Clinical trial design is evolving. At the forefront of pharma 4.0 and expedited by the COVID-19 pandemic, digital technology is playing an increasingly prominent role in patient enrolment and engagement.
It is a welcome development with exciting implications for accelerating therapeutic development and patient access to life-changing treatments. For example, digital marketing makes targeting broad groups of people easier, enabling sites to reach a more diverse mix of patients for a stronger evidence base. Decentralised clinical trials (DCTs), which have become more popular since the COVID-19 pandemic, can remove financial and logistical barriers that may have previously prevented some patients from participating. Moreover, the utilisation of wearables and mobile technology to monitor patients remotely promotes time and resource efficiencies for sites.
This digital transformation firmly places patients’ needs at the heart of clinical trial design, a long- overdue and welcome change to traditional clinical trial design, which centred primarily around the therapeutic in question. While more studies are needed to examine the impact of digital technology on overall costs – particularly its use in patient recruitment – it enables work to become more streamlined and research timelines to easier to meet or exceed.
However, despite these obvious benefits for sites and sponsors, an over-reliance on this technology may prove detrimental. It is still traditional, off-line methods that typically result in a better conversion rate for patient recruitment and digital enrolment strategies also do little to address the core underlying issues associated with low clinical trial participation among groups, such as disabled people, people of colour, women and older people.
In-person community engagement may often be considered more time- and resource-intensive, but it has been shown to help dismantle long-standing barriers to patient participation in trials and increases equity in clinical research. As sponsors increasingly look to adopt digital technologies within trials, it is imperative for the long-term success of clinical research that traditional community engagement is not sidelined.
The challenge of clinical trial patient recruitment
Clinical trial patient recruitment and retention is often the most important, yet most challenging, aspect of any clinical trial.
Around 80% of all clinical trials miss their recruitment target and deadline, resulting in lost revenue of as much as $8m per day for trial sponsors. In addition, a failure to recruit enough patients can force trials to terminate early. This can result in significant delays in patients being able to access new and innovative medicines or, even worse, can mean that potential effective therapies cannot be brought to market at all.
Without enough patients – or indeed, without the right mix of patients – clinical research will fail to provide robust efficacy and safety data across all relevant populations. This has important implications, such as the suboptimal development of new medicines and the potential to aggravate health disparities among different racial and cultural groups.
Between 2008 and 2013, around one in five newly approved drugs demonstrated differences in treatment response across ethnic groups leading, in some cases, to doctors prescribing drugs differently according to ethnicity. In 2020, a study found that women are nearly twice as likely as men to experience adverse reactions to therapies, because drug dosages are traditionally based on clinical trials involving men.
Throughout clinical trial history, distinct groups of people have been consistently under-represented in research: disabled people, women, older people and those from racially and ethnically diverse backgrounds. An analysis by the Food and Drug Administration (FDA) in the US highlighted that, of the 292,537 people who participated in clinical trials globally between 2015 and 2019, more than three in four (76%) were white, 11% were asian and 7% were black.
Reasons for this under-representation are complex, but we know cultural barriers and a lack of knowledge of clinical trials contribute. A lack of trust can also play a part. A recent study found more than one in three participants (35.5%) said they did not trust pharmaceutical companies, with women being among those more likely to express distrust.
With the COVID-19 pandemic temporarily halting the entire drug development pipeline in 2020, more trials than ever have been in need of patient recruitment, piling pressure on sites that are already stretched in terms of time and resources.
More than 5,000 new clinical trials were scheduled to begin in 2021, a 14% increase compared with 2020. This was in addition to suspended trials restarting. More recently, as of 15 September 2022, almost 428,000 clinical trials are registered on ClinicalTrials.gov, of which 64,058 are currently recruiting. This number of registered trials is significantly higher than the 362,499 studies registered by the end of 2020.
Sites have reported struggling to cope with such high enrolment demands with many admitting that studies are falling behind due to delays in patient recruitment. It is therefore vital that the pharma industry addresses these long-standing, underlying challenges to ensure sites are able to meet their recruitment deadlines and research is fully inclusive.
The role of digital technology in clinical trial patient recruitment
The idea of utilising digital technologies within clinical trials is not new. Pfizer’s REMOTE trial, which launched in 2011, was widely hailed as the first ever ‘virtual’ trial where patients would use mobile and web-based technology to participate. Unfortunately, it was forced to close in 2012 due to a lack of patients enroling.
But a decade later, we are in a much more technologically advanced space. The COVID-19 pandemic forced sponsors and sites to adapt quickly to minimise the risk to trials, bringing decentralised clinical trials (DCTs) into sponsors’ consciousness like never before.
A report earlier this year found that DCTs more than tripled during the pandemic, compared with pre-pandemic numbers. Despite this, only 56% of sponsors and Clinical Research organisations (CROs) reported that DCTs had improved the patient experience and positively impacted retention. It is clear that deploying digital solutions alone is not enough. An integrated strategy is needed.
Community outreach: the cornerstone of patient recruitment
While digital methods to enrol participants into clinical research has the potential to be more cost- effective and time efficient than more traditional recruitment methods, it is these offline activities that typically lead to a better conversion rate.
Community outreach has a pivotal part to play in this. In patient recruitment, it helps clinical trial teams engage meaningfully with underrepresented communities, foster respect and trust, and overcome existing barriers to participation. Community engagement processes have not only contributed to the successful implementation of clinical trials but also enhancing equity in trials.
Of course, a challenge associated with community engagement is the often time-intensive nature of the outreach. Building relationships, particularly with traditionally marginalised groups, does not happen overnight and requires patience. With research sites and staff under pressure to start and keep clinical trials progressing, it is understandable that ‘easier’ options are explored.
But digital recruitment methods, while able to target vast numbers of people quickly, will never be able to tackle the underlying barriers that prevent people from taking part in the first place. In addition, the ongoing existence of a global ‘digital divide’ continues to exclude certain populations from online activities. Therefore, a focus only on digital recruitment methods will fail to adequately address the ongoing inequalities in research.
To be successful both in the short- and long-term, clinical trial patient recruitment must acknowledge these challenges and address them head-on. Community engagement via a ‘boots-on-the-ground’ approach is the only way to do this effectively.
For sites that find themselves limited in terms of resources, there is the option to commission a company specialising in community outreach to lead this important work.
Tactics, such as expanding sites’ referral network, visiting communities where people live and work, including libraries, nail and hair salons, gyms and educational and religious institutions, and engaging with trusted community groups and leaders can often be more effective for patient recruitment, particularly for under-represented ethnic groups.
In sponsors’ rush to embrace digital technology, the vital role of in-person community engagement in reaching under-represented groups, changing people’s perceptions of medical research and increasing trust must not be forgotten. When used alongside digital marketing in a cohesive and strategic manner, community engagement can optimise and bolster recruitment processes to meet enrolment deadlines while actively breaking down barriers and promoting inclusivity across clinical research.
