Expanding clinical trial access: a global imperative requiring local focus

As an industry, we aim to improve patient outcomes. Through clinical trials, we strive to better understand how treatments work for those who are impacted by disease. Within that, trial participation can provide patients with alternative treatment pathways which could improve their outcomes. However, we all fall short of our collective mission when clinical research does not sufficiently represent all populations affected by the disease in the real world.

Opportunities to participate in trials can be limited for certain demographic groups due to trial sites’ geographical locations and related accessibility as well as other cultural and socioeconomic variables. This contributes to under- representation in research, particularly among those demographic groups that are similarly underserved in healthcare broadly. The disproportionate impact of COVID-19 on racial and ethnic minorities raised global consciousness about health equity and catalysed our industry to take a harder look at fairness in access to clinical trials, especially among traditionally underserved populations. In Europe, industry stakeholders, including regulators, health agencies and patient advocacy groups, are coming together to discuss opportunities to optimise trial access and participation among representative patient populations for COVID-19 studies and many disease indications.

IQVIA has worked with industry stakeholders for many years to expand trial access and participation and improve our ability to engage diverse and underserved populations. We have particularly focused efforts on meeting the Food and Drug Administration’s expectations (see guidance for reflecting the demographics of treatment populations and collecting race and ethnicity data in trials). However, broadening clinical trial access is an important goal in every part of the world. At IQVIA, we believe it requires us to rethink how we encourage participation through local community collaboration and broaden trial access through innovative patient-centred approaches that are intentional, integrated into trial design and planning and a point of focus throughout the trial life cycle.

In our most recent work in COVID-19 vaccine and treatment trials, there were several key ways that intentional a priori design and execution helped broaden participation among underserved populations that were most impacted by the virus.

A trial life cycle approach

IQVIA believes the implicit goal of demographic representation should be factored into the earliest aspects of trial planning and emphasised throughout execution. This includes focus and coordination of:

* Upfront planning, goal setting and representative patient voice and insights

* Building trust, acknowledging historical mistrust of clinical trials within diverse communities and reducing barriers  to access

* Diversity-informed site selection

* Site support augmentations and diversity-focused site training

* Consideration of local and community-level participation factors

* Diverse participant retention and continuous engagement

* Careful monitoring and agile approaches to deliver diversity goals within the broader trial.

Mining insights, enhancing engagement

Proactively securing and embedding diversity perspectives using real-world data and the right mix of advanced data analytics, technology solutions and expertise early in the process is key. In our work on US-based COVID-19 vaccine trials, we leveraged real-world and clinical data sets from various sources along with advanced analytics tools to identify the right mix of sites and locations and apply patient insights to identify the right patients for the right trials. Explicit discussions and support of sites were complemented by customised messaging through hyper-targeted multichannel campaigns (eg, social media, pharmacies, labs, patient communities, etc) and real-time adjustments. This approach helped one sponsor meet its urgent goal of recruiting 40,000 volunteers in several weeks, while ensuring proportionate diversity among those volunteers.

The local factor

It is also critically important to consider community-level factors. While historical mistrust in healthcare and clinical trials cannot be discounted, we need to consider a key reason for lack of participation cited by minority patients in survey feedback: they have simply not been asked to participate. With such patient insights, IQVIA collaborated in unprecedented ways to build community-based clinical trial sites and bring research to patients, while also educating and engaging underserved communities and minority investigators. For example, we deployed mobile units in underserved communities to assess interest in COVID-19 vaccine trial participation and understand needs while providing culturally appropriate educational materials to help address research hesitancy. IQVIA also staffed sites with culturally trained personnel to enhance diversity in patient and caregiver engagement.

Reducing burdens and opening doors

Because we understood the need for patient- centered approaches, IQVIA invested in decentralised trial solutions years before the pandemic. This base of experience and insights helped us maintain trial continuity during the pandemic, because we had already scaled and included decentralised clinical trial (DCT) solutions where appropriate and according to trial, patient and site needs. DCT solutions, such as telehealth visits, connected/wearable devices, IQVIA’s Research Nursing and Phlebotomy Solutions services (providing at-home lab collection capabilities and trained nursing visits) and direct-to- patient treatment delivery, helped reduce patient burden and opened participation to a more geographically, racially and ethnically diverse patient population.

Evolving and committed focus

Regardless of where IQVIA runs trials, broadening clinical trial participation and improving access for the traditionally underrepresented is a critically important pursuit. Alongside multi-stakeholder groups, IQVIA continues to embed innovative approaches throughout the entire trial life cycle to help sponsors achieve diversity goals. We have demonstrated that diversity goals can be achieved alongside overall trial goals. We are committed to fine-tuning intelligent connections between our analytics, technologies, breadth of global data and domain expertise with patients and communities where we work to make trial diversity a sustainable and lasting change.

Pankaj Patel is Head of Diversity and Inclusion, Research and Development Solutions at IQVIA