A Phase IV, Interventional, open label, multicentric, single arm clinical trial to assess the safety, tolerability and immunogenicity of bivalent Oral Polio Vaccine (bOPV) in healthy Indian infants

The main aim of the study was to explore the safety and efficacy of BIBCOL bivalent Oral Polio Vaccine (bOPV) in new-borns who are naïve to Oral Polio Vaccine (OPV). This was an open label, multi-centric, single arm study, conducted at 5 clinical sites in India. CDSA was responsible for the overall project planning and management, finalization of clinical trial documents, regulatory advisory, clinical and safety monitoring, data management and statistical support.

iKMC Study

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)

The study aims to evaluate the impact of continuous Kangaroo Mother Care (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. 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.

Concurrent Monitoring of CNNS

Concurrent Monitoring of 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/ UTs of India, was conducted by the Ministry of Health and Family Welfare (MoHFW), Government of India in partnership with the United Nations Children’s Fund (UNICEF). The survey aimed 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.

Verapamil Dose-finding Study

An open-label, non-randomized, two-stage, dose-finding study of verapamil tablet formulation in adult tuberculosis patients in continuation phase of anti-tuberculosis treatment

This is a stage 2 of multicentre open-label dose-finding pharmacokinetic study of verapamil given in conjunction with standard therapy of Rifampicin, Isoniazid and Ethambutol (HRE).
Study objectives are:

• Determine the compensatory increase in verapamil dose that can offset the increased metabolism of verapamil when it is co-administered with rifampicin
• Confirm the safety and tolerability of verapamil in patients with TB without underlying cardiac disease

Eligible participants will be enrolled up to 12 study groups gradually in increasing order of total daily dose of verapamil. Six participants in each sequential study group will be enrolled till achievement target AUC to repeat the confirmatory group with 12 participants.

PLACID Study

SURAKSHA

South Asian Breast Cancer Risk Prediction, Genetic testing and Health Management

The Cancer Research UK (CRUK) has collaborated with the Department of Biotechnology (DBT), Govt. of India to address research challenges in cancer on a global scale by involving researchers from both India and the UK. The aim is to plan research programmes, which complements the research strengths and address the high-unmet need in both the countries in alignment with the key theme “affordable approaches to cancer”.
The team is in the process of developing a research programme around risk prediction or risk assessment and genetic testing of female breast cancer in India. The intention is to validate established breast cancer risk factors and models for the Indian (therefore South Asian) population. This multicentre multidisciplinary project will also evaluate implementation of a pathway of multi-gene testing at breast cancer diagnosis through 4 – 5 academic research centres in India.
During the seed-funding phase, the researchers will perform a systematic review of breast cancer risk factors in South Asian population. In addition, it will include a strong element of co-creation with patients and public of context specific transmedia patient information and risk-communication tools.

IMPART

Abbreviated Immune Checkpoint Inhibition following Radical Treatment Across the Mucosal Squamous Cell Cancers

The Cancer Research UK (CRUK) has collaborated with the Department of Biotechnology (DBT), Government of India to address research challenges in cancer on a global scale by involving researchers from both India and the UK. The aim is to plan research programmes, which complement the research strengths and address the high-unmet need in both the countries in alignment with the key theme “affordable approaches to cancer”.

IMPART aims at assembling a multidisciplinary team of trialists and clinicians across India and the UK to demonstrate the efficacy of abbreviated consolidated immune checkpoint inhibitor (ICI) in improving outcomes across the mucosal cancers in the context of the Indian (and subsequently UK) populations. Initial seed funding will develop the clinical, organisational, patient related and regulatory frameworks required to address and answer this question.

