What does biomedical research means?
Biomedical Research is the broad area of science that looks for ways to prevent and treat diseases that caused illness and death in people and in animals. This general field of research includes many areas of both the life and physical sciences. Biomedical Research is an evolutionary process requiring careful experimentation by many scientists, Including Biologists and Chemists. Discovery of new medicines and therapies requires careful scientific experimentation, development and evaluation.
Biomedical Research in Nepal:
- Unlike other countries in South Asia, research in the health sector in Nepal has a relatively recent history
- Health research in Nepal has its origin in aid from the United States started in 1951. USOM (United States Operations Mission, later renamed as USAID) undertook Nepal's first systematic research activity, a survey on malaria, in 1952, designed within the context of the country's Malaria control interventions
- Over the last 60 years, health related research conducted in Nepal has been varied. It ranges across more pure biomedical research, into arenas where evidence is being generated for programmatic interventions into the health field more generally. This generation of evidence around programmatic interventions has been sustained by assemblages of local and international organizations and universities, and supported and funded by aid institutions
- Data from Nepal Health Research Council shows that, officially, 1,212 health research activities have been carried out between 1991 and 2014
- Established in 1991, the Ethical Review Board of the Nepal Health Research Council (NHRC) is the central body that has the formal regulating authority of all the health research activities in country, granted through an act of parliament.
- evidence says, Much of the scholarship focusing on health sector research in low‐income countries has focused on pharmaceutical development and direct research on human subjects within the field of clinical trials and health experimentation
Currently Ongoing Research Program In Nepal:
Nepal health research council is governing body of biomedical researches including clinical trial and population based observational studies throughout the country. Following research activities are being registered and being conducted according to official website of NHRC .
- Population based screening of Sickle Cell anemia in Tharu community of Bardiaya district of Nepal, 2018.
- Population based cancer registry in Kathmandu, Lalitpur, Bhaktapur, Sarlahi, Saptari, Mahottari and Rukum district in Nepal, 2018.
- Descriptive study of Scrub typhus in Nepal, 2018.
- Unknown Disease Outbreak Investigation In Sundarharicah Foklan Tapu Morang District, 2017.
- Non communicable risk factors STEPS survey in Nepal 2018.
- Global school based student health survey in Nepal, 2017.
- Population based intervention for prevention and control of NCD risk factors in Nepal, 2017.
- Prevalence study of selected chronic disease ( chronic kidney disease, chronic obstructive pulmonary disease, Diabetes mellitus, Coronary Artery disease) in Nepal, 2017.
- Assessing the trends of Heat waves and perception of people on health risk of heat wave in Nepal, 2018.
- Effect of climatic factor in Diarrhea disease prevalence at National and sub- National levels in Nepal, 2017.
- Evaluation of Introduction of Electronic Medical Record system in District Trishuli Hospital Nuwakot, 2018.
- Estimating burden of disease in Nepal using Globally used method, 2018.
- Disbursement Linked Indicator, 2018.
- Study on quality of drugs and drugs used pattern in different healthcare settings in Nepal, 2018.
- Review of social Health Insurance scheme in selected districts of Nepal, 2018.
- Quality of essential medicine in public Health care facility of Nepal, 2018.
- National mental health survey of Nepal, 2018.
- Assessment of suicide and related factors in Illam districts of Nepal, 2018.
- Institutional mapping of traditional and complementary medicine service outlet and human resource in Kathmandu valley, 2018.
- Effectiveness of selected Yoga practice among hypertensive patients, 2017.
- Evaluation of Ayurvedic treatment in Hepatitis B, 2017.
- Asparagus distribution programme for Breastfeeding promotion: perspectives from mother and health service providers, 2017.
Challenges of conducting clinical trials in Developing countries
- Inadequate protocol: The application of protocols and techniques for research into human subjects is now increasingly criticized as inappropriate or inadequate for research into more complex health systems related issues in low‐income countries
- Dependency: since health care system in developing countries is mainly dependent on developed one in terms of medication, medical devices, subject matter experts, Research funding and even heath statistics sometimes. it is hard to reflect need of land of particular country in such cases.
- Lack of data: inadequacy of health statistics can't demand competent research protocol. Recently, Nepal Health research council has taken initiative in finding prevalence of different disease in different geographic regions of country to combat such issues.
- Funding : local Research grant or any philanthropist organization conduct only for particular type and time. In order to conduct sustained research activities, federal funding should be in adequate amount.
- Only few hospital are conducting biomedical researches. although number of hospital is very high, only Patan hospital, Teaching hospital and Anandaban hospital comes in list for conducting clinical studies.
- Registration: It is, however, impossible to trace all the research activities in Nepal, especially those that are designed to generate evidence around programmatic interventions. This is mainly because not all research activities are registered with Nepal Health Research Council (NHRC), there is no standard database and no clear definition as to what is regarded as health research Without knowing how many and what research activities are taking place in the health sector. as for example: Oxford University Clinical Research Unit (OUCRU) is conducting clinical trials in Patan hospital as a daughter branch of Hospital of Tropical Disease Vietnam, in collaboration with NHRC since 2003., but official website of NHRC doesn't show any evidence.
- Inadequate distribution of resources: specially in rural part of countries, not only diversity in diagnosis is there but also availability of research subject is easy. problem to conduct research activities is inadequacy of resources and its distribution.
- Political economy is not visionary for long term planning and execution.
Analysis of South Asian countries in reference to India:
India is considered as hub for clinical research. interests of foreign and local sponsors, government, public and health care professional makes India the most valuable country for drug development. According to official site of Clinical Trial Registry on India (CTRI), 13,345 intervention studies are being conducted all over the country. Number will be more than double, if we consider observational and post marketing surveillance study. researches shows that even this number is not enough to justify adequacy of clinical study in a country such high diversity and population. Taking into consideration of Global scenario, India lags behind US, European Union, Japan and Canada. These are few factors which make India to stand in Global scenario of clinical Research:
- Increasing number of Non- transmittable diseases like DM, HTN, dyslipidemia ( previously known to be Western disease)
- Diversity of Medical diagnosis because of socioeconomic, geographical and cultural reason
- Aggressive increasing in number of health care centers in different geographic locations
- Financial interest of Public and professional ( Since participants in clinical trial are provided with free health care facility)
- Proper Governmental agency to regulate, register and controlling research activities eg: Indian ICH GCP guideline, CTRI ( clinical trial registry of India), ICMR (Indian council of medical Research), CDSCO ( central drugs standard control organization), DCGI ( director general of India).
- Rapid population growth
How Can we Take Rapid Growth In Research Activities:
- Attracting more sponsor: In order to conduct large Multicentric international study, sponsors also need spend millions of money. International investors will only work here if they find security of investments. To insure safety and yield robust data, all Governmental regulatory activities should meet perfection. since from entry and Registration in country, finding feasible site for study, getting ethical approval, maintaining supply chains up to completing and approving drugs for marketing.
- Management of conflicts of interest: only meticulous follow of guidelines and law enforcement can manages conflicts of interest, no matter from where it aroused.
- Increasing federal fund
- Strengthening of Institutions, national and international collaborating centers.
- Empowering local, traditional treatment system, to collect scientific evidences, which are suitable to this environment.
Thank you !!!
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