120
+
700
+
38
+
97
%
17600
+
44% More Patients Randomized Per Month: Global Recruitment Support for a Phase III COPD Study
At a glance
44% increase
in average patients randomized per month
6.18 months
saved on the enrollment timeline
31% of total study
randomizations delivered through AutoCruitment
5 countries:
Launched across USA, Germany, UK, Spain, and Canada
The Challenge
A large pharmaceutical company was planning a multi-country Phase III COPD study and needed a recruitment partner who could keep enrollment timelines on track from day one.
The study spanned five countries, which meant the sponsor needed more than a US-based vendor. Site and patient engagement had to work in each local language, with a team that understood the regulatory and cultural nuances of every market involved.
The trial compared a triple combination inhaled therapy against both a placebo and a dual combination inhaler in patients with moderate to severe COPD. The primary objective was to assess the treatment’s effect on dynamic hyperinflation, with exercise endurance time as a key secondary measure. Every candidate had to be stable on background COPD medication before entering the study, not simply diagnosed with COPD.
The study enrolled adults 40 to 80 years old with moderate to severe COPD, confirmed by spirometry and a dyspnea score of 2 or higher on the mMRC scale. Eligible patients also had to show a degree of lung hyperinflation on baseline testing, be current or former smokers with at least 10 pack-years of smoking history, and already be on a stable dose of inhaled maintenance therapy for six weeks prior to enrollment, with roughly half the study population required to be on dual therapy.
The Protocol Complexity
The protocol added complexity beyond a standard COPD trial. Every candidate had to fall within a narrow endurance window on a baseline cycling test, meaning candidates had to be sick enough to meet severity thresholds but fit enough to sustain a set workload for at least a few minutes, with only one chance to retest if they landed outside that range.
Exclusion criteria touched nearly every organ system, ruling out significant cardiovascular, renal, hepatic, neurological, or endocrine conditions, plus cardiac contraindications to exercise testing like recent heart attack, uncontrolled arrhythmias, and heart failure. Patients also had to be free of respiratory infection within 8 weeks of screening and off supplemental oxygen. Finding patients who cleared every criterion, across five countries and three languages, called for precise targeting over broad-reach advertising.
The Approach
AutoCruitment built and launched the campaign across the USA, Germany, UK, Spain, and Canada, with site and patient engagement support delivered natively in each country.
Patient flow began within the first week of launch, giving the study early momentum right out of the gate.
The recruitment strategy included:
- 8 marketing channels, working together to reach eligible patients in every country
- 300+ ads across three languages, continuously tested and optimized to identify the messaging and creative most effective in each market
- 175 landing pages tailored by country, allowing messaging, calls to action, and patient journeys to be optimized for local audiences
- Native-language site and patient engagement, so sites and patients never hit a language gap during outreach, screening, or scheduling
- In-country call center support, giving patients someone to talk to in their own language and time zone
- Full-service project management overseeing the whole campaign across all five markets
The Results
Study teams saw the impact quickly. With AutoCruitment’s support, the study averaged 7.93 randomized patients per month, compared to 5.50 per month without it. That is a 44% increase in monthly randomization pace, which translated into 6.18 months saved on the overall enrollment timeline.
By the end of the campaign, AutoCruitment contributed:
- 73 consented patients, or 29% of total study consents
- 34 randomized patients, or 31% of total study randomizations
Two parts of the process outperformed plan by a wide margin. AutoCruitment-delivered patients experienced a 11% higher contact rate than projected, and visit reminders sent by AutoCruitment helped deliver 29% better visit attendance than predicted, keeping more scheduled patients from missing their appointment.
What the Site Coordinator Said
"The collaboration with AutoCruitment during the study was extremely professional and efficient. The portal is user-friendly and easy to use in everyday clinical practice. Particularly noteworthy is the proactive communication of the team, which was always prompt, solution-oriented, and extremely friendly. The quality of patient referrals was good and contributed to successful recruitment. AutoCruitment has proven to be a reliable partner with whom we would be very happy to work again in the future."
Ready to Keep Your Enrollment Timeline on Track?
This is what happens when global reach, local execution, and full-service support come together. If a study team is planning a multi-country trial and needs a recruitment partner who can move fast without losing quality, AutoCruitment can help.
Talk to our team about your studyAutoCruitment’s patient recruitment platform supports Sponsors, CRO Partners and Research Sites by decreasing time, risk and cost to bring new therapies to market.