scholarly journals How can Clinical Research Trials Conducted in Developing Countries Minimize Exploitation?

2021 ◽  
Vol 4 (3) ◽  
Author(s):  
Gia Mukherjee

Western scholars, pharmaceutical companies, and academic institutions are and have been conducting research in developing countries for many years. These locations boast substantial cost savings, expedited timelines, and little to no regulatory oversight, making them attractive to developed-world researchers. Residents of these communities are impoverished, often illiterate, unemployed, and with untreated health conditions. Because established ethical protocols for international research are often compromised or misconstrued by researchers and/or their sponsors, these individuals are left vulnerable to exploitation and abuse. In this paper, I explore how current utilization of ethical guidelines is enabling exploitation. I identify ethical questions regarding subject recruitment, informed consent, standard of care, and the post-trial obligations of researchers. I then examine specific situations in which exploitation occurred because of drug, vaccine, or clinical trials. I conclude by offering recommendations to create a more streamlined approach to international research that takes into account the experiences and needs of vulnerable populations. This approach helps ensure that participants are fully involved in the ethical approval process; able to choose whether or not to participate without any undue influence or pressure; treated with the standard of care best suited to their context and surroundings; and reasonably given access to any interventions proven effective during the course of the trial.. A respect for beneficence, justice, and self-autonomy should guide researchers’ interactions with subjects before, during, and after the trial.

2021 ◽  
pp. 27-86
Author(s):  
Alex John London

This chapter traces the practical and conceptual origins of eight problematic commitments including the perception that there is an inherent moral dilemma at the heart of research with humans and the tendency to conceptualize research as a private transaction between researchers and participants without clear connections to the requirements of a just social order. It introduces readers who are new to research ethics to key cases and documents relating to domestic and international research and illustrates how they gave rise to the problematic views that produce conceptual and practical tensions in the field. The chapter frames the questions that will be addressed in subsequent chapters, including issues about research risk; the role of paternalism in research ethics; and requirements relating to responsiveness to host community health needs, the standard of care, and post-trial access in international research.


2021 ◽  
pp. 343-374
Author(s):  
Alex John London

Although the principle of justice plays a peripheral role in domestic research in high-income countries, it grounds a series of requirements in international research relating to responsiveness to host community health needs, the standard of care, and assurances of post-trial access. This chapter reviews a proposal to eliminate what is seen as a cumbersome mix of requirements on international research in favor of a framework of procedures that render considerations of fairness more manageable within the confines of orthodox research ethics. This might appear to be an alternative to the approach defended in this book because it would avoid having to engage with difficult issues of justice that reach beyond the confines of the field as it is currently configured. This chapter argues that efforts to avoid substantive conceptions of justice wind up tacitly enforcing a particular conception of justice, and it is shown that the proposal to streamline the ethics of international research cannot satisfy some of the requirements that its proponents advocate.


2021 ◽  
pp. 375-422
Author(s):  
Alex John London

This chapter articulates and defends the human development approach to international research. This approach extends into the international context the egalitarian research imperative outlined in chapter 4, the integrative approach to research risk in chapter 6, and the non-paternalistic approach to research oversight in chapter 7. In this approach, requirements related to responsiveness to host community health needs, the standard of care, and post-trial access to study interventions are grounded in requirements of justice and the egalitarian research imperative. The result is a unified foundation for both domestic and international research ethics that treats research as a social undertaking, recognizes justice as the first virtue of social institutions, and gives moral force to the imperative to generate the information needed to improve the ability of social institutions to advance the common good.


2020 ◽  
Vol 9 (13) ◽  
pp. 907-918
Author(s):  
Aseel Bin Sawad ◽  
Fatema Turkistani

Background: Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). Aim: To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. Materials & methods: This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. Results: VLUs impact patients’ physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Conclusion: Payers’ coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.


2022 ◽  
Author(s):  
Rong Chen ◽  
Dmitry Gultyaev ◽  
Johanna Lister ◽  
Rong Han ◽  
Nan Hu ◽  
...  

