Three ways clinical trials will become more inclusive in 2022

At Innovative Trials, we’re passionate about clinical trials being designed around patients’ needs and patient recruitment strategies that promote diverse representation within studies. Following on from our last blog reflecting on 2021, our Founder & Chief Executive Officer, Kate Shaw, looks ahead and shares her top three predictions for the clinical trials industry in 2022.

Clinical trial design is changing. We are seeing priorities and processes evolving, just as they naturally would in any other work setting, and this holds exciting promise. One of the key factors is patient centricity. Patients are increasingly being put at the heart of clinical trials and, as a result, we are also seeing patient recruitment and retention practices change and shift. With this in mind, here are my top three predictions for the clinical trials industry in 2022.


From decentralization to hybrid clinical trials

Decentralized clinical trials have grown in popularity over the last couple of years, necessitated by the COVID-19 pandemic and the resultant need to conduct trials remotely. Embracing technologies that enable trials to run virtually and in people’s homes is a positive development, supporting a shift to more inclusive trials.

However, despite fully decentralized trials being a reality for some studies, it is more likely that a hybrid model will prevail in the long-term. As a company, we are seeing increased demand for clinical trials that combine the best parts of decentralization with elements of more traditional ‘on site’ clinical trials. This is likely to become more common in 2022 and beyond.

COVID-19 has shown us what is possible in terms of how we utilize technology to make trials easier and more convenient for both patients and investigators, but we know many patients value the physical presence of clinicians and the reassurance this can bring. For example, taking part in clinical research is a big decision; knowing there is a face behind the study and someone patients can speak to on a semi-regular basis can make them feel more confident and at ease with the process. Meanwhile, people with complex conditions may prefer site visits over remote monitoring as a clinical setting can be more comforting. 


The continued rise of digital

Digital is becoming increasingly popular for patient recruitment and this shows no sign of slowing down in 2022. For some trial sponsors, digital outreach is seen as a key part of every clinical trial patient recruitment strategy. For others, it is still very new. One thing they all generally have in common though, is a growing enthusiasm for digital as a potential clinical trial patient recruitment method. There is definite promise in digital outreach. It enables Investigators to target broad groups of patients and is not time intensive, reducing the already heavy workload of research staff. Digital outreach can also simplify the process of assessing a person’s eligibility and enrolling them into a study. 

However, this activity can have its downsides. Digital outreach can be expensive to implement and, although it can increase the number of patients coming forward for a study, the quality of referral is sometimes lower compared with standard methods. This can frustrate sites and make recruitment challenging. We also know that patients who enrol via this method can be less engaged with the trial than someone who enrolled following a conversation with their doctor.  As experts in the clinical trial patient recruitment field, we work closely with our clients to make sure they understand the best, most cost-effective patient enrolment strategies for their study. Where digital outreach is requested or deemed necessary, our global team of Clinical Enrolment Managers (CEMs) ensures  patient referrals via digital methods undergo robust pre-screening before progressing to the next stage making sure only high quality referrals reach the study sites, thus avoiding upsetting sites.

Digital outreach will remain an area of growth for clinical trial patient recruitment throughout this year. But, we acknowledge that this activity may not always be the best option for some trials. This is why we will continue to focus on creating bespoke strategies to achieve the best outcome for every client. With an agile team, we can not only shape and execute digital outreach campaigns, but also create patient-centered educational materials, carry out bespoke wider community engagement in over 70 countries and develop retention strategies to keep patients engaged from start to finish.


Increased focus on patient diversity in clinical trials

As an industry there is a growing desire to address the lack of diversity within clinical trials. As I mentioned in my last blog, we’re working with COUCH Health and Egality to facilitate a change in the UK and encourage a more diverse representation of patients within health research. Making trials more inclusive for people who have traditionally been under-represented in clinical studies will not be easy or fast, but we are seeing steps in the right direction. The ABPI’s patient engagement strategy, published in June 2021, includes a commitment to ‘make it easier for people from diverse communities to take part in research. Meanwhile the Wellcome Trust’s policy for funding clinical trials states that people from underrepresented groups should be recruited into studies to ensure the healthcare intervention being investigated is safe and effective for the entire patient population. Increasing patient diversity in clinical trials is a key issue. I am looking forward to seeing how we, as an industry, can come together in 2022 to advance progress and make sure all clinical trials fully represent the entire patient population. Join us on Thursday 24 February for a webinar we are hosting to discuss the challenges of recruiting people from underrepresented communities and what can be done in practice to tackle this. We are committed to supporting our clients with all their clinical trial patient recruitment needs, from site enrolment optimization to referral support and community engagement. This includes bespoke, patient-centered strategies, digital and community outreach, and patient-centric materials. 

Find out more about our clinical trial patient recruitment services and how our approach has contributed to six new treatments being successfully approved and brought to market.