In this blog we explore the impact of COVID-19 on clinical trial recruitment, the role of patient-centricity in creating long-term engagement and more.
Introduction
Recruitment is one of the most challenging stages of a clinical trial. It’s estimated that 19% of trials are closed or terminated early because they cannot accumulate enough participants, while as many as 86% of clinical trials do not reach recruitment targets within their specified time periods.1 Delays in recruitment are also very costly, resulting in huge loss of revenue opportunity for each day a trial is delayed. That in mind, it’s important to use a diverse and well-planned-out approach to recruitment.
The impact of COVID-19
The global impact of COVID-19 has caused seismic changes in the traditional clinical trials landscape, forcing organisations to rapidly pivot, forge new regulations and identify alternative recruitment methods which allow participants to consent and take part from home in some cases. Progress towards virtual clinical trials has been rapidly accelerated, boosted by significant investment and regulators implementing new guidance at unprecedented speeds.7
As a result, clinical trials have seen a significant rise in the use of digital practices, including recruitment through social media advertising and the integration of technologies such as telephone and video check-ins and electronic consent.8
Understand what matters most to patients before starting recruitment
But whether digitally focused or applying more traditional techniques, the best clinical trial recruitment strategies start by considering the patient perspective. To ensure that recruitment will be faced with as few roadblocks as possible, the patient voice should always be included in a study’s design.
For example, research has shown that oncology patients or those living with acute conditions were more likely than those living with chronic conditions to participate in research.2 Therefore when recruiting for those with chronic conditions such as multiple sclerosis or lupus, it’s important to highlight the benefits of taking part and how the investigational treatment may be an improvement to existing options.2
When working with a patient recruitment company, it’s important the organisation differentiate its outreach approaches depending on the condition the trial is focused on.
Decide your methods of outreach - a diverse approach is best
While digital is now the new normal, with many patients looking up medical and treatment information online, data from 2018 shows that only 11 per cent of clinical trials were actively using social media for patient recruitment prior to the pandemic.3
Utilising social media or search engines provides a powerful recruitment tool which allows researchers or clinical recruitment companies to meet patients where they are through targeted advertising for specific interests, ages and locations. This makes it easier to find and outreach to patients who are more likely to meet eligibility criteria, without being limited to a doctor's surgery or hospital and reducing the risk of exposure to COVID-19.
However this doesn’t mean that more traditional recruitment methods should be discarded. On average, 37% of trials under-enrol and 11% fail to enrol a single patient. It’s therefore best to adopt as diverse an approach as possible when it comes to recruitment.
In addition to this, patients are often more responsive to a clinical trial if it’s been recommended to them by a person they trust. For example, up to 73% of people would like to find out more information about clinical trials from their doctor.2 With this in mind, it’s recommended to create outreach materials which doctors can share directly with their patients in person.2 As well as working with doctors, connecting with patient advocacy groups or working with a patient recruitment company is another impactful avenue of approach.2
Convert leads into enrolments
It’s all well and good to have gotten the attention of patients online, via doctors or through patient advocacy groups, but without a streamlined conversion to enrolment, that’s only one part of the process. Timing is the most important thing to keep in mind during this phase. Whether that’s reaching out via telephone call, email or an online form it must be as soon as possible after the initial outreach.
Make sure to arrange initial screening appointments within the next few days, do not wait a week or more. One of the biggest reasons potential participants drop out before the study starts is because there is a loss of urgency, they lose interest or get busy, and it’s essential to avoid either scenario.3 Keeping every part of this phase as streamlined as possible, with no excessive paperwork or waiting times and maintaining excitement about participating are vital to participant engagement.
Strive for patient retention
What makes recruitment easier is retaining patients to participate in multiple trials as well as completing multiple-stages of the same trial. The key to this is keeping patients engaged, whether that be through regular follow-ups or joining a mailing list. Sponsors should also work to:
- Maintain contact
Keeping the door open for questions and providing clear answers, as well as sending regular updates and messages to keep participants engaged, is a surefire way to improve patient experience.
One of the top reasons patients do not enrol is that the trial is too complex and is not communicated plainly to participants.5 It’s best to describe everything as simply as possible and be open to answering any questions when they arise.
- Listen to participants
Actively try to understand how patients are feeling about the trial. From focus groups and advisory boards, to partnering with a community organisation that works closely with the relevant patient population, there are several methods to get feedback before and during the trial.4
- Be convenient
It’s important to be accommodating and flexible. The patients that enrol are volunteers, regardless of the compensation provided, and the research study is likely not their top priority. The more adaptable a team can be to individual patient situations and needs the better that experience will be.
- Have a positive attitude
For participants to feel positive about the trial, researchers should be excited about it too. Therefore, it’s best to remain confident, optimistic and upbeat throughout the trial.4
Conclusion
All researchers, doctors and patients depend on people who participate in research, although spreading awareness about clinical trials and reaching out to those who meet eligibility criteria has proved difficult in the past.6 Focusing on patient voice and using a diverse approach to recruitment, including through digital media and more traditional methods, is the surest way to improve enrolment rates in the future.
References
- www.sciencedirect.com/science/article/pii/S155171441730753X
- docplayer.net/2177721-Whitepaper-e-recruiting-using-digital-platforms-social-media-and-mobile-technologies-to-improve-clinical-trial-enrollment.html
- trialfacts.com/how-to-improve-patient-recruitment-clinical-trials-know-process/
- gpctr.unmc.edu/wp-content/uploads/2018/10/Kubicek2016TipsTricksSuccessfulResearchRecruitment.pdf
- www.ncbi.nlm.nih.gov/pmc/articles/PMC2878987/
- www.bmj.com/bmj/section-pdf/187256?path=/bmj/342/7811/Feature.full.pdf
- www.nature.com/articles/d41586-020-01524-0
- www.ncbi.nlm.nih.gov/pmc/articles/PMC8288280/
Further reading
- www.reutersevents.com/pharma/clinical/5-tips-how-facilitate-clinical-trial-recruitment
- credevo.com/articles/2020/03/31/how-to-improve-patient-recruitment-in-clinical-trials/
