Clinical Research in Jammu and Kashmir
Clinical research is an integral part of medical Sciences and plays a vital role in advancing medical knowledge. This is done through improving patient care and developing new treatments and advancing medical knowledge. For achieving this objective developing Clinical trials to evaluate the safety and efficacy of new treatments, such as medications, devices and procedures is essential. Clinical trials are always regulated by the Ministry of Health and Family Welfare, Govt of India more specifically, Central Drugs and Standard Control Organization (CDSCO). CDSCO functions under the Directorate General of Health Services (DGHS) within the Ministry of Health and Family Welfare.
In Kashmir valley there are only three Institutions registered by the CDSCO for carrying out human clinical research. Two of them: Govt Medical College (GMC) Srinagar and Sher I Kashmir Institute of Medical Sciences (SKIMS) both Government institutions. The author (Prof U Kaul) is the chairman of the Ethics Committee of the SKIMS.
The third one is the Gauri Research Centre a subsidiary of Gauri Kaul Foundation, a Section 8, Private Limited Company, governed by the Companies Act . It is Classified as a non-government organization registered under the Registrar of Companies RoC-Delhi. According to the Ministry of Corporate Affairs (MCA), Its Corporate Identification Number (CIN) is U85300DL2022NPL399372, and it carries the registration number 399372. Its registered office is located in Delhi with Dr Upendra Kaul and Dr Priyadarshini Arambam as the Directors and Promotors. GRC has as per the rules has an ethics committee, headed by Prof Abdul Hameed Zargar, former director of SKIMS as its chairman.
GRC has a full-time research coordinator Dr Irtiqa Malik, who works directly under both the directors. The research wing of the GRC has been active and has successfully completed a study on “Uncontrolled hypertension in a rural population of Jammu and Kashmir”. The cross-sectional study was conducted in 6 rural districts of Jammu and Kashmir. The findings were startling. It was found that 56.5% patients in the study who were on BP lowering medicines had their blood pressures uncontrolled. This important observation needs to be taken seriously because hypertension is a very important treatable risk factor for heart attacks.
GRC has also partnered with St John’s Medical college in the SUPPORT study conducted in village Hawal, Tehsil Rajpora, Pulwama district. It was part of a nationwide study focusing on non-communicable disease prevention in 2024. The project length was one year. It was conducted at the Prasad Joo Khan Heart Centre, Pulwama. The aim was to evaluate the impact of interventions like lifestyle modifications, medication adherence, and behavioural changes on diseases such as cancer, mental disorders, hypertension, diabetes, and high cholesterol. The study particularly benefitted the vulnerable populations facing socio-economic and geographical disparities. The health workers implemented the study protocols and were involved in educating the communities on healthy lifestyle choices.
Currently GRC is involved in a multi centric international study “POSEIDON”. The study is meant to find out the levels of inflammation in patients with cardiovascular diseases with or without kidney involvement. Forty-one patients have been recruited so far and their blood samples for hs CRP and related inflammatory bio-markers were collected and sent to the core lab of the sponsor in Mumbai. This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease). Participants will continue their normal care and will not get any treatment other than those the study doctor has prescribed.
There are several other studies for which feasibility questionaries have been received by GHC and some of the feasible ones would be started in due course.
GRC is starting the school surveys in South Kashmir to perform, echocardiography and general examination in school children between the ages of 5 and 15 years. The purpose is to find the prevalence of rheumatic heart disease (RHD) and congenital heart disease (CHD) starting on 24th of April in Govt High School of Hawal, Rajpora. It will be done using the “Heart Clinic on wheels”. The children who are detected to have these problems would be advised preventive measures like penicillin prophylaxis for RHD and counselling for those with CHD. Children needing mechanical interventions would be referred to SKIMS which is our partner. In addition, our aim will be to find the prevalence of childhood obesity a growing menace. Proper counselling through teachers and parents will be given.
The vision of GRC is to advance the medical knowledge through research to optimize medical practice. Our mission is to provide an excellence in patient care, education, research and community service with innovative therapies by facilitating access to cutting edge clinical research opportunities.
GRC also facilitates the timely execution and completion of high-quality clinical research. The centre provides a variety of services to assist Investigators and sponsors with all aspects of clinical research for conducting phase I to IV trials. The staff has extensive training & experiences to ensure that studies are conducted in accordance with sponsors’ standards as well as with local & International regulations and current guidelines for good clinical practice.
GRC also is a single point contact to initiate clinical research and ideas generated by the investigators or the sponsors. The centre provides services in academic leadership to full-service clinical trial management capabilities, including site monitoring, data management, statistical analysis, safety monitoring, and clinical events classification, in addition to clinical expertise, guidance on protocol development and .protocol writing.
Tailpiece:
Clinical research is an integral part of the holistic medicine for advancing medical care and the much-needed improvement in health care. GKF realises this and has a state of art GRC, located in its Srinagar and Pulwama centres. It is the only private centre in Kashmir which is approved by the CDSCO of the Health Ministry, Government of India for this purpose. The centre has been involved in clinical research and has been publishing the findings in peer reviewed journals. GRC wants that eventually Jammu and Kashmir become a research hub for the country.
The author is Founder Director Gauri Kaul Foundation