Projects

 

BIBCOL
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

Sitting row (L to R)- Tarun Puri(PM), Ashwani Singh (CRA), Panna lal(DOE)
Standing row (L to R) Jinisha Shukla (CRA), Shinjan Kapur(QA),Tina yadav (DOE)
On leave- Shristi Sharma(Biostatician)
 

 

CNNS
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.


 

 

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.

GLSE project team [from left to right]: Dr Shantala Bellary [Clinical Data Coordinator], Ranjan Kumar [Clinical Research Associate], Sumit Kumar [Project Manager]

 

 

iKMC
Project Title: A multi-country randomized clinical trial to evaluate the impact of continuous KMC initiated immediately after birth compared to KMC initiated after stabilization in new-borns with birth weight 1.0 to <1.8 kg on their survival in low-resource settings (iKMC Study)
 
Project Status: 
  • In India, study initiated in November 2017 and so far we have recruited more than 200 babies in both intervention and control groups. 
 
Study Sites:

1.  India – Safdarjung Hospital (SJH)

2.  Ghana - Komfo Anokye Teaching Hospital

3.  Malawi - Queen Elizabeth Central Hospital

4.  Nigeria - Faculty of Medicine, Obafemi Awolowo University, Nigeria

5.  Tanzania - Muhimbili University of Health and Allied Sciences

 
Achievements:
• Site set-up support

• Site initiation

• Data management support

• Internal Quality Improvement support

 

 

INVICTUS
Project Title: Investigation of Rheumatic Af Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies (INVICTUS)
 
Project Status:
  • INVICTUS is a global study participating 27 countries with 171 centres. In India study initiated in 07 out of 09 sites. 
 
Study Sites (India):  

1. AIIMS, Delhi

2. GB Pant , Delhi

3. RML, Delhi

4. SGPGI, Lucknow

5. KGMC, Lucknow

6. Sri Jayadev, Bangalore

7. PGIMER, Chandigarh

8. SMS, Jaipur

9. JIPMER, Pondicherry

 
Achievements:

• Successfully activated 07 out of 09 sites.

• EC submission was done for remaining 02 Sites

Study specific webpage link: https://rome.phri.ca/invictus

 
PTB
Study Title: Inter Institutional Program for Maternal, Neonatal and Infant Sciences- a translational approach to studying Pre-term birth
 
Study Site:
1. Primary site – Gurgaon civil Hospital (Participant enrolled here)
2. Referral site - Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
(referred here in case of any complications during pregnancy)
 
Study Status:
  • FPFV- 11 May 15
  • Participant enrolment as of 9 May 2018 – 4528  
 
Quality Management data review status:

1. Concurrent enrolment – till 4476

2. Ongoing outcome – till 3151

3. Ongoing follow up – till 3840 

 
Achievements:

• Concurrent monitoring of the enrolment data 

• Release of monitored data after query resolution on daily basis

• Escalation of critical quality issues to clinical team on weekly basis and their resolution

 

ZINC SEPSIS
Project Title: Zinc as an adjunct for the treatment of clinical severe infection in infants younger than 2 months
 
Project Details: 
• Individually randomized double-blind placebo-controlled parallel group superiority trial
Multi site (7 hospitals- 4 in Delhi, India and 3 in Nepal) 
Study implemented under Dept of Biotechnology, GOI, Program  of Cooperation
Trial start date: 28 February 2018
 
Project Status: 
  • Recruitment ongoing (Enrolments as of 30 Apr 2018: 677 )
 
Study Sites (India):    

1. Maulana Azad Medical College (MAMC), New Delhi

2. Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC & SJH), New Delhi

3. Chacha Nehru Bal Chikitsalaya, (CNBC), New Delhi

4. Kasturba Hospital (KH), Delhi

 
Achievements : 

• The QM team along with the  Coordinating Centre at THSTI successfully initiated the study at the 4 hospital sites  in India.

• Conducted GCP training for all site investigators and study staff at the India sites and

supported the investigator for training of research staff in study specific activities.

• Conducted a GCP training for the investigators and study staff for the Nepal sites.  

• Supported the project management team in equipment  calibration, procurement of

mobile temperature loggers and other temperature monitoring device.

• Prepared and successfully implemented the QM plan along with a monitoring checklist.

Mr. Gourav Khurana (S.CRA), Dr. Nitya Wadhwa (PI), Ms. Divya Pillai (PM,CPM)