Global clinical trials are a vital part of the drug development process. But when it comes to clinical trial patient recruitment, a standardized global approach fails to consider factors such as differing cultures, healthcare systems and patient needs. Instead, success hinges on local strategies for clinical trial patient recruitment. In a recent webinar, our Site Operations Lead, Georgia Hardy, discussed why we must ‘think global but act local’ when it comes to clinical trials and patient recruitment and retention. She was joined by Nicola Yingst, former Associate Director for Patient Recruitment at Pfizer, and Barbara OrlosKaminska, one of our Clinical Enrollment Managers in Poland.
In our earlier blog post about how ‘thinking local’ promotes clinical trial success, we highlighted how local, in-country specialists can accelerate clinical trial patient recruitment for global studies. During our recent webinar ‘Think Global, Act Local’, our Site Operations Lead, Georgia Hardy, Nicola Yingst, former Associate Director for Patient Recruitment at Pfizer, and Barbara OrlosKaminska, one of our Clinical Enrollment Managers in Poland reflected on how our network of in-country specialists successfully accelerated recruitment for a Phase IIb study – so much so that the target was reached 12 months early.
In this blog post, we highlight the different barriers to enrolling participants that existed in three separate countries and how our Clinical Enrollment Managers (CEMs) used their local knowledge and expertise to overcome these hurdles.
While COVID-19 posed a universal challenge in recruiting eligible people for trials, different countries also encountered their own specific enrollment hurdles.For example, the biggest recruitment barrier in Thailand was not COVID-19. Instead, it was competing studies that involved oral administration of a therapeutic over other types of clinical trials. This differs from other countries where treatment given via a subcutaneous injection is viewed positively.
In-country strategies to boost clinical trial enrollment in Thailand
In addition to competing studies, recruitment challenges in Thailand included:
- a government-funded patient access program, which subsidized treatment costs. Many patients preferred to receive a registered drug
- private sites unable to recruit as well as hospitals run by the country’s Ministry of Public Health. This was because patients treated by the Ministry of Public Health can only be referred to private sites if there are no other medications available or if the doctors can’t diagnose them
- the prevalence of HIV in the country, which impacted eligibility criteria
- the use of an e-diary during the study.
Strategies to boost recruitment involved:
- ensuring potential participants were screened quickly during an active ulcerative colitis flare-up
- prescribing the study drug via the internet so that participants didn’t have to keep visiting the site during the pandemic
- making sure patients were fully trained using the e-diary. For example, one site ran a virtual training session for both patients and site staff.
Optimizing external referral networks to power-up recruitment in France
France can sometimes be reluctant to receive recruitment support as sites typically have strong recruitment strategies and can recruit well. However, for this global Phase IIb trial, four in five sites opted for some form of in-country recruitment support. The main challenges for France included the cancellation of endoscopies during the COVID-19 pandemic and concerns related to the trial’s protocol, the eligibility criteria being too strict and the washout period being too long.
The most common strategy our CEMs in France used was to build and enhance sites’ already strong external referral networks. This included quarterly meetings with physicians to keep the study at the forefront of their minds and boost the pool of potential participants. Appropriate site-facing materials were developed alongside patient information to support this activity.
As a result of our support, screening and randomization rates were three times higher than the target for France.
Bespoke site support with tangible results in Poland
In Poland, sites supported by our CEMs reported a screening rate of 136% higher compared with sites without in-country support. The randomization rate was 0.43 higher compared to non-supported sites, which did not randomize a single patient.
Our approach to clinical trial patient recruitment in Poland, broadly involved:
- Database review – in Poland, patients usually stay with the diagnosing physician
- External referrals, such as referrals from a physician’s colleagues
- Patient-to-patient referrals, where patients looking for new treatment opportunities and are sharing their experiences
- Digital marketing.
“Social media advertising is becoming more and more popular in Poland,” said Barbara during our webinar. “Sites are willing to use social media to post about clinical trials on their Facebook or [in] patient advocacy groups. But still, for most sites, they rely on site-specific materials.”
Alongside this overarching strategy, our CEMs, as experts in the clinical trial landscape in Poland, were able to identify specific recruitment hurdles and implement solutions quickly.
For example, a major challenge to recruitment in Poland was the high screening failure rate due to endoscopy or laboratory results. This was resolved through a careful review of medical records to determine if the procedure would be successful.
Other country-specific challenges – and their solutions – included:
- Competing trials. Our CEMs had monthly contacts with sites to keep them motivated and make sure this study remained at the top of their minds
- COVID-19. Flexible hours and safety measures were implemented to ensure participants visiting sites felt safe
- Low disease activity. We supported sites to build a watchlist of people who may meet eligibility in the near future
- Lack of confirmation of an ulcerative colitis diagnosis from many responding to Facebook adverts. Our CEMs created a prescreening checklist and interviewed each patient thoroughly before scheduling the on-site prescreening visit.
Another factor that benefited study recruitment was the involvement of private sites. In Poland, these sites typically do not have resource issues. There is also easier access to healthcare provided by these sites, especially during the pandemic.
How Innovative Trials can help you think and act local for your next global clinical trial
At Innovative Trials, we believe there should never be a ‘one size fits all’ approach to clinical trial patient recruitment. As Georgia, Nicole and Barabara demonstrated during our recent webinar, each country needs to be considered separately – what works for one may not work as well for another.
Each country should have a bespoke recruitment strategy, potentially even filtering down to site level. It is through our network of CEMs, our ‘boots on the ground’ specialists, that we can provide a tailored, local service proven to support global clinical trial success.
Watch the full webinar
Need help accelerating your clinical trial patient recruitment? Contact us about how our Clinical Enrollment Managers, who are based in more than 70 countries, can supercharge your global clinical trials.