Current 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, and5) 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.

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

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).
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. 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

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

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: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:

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.

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: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.

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.

Project Title:Inter Institutional Program for Maternal, Neonatal and Infant Sciences- a translational approach to studying Pre-term birth

Project Status:
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 Sites: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)
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

Beat India TB Study

BEAT stands for ‘Building Evidence for Advance Treatment against Tuberculosis’. The emergence of drug resistance is a major threat to tuberculosis (TB) care and control. Extensively drug-resistant TB (XDR-TB) is a form of TB caused by M. tuberculosis that are resistant to isoniazid and rifampicin (i.e. MDR-TB) as well as any fluoroquinolone and any of the second–line anti-TB injectable drugs.

The treatment of XDR-TB consists of 24-30 months of 7-8 drugs along with an injectable for 6-9 months, all drugs given on a daily basis. Considering the complexity of the treatment of pre-XDR and XDR-TB cases, there is an urgent need to build a better, safer, less toxic, shorter and cheaper regimen to reduce patient suffering and mortality with careful evaluation.

The World Health Organization (WHO) recommends using well tolerated Bedaquiline (BDQ), Delamanid (DLM) and PA-824 anti-TB drugs for a standardized duration of 24 weeks in patients with drug-resistant tuberculosis. The scientific validity of comparing a 24-36 weeks (6-9 month) endpoint with a 24-27 month endpoint (standard of care) would represent a significant challenge.

This study evaluate the efficacy of a new treatment regimen of 6-9 months duration consisting of Bedaquiline (BDQ), Delamanid (DLM), Linezolid (LZD) and Clofazimine (CFZ) in adult patients with pre-extensive (pre-XDR) or extensively drug resistant (XDR) pulmonary tuberculosis.

CDSA is responsible to verify the authenticity, accuracy, and completeness of the data through routine monitoring in all the identified five clinical sites. Also, ensure Safety and rights of patient are being protected and the study is being conducted in accordance with the currently approved protocol and all applicable regulatory requirements.

Study Title:Evaluation of the Efficacy and Safety of a Combination regimen of Bedaquiline, Delamanid, Linezolid and Clofazimine in Adults with Pre-extensive (Pre-XDR) and Extensively Drug-resistant Pulmonary Tuberculosis (XDR-TB): Prospective Cohort Study

Study Site:
1. National Institute for Research in Tuberculosis and Govt. Hospital of Thoracic Medicine, Chennai
2. National Institute for Tuberculosis and Respiratory Diseases, Delhi
3. Rajan Babu Institute of Pulmonary Medicine & Tuberculosis, Delhi
4. BJ Medical College, Ahmedabad
5. Group of Tuberculosis Hospitals, Mumbai
Study Details:• Study is in its site preparedness phase.
• Regulatory approval from DCGI dated 18 Mar 2019 and IEC approvals of all the sites are in place.
• Investigational Products have been imported.
• Study staff hiring and Protocol and GCP training are in process.