Challenges and Opportunities of Clinical Research In Nepal : A Closer Look

Clinical research plays a crucial role in advancing medical knowledge, developing new treatments, and improving patient care. While numerous countries around the world have established a robust culture of clinical research, Nepal is yet to make significant progress in this area. In this blog post, we will delve into the factors that have hindered the development of a thriving clinical research culture in Nepal and explore potential opportunities for growth

The Landscape of Clinical Trials in Nepal

Nepal has been involved in a number of clinical trials; however, it has primarily served as a research subject rather than actively contributing to the design and execution of trials. Most trials are initiated elsewhere, leaving Nepal to participate and provide data as required by the sponsor. This raises questions about the country's role in clinical trials and its ability to leverage research for its own benefit.

Reasons For Lack of Progress 

1. Absence of Investigational Medicinal Products (IMPs): A significant factor inhibiting Nepal's progress in clinical research is the absence of its own investigational medicinal products or devices. Currently, clinical trials are conducted for products developed by external entities, limiting the potential benefits for Nepal. By developing its own IMPs and successfully conducting clinical trials on them, Nepal could harness economic benefits and contribute to its own scientific advancement. 

2. Inadequate Resources and Infrastructures: Clinical trials demand a dedicated workforce and suitable facilities. Nepal faces challenges in terms of both human resources and infrastructure. Well-trained clinical research personnel are essential to maintain protocol adherence and ensure data quality. Currently, there is a lack of organizations offering clinical research training and certification courses, contributing to the suboptimal structure of clinical research activities.

3. Regulatory Framework: The regulatory framework for clinical research in Nepal involves the Nepal Health Research Council (NHRC) and the Department of Drug Administration (DDA). Both of these organizations work in collaboration to control regulatory as well as ethical aspects of clinical trials respectively. However, in reality, both of these organizations are not clear and concise on their own roles and responsibilities and hence are functioning without any solid guiding documents underneath. Since any of the clinical trials are not well monitored / inspected from the governmental authority, the quality of the data hence produced is solely dependent on the integrity of the researchers. 

Opportunities For Growth

1. Developing Own IMPs - Nepal has the potential to embark on the journey of developing its own investigational medicinal products and medical devices. This would involve investment in research and development, fostering collaboration between academia and industry, and aligning efforts with the country's healthcare priorities. 

2. Building Skilled Workforce: Establishing dedicated organizations or courses for clinical research training can bridge the skills gap. A workforce equipped with the necessary knowledge and expertise will ensure the integrity of trials, adherence to protocols, and accurate data collection.

3. Enhancing Regulatory Clarity:  Refining the regulatory processes and guidelines can attract more sponsors and researchers to consider Nepal for clinical trials. Clear and efficient regulations inspire confidence among stakeholders and expedite the initiation and execution of trials.

Conclusion

While Nepal may currently face challenges in establishing a vibrant culture of clinical research, there are significant opportunities for growth and progress. By addressing the identified hurdles and leveraging its strengths, Nepal can transition from being a passive participant in clinical trials to an active contributor, fostering its own scientific and economic development. With focused efforts, collaboration, and strategic planning, Nepal can pave the way for a promising future in clinical research

Disparities on Out of Pocket Expenditure In Nepal - Seed of Social Injustice

When it comes to seeking medical care, one cannot ignore the financial aspect. Have you ever wondered if the amount you paid for healthcare services was truly justifiable for what you received? The disparity in healthcare costs between hospitals often leaves us questioning the fairness of the expenses incurred. In this blog post, we delve into the world of out-of-pocket expenditure and the factors that contribute to the variance in costs between hospitals.

Understanding Out-of-Pocket Expenditure

Out of Pocket (OOP) expenditure is the portion of medical cost that individuals pay directly from their own income or through debt, excluding contributions from insurance or social security. It's a crucial metric that sheds light on the affordability and fairness of healthcare services. Imagine visiting two different hospitals for similar health issues and discovering a significant difference in costs. This raises the question of whether the price gap is equitable given the services provided and the severity of the condition.

Factors Influencing Out-of-Pocket Expenditure

1. Care Providers Cost: The initial ticket cost charged by hospital can vary greatly. This charge often reflects the hospital's internal expenses, equipment quality, and staff availability. Higher charges might correlate with more advanced services, allowing patients to choose according to their financial capacity and medical needs

2. Inpatient Admission Cost: The cost of staying overnight in the hospital various services can vary significantly. This disparity can make sophisticated hospitals seem unaffordable to many.

3. Diagnostic Tests: The cost of the diagnostic test can be a major component of OOP expenditure. In some cases, excessive tests are ordered, inflating costs unnecessarily.

4. Medicine Import: Nepal's reliance on imported medicines increases their cost due to import expenses. A local manufacturing approach could alleviate this burden and reduce overall healthcare costs.

5. Insurance and Social Security: The absence of robust health insurance and social security schemes in Nepal contributes to high OOP expenditure. Strengthening these systems can greatly alleviate the financial burden on patients.

