As the complexity of clinical trials continues to grow, enhancing patient centricity, improving site and contract research organisation (CRO) collaboration and leveraging real-world data have been highlighted as core strategies for derisking participant enrolment.
The number of key variables in protocol design, such as the total number of eligibility criteria, endpoints, and investigation sites, has increased over time, according to data presented by Ken Getz, executive director and research professor (PHCM) at Tufts Center for the Study of Drug Development (CSDD), Boston, Massachusetts, at the recent Outsourcing in Clinical Trials Europe 2026 Conference.
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Based on a Tufts CSDD analysis of 10-year data for Phase III pivotal trials, Getz said trial dropout rates have doubled. Meanwhile, the total number of protocol deviations was up 184% between 2013 – 2015 and 2023 – 2025, which manifests as increased burden at the sites, he said.
Strategies to prioritise the needs of participants while navigating the challenges related to trial execution emerged as central themes at the OCT Europe conference, which took place in Barcelona, Spain, from 6–7 May.
Trial complexity creates additional burden for participants
Challenges related to trial complexity are seen daily in the clinic, said Joana Claverol, drawing from experience as clinical research director at the Hospital Sant Joan de Déu, SJD Pediatric Cancer Center Barcelona, Spain.
The long-term trend in trial complexity is the result of many factors, said Getz. This includes the nature of the diseases studied, an increase in regulatory precautions, and the desire to gather data that differentiates assets from others on the market, he said. While additional data can add value, the intent and curiosity must be balanced with the feasibility of the study to ensure that sites and patients can easily participate, argued Getz.
The completion of questionnaires and diaries is the fastest growing area of procedural burden in protocols, said Getz. Based on a Center for Information and Study on Clinical Research Participation (CISCRP) survey, 32% (n=5,505) of respondents said the completion of diaries and questionnaires was “somewhat” or “very burdensome” in 2025, rising from 18% (n=3654) in 2021.
Patient input during protocol design is essential to ensure the likelihood of a patient participating in the study, said Claverol. Dermatology-focused pharma company Almirall has recently incorporated patient advisory boards earlier in the trial design process to ensure the protocols reflect patient needs, noted Estrella Garcia, PhD, the company’s executive global clinical operations director.
However, despite efforts to reduce complexity, best intentions can be derailed due to the multitude of stakeholders involved in protocol design, said Bernhard Glombitza, PhD, Vice President, head of clinical operations & customer engagement, EMEA & LATM, Bayer. So effective collaboration is key, he added. A strategic, long-term relationship should be built between an investigation site and a CRO or sponsor, said Claverol. Sites have extensive experience in running clinical trials, so they can anticipate challenges and offer valuable insight during protocol design, she said.
In a survey conducted by GlobalData, the top strategy to improve patient recruitment identified by industry professionals was designing trials with a patient-centric approach, said Revati Tatake, global head of Pharma Research, Analysis and Competitive Intelligence for GlobalData. Furthermore, 79% of 120 respondents said that patient advocates had a “somewhat” or “substantial” impact on recruitment.
Novel technologies to reduce site and patient burden
The gamification of participation in clinical trials, like incorporating rewards or points, can enhance the patient experience, and is one tool within the larger discipline of applying behavioural science to study design, said Christer Nilsson, CEO of Replior, a software company specialising in data collection for clinical trials. In line with the self-determination theory, providing a patient with a sense of autonomy (choosing to be there), competence (experience of progress), and relatedness (feeling connected to something bigger) can improve engagement and retention, he said. People tend to weigh losses roughly twice as heavily as equivalent gains. This phenomenon, known as loss aversion, explains why streaks can be particularly motivating, he said.
In addition, Nilsson highlighted the utility of remote monitoring tools like Replior’s ring-based wearable sensor, which can be used to track scratching and sleep in itch trials. Industry experts have noted the potential of reducing patient burden and need for face-to-face interaction.
Leveraging real-world data
Trial complexity also increases costs, which is not only a hindrance to sponsors but also translates to increased burden for healthcare systems as companies attempt to recoup funds, said Glombitza.
Utilising real-world data is one way to reduce cost and improve the efficiency of clinical trials, he noted. The European Health Data Space (EHDS) aims to establish a common framework for storing and sharing electronic health data across the European Union, with a goal of achieving full operational maturity by 2035. This centralised data repository will facilitate more effective use of real-world data in clinical trials, said Glombitza.
Implementing electronic source data (eSource) can transform how clinical trials are run, said Peter Casteleyn, clinical data strategy advisor, The European Institute for Innovation Through Health Data (iHD). Casteleyn proposed Electronic Health Record (EHR) to Electronic Data Capture (EDC) as an eSource approach for automated transfer of patient medical data from a hospital directly into a clinical trial system. This would substantially reduce manual data entry and risk of errors, said Casteleyn. In an EHR-to-EDC pilot at Memorial Sloan Kettering Cancer Center (MSKCC), 58% more data elements were captured in the same timeframe, he said.
Furthermore, real-world data can also be used to conduct patient feasibility studies, said Tobias Kruse, PhD, CSO, Clariness. This involves targeted awareness campaigns and questionnaires at the proposed sites to estimate eligibility rates and identify a pool of potentially willing participants, he said. Furthermore, recruitment can be optimised by selecting communication channels that are matched to target demographics, for example, Facebook for older participants and TikTok for younger adults, he explained.
He presented a case study of an online campaign utilising Google Ads and Facebook to recruit patients for a dysmenorrhea (menstrual cramps) study. Here, digital platforms reached women suffering from dysmenorrhea with high specificity, with 95% of 3,413 respondents reporting relevant symptoms. Additionally, 73% reported that they had not previously sought medical advice, representing a population that may not have been reached via traditional recruitment methods in clinical settings, he highlighted.
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