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Patient recruitment can be a major hurdle for pharmaceutical companies trying to establish clinical trials for their investigational new drugs, especially when patients already have access to well-established treatments.

This, together with geographical challenges and other factors, can lead to patient cohorts that are not always truly representative of a disease population.

Boosting diversity in trials has therefore become a focus for the industry, adding a new dimension to the issue of enrolment.

This article explores how an in-depth understanding of a disease and its population demographics, as well as strong investigator site relationships, can help to overcome these challenges and improve trial outcomes.

Clinical trials provide invaluable information to help ensure effective treatments and positive patient outcomes. Addressing barriers such as access, bias and trust is crucial to advancing health equity, improving study validity and ensuring inclusive medical research benefits everyone.

A patient-centric approach can help to achieve this by prioritising patient needs at every stage of the clinical trial process.

This means designing protocols that minimise burdens on participants, incorporating patient feedback early on and ensuring that study sites are accessible to diverse communities.

Engaging patient advocacy groups and improving trial communication with plain language summaries can also improve trust and participation. This leads to better outcomes and a deeper understanding of how treatments work across all populations.

This shift toward patient-centricity is widely accepted as necessary and encouraged by regulatory bodies such as the European Medicines Agency (EMA). However, it presents challenges for sponsors and contract research organisations (CROs).

Recruiting a more diverse cohort often means engaging with underrepresented populations, including those facing socio-economic and geographical barriers to trial participation.

These challenges can affect study timelines and budgets, particularly for industry-sponsored trials, which have historically been criticised for not prioritising diversity.

Ensuring greater inclusivity enhances research quality by reducing potential biases in study outcomes. Patient input also helps to identify potential challenges early on, ensuring that protocols are designed in a way that minimises burden while maximising compliance.

While sponsors naturally aim to gather as much data as possible from a study, patient insights can help to distinguish between essential and non-essential endpoints.

This makes trials more practical and appealing for participants. This can lead to higher retention rates, better compliance and, ultimately, more reliable study results.

Patient associations are playing an increasingly valuable role in bringing together researchers and potential trial participants.

These groups range from large national and regional advocacy organisations to smaller, informal patient-led communities that connect people with shared conditions through social media and online forums.

Sponsors and CROs can collaborate with these groups to locate and engage active and well-informed patients who already have a strong understanding of their condition.  This improves recruitment efforts and helps to refine trial protocols by incorporating patient perspectives into study design.

However, it is important to ensure that these partnerships do not introduce bias, as patients from these communities tend to be more knowledgeable about their condition and the clinical trial process than many others.

This could result in a participant pool that is not fully representative of the broader patient population affected by the disease or within the therapeutic area.

A major part of truly patient-centric trials is making information accessible and clear.  Participants must be able to easily understand study information and feel confident in their decision to enrol, knowing what to expect.

One of the biggest barriers is that trial reports and communication materials are often too technical, making it difficult for non-specialists to comprehend the results.

Simplifying the language used in study documents, creating summaries and using multimedia resources can give a better overview of the clinical trial and increase participation.

This improved accessibility benefits patients and strengthens the broader healthcare community by encouraging greater awareness of the role of clinical research in advancing medical science.

The most effective approach to increasing diversity in trials is to take a holistic view of patient recruitment. This means considering not just the eligibility criteria, but also how, when and where patients are engaged.

Investigator sites play a key role here, as they know their local patient populations best and can advise on what outreach strategies work in specific communities. This could involve partnering with local healthcare providers, using digital marketing tools and working with community organisations.

However, accessibility must go beyond outreach efforts. Study sites should be easy to reach, offer flexible hours, and minimise the logistical barriers that might prevent certain groups from participating.

The increasing use of decentralised clinical trials is another important trend shaping patient-centric research. These trials allow patients to complete certain study activities remotely, reducing the need for frequent in-person visits.

However, while digital tools such as apps, wearable devices and remote monitoring systems can improve convenience, they can also create accessibility issues for participants who may lack the necessary technology or digital literacy.

Trial designs must therefore offer multiple options for data collection to ensure that participants do not back out due to technical barriers.

This brings about additional challenges, as maintaining high quality and consistency becomes more complex when data is gathered through multiple methods.

This requires careful standardisation and validation to ensure reliability across different collection approaches.

Over the next decade, patient-centricity is expected to become a fundamental part of trial design, rather than a nice-to-have consideration.

As the EMA and other regulatory bodies continue to push for greater inclusivity and patient involvement, trial designs will become increasingly holistic, focusing not only on scientific validity but also on participant experience.

While these shifts may increase costs in the short term, the long-term benefits – faster recruitment, better compliance and stronger study outcomes – will ultimately lead to more efficient and effective clinical trials.

Engaging patients early, simplifying trial communications and removing barriers to participation will allow the industry to take meaningful steps toward truly inclusive, patient-centric research that benefits everyone.