New Delhi: As many as 1,144 people died during clinical drug trials in 2010 and 2011, the union health and family welfare minister Ghulam Nabi Azad on Tuesday informed the Rajya Sabha.
The number of people dying during such trials also includes 1,106 people whose death could be attributed to diseases like cancer, terminal illness or various unrelated causes, which is also known as Serious Adverse Event (SAE) of death.
“The number of SAE of deaths in clinical trials reported during the last two years (2010-2011) were 668 and 438 respectively. However, deaths attributed to clinical trials in 2010 and 2011 were 22 and 16 respectively,” the minister said.
Azad said the serious adverse events of death may occur during clinical trials due to various reasons, which could be attributed to deaths relating to diseases like cancer or administration of drug on critical or terminally ill patients or side-effects or unrelated causes. [Source: ET]
The clinical drug trials have been under scanner by the media and public in recent years.These statistics are eye opener to them. Sometime back in Andhra pradesh,the print media was against the clinical drug trials when some participants reported vomittings etc after taking the investigational product(I.P) in a drug trial.The state government wanted to have control over clinical drug trials just as MCI over medical education. Any drug invented will first be tested on animals and then only allowed to be used first by volunteers and then by patients.If a person with cancer is given I.P and dies after three days.Nobody can blame the investigator provided he recruited the subject as per study protocol.Once hailed as great discovery, how many are using penicillin now?. It could be fear of drug reaction or availability of better drugs.New drugs can be introduced in market only when more clinical drug trials are conducted and its proper dose,safety and efficacy are evaluated well.Even today,the percentage of clinical drug trials done in India is very less compared to western countries.