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Addressing challenges in recruiting patients for clinical studies

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By Dr Matt Wilson, CEO and founder at uMed.

Delivering clinical studies at a primary care setting is hard. One of the biggest challenges is that clinicians and allied health professionals have limited capacity to support the extensive logistics required for recruiting and engaging patient volunteers.

It requires time, knowledge of the research process, and often capital expenditure to set up the infrastructure to deliver research programmes.

And the time invested in a clinical study equates to precious time and budget expended away from clinical demands. As a result, opportunities for clinical research in primary care are lost as potential study sites decide against involvement.

Even when a study is successfully launched in a primary care setting, there is a risk of studies not recruiting sufficient patients with the result that studies can be cancelled, delayed, only partially recruited for, or are terminated midway.

In fact, a 2018 paper published by Elsevier Inc. found that as many as 86% of clinical trials fail to reach recruitment targets within their specified time periods. So what’s the problem?

A key hurdle is that most healthcare providers in primary care still use traditional ‘manual recruitment’ methods to recruit patients.

This typically involves a member of the practice staff approaching a patient based either on their ‘local’ clinical records or using the patient’s Electronic Health Record (EHR) data which identifies them as relevant for a particular study.

The primary care team would use a standard invitation script, effectively a ‘one size fits all’ approach when engaging with the patient.

However, this may be a disincentive for patients who do not engage automatically with ‘template’ research approaches. Another challenge is that the EHR does not provide all the data needed to determine the eligibility of a patient for a study. For example, symptom severity may not be registered in the EHR with sufficient accuracy given the format of the records.

Finally, traditional recruitment methods rely on ‘cold calling’ of patients who may not be prepared for the invitation to join a study and so may not respond as positively as they would, had they been given an opportunity to consider the request through a non-intrusive communication ahead of a more formal call or invitation letter. This could weaken their inclination to participate.

It’s these challenges that call for a new way of managing the clinical study process, from recruiting through to engaging with patients. Automated Recruitment Platforms (ARPs) could be the answer.

They open up opportunities for ‘time-poor’ medical staff and practice nurses to participate in clinical studies as well as empower practices that have no heritage in research. What’s more, it can automate important messages and deliver them to patients – both at scale and speed.

In fact, a fully operational ARP has the ability to send 10,000 texts in one go. Messages also appear as if they originated from the practice team (similar to a ‘white label’ marketing approach where a contractor offers a service under the branding of their client).

This saves time for staff who would otherwise be the ‘front of house’ team members responsible for managing communications with patients.

The messages are personalised too – there is no standard script so healthcare providers may receive a more positive response from the recipient patient.

They also benefit from being able to screen patients for symptom severity and engage patients with bespoke questionnaires. For example, issuing letters to older, less digitally engaged patients explaining that they may receive a text message; and sending text at times for different demographics.

For example, many older people who have a mobile/cell phone prefer to receive texts in the morning and younger people in the afternoon. ARP technology enables different text messages to be sent at different times.

And, when fully operational, ARPs can capture data remotely and directly from the patient, the patient’s EHR and their clinician.

They automatically link this composite data back to a clinical study’s dataset (the overall data accruing from the clinical study), in doing so further reducing the burden on clinicians and allied professionals who form the study site team.

The bottom line? These benefits combine to make clinical study participation and recruitment of patients by primary care health providers more viable.

ARPs could be just the panacea that healthcare providers need to participate in clinical studies in a time-efficient way. They will be able to participate in studies simultaneously, at speed and at scale, helping researchers understand which treatments are both effective and safe for patients sooner – a win-win for all involved.

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