DECENTRALISED CLINICAL TRIALS AND THE FUTURE
past few years, with several companies pledging their commitment to diversify studies. The reticence of minority populations to enrol in trials is often cited as a major cause of the lack of diversity in trials. However, experts say that it is, in fact, trial-related costs, and protocols requiring significant time from participants, that often keep them from participating. Moreover, institutional and systemic biases
T
prevent minority populations from even being offered clinical trials. While successes from pilot projects are encouraging, these structural prejudices and logistical and economic barriers need to be addressed on a national level to encourage better trial participation. Recently, some of these issues were
addressed by the Diverse Trials Act in the US. The act, which referred to the Senate Committee on Health, Education, Labor, and Pensions in August last year, seeks to provide a framework for decentralised trial recruitment and remuneration for trial-related expenses. In November 2021, representatives from 150 organisations that deal such as the American Society of Clinical Oncology, American Heart Association and KidneyCAN – had pushed for the committee to prioritise the bill.
Legislation needed to address logistical issues While explicit and implicit biases on the part of investigators and institutions have kept eligible minority populations from participating in studies, economic or logistical factors often prevent interested individuals from being able to participate. As per current federal rules, in the US, payment for trial-associated costs is deemed as ‘coercion’, so pharma companies cannot provide such payments. Some US states, such as Pennsylvania and
Massachusetts, have passed individual laws to not consider reimbursing individual patients as coercion or exerting undue influence. However, passing individual state legislation in this regard will take a long time considering there are 50 states, says Dr Carmen Guerra, vice chair of diversity and inclusion, Department of Medicine, University of Pennsylvania,
rial diversity, specifically concerning race and ethnicity, has emerged as the latest buzzword in pharma over the
Philadelphia. Including a ‘safe harbour’ law in the Diverse Trials Act would let companies reimburse patients for travel-related and accommodation costs, she explains. While traditionally, trials cover the cost of an
investigational treatment, pharma companies are not responsible for ancillary costs of standard therapies and doctors’ visits, which in the US are covered by Medicare, the federal insurance programme, and private payers. However, the lack of a US-wide mandate on
this issue for those reliant on the federal-state assistance programme Medicaid – which includes low-income people, the elderly, pregnant women and those with disabilities – has meant they must rely on local bodies to decide this additional coverage, explains Guerra. The omnibus appropriations legislations, one of the last major packages passed by the previous administration, included a provision under which trial-related costs for Medicaid beneficiaries would be covered from January 2022. There have also been efforts by the National
Cancer Institute (NCI) and other US bodies to ensure that the control arm of the NCI trials is covered by regular insurance, and recent insurance expansion will make that even more feasible. Still, people for whom day-to-day economics are challenging may have a perception that they may be unable to afford any trial-related costs, says Dr Lori Minasian, deputy director for the Division of Cancer Prevention at the NCI. In recent years, the US Food and Drug Administration (FDA) and other federal agencies have required sponsors to include information on race, ethnicity, age and gender to encourage researchers to prioritise making studies diverse and inclusive. Starting this year, the New England Journal of Medicine will require studies that it publishes to have information on how well represented the trial population is with respect to the broader patient population. However, it remains to be seen if any federal funding has been denied for not having diverse participation, says Dr Melissa Simon, founder/director of the Chicago Cancer Health Equity Collaborative. There has not been a comprehensive
analysis of how pharma giants are approaching equity, says Guerra. Some are very engaged and have done more than others, which are still
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