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How can I participate in clinical trials in India?
How to Register?
- One should first login to CTRI website: www.ctri.nic.in[2]
- Following which, he/she should register himself in CTRI using “Username” and “Password” and create his/her profile.
- New trial is then added using the CTRI registration data set as detailed in Box no.
- The above dataset is submitted to CTRI.[2]
How do you get involved in drug trials?
Volunteer Opportunities ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.
Are clinical trials allowed in India?
Government regulation Since 2009 the Central Drugs Standard Control Organization has mandated that anyone conducting clinical research in India must preregister in the Clinical Trials Registry – India before enrolling any research participants. Various government agencies and laws regulate clinical trials.
Who gives approval for clinical trials in India?
The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.
How long does clinical trials take?
Clinical trials alone take six to seven years on average to complete. Before a potential treatment reaches the clinical trial stage, scientists research ideas in what is called the discovery phase. This step can take from three to six years.
Who gives permission for clinical trials in India?
In accordance with the provisions of the 2019-CTRules, the Drugs Controller General of India (DCGI) heads CDSCO, and is responsible for granting permission for clinical trials to be conducted and for regulating the sale and importation of drugs for use in clinical trials.
Who approves clinical trial in India?
How much money is needed for clinical trials?
The average cost of phase 1, 2, and 3 clinical trials across therapeutic areas is around $4, 13, and 20 million respectively. Pivotal (phase 3) studies for new drugs approved by the Food and Drug Administration (FDA) of the United States cost a median of $41,117 per patient.
Is it safe to take part in clinical trials?
Yes, all clinical trials have risks. But any medical test, treatment, or procedure has risks. The risk may be higher in a clinical trial because there are more unknowns. This is especially true of phase I and II clinical trials, where the treatment has been studied in fewer people.