Abstract Background: Long-term prophylactic therapy is considered the standard of care for hemophilia A patients. This study models the long-term clinical and cost outcomes of two factor VIII (FVIII) products using a pharmacokinetic (PK) simulation model in a Chinese population. Methods: Head-to-head PK profile data of BAY 81-8973 (KOVALTRY®) and antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM, ADVATE®) were applied to a two-state (alive and dead) Markov model to simulate blood FVIII concentrations at a steady state in prophylactically-treated patients with hemophilia A. Worsening of the Pettersson score was simulated and decline was associated with the probability of having orthopaedic surgery. The only difference between the compounds was FVIII concentration at a given time; each subject was treated with 25 IU/kg every 3 days. The model used a lifetime horizon, with cycle lengths of 1 year. Results: Cumulative bleeding events, joint bleeding events, and major bleeding events were reduced by 19.3%, 9.3% and 19.3%, respectively for BAY 81-8973 compared to rAHF-PFM. Hospitalizations and hospitalization days were also reduced by 19.3% for BAY 81-8973 compared to rAHF-PFM. BAY 81-8973 resulted in both cost savings and a gain in quality adjusted life years (QALYs) compared to rAHF-PFM. Conclusion: Based on modeled head-to-head comparisons, differences in PK-properties between BAY 81-8973 and rAHF-PFM result in a reduced number of bleeding events, leading to reduced costs and increased quality of life for BAY 81-8973. These results should be used to inform clinical practice in China when caring for patients with severe hemophilia A.


2015 ◽  
Vol 6 (1) ◽  
pp. 1-5
Author(s):  
Shahinul Alam ◽  
Nahiduz Saman ◽  
Monsur Hallaj Hallaj ◽  
Jahangir Ul Alam ◽  
Shoaib Momen Majumder

Relation between physicians and pharmaceutical industry is required for the benefit of the patient. But it may turn into business and overthrow the patients’ benefit. The relation might be in question at present and in future. Several questions are flowing in Bangladesh. To solve these queries we have explored the situation in developed and developing countries. The physicians and associations of pharmaceutical industries developed several ethical guidelines in those countries. They have addressed the long lasting issues on gift provided to physician, cash back, sample, industry sponsored scientific meetings, research and hospitality. There are huge restrictions to ensure the right of the patient’s e.g. limitation of inexpensive gift by the pharmaceuticals, avoiding expensive medicine instead of equally effective low priced medicine. We are lacking behind to protect the patient right properly: regulation, adherence to existing guide line, lack of guidance from statutory bodies. The current scenario is far behind the right of patient. In Bangladesh it is not yet addressed either by professionals or by pharmaceutical associations. It is the immediate need to construct a guide line for physicians and pharmaceutical industry of Bangladesh.Bangladesh Journal of Bioethics 2015 Vol.6 (1):1-5


2020 ◽  
Author(s):  
Sandeep Reddy ◽  
Sonia Allan ◽  
Simon Coghlan ◽  
Paul Cooper

The re-emergence of artificial intelligence (AI) in popular discourse and its application in medicine, especially via machine learning (ML) algorithms, has excited interest from policymakers and clinicians alike. The use of AI in clinical care in both developed and developing countries is no longer a question of ‘if?’ but ‘when?’. This creates a pressing need not only for sound ethical guidelines but also for robust governance frameworks to regulate AI in medicine around the world. In this article, we discuss what components need to be considered in developing these governance frameworks and who should lead this worldwide effort?


2022 ◽  
pp. 1-22
Author(s):  
Luis F. Herrera ◽  
Belinda del Carmen Carrion ◽  
Andrea Figueroa ◽  
Jesseyfer Guzmán ◽  
Salma Helena Armendariz de la Fuente ◽  
...  

Using telemedicine systems, physicians around the world have been able to provide health access to their own communities and others abroad. Telemedicine is still a developing field in the health sciences, but much progress has been made with the advent of new communication technologies. Today, telemedicine offers an alternative to traditional physician consultations, especially for those patients with different needs. Patients with mobility issues, low socioeconomic standing, and far away from big cities have seen benefits from this form of patient care. Not only has telemedicine been able to just bridge these gaps, but it has also provided a new way for the international community of health practitioners to cooperate and aid areas in need of specialized care in the developing world. New cooperation programs between developed and developing countries have been developed to bring specialist knowledge to areas that otherwise would not have access to it. Telemedicine is a way to take care of patients in this technological area and perhaps will become the new standard of care.


Author(s):  
Ruth McNerney ◽  
Kimberly Sollis ◽  
Rosanna W. Peeling

A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient orover zealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, aswell as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable.


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