Adverse Events in a clinical trial patient have to be reported, whether study related or not, in most countries overseas, it is only Suspected, Unexpected Serious Adverse Drug Reactions that are reported. An Adverse Drug Reaction is one where there appears to be a reasonable possibility that the adverse event is related with the medicinal product being studied. This in itself accounts for the number of SAEs reported in India being high although again, we would like to stress that this does not mean that all the SAEs are study related,” the ISCR said.