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Citeline Connect关键记录临床试验招募

医药生物 2023-07-01 citeline 单字一个翔
报告封面

How Citeline Connect Supported theFastest-recruiting COVID-19 Clinical Trialin Operation Warp Speed History July 2023 Use Case| Trial Recruitment at Warp Speed Recruiting with Scale, Speed and Diversity A late-stage biotechnology company developing a next-generation vaccine againstCOVID-19 was set to conduct a large Phase III trial. The trial design was aligned with otherPhase III trials conducted under the auspices of Operation Warp Speed, and planned withspecific recruitment diversity goals and an enrollment target of 30,000 volunteers. Locationof trial sites emphasized communities and demographic groups most impacted by thedisease, including people over age 65 and those living with comorbid conditions that placedthem at higher risk of complications from COVID-19. “The full enrollment of [this trial] is another important step in buildinga body of evidence to demonstrate that [the vaccine] will be safe andeffective across diverse, representative populations.” PRESIDENT, RESEARCH AND DEVELOPMENTCOVID-19 TRIAL SPONSOR ENROLLMENT GOALS AT LAUNCH: ≥ 25%of the study population65 years of age or older ≥ 15%Black/African-American 10-25%LatinX 1-2%American Indian Use Case| Trial Recruitment at Warp Speed Citeline Connect Selected Operation Warp Speed partners who had previously succeeded in recruiting for a high-profile Phase III COVID-19 trial with Citeline Connect introduced the solution to the studysponsor’s CRO. Citeline Connect was selected to support the trial’s 30,000-participant goal.The sponsor was now able to work with many of the same recruiting partners that hadalready responded to its RFP, simultaneously and without the burden and risk associatedwith selecting just one. Within just days of launch, 20 recruitment partners across a variety of specializations andrecruiting methodologies — each armed with IRB-approved assets co-created by theCiteline Connect team — mobilized to instantly begin referring patients to enrolling researchsites at once. SOME OF THE RECRUITMENTPARTNERS WHO ACTIVATEDFOR THIS TRIALSome of the recruitment partnerswho activated for this trial Use Case| Trial Recruitment at Warp Speed Reinventing the Recruitment ModelReinventing the Recruitment Model Unlike traditional clinical trial recruitment models, Citeline Connect works as a collective,empowering over 100 different recruitment partners to refer patients to research sitesconcurrently using a pay-for-performance model. In this specific trial, recruiters werecompensated for both referrals and randomizations, through a predetermined rate cardagreed upon by the sponsor and CRO. This pay-for-performance model incentivizedrecruiters to directly optimize their outreach and performance.Unlike traditional clinical trial recruitment models, Citeline Connect works as a collective, empowering up to 75different recruitment partners to refer patients to research sites concurrently using a pay-for-performance model.In this specific trial, recruiters were compensated for both referrals and randomizations, through a predeterminedrate card agreed upon by the sponsor and CRO. This pay-for-performance model incentivized recruiters to directlyoptimize their outreach and performance. TraditionalRecruitment ProcessTraditionalRecruitment Process CentralizingIRB-Approved AssetsCentralizingIRB-Approved Assets Citeline Connect’s built-in content repository was usedto provide all recruitment partners with the same IRB-approved copy and imagery, including email and callcenter scripts. Sample advertisements were also createdto ensure proper use of recruiting materials across socialchannels such as Facebook, Twitter and Instagram.Citeline Connect’s built-in content repository was used to provide allrecruitment partners with the same IRB-approved copy and imagery,including email and call center scripts. Sample advertisements were alsocreated to ensure proper use of recruiting materials across socialchannels such as Facebook, Twitter and Instagram.Citeline Connect’s built-in content repository was used to provide allrecruitment partners with the same IRB-approved copy and imagery,including email and call center scripts. Sample advertisements were alsocreated to ensure proper use of recruiting materials across social Use Case| Trial Recruitment at Warp Speed Setting Sites Up for SuccessSetting Sites Up for Success In a study such as this one, with a large volume of prospective participants and accelerated startup timelines,creating processes to prevent catastrophic site congestion and streamlining the enrollment process throughtechnology were key to success. First, a Trial Site Administration portal was established to allow local site staff toedit and confirm the correct contact details for their locations and, most importantly, change their site recruitingstatus in real time as needed to pause referrals during busy spurts.In a study such as this one, with a large volume of prospective participants and acceleratedstartup timelines, creat