Ethical considerations in industry‐sponsored Multiregional clinical trials

Abstract

During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider.

A comparison of neuropsychological performance between US and Russia: Preparing for a global clinical trial

“…Global clinical trials present challenges including: harmonizing procedures across countries, finding culturally appropriate diagnostic tools, and identification or creation anew of qualified research sites[3]. In recent years, AD researchers have turned to primary prevention rather than secondary or tertiary treatments, thereby pushing the clinical diagnosis back from onset of AD to onset of mild cognitive impairment (MCI) due to AD[4].…”

A Comparison of the Quality of Data, Assessed Using Query Rates, From Clinical Trials Conducted Across Developed Versus Emerging Global Regions

“…13 Although some of the emerging regions are experiencing significant economic growth, advances in biomedical education, and an overall improvement in the standard of living, the increased participation of these regions is fraught with numerous challenges and ethical dilemmas. 12,14 In many regions, the benefits of the economic surge have not helped vast segments of the society. There continues to be a widespread disparity in the socioeconomic and educational background, and often, basic amenities of life and access to even low-cost medication are unavailable to large sections of the population.…”

“…Ethical questions also extend to posttrial benefits and continued access to standard of care available to these participants relative to those in the mature regions of the globe. [14][15][16] These disparities raise concern regarding the quality of data generated from clinical studies conducted in developing/emerging countries relative to mature regions such as North America and Western Europe. Indeed, various regulatory and governmental agencies and the public at large are apprehensive about the assimilation of data from the emerging countries for the approval of drugs in the United States and Western Europe.…”

“…Ethical questions also extend to posttrial benefits and continued access to standard of care available to these participants relative to those in the mature regions of the globe. 14 –16…”

Challenges of emerging countries: a relatively positive view for the future

“…According to Bansal, 83% of US clinical studies fail to recruit the required number of participants within the given timeframe; enrollment in developing countries can be between five and ten times faster than in the US (3) . Additionally, the number of patients with untreated or undertreated diseases can be a great advantage in researching new therapies although some would argue that the results cannot be generalized to treated populations whose diseases are refractory to treatment (4) .…”