पूर्व छात्र

Clinical Research Unit

2020-08-20T16:03:17+05:30

Other activities

In the wake of Covid-19 pandemic, fast track intramural grant was announced and over 80 proposals were received. The proposals were reviewed and the shortlisted proposals were approved for funding.
Out of these, 9 clinical observational studies were having similarities, so it was decided to develop common Case Record Form (CRF) for investigators for the multiple sites where Covid-19 patients are being admitted. The data of common CRF is being stored on AIIMS server and different components for each patients can be filled by at different time points and from multiple locations as required.

CRU prepared the common informed consent documents and developed the online case record form in collaboration with the Principal Investigators of the nine observational studies. These studies also required a common consent form, so that in each area the first team in patients care can take consent for all components of the data related to the patients.
The Common CRF and a common Consent Form was designed and ethical approval was obtained for the nine PIs.
The software for Common CRF has been developed, pre tested and been made functional for all teams working for Covid-19 related research.

Clinical Research Unit

2020-08-20T13:48:31+05:30

Events

DBT Wellcome Trust grantsmanship workshop series: Glimpses

Clinical Research Unit

2020-08-20T13:03:11+05:30

CRU support for different stages of clinical research

CRU support for different stages of clinical research A fully operational CRU shall have the necessary expertise in the design and conduct of various types of studies and multiple activities

Clinical Research Unit

2020-08-20T12:55:45+05:30

CRU activities

DBT Wellcome Trust grantsmanship workshop series

As a first exercise, the CRU planned and initiated the grantsmanship workshop series to foster interest and enthusiasm among the faculty, scientists, and residents to apply for the prestigious research fellowships of the DBT Wellcome Trust.

1.1. The first sensitization workshop was conducted on 6 Nov 2019 at the Dr Ramalingaswami Board Room, AIIMS. The Director, AIIMS, Dr Randeep Guleria, chaired the session; Dr. Shahid Jameel, CEO of Wellcome Trust/DBT India Alliance and Prof. Usha Menon from the Clinical Trials Unit, Medical Research Council, UCL London joined as speakers. About 200 participants ranging from faculty, scientists, research staff, and PhD and postgraduate students from various disciplines participated in the activity.

1.2. The second Grantsmanship Workshop was planned for aspirants for concept proposal for the Wellcome Trust/ DBT India Alliance Clinical and Public Health Fellowships. A total of 38 faculty members and two (02) senior residents submitted the concept notes to the research section, which were reviewed by three of the lead mentors. Of these, 23 were selected for the mentoring workshop held on 15-16 Jan 2020. There were four lead mentors (Dr Usha Menon, UCL, London; Dr Shinjini Bhatnagar, THSTI; Dr Madhulika Kabra, AIIMS and Dr V Sreenivas, AIIMS) and 2-3 in-house subject experts for each proposal.

1.3. The third workshop of Grantsmanship Workshop series was held online (Zoom) on 27-28, Apr 2020, for the 17 proposals that cleared Stage-I and were invited for full/detailed proposal submission by India Alliance. Of the 17 final proposals submitted, 11 were reviewed by the lead mentors and subject experts besides online mentoring and remaining took help from the mentors by electronic methods.

1.4. Of the 18 concept notes submitted, 17 cleared Stage-I and all the 17 candidates submitted full/detailed proposal for the stage-II evaluation of the India Alliance for Clinical and Public health Fellowships in April 2020.

Clinical Research Unit

2020-08-20T12:53:21+05:30

Meet the Team

Dr. Chitra Sarkar, Dean, Research

Dr. Vineet Ahuja, Associate-Dean, Research

Working Committee

Dr. Sameer Bakshi, Deptt. of Medical Oncology

Dr. Vijay Prakash Mathur, Centre for Dental Education and Research

Dr. Rakesh Lodha, Deptt. of Pediatrics

Dr. Sumit Malhotra, Centre for Community Medicine

Dr. Pooja Gupta, Deptt. of Pharmacology

Dr. M Jeeva Sankar, Deptt. of Pediatrics

Dr. Saurabh Kedia, Deptt. of Gastroenterology

Dr. M. Kalaivani, Deptt. of Biostatistics

Clinical Research Unit

2020-08-20T12:48:48+05:30

Core expertise of the Clinical Research Unit (CRU)

