How AI Will Transform Health Equity In Clinical Trials In 2025
By Shaheen Lakhan, MD, Ph.D., FAAN, chief medical and scientific officer, Click Therapeutics
As we head into the new year, the integration of AI into clinical trials is likely to lead to a revolution for health equity and a shift in how we finally tackle the entrenched disparities that have plagued medical research for decades. Imagine a future where patient diversity in clinical trials isn’t just a target but a built-in feature that ensures that therapies benefit all people, not just a select few. AI can deliver this vision, but only if we commit to ethical frameworks and equitable standards that will shape the future of healthcare for everyone.
Clinical trials have long fallen short in representing racial, ethnic, and socioeconomic diversity, which can negatively impact treatments for vast populations, creating a healthcare system that doesn’t serve everyone. But there are leaders who prioritize leveraging AI to enable researchers to identify and recruit participants from historically underserved communities with unprecedented precision. However, we must consider AI’s application across all phases of development, from clinical trials to post-marketing surveillance. This involves a holistic approach, ensuring that AI is used responsibly with a focus on data privacy and the objective of developing personalized treatment options with minimal bias. To do so, we must ensure that AI’s predictions are based on comprehensive and diverse data sets. By analyzing social determinants of health alongside geographic and genetic data, clinical research leaders who utilize AI can help fill in the gaps where traditional trials have failed, ensuring that trials reflect real-world populations.
This AI-driven shift is the first step in actively addressing diversity in trials. Algorithms can now allow researchers to actively monitor recruitment in real time, spot imbalances early on, and take corrective action before it’s too late. If enrollment data shows underrepresentation from certain racial groups, recruitment efforts can now be recalibrated, ensuring that diverse populations have an equal stake in research outcomes.
The Promise Of DCTs Integrated With AI
The potential of AI isn’t limited to in-person trials. DCTs are already making it possible for people to participate from home, enabling a diverse trial with participation from all populations. Now that trials can meet patients where they are, without geographic and logistic barriers, we are increasing access to those who would never before be able to participate in trials. Combined with AI’s ability to monitor and personalize patient interactions, DCTs are poised to make clinical trials accessible to a truly representative cross-section of society.
By the end of 2025, DCTs and AI-driven recruitment could be the new standard for inclusivity in clinical research. Additionally, through the use of mobile apps and wearable devices, data collection has become more efficient by engaging patients continuously while safeguarding privacy through advanced data security protocols. These innovations will continue to evolve, empowering patients with chronic conditions to participate in trials designed around their real-world experiences.
Maintaining High Ethical Standards And Rigorous Trial Design
Yet for AI to be a true ally in this movement, we must hold it to the highest ethical standards, as we do in other aspects of healthcare such as drug development, data management, and care coordination. AI algorithms are only as objective as the data we use to train them. If they are built on biased or incomplete data sets, they risk perpetuating the very inequities they aim to correct. According to the National Cancer Institute, black patients with sickle cell disease have often been underrepresented or mischaracterized in research, which leads to disparities in treatment efficacy. We must ensure that AI models are trained on comprehensive, inclusive data sets to prevent such biases from being codified into clinical trial processes.
Beyond eliminating biases, AI has become essential for processing large data sets, and its use in trials could lead to improved real-time monitoring, but regulatory frameworks might lag behind innovation, creating additional checklists without fostering true progress. With the powerful potential that AI holds, we must also establish guardrails. Regulatory bodies like the FDA and GDPR already set important standards for data privacy and patient safety, such as the FDA’s recent guidance on AI but as AI technologies evolve, these frameworks must adapt to keep pace. We should maintain regular audits of AI algorithms and corresponding regulatory frameworks to address any emerging biases and patient safety concerns.
We have the chance to build a sustainable, patient-centered, and genuinely inclusive research ecosystem. We also have an opportunity to advance medical innovation while ensuring that the benefits of this progress reach everyone — not just those who have traditionally had access to it. Health equity should not be a regulatory checkbox but a guiding principle that shapes every phase of a clinical trial.
Recently, outdated clinical trial processes have impeded teams, demanding a shift toward agile working practices that can effectively challenge established norms for more cost-effective and efficient outcomes. For example, traditional in-person trial recruitment methods have been plagued with geographic constraints and slow manual processes for patient monitoring, data collection, and reporting. However, as digital technology has worked to address some of these inefficiencies, clinical trial sites must now uphold their digital literacy but also embrace the opportunities that this technology affords. Today, technological integration is an integral aspect of clinical trials moving forward. Through the use of AI and DCTs, we must now commit to a healthcare model where diversity is not just encouraged — it’s empowered by design.
About The Author:
Shaheen Lakhan is the chief medical and scientific officer at Click Therapeutics. He is a physician-scientist, biotech executive, and biopharma board director with more than 20 years of experience in healthcare, academia, and industry focusing on neuroscience research and development. Dr. Lakhan is board-certified in both neurology and pain medicine, with clinical training from Cleveland Clinic and Massachusetts General Hospital. His interests lie in transforming medicine and democratizing healthcare through prescription digital therapeutics and novel drug-delivery platforms. His clinical development experience spans Phase 1-4 drug and medical device trials, including HEOR, RWE, IIS, and DCTs, and has facilitated the approval of several first-in-class drugs and medical devices. With over 100 peer-reviewed publications, books, and book chapters to his name, he was conferred the President's Call to Service Award for Lifetime Achievement by President George W. Bush and the U.S. Congressional Award Gold Medal by Representative Nancy Pelosi and Senator Harry Reid.