The pharmaceutical industry continues to feel the effects of disruption from the COVID-19 pandemic. Lessons learned in drug development during this period have provoked a faster adoption of new techniques within clinical trials. Sponsors and their vendors are embracing clinical trials’ digital transformation and orienting their focus on the patient and FDA regulation to guide these efforts. DE&I considerations lay at the core of patient recruitment while real-world data is enabling new avenues to reach patients during studies. Further, outsourcing continues to be a strong capital allocation for sponsors; these same sponsors are feeling the effects of the recently passed Inflation Reduction Act, hitting at the margins of new drugs. New technologies like artificial intelligence provide enticing possibilities for data analysis and patient identification. In this report, we dive into some of the key trends impacting the clinical trials industry for 2024.
2024 Clinical Trial Trends
Trend #1: Digital Tools Empower Industry Transformation
The COVID-19 pandemic had transformative effects across the entire healthcare industry. This disruption has driven transformation within the clinical trial industry, in particular, where typical patient research options (i.e. on-site testing) have been supplemented by home trials and studies away from the traditional clinical test site. Patients who may not be close to a testing site, or ones who – for social, economic, or health reasons — cannot participate in on-site trials, have benefited from more flexible options.
Digital tools play a large part in this industry transformation. Digital health technologies (DHTs) establish a closer relationship with the patient during trials, as their symptoms can be more closely monitored. The patient’s data is recorded concurrently while they participate in a clinical trial; the patient can also provide primary data of their symptoms with their mobile phone. Digital tools also enable sponsors to conduct decentralized clinical trials away from the clinical site.
At the core of clinical trial transformation is a focus on the patient and FDA regulations. Sponsors and vendors are departing from a purely operational focus on clinical trials in favor of a focus on patient safety and risk and quality approaches. As an example of this patient focus, sponsors continuously seek high participation on enrollment schedules. This is particularly tricky when the patients required for the trial are a subpopulation with a rare disease or condition. What’s more, some clinical trials can only take place in one trial (as is the case of cell therapy drug development). Any delay in clinical development from patient identification could set back schedules and increase operating costs.
Sponsors can increase participation in clinical trials and reduce barriers for underrepresented groups yet technological hurdles do still exist. Patients must conform to the usage of digital health technologies, and companies must also consider the implementation costs and challenges to implement new research techniques. The FDA is giving more and more guidance to handle digital health technology that will aid this transformation.
Trend #2: DE&I Remains at the Core of Clinical Transformation Efforts
Clinical trial sponsors face patient recruitment challenges in underrepresented groups. A lack of diversity in clinical trials threatens data and output bias. Researchers may misrepresent the intended target population of a drug product if its patient recruitment doesn’t meet expectations.
Underrepresentation within clinical trials can stem from a variety of factors: the targeted community may already have established distrust in the clinical trial process due to poor treatment in the past. There could be a lack of reliable information being transmitted/marketed to the target population, or strategies to engage with these groups could be non-existent.
Regulation is continuously being added to help improve diversity, equity, & inclusion in clinical trials. In December 2022, the United States Congress signed a bill (Food & Drug Omnibus Reform Act) with the provision that research sponsors will have to submit Diversity Action Plans (DAPs) during studies to meet certain enrollment goals. Further, the FDA has also recently introduced guidance that companies can continue studies of under-represented groups post-Phase III if the therapy is deemed unique and needed.
Sponsors are integrating more ‘frontier’ sites into their network of clinical research sites to mitigate a lack of diversity in clinical trials. Frontier sites include local doctors’ offices, community clinics, and pharmacies; employees at these sites collect and send basic patient data like side effects to the coordinating site of a clinical trial (usually an academic medical center). Frontier sites can exist in almost any community, so patients don’t have to travel as far to participate in a clinical trial. Sponsors benefit from this ‘hybrid’ clinical trial approach as they can widen their geographical outreach to patients without expending capital for more costly clinical researchers.
Overall, more capital and different approaches should be devoted to DE&I efforts to adapt. A transformative approach to increase DE&I in clinical trials is needed, like leveraging culturally relevant marketing, building better patient relationships, and educating communities. Sponsors can also avoid a traditional paper enrollment process, as this process can be transferred to a mobile phone, where everything is done in real time. Firms can also leverage various digital marketing techniques like social media advertising, search engine optimization (SEO), content marketing, and email to help increase their outreach to different patients.
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Read last year’s Clinical Trial Trends Report here.
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Contributions by Benjamin South