No abstract

Immuno‐oncology therapies have been approved for various solid tumors; however, the high cost of these treatments and their potential toxicities require a thorough assessment of their risks and benefits. Collection of data directly from patients through patient‐reported outcome instruments can improve the precision and reliability of adverse event detection, assess tolerability of adverse events, and provide an evaluation of health‐related quality of life (HRQOL) changes from immuno‐oncology therapies. There is robust development in HRQOL tools specifically for patients treated with immuno‐oncology agents. This review examines the history and basic concepts of HRQOL and patient‐reported outcome assessments commonly used in oncological trials, highlighting the strengths and weaknesses of current approaches when applied to immunotherapies, as well as some of the current efforts to develop tools for this field and opportunities for future research. Lay Summary Immuno‐oncology (IO) therapies are costly and carry potential toxicities known as immune‐related adverse events. Evaluation of health‐related quality of life (HRQOL) can impact the risk‐benefit assessment of IO therapies. Integration of HRQOL end points and patient‐reported outcome data for IO therapies are urgently needed. Ongoing robust development of patient‐reported outcome tools specific to IO therapies are currently underway and will permit the evaluation of HRQOL for IO agents. Improvement in precision and reliability of HRQOL evaluation will enhance the ultimate true value of these expensive and effective drugs.

Historically, the majority of oncology clinical trials are conducted in Western Europe and North America. Globalization of drug development has resulted in sponsors shifting their focus to the Asia-Pacific region. In Malaysia, implementation of various government policies to promote clinical trials has been initiated over a decade ago and includes the establishment of Clinical Research Malaysia, which functions as a facilitator and enabler of industry-sponsored clinical trials on a nationwide basis. Although oncology clinical trials in Malaysia have seen promising growth, there are still only a limited number of early phase oncology studies being conducted. Hence, the Phase 1 Realization Project was initiated to develop Malaysia's early phase clinical trial capabilities. In addition, the adaptation of good practices from other countries contribute to the effective implementation of existing initiatives to drive progress in the development of early phase drug development set up in Malaysia. Furthermore, holistic approaches with emphasis in training and education, infrastructure capacities, strategic alliances, reinforcement of upstream activities in the value chain of drug development, enhanced patient advocacy, coupled with continued commitment from policy makers are imperative in nurturing a resilient clinical research ecosystem in Malaysia. K E Y W O R D S clinical trials, early phase oncology trials, Malaysia, oncology EARLY PHASE ONCOLOGY CLINICAL TRIALS IN ASIACancer ranks as a leading cause of death and an important barrier to increasing life expectancy globally, accounting for nearly 10 million deaths in 2020. 1 The overall burden of cancer incidence and mortality is growing rapidly, and this reflects both aging and growth of the population as well as changes in the prevalence and distribution of the main risk factors for cancer, several of which are associated with socioeconomic status.Oncology clinical trials are intended to evaluate the safety, toxicity, and efficacy of new anticancer agents and represent an essential component to drive advances in this field. 2,3 Historically, the majority of oncology clinical trials were conducted in high income countries, especially in Western Europe and North America. The reasons for this are multifactorial, including the availability of an established trial infrastructure incorporating both physical and manpower requirements, along with the geographical location of major pharmaceutical companies in these countries. 4 However, in recent years, globalization has resulted in a shift of this practice, with more clinical trials being conducted outside of Western Europe and North America, such as in Asia. One of the main reasons for this shift is attributed to the fact that clinical trial data are often collected from varied populations and ethnic groups to support a license application for a novel drug