Projects

Accelerator Program for Discovery in Brain Disorders using Stem Cells (ADBS)

There is emerging evidence that there are shared genetic, environmental and developmental risk factors in psychiatry, that cut across traditional diagnostic boundaries. With this background, the Discovery biology of neuropsychiatric syndromes (DBNS) proposes to recruit patients from five different syndromes (schizophrenia, bipolar disorder, obsessive compulsive disorder, Alzheimer’s dementia and substance use disorders), identify those with multiple affected relatives, and invite these families to participate in this study. The families will be assessed: 1) To compare neuro-endophenotype measures between patients, first degree relatives (FDR) and healthy controls., 2) To identify cellular phenotypes which differentiate the groups., 3) To examine the longitudinal course of neuroendophenotype measures., 4) To identify measures which correlate with outcome, and 5) To create a unified digital database and biorepository.
CDSA is pleased to collaborate with NCBS, inStem and NIMHANS towards the successful completion of the study. Through the combination of project staffing and innovative project monitoring for the significant study, CDSA is selected provide the overall quality management to meet high standard of quality for the project. 
 
ADBS

Study Title- Accelerator program for Discovery in Brain disorders using Stem cells (ADBS)

Study Site: NIMHANS, Bangalore (participants enrolment); NCBS & inStem (Biorepository), Bangalore

Study Status: Screened families 2499 , participants recruited 809 (as of April 2018)

Quality Management data review status:

  • Overall Quality Management
  • Risk Based monitoring strategy for Data monitoring and Process monitoring by identification of Critical Data Fields
  • Quality management through online monitoring reports and tracking of each participant monitored
  • Online resolution of monitoring queries

Achievements:

Concurrent monitoring of the enrolment data and processes
Release of monitored data after query resolution on daily basis
Escalation of critical quality issues to clinical team on weekly basis and their resolution
Trend Identification and lessons learnt for prospective monitoring and data quality

Project Team Members:- Dr. Siddhartha Roy with NIMHANS team

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

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

Project Team Members :- Mr. Tarun Puri, Mr. Panna lal,
Ms. Jinisha Shukla, Ms. Shinjan Kapur, Ms. Tina yadav,
Ms. Shristi Sharma, Dr. Sonali Gupta

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.

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.


Project Team Members: - Dr. Sucheta Banerjee Kurundkar, 
Dr. Juhee Chandra, Dr. Nidhi Sejpal Pouranik, Mr. Muddasir Ashraf, Dr. Anjana Tomar, Mr. Wajahat Ali Khan, Mr. Hari Prasad Bhargava, Mohd. Nabid Ansari, Ms. Navodita Rashmi, Mr. Praveen Bansode, Mr. Suraj Gajbhiye, 
Ms. Niranjana PG, Mr. Rajkumar Ragan, Mr. Yadunath Sharma, Mr. Lokesh R, Mr. Manzoor Sheikh, Mr. Tanmoy Kumar Saha, Mr. Murari U, Mr Jitender

Immediate KMC Study 
 
The study aims to evaluate the impact of continuous Kangaroo Mother Care (KMC)  initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to <1.8 kg on their survival in low-resource settings .  This multi-country randomized clinical study has been implemented in tertiary care hospitals in five low- and middle-income countries in Asia and Sub-Saharan Africa (India, Ghana, Malawi, Nigeria and Tanzania). In this study, the proposed method of care will be provided to infants with a birth weight between 1.0 to <1.8 kg. This will be compared with the current recommended method of initiating continuous KMC after stabilization of the neonate. All neonates enrolled in this study will receive the WHO minimum package of care for small babies (warmth, hygiene, breast-milk feeding, and if required intravenous fluids, parenteral antibiotics, oxygen, continuous positive airway pressure, and monitoring). This care will be the same for the intervention and control groups, except that babies randomized to intervention will be given continuous KMC with mothers or surrogates in the neonatal special care unit, but babies allocated to control group will receive care in incubators, radiant warmers or cots while they are unstable. 
 
