Company insight
The case for trial diversity R
Life science experts at Lionbridge explain how a diverse clinical trial population ensures more effective outcomes.
ecruiting and retaining participants in clinical trials is a key factor for success, and the diversity of participants plays a prominent role. Inclusion of broad patient populations – for example, people of different races, ethnic groups, sex/ genders, ages or those with rare conditions – help provide evidence that the study drug or medical device will be safe and effective in the wider target patient pool. Clinical trial recruitment follows a defined methodology where people who want to volunteer must meet a set of eligibility criteria and provide their informed consent for participation. These criteria are to minimise the chance of side effects, comorbidity interactions and early withdrawal from the trial.
Why diversity matters When a clinical trial population is homogenous, research findings may be skewed and result in clinical data that would not be generalisable to a wider patient population for which the study drug or medical device is intended. This outcome could result in the drug or medical device being less beneficial or, more so, unsuitable for some patient subgroups. Even in times of global health emergencies, recruiting participants from diverse backgrounds remains an important consideration. As is the case with Covid-19, research data shows that its severity and mortality rates vary according to age, sex and ethnicity, with higher rates of hospital admissions, critical-care admissions, and death in older individuals, men, and individuals of Black, Asian and minority ethnic groups. The inclusion of information relevant to patient subgroups in the product labelling can help better inform healthcare providers and patients about the use of a drug or medical device.
Patient and public perspectives Historically, the public’s feeling towards clinical research, especially among those
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from the racial and ethnic minority communities, was that of a distrust. This has been mainly attributed to past abuses in clinical research, perceived discrimination in health care and the lack of awareness about clinical research. Over the past decades, this feeling has improved, but it has not gone away completely. These feelings are reflected in the results from a recent perceptions and insights survey by the Centre for Information and Study on Clinical Research Participation (CISCRP). In April of 2020, the centre surveyed 500 respondents from across the US, UK, France, Germany and Italy to assess the impact of the pandemic on levels of public’s understanding, perceptions and experiences related to clinical research. The results of the survey showed that most respondents (58%) had not heard of specific clinical research studies for Covid-19 and that, overall, trust in pharmaceutical companies ranks lower than other research stakeholders.
Improving industry practices In November of 2020, the US Food and Drug Administration (FDA) published its final guidance on enhancing the diversity of clinical trial populations, which provides sponsors with the recommendations that can help increase enrolment of underrepresented populations in clinical trials that support a new drug application or a biologics license application. Distinct attention has been given to the strategies for broadening clinical trial eligibility criteria for the participants in clinical trials in rare diseases. Likewise, the FDA’s guidance on the evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies calls for sponsors to develop enrolment strategies that include representative proportions of relevant age, racial and ethnic subgroups, which are consistent with the intended users of the
device, and includes recommendations for developing such strategies. The roadmap to improve trial delivery for underserved groups, recently commissioned by the UK National Institute for Health Research Clinical Research Network (NIHR CRN), sets out a methodological framework to help researchers work with underrepresented (“underserved”) groups and to improve their access to clinical research.
Bridging the diversity gap in clinical trials
Numerous regulatory guidance and scientific papers provide trial sponsors an abundance of information that can help in defining and operationalising their strategies related to patient diversity and inclusion. Equally valuable are the industry’s practical case studies and lessons learned, which can offer insights into how to find the right balance between the need to enrol diverse patient groups and conducting research in a timely and cost-effective manner.
Still, among the methodological considerations and technical details, there is a simple fact that stands out. Clinical trials are conducted with human volunteers. People learn about things, connect with other people and build stronger relationships through communication and transparency. Clinical trials are no exception to this. Patient engagement and outreach developed in partnership with the target communities; appreciation and removal of barriers to trial participation; comprehensive, culturally sensitive education on medical product development; and meaningful communication of research findings to those who participated remain key prerequisites to building trust and fostering diversity in clinical trials. ●
www.lionbridge.com Clinical Trials Insight /
www.worldpharmaceuticals.net
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