Even before the COVID-10 pandemic suddenly appeared and emphatically nudged the entire healthcare system towards virtual delivery models, 83bar was on the cutting edge of site-less virtual clinical trial recruitment.

From August 26th, 2019 to March 30th, 2020, 83bar successfully located, educated, and navigated 1,402 patients through a multi-step virtual clinical trial to evaluate an at-home colon screening test at a 30% lower cost than traditional site-based recruitment.

This campaign required patients to:

• Complete a 20-30 question pre-screening survey
• Complete a second screening process and detailed enrollment intake via telephone with an 83bar patient education specialist
• Collect then return an at-home stool sample via a provided kit
• Schedule, attend, and self-finance an in-office colonoscopy procedure with a gastroenterologist of their choice
• Assist with the medical records collection process

Virtual trial recruitment pricing depends on three key variables: Total number of patients required, length of recruitment time, and how severely inclusion and exclusion criteria narrow the available patient population.

The success of this campaign helped the 83bar client secure “Breakthrough Device” designation from the FDA and funding for a large pivotal study to begin recruitment in late 2020.

Background – Pre-Study Pilot

In the second quarter of 2019, 83bar helped develop and conduct a smaller-scale pilot to refine processes and help determine if a virtual, traditional, or hybrid approach to patient recruitment was best suited for the larger 1,000-patient study.

83bar conducted a virtual Patient Activation campaign while a partner vendor simultaneously conducted a traditional recruitment campaign at six separate gastroenterology offices.

The results were conclusive:

Methodology

Based on learnings from the pre-study pilot, 83bar worked closely with the study sponsor and partner vendors to design an end-to-end virtual patient activation campaign using the following tactics:

• Locate and screen patients via paid social media ads.

• Screen, educate, and support patients via a rapid response contact center

83bar patient education specialists (who are primarily registered nurses) reached out via telephone to 31,877 potential patients during the recruitment period. Nearly 2,400 total patients were then enrolled into the study.

83bar’s rapid response team helped patients:

1. Understand the study commitment
2. Capture consent
3. Navigate insurance, scheduling, stool sample collection, and other participation obstacles
4. Facilitate patient-facing medical records collection process
5. Prepare patients to visit any gastroenterologist

Our team of patient education specialists helped study participants secure the release of their relevant medical records to be compared with data gathered during the virtual trial.

Zero sites were onboarded for the campaign, meaning patients were free to choose their own provider. After their colonoscopy, patient medical records were sent from the gastroenterologist to a designated, central pathologist for review.

Conclusion

Virtual clinical trial recruitment can be achieved in significantly less time than a traditional site-based model, often at a reduced cost. Although logistical hurdles exist, partnering with capable solution-oriented vendors can help bring your trial into the new virtual future and help you augment or replace expensive, traditional, site-based recruiting.