ultiple myeloma (MM) is a blood cancer that evolves from the early precursor conditions of monoclonal gammopathy of undetermined significance (MGUS). MGUS progresses to overt myeloma at a slow rate, and early diagnosis and treatment are critical to ease the personal and economic burden to patients. This article discusses why early detection matters, who should be screened, and the need for precise risk stratification.

n 2020, the United States Congress passed the Clinical Treatment Act, a law “to promote access to life-saving therapies for Medicaid enrollees by ensuring coverage of routine patient costs for items and services furnished in connection with participation in qualifying clinical trials, and for other purposes.” The law became effective in January 2022, yet a 2021 diversity and inclusion survey of eight major pharmaceutical sponsors reported that none of the respondents indicated that they are actively encouraging “sites to recruit Medicaid beneficiaries to participate in our active cancer clinical trials.”

This article aims to answer each of these questions, outline stakeholder perspectives for clinical development, and recommend next steps for organizations and individuals.

Key Takeaways

1. The Clinical Treatment Act removes a financial barrier for Medicaid beneficiaries to participate in qualifying clinical trials across disease areas, including cancer.
2. Medicaid is a public health insurance program covering about 1 in 5 people in the United States, including about 40% of America’s children, as well as low-income adults and disabled individuals.
3. Racial and ethnic minorities represent a disproportionately high fraction of Medicaid beneficiaries, and nearly two-thirds are living with one or more chronic conditions.
4. Organizations can continue to transform their culture toward patient-centricity by learning how to reflect the clinical experience and social needs of the Medicaid population in medicines development processes and operations.
5. Individuals can take the lead by educating themselves and advocating internally within their organizations for collaborative, community-based strategies that reach the Medicaid population and other patients where they live.

atient involvement is becoming an embedded part of the life sciences industry; however, often patients are still not involved simply because industry professionals do not know how to involve them. Could the answer lie in including patient involvement as a key part of the curriculum for vocational training in the life sciences and medical technology industries? Examples from the UK show how this could be done and what it might mean for the future of professional training in these industries.

n September 2021, DT Consulting, an Indegene company, launched the 2^nd DT Digital Tracker, a methodology to assess the current state of digital technology adoption by clinical trial sites globally. The inaugural survey, which was published in February 2021 (see April 2021 Global Forum), showed that many clinical trial sites were still reluctant to integrate digital technologies into their processes and that cost, complexity, and finding the right technologies were the main barriers to digital adoption. The second wave of results shows that digital adoption is increasing and that concerns about patients’ ability to use digital tools is now the main barrier to digital adoption.

iven the complexity of cancer, some researchers are skeptical about the use of a decentralized clinical trial (DCT) model for oncology research. However, DCTs offer tremendous benefit, particularly in decreasing patient dropout rates and increasing patient engagement, two critical factors for oncology.

Japan and the Pandemic: New Challenges, New Solutions

Stewart Geary
Eisai Co., Ltd.

he theme of DIA Japan 2021, “New Challenges, New Solutions: To Overcome With People All Over the World,” reflected the current background of marshaling resources from regulatory authorities, industry, and academia to develop innovative new therapies in the midst of an unexpected public health emergency while simultaneously transforming daily work practices during lockdowns and limited public access to hospitals.

eclaration of the global pandemic signaled the beginning of an unprecedented global race to develop COVID-19 vaccines and drugs. Japan’s rapid approval of a vaccine (in February 2021) while continuing development of other therapies can be viewed as a success. On the other hand, these efforts also illustrated the unpredictability of infectious diseases and the importance of preparing countermeasures for the unknown, in Japan as elsewhere, during “normal” times.

he following report provides updates on the state of joint assessment procedures in the East African and West African communities.