India will collaborate with UK to conduct 'Add-Aspirin' global drug clinical trials to investigate whether the use of widely-used medicine, aspirin prevents recurrence of the most common cancers, like breast and gastric or oesophagus.

Aspirin is widely-used as an analgesic to relieve pain, as well as to manage heart disease and stroke in certain patients.

Till now, there is only "incidental findings" that aspirin can prevent the cancer from coming back in patients who have earlier undergone treatment and are cured from the disease, while these trials will now establish the drug's role.

While the UK trials have already started, India will be initiating them here on Indian subjects as soon as the approval comes in.

esearchers at Mumbai-based Tata Memorial Hospital have submitted the research application to the ethics committee and plan to conduct these trials on over 1600 subjects in the first quarter this year, Dr Manju Sengar medical oncologist at the Tata Memorial Hospital told TOI.

Add-Aspirin is the first-ever large randomised clinical trial, being done in the UK, and soon in India, involving 11,000 participants which will establish whether regular aspirin use on 'cured' cancer patients can prevent the cancer from coming back, and hence prevent deaths.

The trials to be conducted at 18-20 sites here in India will be funded by the Sir Dorabji Tata Trust, and other philanthropic entities, while the one in UK is supported by Cancer Research UK and National Institute for Health Research.

Aspirin has already been proved to help prevent heart attacks and strokes, and research has suggested it could do the same for some cancers, she added.
Individuals who have had an early stage cancer of the breast, stomach or oesophagus will be able to take part in the trial in India.

This, she said, will be possible due to a new circular by the health ministry which exempts institutional clinical trials from drug controller-general's approval.

In what may boost academic and institutional research, the health ministry has said that investigator-initiated clinical trials no longer need permission from the drugs controller in cases of "drug-repurposing".

In a recent circular, the ministry said those trials which are "academic and non-regulatory" in nature, and for drugs which are not new chemical entities, and have already been approved for a particular indication with established safety profile, the respective ethics committee will give the approval after a proper due diligence.

Other proposed measures to strengthen the regulatory-ethical-operational framework for conducting clinical research include an IT-enabled system for online submission of clinical trial applications, system of formal pre-submission meetings of applicants with drug regulatory officials and subject experts, adding trial sites with approval from ethics committee, and elimination of repeating pre-clinical or toxicology animal studies for drugs approved for use outside India, an Indian Society for Clinical Research official said.