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Trust and transparent collaborations at the heart of clinical trials

Article-Trust and transparent collaborations at the heart of clinical trials

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Address recruitment and retention challenges by tailoring approaches to incorporate potential participants' input.

Advancing medical science, healthcare while ensuring the safety and effectiveness of new medical treatments and interventions is impossible without clinical trials. However, realising that putting people at the heart of research not only reshapes trials but also enhances the overall experience for trial participants, improves recruitment and retention rates, and leads to more accurate and meaningful results is even as equally fundamental.  

Patient enrolment and retention are major issues that clinical trials run into. It has been identified that 80 per cent of trials have difficulty enrolling patients, and some studies estimate that up to 30 per cent of patients who enrol in a clinical trial will eventually withdraw from the study. 

Participant-centred studies have the potential to enable easier enrolment and retention of participants, lead to tailored therapies, faster innovation, improved decision-making. Chukwunonso Udeh, Managing Partner at Utano CRO, shares: “Endpoints derived from patient-centric studies offer clearer insights, aiding in the customisation of disease therapies. These trials stimulate innovation, accelerate timelines, facilitate decision-making, and impact health policies. Patient-centric approaches optimise research utility, patient education, and collaboration among patients, healthcare providers, and researchers, ultimately advancing medicine and patient welfare.” 

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As medical research keeps advancing, the clinical trial industry seems to be committed to enhancing the participant experience. We have heard phrases like "patient convenience" and marketing campaigns focused on "patient-centricity". However, the genuine concern is, are the participants really feeling this impact? 

A review of studies suggests that the major causes of the reason why participants are not likely to participate in a clinical trial include the fear of the unknown, opting for the perceived safety of established treatments, reflecting a preference for familiarity over uncertainty. Another unsettling concern for most participants is the perceived inconvenience of clinical trials. Participants with busy schedules or significant responsibilities may find the additional time, travel, and commitment required difficult. Individuals who are comfortable with their current medical regimen may be put off by the need to change routines, causing them to weigh the potential benefits against the disruptions. Some people have misconceptions about clinical trials, such as fearing that they will be treated as "guinea pigs" or that the trial will be dangerous.  

Participation can also be discouraged by mistrust of medical institutions, a history of ethical violations, or concerns about potential exploitation. In addition, the question of immediate benefit cannot be neglected in clinical trial participation. Participants may be hesitant to enrol if they perceive little personal benefit or unclear benefits from the trial. Clinical trials that do not cover all associated costs can also be financially burdensome, especially for participants with limited resources. 

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As much as these could throw a spanner in the wheel of clinical trial operations. The ultimate objective is to create an enabling environment for participant-centred clinical trials and sustain it due to its necessity. The profound impacts that participant-centred clinical trials bring to the forefront of medical advancement include fostering trust and transparent collaborations between researchers and participants thereby creating a conducive research environment. The inclusion of feedback loops also enables trial design adaptation, fostering innovation and relevance. 

Participant-centred trials are addressing recruitment and retention challenges by tailoring approaches to incorporate potential participants' input. This enhances trial attractiveness, resulting in higher recruitment rates and sustained participant commitment. This model of trial mirrors real-life scenarios, enhancing the applicability of results across diverse patient populations. This authenticity is crucial for assessing the true impact of interventions and making room for reflection on real-world relevance and generalisation. 

Another pain point it addresses is improving the relevance of research questions, outcome measures, and interventions. This uplifts the overall quality of trials, ensuring a robust structure. This helps to optimise trial design and research quality as participant insights yield fresh perspectives. 

Participant-centred clinical trials enhance participant engagement and satisfaction. The active involvement of participants ensures that trial procedures and outcomes are aligned with their preferences, heightening engagement, and satisfaction. This empowers them, fosters ownership, facilitates productive interactions with researchers, and accelerates the overall timeline of clinical research. 

The impact of clinical trials driven by the voices and aspirations of those it aims to serve will not only improve health outcomes and advance medical knowledge but also shape a more compassionate and effective healthcare system. 

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