Phase I: Planning

· Grant preparation

· Study hypothesis

· Study Design

· Sample Size

· Study Protocol

· Feasibility

· Outcomes

· Outcome development

· Costing

•Translating research idea into a feasible study hypothesis

•Support for literature review – conduct of systematic reviews and meta-analysis

•Interdepartmental liaison/ collaborations

•Protocol writing and study methodological aspects

•Budgeting

•Statistical Analysis Plan

•Registration of protocols and preparing documents for funding agencies

Phase II: Study Conduct

Set-up

Conduct

Analysis

Report

Publication

Consent Form

Protocol development

Case report Forms

Database design

Randomization

Ethical approval

Administrative approvals

Logistics

Trial/Study management

Coordination

Randomization

Adverse event management

Monitoring

Trial meetings

Quality assurance

Statistical analysis plan

Data validation

Programming and analysis

Study Reports

Data interpretation

Trial/Study Steering Committee reports

Advice and consulting

drafting aspects of the publication

Clinical Research Unit

2020-08-20T12:43:01+05:30

Working Objectives

The CRU team comprising scientists and faculty with varied sets of research skills shall support research investigators (AIIMS faculty and scientists) to design, conduct, analyze, and publish high-quality clinical research. The primary objectives of the CRU shall be the following:

Phase I: To provide technical expertise to AIIMS faculty and scientists to plan clinical research proposals and submit grant applications for funding

Phase II: To provide support to AIIMS faculty and scientists for conducting research (assisting set-up, the conduct of the study; data management and analysis; report writing; publications)

Clinical Research Unit

2020-08-20T12:27:05+05:30

Goal of the Clinical Research Unit (CRU)

The overarching goal of the CRU is to provide resources and services to advance clinical research and inform the best practices for clinical research. It will be a core facility with centralizedand shared resources. It shall work as a specialized biomedical research unit that shall help to design and centrally coordinate clinical research by assisting in the development, application, and implementation of investigator-initiatedstudies in compliance with the best practices.

The CRU envisages but is not restricted to the following types of studies: investigator-initiated clinical trials, cohort, case-control, cross-sectional studies as well as the studies evaluating diagnostic tests. The ultimate aim is to facilitate practice-changing research at AIIMS, addressing the critical priorities of the country in disease diagnosis, prevention and treatment.

Clinical Research Unit

2020-08-20T12:21:18+05:30

Introduction

Clinical research forms the cornerstone of evidence-based medicine and advances in clinical practice. An essential component of clinical research is clinical trials, some of which may be multi-centric and engage collaborative efforts. Non-trial clinical research is the other equally important component which helps to understand and answer critical treatment-related questions, identify further research questions, and support development of new biomarkers, etc.There is a need for clinicalresearch designed and led by academic Investigators to address the specific challenges that patients face in India.

Researchers at AIIMS come with varied scientific backgrounds and levels of exposure. While most are well conversant with the intricacies of research methods, a few may need guidance to develop their idea into a research protocol or to arrange funding or with conduct, analysis, and publication of the study. Also, there is a need to conduct larger studies and trials to make a meaningful impact on the care of patients. In addition, excellent data management and statistical analytical skills are required for optimal utilization of the data generated in various clinical studies.

The Honourable Vice President Sh. Venkaiah Naidu in his convocation address on 7 Dec 2018 on the occasion of 46th Convocation Day of AIIMS, stressed upon the need for the institute faculty to take clinical research to a higher level and to set up newer mechanisms to foster collaborative research answering translational research issues. The Honourable Vice President urged the AIIMS administration and faculty to launch new initiatives which facilitate clinical research. The administration under the leadership of the honourable Director of AIIMS, Prof. RandeepGuleria and the Dean (Research), Prof. Chitra Sarkar and with the guidance and sage advice of the former Secretary, Department of Biotechnology (DBT) the Late. Prof M.K. Bhan conceptualized and created the Clinical Research Unit (CRU) under the Research Section, AIIMS, New Delhi.

The Clinical Research Unitshall serve the purpose of improving the quality and quantum of research output through i) Providing high-quality technical expertise in designing clinical research and ii) Providing support for the conduct of studies conforming to international standards.