This is the second in a two-part series examining how the pharmaceutical industry can adopt the DEI program to create more effective drugs through more representative clinical trials. You can read the first part of this article here.
As the shift to working from home has proliferated during the pandemic, work has become decentralized – and many businesses have been able to be productive with a work-from-home workforce. Teams and Zoom have become the backbone of communication and businesses have embraced new ways of working. The same principles are increasingly being applied to clinical trials to improve diversity, reduce bias, and enhance inclusion in clinical trials.
Virtual and decentralized clinical trials – where trials are conducted outside of traditional sites (i.e. at home or in community centers) – could potentially help reach more participants in rural communities or those who do not may or may not want to regularly visit a traditional study site such as a general hospital. Although virtual trials come with their own inherent access barriers, i.e. the need for a computer and reliable broadband, the theoretical benefits are clear.
The way we use technology has already gone through a paradigm shift, with telemedicine and remote monitoring becoming necessary during the pandemic. There is a huge opportunity to work collaboratively with technology companies and utilize digital advancements that can improve access, ease patient burden and increase participant diversity.
By bringing the trial to the patient, we can build on established and trusted relationships between healthcare practitioner and patient. Patient-centered clinical trials also expand access to clinical trials beyond conventional trial sites, which can be expensive and time-consuming to travel to.
How technology can be used
Digital technologies can cover a wide range of applications and include mobile health (mHealth) tools (e.g. wearable device worn by patients to measure certain health-related parameters, remote monitoring of patients) and telemedicine in clinical trials (eg, video consultations), health data analytics (eg, data processing systems that support bioinformatics modeling), and digital record systems (eg, digital applications, also called “apps”, which function as patient diaries).
Once stakeholders are satisfied that the technologies are properly validated, a selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. The possibilities are endless and, in the context of trial participation and access to medical technologies, could help:
- Reduced assessment times and therefore increased patient compliance
- Improving access to people with rare diseases in remote areas
- Reasonable adjustments to allow equal access for people with disabilities
- Engagement of patients from marginalized groups with a preference for remote access
To address the implementation of computerized systems (including instruments, software and services) used in clinical trials in the creation/capture of electronic clinical data, the EU EMA has recently published the “Guideline on systems computerized and electronic data in clinical trials”. Using digital technology is not a panacea and work needs to be done to ensure it is done correctly. The development of guidance to assist companies that require risk assessments when working with clinical trial data on selected computerized systems is welcome.
It is important that all digital health tools comply with national and supranational data protection legislation governing the processing of patient health data, where the legislation falls outside the scope of medicines regulation . However, if considered early in the drug development plan, compliance is by no means insurmountable and would be outweighed by the benefits of digital health tools for patient engagement. The adoption of digital healthcare tools in clinical research has accelerated significantly during the COVID-19 pandemic and it is expected that these tools will continue to aid clinical research in the future.
What happens afterwards?
There is a huge opportunity for pharmaceutical companies to capitalize by focusing on increasing DEI in clinical trials. Not only can conducting clinical research on representative patient groups help to actively address the unmet medical needs of underrepresented populations, it has the side effect of helping companies gain a competitive advantage in a changing marketplace.
Companies that can demonstrate a diverse and inclusive clinical trial data set to support the safety and efficacy of their product will not only gain payer and regulator approval, but also improve patient confidence. and the use of their medicine. Ultimately, creating a more comprehensive data set for new and generic treatments will lead to better health outcomes for everyone.
As we have seen during the incredible response to the global COVID-19 pandemic, the industry has shown resilience and been able to rise to the challenge of an existential threat to humanity and overcome incredible difficulties in developing and deploying life-saving vaccines.
But more needs to be done to help build trust in marginalized groups and overcome barriers to achieving proportional representation in clinical research.
Underrepresentation is multifactorial, so concerted efforts by life sciences companies are needed to address inequitable healthcare. Otherwise, the paradigm shift around diversity, equity, and inclusion in clinical research, including all the lessons we should have learned during the COVID-19 pandemic, might be forgotten.
About the interviewees
Tanya Chambers is a former Senior Evaluator for the Medicine and Healthcare Regulatory Agency (MHRA) with over 15 years of experience primarily in the evaluation of preclinical datasets (small molecules and biologics) accompanying clinical trial applications, EU and UK marketing authorization applications (MRP/DCP/Centralized submissions) and variations across all therapeutic areas. Most recently, Tanya led the ongoing preclinical review of COVID antiviral applications, which resulted in national rollout, and served as product manager for review of a wide range of development programs through innovative licensing pathways at United Kingdom: iLAP and EAM. Additionally, Tanya has a working knowledge of collaborative review of promising oncology treatments alongside Australia (TGA), Canada (Health Canada), UK (MHRA), Singapore (HSA), Switzerland (Swissmedic) and Brazil (ANVISA): ‘Project ORBIS’.
Liam Johnstone has six years of toxicology experience with regulatory bodies in the UK, developing expertise in the areas of medicine, consumer products and agrochemical safety while working respectively at the MHRA, OPSS and HSE. As a non-clinical evaluator at the MHRA, he assessed non-clinical datasets for new and generic drugs. He has provided scientific advice to companies both nationally and as part of the Scientific Advice Working Group (SAWP) on the relevance of non-clinical datasets and study designs, as well as on the production of guidance for the European Medicines Agency (EMA)
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