CDSA is collaborating with VMMC and SJH for conduct of the study at the India site (Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi) and is responsible for the finance management, Internal Quality Improvement  and data management support to the site in India. Duration of this collaboration will be of 3 years (up to 2020). 
 
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

Project Team Members: Dr. Nitya Wadhwa, Mr. Ashish Dass

INVICTUS Study

INVICTUS is a comprehensive evaluation of RVHD, AF and stroke. The study includes three components, A registry of RVHD, a randomized clinical trial of rivaroxaban versus Vitamin K antagonist therapy (VKA) to establish the non-inferiority and potential superiority of rivaroxaban compared to VKA and a superiority trial to compare rivaroxaban to aspirin in patients who are unsuitable for VKA therapy or who do not have AF/flutter but who do have other risk factors.

INVICTUS study will establish the efficacy and safety of rivaroxaban in a broad cross section of patients at substantial risk of stroke and death. Currently this program is being carried out in 27 countries with 171 centres. In India, the study has been activated in 09 tertiary care hospitals (AIIMS, GB Pant and RML in Delhi, SGPGI and KGMC in Lucknow, Sri Jayadev in Bangalore, PGIMER in Chandigarh, SMS in Jaipur and JIPMER in Pondicherry). CDSA has extended pre-study activities support and accomplished activation of all clinical sites in India. 

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

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

Project Team Members:- Ms. Divya Pillai, Mr. Ashish Dass


GARBH-INI– interdisciplinary Group for Advanced Research on BirtH outcomes – DBT INdia Initiative (PTB)

Unique collaborative interdisciplinary program between research institutes (Translational Health Science and Technology Institute, National Institute of Biomedical Genomics, Kalyani; Regional Centre for Biotechnology, Delhi NCR, and district (Gurugram Civil Hospital (GCH), Haryana) and tertiary care hospitals (Safdarjung Hospital (SJH), Maulana Azad Medical College, New Delhi; Coordinated by Pediatric Biology Centre, THSTI).

Globally, preterm birth is a major public health problem. In India, annually about 13% (3.6 million of 27 million) of all babies born are preterm. About 300,000 of preterm babies die each year because of complications, contributing to 25% of the overall global preterm-related deaths. The adverse consequences of preterm birth (PTB) extend beyond early infancy with substantial consequences later in life. Effective solutions have not been possible because PTB is a complex syndrome with multiple etiologies that include interacting biological, psychosocial and environmental factors. Risk stratification of women based on multidimensional risk factors assessed during pregnancy is critical for prevention of preterm birth. To address this, an interdisciplinary Group GARBH-INi has been established across DBT autonomous research institutes and hospitals. A cohort of pregnant women was started in May 2015 at the civil hospital in Gurugram, Haryana, India with the objectives to identify the clinical, epidemiological, genomic, epigenomic, proteomic and microbial correlates, discover molecular risk-markers by using an integrative omics approach, and generate a risk-prediction algorithm for preterm birth.

CDSA supported in setting up a co-ordination unit for site preparation, role-based training, and standardized processes to ensure efficient implementation/compliance. CDSA is ensuring the quality of this study by conducting the monitoring activities.

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

Project Team Members:- Dr. Shilpa Malik , Ms. Preeti Semwal, Ms. Kamaljeet Sheokand

Zn-Sepsis Study

This superiority trial is a individually randomized double-blind placebo-controlled parallel group clinical trial to evaluate the role of zinc acting as an adjunct for the treatment of clinical severe infections among infants below two months of age. In India, the study is being conducted at 4 tertiary centres in Delhi (Safdarjung Hospital, Kasturba hospital, MAMC and CNBC). CDSA has taken up the responsibility of quality management to ensure the quality standards of the study as per the project requirements and applicable guidelines. 

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.

Project Team Members:- Mr. Gourav Khurana, Dr. Nitya Wadhwa, Ms. Divya Pillai

 

 

    

Completed Projects