Completed Projects

GLSE Study
 
A translational research to validate investigational product to evaluate if the efficacy and safety are comparable to the standard product. It aimed to compare the efficacy and safety of GLSE with a standard preparation (Survanta; Abbott, USA) in a multicentre, investigator blinded, non-inferiority randomized trial in preterm neonates with Respiratory Distress Syndrome (RDS). It was being conducted in 7 sites across the country - AIIMS, Maulana Azad Medical College, Lady Hardinge Medical College, Chacha Nehru Bal Chikitsalaya Delhi, PGIMER, Chandigarh, JIPMER, Puducherry and Institute of Child Health, Chennai. CDSA has been involved in the project management, clinical operations, site management and data management support to the study. The study was completed in May 2018.
 
GLSE
Project Title: Evaluating the efficacy and safety of an innovative and affordable Goat Lung Surfactant for the treatment of respiratory distress syndrome in preterm neonates: a multi-site randomized clinical trial
 
Short title: GLSE / Surfactant study
 
Project Status: 
  • Prematurely terminated 
  • Terminated on the recommendation of DSMB after second interim data review (n=98)
  • Study is stopped with immediate effect since the research question stands answered with the data collected so far
  • All sites are closed out. Close-out Visit reports are approved, Follow-up letters of COVs have been dispatched to the investigators. 
  • Database has been locked.
  • IP return: Cadisurf has been returned to Cadila, Survanta has been handedover to the Sponsor for disposal
  • CSR planned in May 2018
 
Study Sites: 

1. AIIMS, Delhi

2. Maulana Azad Medical College, Delhi

3. Lady Hardinge Medical College, Delhi

4. PGIMER, Chandigarh

5. JIPMER, Puducherry

6. Institute of Child Health, Chennai

7. Chacha Nehru Bal Chikitsalaya, Delhi

 
Achievements: 

• The project team, working in tandem with the sponsor, successfully initiated the study at seven sites, extended technical support, and carried out capacity building exercises. 

• Conducted close monitoring of study conduct at sites by augmenting on-site monitoring  with regular Remote Monitoring Calls to secure compliance with the protocol, regulations and GCP standards.  

• Achieved subject enrolment targets and provided high quality clinical data [overcoming the challenges of complex / enormous source data and working with research-naïve site staff] well within the timelines for DSMB reviews. The high standard of data quality received special appreciation from the DSMB and Research Steering Group.

Project Team Members :- Dr. Shantala Bellary, Mr. Ranjan Kumar, Mr. Sumit Kumar 

SAM Program

An alliance has been formed among Departments of Health Research (DHR) and Biotechnology (DBT), and Ministry of Health and Family Welfare of the Government of India to support research to generate evidence for development of practical and scalable regimens to medically rehabilitate children suffering from Severe Acute Malnutrition (SAM) without serious complications at home/community level and/or at peripheral inpatient facilities.

CDSA has been engaged to conduct the following activities specific to the SAM program:

  • Serve as a secretariat for the SAM program. Coordinate meetings of the Steering Committee and TAG and implement their decisions.
  • Conduct monitoring and quality assurance of the various clinical research projects as pertinent to the objectives of the program.
  • Constitute Data Safety Monitoring Board(s) for the various projects.
  • Commission a consultative peer review process to discuss and evaluate evidence generated through various projects of the program in order to aid formulation of a national policy on the community management of SAM.

Studies under SAM alliance have been completed / terminated and the data or findings presented in National consultation meeting in July 2015 for policy and advocacy. 

 

Reflexology Study

CDSA has been providing clinical study support services for the investigator initiated study with study sites in North Eastern region of India. We have successfully undertaken Study start-up support and Clinical monitoring of AIIMS lead study on Reflexology for intractable epilepsy at clinical sites in NER (AMCH, Dibrugarh and RIMS, Imphal). Study completed and study report has been submitted to DBT-NER.

 

Verapamil Stage 1

CDSA has provided Medical writing, clinical monitoring, , statistics and data management support for Phase 2 clinical study on verapamil in multi-drug resistant tuberculosis sponsored by National Institute of Research in Tuberculosis (NIRT), Chennai, funded by DBT and conducted at National Institute of Tuberculosis and Respiratory Diseases (NITRD), New Delhi. Study completed successfully and CDSA is working in collaboration with NIRT, setting up the quality management systems for the next stage of this study.