To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. CROs assist in increasing the speed with which new interventions, including drugs, devices, and technology, are brought to market. In recent years, however, clinical trials have become increasingly complex, adding burden to research teams and clinical research sites. Starting with describing challenges faced in managing clinical trials, we explore how CROs address challenges and how sponsors benefit from partnering with CROs.
Challenges in managing clinical trials
Patient recruitment
Among the significant challenges faced in managing clinical trials is patient recruitment, which, if not addressed, contributes to costly delays.
Study start-up
According to a Clinical and Translational Science Awards (CTSA) study, the average contract negotiation duration exceeded 100 days for industry-sponsored or investigator-initiated contracts. The lengthy process adversely impacts clinical trial start-up time and trial costs.
Multi-site trials
Managing multiple sites adds to trial complexity, more so when managing global, multi-region clinical trials (MRCTs), as there are additional concerns, e.g., trial start-up and regulatory hurdles, and the desire to execute innovative patient-centered clinical trials juxtaposed with outdated legislation.
Clinical site challenges
As clinical trials become increasingly complex, there is an additional burden on research sites, which already face resourcing and enrollment issues. A recent survey on challenges experienced by clinical research sites identified the top challenges as staffing and retention, recruitment and enrollment, trial design complexity, and study start-up. Research sites are enduring a scarcity of research professionals that go beyond clinical research coordinators (CRCs) to include administrative functions necessary for trial start-up.
Diversity and inclusion
According to the National Institute on Minority Health and Health Disparities, clinical trials historically relied almost exclusively on White male study participants, leading to gaps in knowledge that prevented the development of effective interventions. Clinical trials should be appropriately inclusive of minority groups, populations experiencing health disparities, and underserved populations that have been underrepresented in trials in the past.
Overview of CROs
In partnership with a sponsor, a CRO plays a vital role in managing clinical trials efficiently, ethically, and in compliance with Good Clinical Practice (GCP) standards. CROs may provide niche services, e.g., limited to regulatory affairs management. Sponsors may also outsource oversight and day-to-day management of clinical trials to CROs. Full-service CROs provide the full range of services for clinical trial management, from selecting clinical sites and investigators to supporting patient recruitment, safety surveillance, clinical monitoring, site audits, project management, data management, and biostatistics. The demand for clinical trial services is growing steadily, with analysts estimating the global market size at US$ 84.7 billion in 2024 and projecting a compound annual growth rate (CAGR) of 6.49% to reach US$123.5 billion in 2030. Growth drivers include increasing R&D investment, growing preference for outsourcing, and patent expiration of blockbuster drugs.
How do CROs solve the challenges of managing clinical trials?
Research teams and CROs continue to adapt and innovate to address the evolving challenges of clinical trials and improve trial efficiency.
Trial efficiency, study start-up & site management
CROs invest in technology that improves workflows and streamlines research operations. Decentralized clinical trials (DCTs) involve digital tools that facilitate research at different stages of a trial, including recruitment, enrollment, informed consent (via eConsent), drug administration, capturing patient-reported outcome measures (using ePRO), and safety monitoring. Additionally, digital technologies can collect data continuously to derive digital endpoints for trials. Sponsors and investigators are interested in CROs using DCTs more. At the same time, regulatory bodies like the U.S. Food and Drug Administration (FDA) have issued guidance on implementing digital health tools.
On a related note, the expanding use of telemedicine for remote patient care delivery plays a role in transforming clinical research. As von Itzstein et al. (2024) indicated, telemedicine enhances cancer clinical research through improved access to novel therapies, streamlined data collection and monitoring, and enhanced communication and trial efficiency. Combining telemedicine and artificial intelligence (AI) can potentially reach geographically dispersed participants for narrowly focused cancer clinical trials, e.g., trials for specific cancer genotypes.
Artificial intelligence (AI) in clinical research
By leveraging AI algorithms, CROs can transform the execution of clinical research and trials. FDA guidance on AI and machine learning (ML) describes the benefits of AI in clinical research and highlights technologies that improve diversity and inclusion of trials. Research teams have applied AI in disease detection, data collection using wearable devices, data processing for DCTs, data mining and patient recruitment, and biosimulation, amongst others.
CROs increase trial efficiency by using
- AI models trained with appropriate datasets to analyze the enormous volume of clinical, molecular, and imaging data collected in health centers to generate meaningful insights that help accelerate clinical trials.
- AI-enabled predictive analysis to identify new molecules that are more likely to meet primary outcome(s) successfully.
- AI tools that use demographic, genomic, and geographical data to match patients to eligibility requirements.
- AI-powered smart wearable devices to remotely monitor trial participants.
Patient recruitment
To improve recruitment, CROs focus on the participant experience from recruitment to enrollment and retention. Shifting from traditional clinical trials to DCTs allows CROs to provide participants remote access to clinical research, potentially enhancing diversity and reducing participant burden. The application of advanced technologies is a prominent trend in patient recruitment and retention. An example is using augmented AI/ML platforms to accelerate patient recruitment for clinical trials. Natural language processing (NLP) algorithms identify and pre-screen potential participants using structured and unstructured data sources.
Diversity and inclusion
CROs implement diversity, equity, and inclusion strategies in recruitment, enrollment, and retention. Additionally, AI-enabled research technologies can cast a wider net and enable more diverse patient recruitment. DCTs and augmented AI/ML platforms help to search, reach, and match eligible patients faster.
Benefits of outsourcing to a CRO
Sponsors benefit from a reduced need for in-house infrastructure and research capacity by leveraging a CRO’s therapeutic and operational expertise and proficiency in navigating the complex landscape of drug development and regulatory pathways.
Patient recruitment time and costs
CRO strategies to expedite patient recruitment described above help target the right audience, thereby reducing the time and costs associated with patient recruitment. With a focus on patient experience throughout the trial, CROs also aim to have patients who are more engaged and willing to complete the trial, leading to improved retention and cost savings.
Optimizing trial management
Leveraging innovations such as DCTs and AI technologies support optimizing clinical trial management. For example, source data verification (SDV) can account for as much as 25% of a study budget; however, CROs can reduce these costs by introducing more automation in data collection and cleaning operations.
Mutually beneficial collaborations
CROs with expertise in niche areas are prepared to adopt the latest tech, identify opportunities, and provide insights on how tech may be deployed to improve clinical trial performance. CROs like Vial build strong relationships that can benefit sponsors, e.g., with Battery Bio, a hyper-scalable, AI-powered biotech reimagining drug discovery to deliver faster, more efficient research at a dramatically lower cost.
Diverse and inclusive participation in trials
Partnering with CROs that implement diversity, equity, and inclusion strategies increases the probability of trials that are appropriately inclusive of racial and ethnic minority groups and populations experiencing health disparities. Sponsors benefit from trials that include sufficient representation across population groups and a better understanding of the effectiveness of their drugs and medical devices to produce more innovative interventions.
Summary
CROs contribute to the efficient management of clinical trials. Finding the right CRO partner is critical and is determined by the CRO’s experience, areas of expertise, geographical reach, and ability to meet the sponsor’s research objectives. Check out this article for insights on selecting the right CRO for you.
The CRO for Biotech, Powered by Technology
Vial is a next-generation, technology-first CRO reimagining clinical trials to deliver faster, more efficient trial results at dramatically lower costs for biotech sponsors. Vial CRO’s modern, intuitive technology platform integrates trial onboarding, patient enrollment, site communication, and data collection into one connected system. By deploying technology at every step, we are driving efficiencies in speed and cost savings for innovative biotech companies of all sizes. To learn more about Vial CRO, contact us today!
