Is CTRI registration mandatory?
Is CTRI registration mandatory?
Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e. the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.
Which disease has the most clinical trials?
Cancers
Fig 1 Data is aggregated using individual hospital clinical trial metrics available on Definitive Healthcare’s Hospitals & IDNs database….Cancers have the highest clinical trial volume.
| Rank | Therapy Area | Total Number of Clinical Trials* |
|---|---|---|
| 1. | Cancers | 361,628 |
| 2. | Cardiovascular & Circulatory Diseases | 62,115 |
Is it mandatory to register clinical trials with clinical trial registry of India?
CTRI is a free and online public record system for registration of clinical trials conducted in India. It was initiated as a voluntary measure; however, registry was made mandatory by the Drug Controller General of India (DCGI) since June 15, 2009.
What is public title in CTRI?
Public title of study Title intended for the lay public in easily understood language. Example: A clinical trial to study the effects of two drugs, ramipril and candesartan in patients with high blood pressure and type 2 diabetes mellitus.
Is ctri registration mandatory for observational studies?
As per the New Drugs and Clinical Trial Rules, 2019 and the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, it is mandatory to register all regulatory trials or studies in CTRI.
How to find a clinical trial?
Gather Details about Your Cancer. If you decide to look for a clinical trial,you will need to know certain details about your cancer diagnosis and compare these
What is a registry in clinical trial?
Clinical trials registries collect basic health information from people who agree to be contacted about participating in future clinical trials or studies. A clinical trial is the study of new ways to prevent, detect or treat diseases or conditions. Volunteering for a registry does not mean a person has signed up for a clinical trial.
What is a CRA in a clinical trial?
A CRA (clinical research associate; also commonly known as a monitor) supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor.
Is Lyrica a clinical trial?
Widely prescribed drug for sciatica low back pain no better than placebo in study. The widely prescribed pain drug pregabalin (brand name: Lyrica) may be no better than a placebo when it comes to treating the back and leg pain known as sciatica, a new clinical trial suggests.