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Blazing a Trail in Clinical Research – ACRP

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Clinical research stands at the forefront of medical advancement, offering promising treatments and therapies to combat diseases and improve human health. Despite its noble objectives, the field faces numerous challenges to reduce the complexity of clinical trials notably due to an increasing demand for more data from regulatory and reimbursement stakeholders.

Complexity in trial design increases resource demands at trial sites, burdens study participants, and creates costlier, longer development cycles (Getz, Tufts Center for the Study of Drug Development). In this first article, we review some aspects that are reshaping the industry landscape as we blaze a trail into the future.

As AI becomes more present in our lives, how can it help clinical research?

Artificial intelligence (AI) is already impacting our daily lives, and clinical research is no different. It is revolutionizing drug discovery and development, offering innovative approaches to target identification, lead optimization, and even drug repurposing, wherein existing drugs are repositioned for new indications based on computational analysis of biological pathways, drug interactions, and disease mechanisms. In clinical development, large language models are helping sponsors understand the implications of specific eligibility criteria so that studies are designed to be representative and void of unintentional bias. Similar technological capabilities, such as federated EHRs, are helping site staff evaluate which protocols are most appropriate for individuals in their communities and health care institutions. For patients and their stakeholders, AI is already being used to match potential participants with relevant studies, including those that may offer a treatment option.

AI has the potential to optimize patient recruitment strategies by analyzing vast datasets to identify eligible participants. Machine learning algorithms can predict patient enrollment rates, identify recruitment barriers, and tailor recruitment efforts to target specific populations. Proponents of this approach claim it will improve the efficiency of recruitment efforts, reduce costs, and accelerate trial timelines. But the challenge sites face is that the resources and technical expertise to do this are likely to be with sponsors and third-party vendors, while the knowledge of the patient and the practical application of this are at the site level. We clearly need to bring both together more effectively to see this promise realized and help democratize individual health data for patients to leverage in their personal health care decision making.

How do we really move the needle on diversity?

Improving diversity in clinical trials is imperative for ensuring that medical interventions are effective and safe for all populations. Sites and sponsors play a pivotal role in addressing this issue and can take several proactive steps to enhance diversity and inclusivity in clinical research.

First, sites and sponsors must prioritize community engagement to deeply understand the priorities of patient communities and include those insights into their study designs and logistical considerations, such as remote and digitally enabled study participation.

Outreach efforts at the community level need to be long term commitments that identify and provide sustainable solutions that build trust and reduce the burden of participation among underrepresented populations. Establishing partnerships with community organizations, healthcare providers, and advocacy groups can help researchers understand social and political determinants of health and subsequent opportunities to bridge cultural, linguistic, and logistical barriers, raise awareness and education about clinical research opportunities, and address misconceptions and concerns.

Clinical trials should be developed in consultation with trial sites and patient communities to design inclusive eligibility and reduce barriers to participation. Offering culturally competent and patient-centered care throughout the trial process fosters a welcoming and supportive environment for diverse participants. Sanofi is honored to work with patient communities in the design of 100% of all clinical trials and establish diversity goals and plans for all US studies, regardless of the phase of development.

Moreover, sites and sponsors must invest in diversity training for research staff to promote cultural sensitivity, enhance communication skills, and address implicit biases. By fostering a culture of inclusivity and respect, research teams can create a welcoming an equitable environment that encourages diverse participation in clinical trials.

Change places a constantly evolving demand on clinical research professionals.

One of the biggest challenges we face is how to engage and encourage individuals to enter the rewarding field of clinical research. The avenues for individuals to develop the needed skills are disparate and lack a consistent educational — and experiential — pathway. As research, technology, and society evolve, the educational demands increase, and the skills needed to be successful constantly change.

Roles ranging from the principal investigator (PI) to the Clinical Research Coordinator and Clinical Research Associate, to sponsor teams are all undergoing significant changes as research methodologies evolve and technology advancements reshape the medical research landscape.

First, there is an increasing emphasis on leadership and collaboration, with individuals expected to facilitate effective communication and teamwork among multidisciplinary research teams and patient communities. As trials become more complex and collaborative, strong leadership and proactive collaboration become essential for achieving research objectives and ensuring study success.

Second, the integration of heterogenous technologies and data sciences is transforming how sites and sponsors manage trials. Electronic data capture (EDC) systems, wearable devices, and AI-driven analytics are enhancing trial efficiency and data quality. PIs and their site staff need to embrace these tools to optimize patient recruitment, streamline data collection, and generate actionable insights.

Third, the adoption of decentralized trial models is reshaping how PIs conduct research, enabling remote participation and data collection outside of traditional clinical settings. PIs must navigate the regulatory and logistical challenges associated with decentralized trials while ensuring participant safety and data integrity. Some of the responsibilities placed on PIs by forward-looking regulatory guidelines add new demands that few have experience in, e.g., the logistics of drug supply and oversight of remote operations.

Thoughtfully done, providing the tools and training to support these demands beyond a single study will make life easier for everyone.

This is the first of two blogs in a collaborative series written by Vicky DiBiaso, Head, Patient Informed Development & Health Value Translation, Sanofi, and Paul Evans, President and CEO, Velocity Clinical Research. In the second blog on May 10, we will consider how change in the clinical trials industry is impacting patients, and how they are blazing a trail for improved health outcomes.