Dr D Y Patil Medical College, Hospital and Research Centre, Pune has been recognized by the Indian Council of Medical Research as the ICMR Centre for Clinical Trials for the Western Zone in India. Further details are given in the communication from ICMR received below:
ICMR Project entitled- ICMR-National Clinical Registry of COVID-19
Funding Agency- Indian Council of Medical Research (ICMR), Delhi
Principal Investigator-Dr. Sachin Shivnitwar
Project duration– 14 June2021 to 31 August 2024. (ongoing)
Budget sanctioned-34,05,192.77/-
Total patients enrolled – 669.
Out of 669 patients, 399 (59.64%) were males and 270 (40.36%) were females.
Out of 399 males, 17 (4.26%) belong to 0 – 19 years age group.
Out of 270 females, 26 (9.63%) belong to 0 – 19 years age group.
The primary objective of the "National Clinical Registry of COVID-19" project is to establish a digital repository for comprehensive data collection on clinical and laboratory aspects, treatments, and outcomes of COVID-19 patients hospitalized in India. Its secondary objectives encompass several key areas: 1) Investigating various facets of COVID-19, such as understanding its natural progression, examining the disease spectrum, identifying prognostic and risk factors, and documenting treatment outcomes. Additionally, it seeks to explore contextual questions, like the impact of COVID-19 on individuals with tuberculosis or those affected by malnutrition. 2) It serves as a platform for conducting additional clinical research studies at specific sites. 3) The registry aims to gather follow-up data on COVID-19 patients discharged from registry sites.
The study commenced after securing approvals from the Central Ethics Committee and Institutional Ethics Committee. It involves prospective data collection on all COVID-19-confirmed hospitalized patients, regardless of age or gender, starting from June 14, 2021. Since the registry does not pose any harm to participants, prior consent is not required. However, written consent is obtained for telephonic follow-ups. Follow-ups are conducted monthly for the first three months and then every three months for up to a year. Data is collected on the day of admission and every other day until discharge or death. Separate forms exist for admission, daily records, death/discharge, as well as specific forms for individuals below 19 and healthcare personnel, as needed. A verbal autopsy form is also available for post-discharge deaths, with telephonic interviews for this purpose.
ICMR Project entitled- Factors associated with sudden deaths among adults aged 18-45 years India: Multicentric matched case-control study.
Funding Agency- ICMR- National institute of Epidemiology, Chennai.
Principal Investigator-Dr. Sachin Shivnitwar.
Project duration- October 2021 and March 2023
Budget sanctioned-1,50,000/-
Enrollment- A total of 5 cases with 25 controls were enrolled in this study.
In response to recent media reports regarding sudden deaths among young adults, the Indian Council of Medical Research has initiated a study to investigate the underlying causes of these unexpected fatalities in individuals aged 18-45 in India. The study aims to compare data from those who passed away suddenly in a hospital or were brought in already deceased between October 2021 and March 2023 with that of individuals who are currently alive. It specifically seeks to explore factors such as a history of COVID, COVID vaccination status, contact with COVID-positive individuals, and intense physical activity immediately preceding the fatal event. The findings from this study will provide valuable insights for both healthcare professionals and the wider community. Study will be conducted in selected hospitals from the National Clinical Registry for COVID-19 network and others as well as at the community level. Data will be collected from the existing case records and from the family members of the participants.
ICMR Project entitled- Effect of COVID-19 vaccine on thrombotic events among 18–45-year-old population in India, 2022: Multicentric hospital-based matched case-control study.
Funding Agency- ICMR- National institute of Epidemiology, Chennai.
Principal Investigator-Dr. Sachin Shivnitwar.
Project duration- October 2021 and December 2022
Budget sanctioned-1,68,700/-
A total of 70 cases with 280 controls were enrolled in this study.
The development of safe and effective vaccines plays a pivotal role in mitigating the SARS-CoV-2 pandemic. Vaccines authorized for inclusion in national immunization programs are deemed safe and effective based on clinical trial data. The Indian Council of Medical Research (ICMR) aims to undertake this study to investigate potential severe health issues linked to COVID-19 vaccines administered in India, focusing on individuals aged 18-45. A methodical evaluation of vaccine safety is essential to ensure the continued use of safe vaccines and to sustain public confidence in vaccination efforts.
ICMR-NIE will employ a hospital-based matched case-control design for this study. Cases are individuals aged 18-45 in study hospitals who have experienced specific thrombotic events in the 18 months following the study's initiation. This timeframe allows for diverse exposure to vaccine doses. Controls are also individuals aged 18-45, admitted to the same hospitals within ±7 days of the cases' hospitalization, but without thrombotic events, adverse events from COVID-19 vaccination, or respiratory illnesses. Control selection includes patients from various departments like orthopedics, ophthalmology, otorhinolaryngology, and more. The outcome variable is newly diagnosed thrombotic events, including arterial and venous thrombosis. Primary exposure is defined as receiving at least one dose of any COVID-19 vaccine within 42 days of thrombotic event symptom onset (for cases) or hospitalization (for controls).
EXTRAMURAL CLINICAL TRIALS AND RESEARCH PROJECTS LIST FOR 2022- 2023
The list below contains the details of the clinical trials that were carried out at the Dr D Y Patil Medical College, Hospital and Research Centre during the period from 2022 to 2023.
Among the extramural projects funded from within the country, there are 19 research project proposals that are either completed recently (11 projects) or are ongoing (8 projects) at our medical college, another seven projects are on the verge of being initiated soon and nine more research projects in the pipeline.
MOU for research collaboration has been signed between DPU Dr. DY Patil Medical College, hospital and Research Centre, Pune and HaystackAnalytics Pvt. Ltd. (IIT Mumbai based start up company). They mainly deal with Whole Genome Sequencing of TB strains (both susceptible and resistant) and have also developed methods for the diagnosis of sepsis.
Internationally Funded Clinical Research Projects
Among the international collaborative research studies of our medical college, presently we have two NIH funded collaborative projects worth $1408705/ and one CDC funded study worth $ 180958/ USD in collaboration with Johns Hopkins university. USA
We have signed an MOU for launching a NIH funded study worth $ 68019/ with Boston University, USA and the project is expected to start soon.
An MOU has been signed between MRI Global & DPU for study of drug resistant TB and the grant for the $27,602/ project has been approved by MRI Global, USA
Collaboration with Harvard University (with funding by Harvard-Dubai Centre for Global Health Delivery Amount: $66000) entitled: Assessing pathways to care among tuberculosis (TB) and drug-resistant tuberculosis (DR-TB) patients in Pune City, India: a biosocial inquiry. Study done during the period Jan 2018 to June 2019. Project has been completed.
