Clinical trials are tests of a new medicine in people, to find out whether it works and whether it is safe. No regulator lets a new medicine be sold until the company that owns it has run trials and recorded every step to a strict standard. In India, a trial needs approval from CDSCO, the Central Drugs Standard Control Organisation, and from an ethics committee at each hospital. It must also be registered on CTRI, the Clinical Trials Registry of India, before the first patient joins.
Take, for example, a drug company in Mumbai that has made a new inhaler for asthma, a lung disease that makes breathing hard. Its final trial will test the inhaler on 3,000 patients at 200 hospitals in twelve countries, 30 of them in India. Every step must follow GxP rules, the rules that make each record checkable by a regulator years later.
First, the trial is planned. Clinical trial design software works out how many patients are needed and how the two groups will be compared. The drug company usually hires a contract research organisation (CRO) to run the trial on its behalf.
Next, patients must be found. This is the slowest step in most trials. Patient recruitment software reads hospital records to find people who meet the trial's rules, such as their age and how severe their asthma is. Say a 34-year-old schoolteacher in Vadodara qualifies. A doctor explains the trial to her, and she signs the consent form.
Then she is put into a group at random. RTSM software decides whether she gets the real inhaler or a dummy inhaler that looks exactly the same, called a placebo. Neither she nor her doctor knows which one she has. This is called blinding. The same software makes sure her hospital has the right tubes in stock.
For the next 16 weeks, every visit is recorded. A hospital staff member types her measurements into electronic data capture (EDC) forms. Each evening, she rates her itching on a phone app, through eCOA. Some patients take part mostly from home, through a decentralised trial platform. The ECGs, or heart tracings, taken at every hospital go to one central reading team, which reads them all the same way.
Finally, a clinical trial data platform brings the data from all 200 hospitals into one place and checks it. Only after the last patient's data is checked are the groups revealed, and the statisticians compare them.