Globalization of clinical research in oncology: Status, challenges, and future directions.

Purpose: Cancer is the second-leading cause of death worldwide, and its burden is increasing around the world, particularly in low- and middle-income countries (LMICs). Yet, cancer research has historically been conducted primarily in high-income countries (HICs).

Methods: In this review, we describe the results of our literature search into the current state of international cancer trials, including the benefits, challenges, limitations, and ethical concerns regarding the international conduct of HIC-led trials. We also propose some possible means of addressing these challenges and overcoming these barriers to extend the benefits of cancer research to people around the world.

Results: Over the last several decades, there has been a shift toward inclusion of investigators and participants from LMICs in pivotal cancer clinical trials.

Conclusions: While inclusion of LMIC countries has benefits, including increased diversity of participant populations, investment in research infrastructure in LMICs, and potential expansion of cancer treatment options around the world, the continued leadership of most trials by HICs presents ethical concerns, including potential exploitation of researchers and participants from LMICs, lack of focus on cancer types prevalent in all participating regions, and disparities in access to approved therapies once the trial is complete.