Tackling the Issues: Solutions and Pathways Forward

1. Enhancing Insurance Coverage: Effective implementation of health insurance can significantly reduce OOP expenditure, providing a lifeline out of the poverty trap. This might involve digitalization, private sector partnerships, and other innovative approaches.

2. Hospital Grading and Cost Transparency: Grading hospitals based on facilities and services, and disclosing standardized costs for each category, can empower patients to make informed choices and level the playing field.

3. Income Based Payment: Integrating annual income data into healthcare  records can guide patients towards suitable healthcare options, especially beneficial for those with limited education.

4. Domestic Medicine Production: Manufacturing essential medicines locally can alleviate costs until robust insurance and digital healthcare systems are established.

5. Stringent Regulation and Ethical Practice: Monitoring hospitals and enforcing ethical practices are essential steps. Implementing reward and punishment mechanisms can shift the healthcare industry toward a patient-centric model.

6. Commitment to Ethical Practice: Ethical responsibility lies with healthcare practitioners, providers, patients, and the pharmaceutical industry. Ethical practices are pivotal in ensuring the healthcare system's benefits are maximized for all.

Conclusion 

Navigating the labyrinth of healthcare cost requires a collective effort from regulatory bodies, hospitals, healthcare professionals, and patients. The journey toward justifiable healthcare expenses involves reimagining insurance systems, fostering transparency, and promoting ethical practices. By addressing the factors contributing to high OOP expenditure and implementing innovative solutions, Nepal can move closer to a healthcare system where costs reflect the value of services rendered, without leaving individuals burdened by financial strain

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Clinical Trials on Rare Disease - Challenges and Opportunity

 Orphan Drug Development

Clinical trials conducted on any rare diseases that are intended for the marketing and approval of a new drug candidate for the purpose of establishing future novel therapy is known as orphan drug development. Orphan drugs trials are always of high importance in scientific community as these are tough to conduct in terms of regulation, Pharmacoeconomics, trials design and implementation. Since there are only a very few rare diseases trials being conducted, all the stakeholders intend to squeeze out maximum benefits from the trial.

As per the United States foods, drugs and cosmetic acts, rare diseases are such disease or conditions which impacts less than 200,000 peoples residing in the United States. Similarly, in European Union, a disease is considered to be rare if it affects one person out of 2000 citizens. There have been more than 6000 rare disease discovered so far affecting approximately around 3.5 to 5.9 % of worlds population. Most of rare disease have genetic origin (72%) and hence are difficult to treat with medication.  

Why Clinical trials on rare disease is difficult? 

1. Understanding Disease mechanics : There is very little understanding of disease mechanisms and pathophysiology of any rare disease which makes it impossible for a new therapy to establish inference on intervention and the outcome.

2. Genetic Variability: Since majority of rare disease have genetic predisposition, clinical manifestation for each of them will be different and drug effective for one type of genetic makeup may not be the best option for another group with different genetics. This specially makes clinical trials more complicated. 

3. Too less events: Though significant number of people are affected with various rare disease throughout the world, there are too few people available for a single clinical trial as the patient pool for each diseases under trial is always lesser than required for the enrollment. 

4. Adolescent predominance: Since most of the rare diseases are manifestoed in early childhood and adolescence, it is difficult to conduct trial on children and people with younger age due to legal and ethical issues. Also the rate of compliance to the clinical trial protocol is still very low. 

5. Statistical Insufficiency: Currently applied outcome measures are not appropriate for rare disease and reliability of newer methods is ambiguous. For example, smaller effect size etc. 

6. Pharmacoeconomic Reasons: Since clinical trials are very costly, if return on investment for any trial is seemingly low, pharmaceutical industry is less likely to invest their money for the good of society and science only. In comparison to other conventional trials and their outcome in the world, conducting clinical trials with inherently very low success rate is nto good idea for commercially oriented pharmaceutical companies and considering their return on investment, it is less likely to invest. 

Current number on  Rare Diseases Trials 

While putting keyword 'Rare Disease Trials', a total of 564 studies are popped out in clinicaltrials.gov, , out of which only 91 studies are currently recruiting participants whereas 342 have been already completed. Rest of the studies are either 'not yet recruiting' or ' suspended' from the process. 

Opportunities and Way Forward 

1. Noncommercial research activities. Unlike other clinical trials on a pharmaceutical product, there are very limited chances of trials getting successful on receiving license for market, sponsors may not be much interested taking such a challenge. Only a researcher organization with multiple collaboration should conduct such trials overlooking cost - benefit analysis of such research projects. 

2. Lenient regulatory obligations: if we apply the same regulatory framework with similar degree of scrutiny in rare diseases trial as we don in other exploratory / pragmatic clinical trials, there are chances of any such trial not to meet regulatory requirements. Hence, right from the pre trial implementation documents, rare disease trials should are conducted with much less of scrutiny and legal system are made easier so that such studies are promoted in the scientific era as well. 

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