Clinical Trials
CSIR-CDRI has identified new drugs and tested successfully on animals. We at department of Clinical and Experimental Medicine, test these molecules in human beings by randomized, controlled, clinical trials.
Currently following molecules are undergoing clinical development
1. CDRI compound 97/78 (Anti-malarial agent): Phase I, Multiple dose study.
2. Compound 99/373 (Anti-osteoporotic agent) : Phase I, Single dose & Multiple dose study.
3. S007-867 (Antithrombotic Agent) : IND under compilation.
4. CDR 134-F194 (Anti-hyperglycaemic agent): Phase I permission granted.
5. Herbal Medicament (Anti-stroke agent): Phase I, IND under preparation.
6. CDR 134 D123 (Anti-diabetic compound): Phase I completed
7. CDRI compound 99/411 (Anti-malarial agent): The preclinical data is under compilation for IND submission in collaboration with IPCA, Mumbai.
8. NMITLI118R(T+): (Antistroke) Phase I, IND under preparation.
A) The clinical trial activities involves
Set the trial up in hospitals; ensure the smooth running of the trial.
• Regular visits to site to ensure data captured is accurate and to collect the data when completed.
• Verifying the data, writing reports as per Drug controller India, FDA regulations, ICH-GCP guidelines.
• Recruitment of investigators, initiation, monitoring and close-down of centres.
• Liaising with doctors and researchers at the site of the trial
• Monitoring progress of trials.
• Meeting with the study staff to sort them out any problems
• Ensuring that the data recorded for the trial is accurate and verifying it against the patients' notes. Checking case record forms for missing data and inconsistencies.
• Tracking patient's samples
• Making sure that supplies at the centre are adequate. Carrying out accountability for any study medication.
• Writing-up trial visit reports; Updating status databases; Preparing for visits; and attending project meetings, Maintaining contact lists
• Writing trial protocol why the trial is being conducted, by whom and how it will be performed.
• The study must minimize bias by use of , for example, placebos and double blind trials.
• Coordinating ethical and regulatory submissions, Processing payments to consultants
• Answering queries. Discussing results with statisticians.
• Reporting adverse drug reactions to ethics committee, regulatory authorities in prescribed time lines.
B) Biomarker & genetic research in disease diagnosis, treatment, prognosis, and prevention.
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valuation of biomarkers for diagnosis of early kidney injury: The current investigations for kidney disease such as creatinine etc. are not sufficient as they become abnormal only after kidney damage occurs of more than 50%. There are also chances of false positive results as this parameter differs with age, sex, race etc. Hence research for suitable biomarkers is essential in this area. We are identifying and validating the potential biomarkers by ELISA technique.
• The metabolic syndrome also termed the insulin resistance syndrome, is the concurrence in an individual of multiple metabolic abnormalities and is associated with cardiovascular disease. Type 2 Diabetes mellitus and its complications susceptibility is determined by the combined effects of multiple genetic and environmental factors. The most likely explanation for the dramatic increase in T2DM prevalence observed over the past two decades is changing patterns of diet and physical activity. However, it is believed that these environmental changes may only lead to T2DM in the presence of a permissive genetic background. The drug response is also variable for each patient of metabolic syndrome.
The research work is ongoing by evaluation of young patients of metabolic syndrome by emerging biomarkers, biochemical tests & SNPs to diagnose the complications at earlier stage and to assess the drug response and treatment regimens which may reduce these risk factors.