Human Clinical Trials
Institute is continuously conducting human clinical trials. Recently institute has taken up Phase-III and Phase-IV trials as well. Several trials are multicentric and multinational. Institute is also conducting sponsored national and International Trails.
Recently Govt. Of India has designated institute as Regional clinical trial unit (RCTU) (MRU/MRHRU Network)
In this regards a committee has been constituted to prepare guidelines for establishing robust mechanism for hassle free conduction of trials with international standards.
| Sn. | Member Name | Designation in RAC |
|---|---|---|
| 1 | Dr. Shailandra Shankar Handu | Prof and HOD, Department of Pharmacology |
| 2 | Dr. Uttam Kumar Nath | Prof. and HOD, Department of Medical Oncology Haematology |
| 3 | Dr. Farhanul Huda | Additional Professor, Department of General Surgery |
| 4 | Dr. Puneet Dhamija | Additional Professor, Department of Pharmacology |
| 5 | Dr. Ashish R. Bhute | Member Secretary, IEC, AIIMS Rishikesh |
| 6 | Dr. Amit Sehrawat | Assistant Professor, Department of Medical Oncology Haematology |
| 7 | Mr. Rajiv Gupta | Account Officer |
Sponsored Clinical Trials
| S. No | Name of PI | Institute Name | Sponsor | Study Setting |
| 1 | Dr. Uttam Kumar Nath | AIIMS, Rishikesh | Protagonist Therapeutics, USA | Rusfertide, a Hepcidin Minmetic, Controls Erythrocytosis in polycythemia vera |
| 2 | Dr. Uttam Kumar Nath | AIIMS, Rishikesh | Medpace Clinical Research, LLC | Phase 3 study of Marzeptacog Alfa activated for on demand treatment control of bleeding episodes in subjects with haemophilia A or Haemophilia B |
| 3 | Dr. Uttam Kumar Nath | AIIMS, Rishikesh | JSS Medical Research India Pvt Ltd | Phase 2 study of the Hepeidin Mimetic PTG-300 in patients with phlebotomy-Requiring polycythemia vera |
| 4 | Dr. Amit Sehrawat | AIIMS, Rishikesh | AstraZeneca | A Phase 3 Study of Dato-DXd in Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer |
| 5 | Dr. Amit Sehrawat | AIIMS, Rishikesh | AstraZeneca | A phase 3, study of durvalumab in combination with tremelimumab in locoregional hepatocellular carcinoma |
| 6 | Dr. Deepak Sundriyal | AIIMS, Rishikesh | Alkem laboratories limited | A prospective, RCT for pharmacokinetics & immunogenicity of biosimilar pertuzumab |
| 7 | Dr. Uttam Kumar Nath | AIIMS, Rishikesh | MEDPACE | Clinical research MMC |
| 8 | Dr. Uttam Kumar Nath | AIIMS, Rishikesh | Novartis Healthcare Privae Limited | A phase IIIB, study asciminib in patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase |
| 9 | Dr. Amit Sehrawat | AIIMS, Rishikesh | Lambda therapeutic Research LTD | A multicenter, open-label,randomized, study to evaluate the efficacy and safety of paclitaxel lipid suspension for injection in patients with recurrent metastatic ovarian carcinoma |
| 10 | Dr. Puneet Dhamija | AIIMS, Rishikesh | Pharmainstinct pvt ltd | Study to Evaluate the Efficacy and Safety of UPLAT in Patients Suffering from Chemotherapy Induced Thrombocytopenia |
| 11 | Dr. Prateek Kumar Panda | AIIMS, Rishikesh | IMPUTE Japan | Efficacy and Safety of IMPUTE ADT-1 in children with autism spectrum disorder aged 2-6 years: a randomized controlled trial |
| 12 | Dr. Prateek Kumar Panda | AIIMS, Rishikesh | Le Jolly Healthcare pvt Ltd, Jaipur Rajasthan | Post marketing surveillance to determine sociodemographic and clinical variables associated with favourable response un children with west syndrome |
| 13 | Dr. Rohit Gupta | AIIMS, Rishikesh | KlinEra Global Services West Mumbai | A phase3, study of Efruxifermin in subject with non- cirrhotic non-alcoholic seatohepatitis |
| 14 | Dr. Amit Sehrawat | AIIMS, Rishikesh | Roche India Pvt | Real world Indian registry study of atezolizumab in lung cancer |
| 15 | Dr. Deepak Sundriyal | AIIMS, Rishikesh | ALKEM LABORATORIES LIMITED Mumbai | Phase IV study to establish the safety & efficacy of biosimilar bevacizumab colorectal cancer |
| 16 | Dr. Deepak Sundriyal | AIIMS, Rishikesh | ALKEM LABORATORIES LIMITED Mumbai | Phase VI study to evaluate the safety and efficacy of biosimilar cetuximab in patients with locoregionally advanced or recurrent locoregional or metastatic squamous cell carcinoma of the head and neck |
*The study was submitted to IEC for their review & approval.