At a time when doctors at the Tata Memorial Hospital (TMH) are pushing the need for research on low-dose, low-cost cancer therapy called Metronomics, the government’s latest notification on clinical trials will make the research on this rather inexpensive form of cancer treatment easier, said doctors at TMH, on Friday.
Researchers and cancer specialists from across the globe have gathered at the TMH for three-day conference on Metronomics cancer therapy. They said that more clinical trials are required to study Metronomics as the treatment is highly affordable, unlike other cancer treatments, where costs run into lakhs per month. The cost of this treatment is estimated to be Rs120 per month, said doctors.
Experts said according to the new notifications by the ministry of health and family welfare, researchers will now not be required to take prior permission from the Drug Controller General of India (DCGI) as long as the research is approved by the ethics committee and is not intended for marketing the drug.
According to Dr Shripad Banavali, professor and head, department of medical and paediatric oncology, TMH, the new notification will give a boost to the hospital’s on-going research on Metronomics therapy. “We have preliminary data from our pilot study, which has shown very good outcomes in a specific subset of breast cancer patients, but we now need to study this in a larger population,” he said.
Metronomics cancer therapy uses a combination of off-labels drugs that are traditionally used to treat other diseases, which have been repositioned as anti-cancer agents, said oncologists.
“The new notification by the government on clinical trials will streamline the process of initiating research across the country, including Metronomics,” said Banavali.
Research experts from the Indian Council of Medical Research (ICMR), said that the government saw a lot of logic in repositioning drugs already available in the market for new indications. “TMH’s research on cancer treatment using off-label drugs is a good move towards making cheap treatment available to people. Such research definitely needs to be promoted by the government,” said Dr Nilima Kshirsagar, national chair clinical pharmacology, ICMR.