Phase 2b Clinical Trials
In partnership with the National Institute for Research in Tuberculosis (NIRT), we have commenced a multicentric phase 2b clinical trial.
According to the Tufts Center for the Study of Drug Development, the estimated average cost to develop and gain market approval for a new drug is approximately $2.6 billion USD. This includes out-of-pocket costs, which total approximately $1.4 billion, as well as opportunity costs of nearly $1.2 billion. The typical time for development ranges from 10-16 years.
At roughly less than 1% the cost and a decade faster than a big pharma model, we have commenced a phase 2B, open label, parallel arm, randomized controlled clinical trial among newly diagnosed sputum smear positive pulmonary TB patients to evaluate the anti-bacterial activity of Metformin.
There are several open elements to this clinical trial:
According to the Tufts Center for the Study of Drug Development, the estimated average cost to develop and gain market approval for a new drug is approximately $2.6 billion USD. This includes out-of-pocket costs, which total approximately $1.4 billion, as well as opportunity costs of nearly $1.2 billion. The typical time for development ranges from 10-16 years.
At roughly less than 1% the cost and a decade faster than a big pharma model, we have commenced a phase 2B, open label, parallel arm, randomized controlled clinical trial among newly diagnosed sputum smear positive pulmonary TB patients to evaluate the anti-bacterial activity of Metformin.
There are several open elements to this clinical trial:
- The trial, as required, has been registered prospectively on the Government of India’s clinical trials site, www.ctri.nic.in, CTRI No. 011176, with the protocol available here.
- A peer-reviewed article concerning the trial and its protocol has been published in the British Medical Journal, and is available, open access, here .
- Data from this trial, after being fully assembled and anonymized, will be made open and publicly available, enabling advanced computational and other analyses.
- Critically, all intellectual property stemming from this trial will be placed in the public domain.