GLSE Study

Evaluating the efficacy and safety of an innovative and affordable Goat Lung Surfactant extract (GLSE) for the treatment of respiratory distress syndrome in preterm neonates: a multi-site randomized clinical trial

A translational research to validate investigational product to evaluate if the efficacy and safety are comparable to the standard product. The study This was an investigator-initiated trial of Dr Ramesh Agarwal (Principal Investigator) aimed to compare the efficacy and safety of Goat Lung Surfactant Extract (GLSE), with a standard preparation (Survanta; Abbott, USA) in a multi-center, investigator-blinded, non-inferiority randomized trial in preterm neonates with Respiratory Distress Syndrome (RDS). The study was phase I/II trial conducted at seven sites across India from Jun-2016 to Jan-2018. Although the study plan was to induct 10-12 sites over a period of time however subject enrolment commenced only at seven sites to collect data for 2nd interim data review by the DSMB. The DSMB (Chaired by Dr Rajiv Bahl, Coordinator of the Maternal, Newborn, Child & Adolescent Health Research and Development at WHO, Geneva) reviewed and analysed the data after enrolment of 98 babies from five inborn sites in two phases in its second meeting. The Research Steering Group, on recommendation of DSMB based, decided to terminate the study prematurely as research questions had been answered by the data collected for 98 participants.

Verapamil Dose-Finding Study In Tuberculosis (Stage-1)

An open-label, non-randomized, two-stage, dose-finding study of verapamil tablet formulation in adult tuberculosis patients in continuation phase of anti-tuberculosis treatment

A stage 1, open label, non-randomized, single dose pharmacokinetics study of verapamil (I.R.) 120 mg. Data conclude that a single dose of verapamil 120 mg when administered with RMP and INH is safe in patients with pulmonary TB who were in last month of their treatment.

Reflexology Study

Determination of efficacy and safety of reflexology therapy for the patients with intractable epilepsy: a multicenter randomized clinical trial

Reflexology is a non-conventional medical therapy, which has been used in managing several acute and chronic ailments. Non-pharmacological, non-invasive, low-cost medical methods are highly desirable in an economic constraint scenario. The study was an effort to examine the anti-seizure effect of reflexology in addition to AEDs in managing intractable epilepsy using more scientific and rigorous methodology. The study also established an innovative on-job training and continued support using telemedicine modalities. This randomized clinical trial was implemented at two study centers in North East Region of India, Imphal and Dibrugarh.

The total sample size estimated for the study was 120 patients aged 15-50 years with intractable epilepsy. The patients were randomized into the real reflexology therapy group and placebo reflexology therapy group. The patients were administered the reflexology therapy by stimulating the identified areas as per the protocol in addition to the ongoing antiepileptic drugs as per the treating physician’s advice.

The outcome measures documented are reduction in seizure frequency, improvement of quality of life in epilepsy and the responses in associated symptoms. This study provided insight into the utility of reflexology as an adjuvant therapy in intractable epilepsy and also modalities of training people in reflexology using the contact and telemedicine modalities.

SAM Program

To monitor and conduct quality assurance of research projects for validation of diagnostic criteria and development of food regimens to medically rehabilitate children suffering from uncomplicated severe acute malnutrition (SAM)

Department of Biotechnology (DBT) awarded the SAM program to Clinical Development Services Agency (CDSA) on 23rd March 2012. CDSA’s role was to coordinate the SAM alliance secretariat and function as an independent monitoring agency for all the projects awarded by inter-ministerial SAM alliance. SAM alliance has been governed by the Inter-ministerial Committees that facilitated in developing and providing technical approvals of study proposals, ensured compliance and formulated strategic decisions for the management of the program. The studies identified fall under different thematic areas that have direct impact on framing National Policies to challenge malnutrition in the country. CDSA has actively contributed in the initiation of awarded studies and dissemination of the results of the completed studies of the program with a national consultation of stakeholders. CDSA has effectively managed and monitored the awarded projects and ensured the study activities are in strict compliance with the ethical requirements and study protocol.

In addition to study monitoring activities, CDSA team has contributed effectively in project planning, execution and setting up of the study sites for sanctioned SAM studies. The team has dexterously coordinated with regulatory consultants, subject matter experts, Data Safety Monitoring Board (DSMB), Technical Advisory Group (TAG) and Steering committee members. This eventually contributed to resolving regulatory issues and critical queries and was instrumental in decision making pertaining to the studies.

The hardships and challenges while supporting the studies, created awareness amongst academic researchers and set up strategies to conduct studies that do not come under the purview of Central Drugs Standard Control Organization (CDSCO) regulations.