Completed Projects

Comprehensive National Nutrition Survey (CNNS)

Comprehensive National Nutrition Survey (CNNS), a cross-sectional, household survey covering more than 1,20,000 children and adolescents (0-19 years) in both urban and rural areas across all 30 states of India, is being conducted by the Ministry of Health and Family Welfare (MoHFW), Government of India in partnership with UNICEF. It aims to assess the national prevalence of biological indicators (micronutrient deficiencies, subclinical inflammation, and worm infestation) and prevalence of overweight/obesity, along with information on body composition, cardio-metabolic risk, muscular strength, and fitness.

CDSA was selected as the national monitoring agency to conduct concurrent monitoring of CNNS biological samples (blood, urine and stool). This monitoring includes, but not limited to primary sample collection at PSUs, processing at collection centres, shipment, and analysis at a central laboratory. CDSA provides ongoing feedback to the central laboratory team and informs lead survey agency and UNICEF on the quality of biological data collection, processing, transportation, analysis, and report.

Other Details

 

Project Title:Comprehensive National Nutrition Survey (CNNS)
Project Overview:Comprehensive National Nutrition Survey (CNNS) is a cross-sectional, household survey that covers more than 1, 20,000 children and adolescents between the ages of 0 to 19 years, in both urban and rural sectors Pan-India. The project is being steered by the Ministry of Health and Family Welfare, Government of India in partnership with UNICEF (United Nations Children’s Fund).
Project Status:Ongoing (Contract until July 31, 2018)
Study Sites:1. Pan India – 30 states

2. States covered in Phase I - Rajasthan, Madhya Pradesh, Maharashtra, Haryana, Andhra Pradesh, Jharkhand, Uttar Pradesh, Delhi, Bihar and Assam (Himachal Pradesh, Mizoram and Telangana – not monitored by CDSA).

3. States covered in Phase II – Manipur, Tripura, Odisha, Uttarakhand, Chhattisgarh, Punjab, Kerala and Gujarat.

4. States to be covered in Phase III (Current Phase) – Arunachal Pradesh, Meghalaya, Sikkim, West Bengal, Tamil Nadu, Karnataka and Jammu &Kashmir.
Achievements:Introduction of temperature data loggers as an evidence based monitoring tool to ensure sample integrity.

Complete cold chain maintenance through the use of deep freezers and proprietary tools at every PSU were deployed in Phase II

CDSA’s monitoring led to the rejection of invalid primary sample and test reports, which in turn led to a significant improvement in the quality of laboratory data.

Better Coordination and communication ensured compliance to best industry practices related to sample collection, packaging, shipment and disposal of biohazard material and completeness and accuracy of primary data collected.

Feedback at pre-determined frequencies from field monitoring significantly improved the quality of sample (Blood/Stool/Urine/BP) collection and transporting.

Laboratory validation exercises for multiple variables (temperature, time, quality, precision and accuracy) were suggested & undertaken at All India Institute of Medical Sciences (AIIMS) in New Delhi. The complete list of 22 biochemical parameters selected for CNNS were under the purview of this study.

BIBCOL-bOPV Study

The main aim of the study is to explore the safety and efficacy of BIBCOL bivalent oral polio vaccine in new-born/infants who are naïve to OPV. This is an open label, multi-centric, single arm study ongoing at 5 clinical sites in India (GSVM, Kanpur, KGMU, Lucknow, AMCH, Dibrugarh, SRM, Chennai and JSS, Mysore). CDSA responsibilities include overall project planning and management, medical writing, regulatory advisory, clinical and safety monitoring, data management and statistical service .

Other Details

 

Project Title:A Phase IV, Interventional , open label, multicentric, single arm clinical trial to assess the safety ,tolerability & immunogenicity of bivalent oral Polio vaccine (bOPV) in healthy Indian Infants.

Project Status:
Recruitment Completed
Completion of trial related activities - subject enrolment, data collection, data entry, statistical analysis and final reporting.
Coordination and arrangement of 2nd DSMB review meeting.
Study samples evaluation in central laboratory(Enterovirus Research Centre) for immunogenicity testing.
Trial data entry and query resolution in progress
Data Base Lock planned in August
Final CSR planned in October
Study Sites:1. GSVM,Kanpur

2. KGMU, Lucknow

3. AMCH, Dibrugarh

4. SRM, Chennai

5. JSS, Mysore

Achievements:
Completed subject enrolment.

• QC and data freezing of 410 subjects completed.

• 1st DSMB meeting completed

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.

Other Details

 

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. GSVM,Kanpur

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.

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  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.