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Case Study

Clinical Trials & Research

Independent Testing & Assessment Program (ITAP) digital clinical studies: protocol approval to study launch in only 2 weeks

The Independent Testing Assessment Program (ITAP) was established by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative to provide support for Food and Drug Administration (FDA) authorization of novel, over-the-counter (OTC) COVID-19 tests, thereby increasing their availability to the public. CareEvolution’s MyDataHelps™ digital clinical trial and research platform is used throughout the University of Massachusetts (UMass) Chan Medical School’s Digital ITAP studies for recruiting and screening potential participants, electronic consent (eConsent), collecting electronic patient-reported outcomes (ePROs), automating participant adherence notifications, and returning results through participant dashboards. As an easy-to-configure platform, MyDataHelps enabled a 2-week lead time from protocol approval to study launch.

Background

ITAP symptoms screenThe FDA has provided emergency use authorization (EUA) to twenty rapid antigen tests that allow for at-home testing for COVID-19. CareEvolution, with the UMass Chan Medical School, has been at the forefront of the at-home testing initiative, first through the Test Us at Home (TUAH) research study and subsequently ITAP. TUAH focused on understanding the accuracy of at-home tests compared to their laboratory counterparts. By using MyDataHelps recruitment features (e.g., email invitations, QR code enrollment, rapid eligibility screening tools, and eConsent), the study enrolled 3600 participants in the first 6 weeks. Ultimately, TUAH was able to demonstrate the value of serial at-home testing for COVID-19 in unprecedented time, releasing a pre-print publication just 4 months after study launch. However, there is still a need to increase the availability of OTC tests for the public. Thus, the NIH RADxSM initiative established ITAP, which provides dedicated resources to support test manufacturers’ applications for FDA EUA.

The UMass Chan Medical School has been awarded funding through ITAP to conduct clinical studies in partnership with test manufacturers, leveraging the MyDataHelps™ digital clinical trial and research platform to enable a decentralized clinical study model. This decentralized model allows people to participate in the study from any of 47 states—participants are screened, eConsent, complete testing, and provide ePROs all from their homes. Ultimately, through the UMass Chan Digital ITAP clinical studies, investigational OTC tests are compared to standard-of-care OTC tests and PCR tests to understand whether the investigational tests meet FDA EUA performance and quality standards.

By the numbers

  • 318 Participants to date
  • 2 Study lead time (weeks)
  • 2-74 Participant age range
  • 72% Participants completed all protocol steps

Cohort

Participants are only eligible to join Digital ITAP if they have not tested positive for COVID within the last 30 days, are accessible for FedEx shipments, are willing and able to schedule a FedEx pick-up or access a drop-off location, and reside within the 48 contiguous United States minus Arizona. Beyond eligibility, Digital ITAP participants are enrolled based on the following characteristics:

  • Symptom status – both symptomatic and asymptomatic participants are enrolled, with symptomatic participants receiving priority to ensure necessary numbers of PCR positivity
  • Days since symptom onset – participants must be within one week of symptom onset
  • Specific symptoms – participants experiencing fever, cough, new loss of taste or smell, congestion, sore throat, or runny nose will receive priority enrollment

 

Data collection/assessment measures & methods

Digital ITAP participants self-administer three types of COVID tests for a study:

  • OTC investigational test – the at-home antigen test being studied
  • OTC standard-of care-test – the at-home antigen test that has already received FDA authorization for emergency use
  • PCR test – participants receive a collection kit delivered to their home and their sample is sent to a lab for PCR testing by mail

Per the protocol, participants take five tests over two days. On day 1, they take both OTC tests and collect their sample for PCR testing. Then, on day 2, participants again take each type of OTC test. For both testing days, participants also provide ePROs in the form of symptom reporting. Additionally, demographic information, health history, and app feedback are collected through ePROs. Automated participant nudges (e.g., SMS and push notifications) are utilized to encourage participant adherence.

The data collected through Digital ITAP is shared directly with the NIH and RADx team to facilitate a more rapid EUA approval process. These data may be shared with the test manufacturer following review by the investigators and ITAP team.

MyDataHelps™ shortens lead time and facilitates recruitment, screening, eConsent, ePROs, and adherence

The MyDataHelps™ digital clinical trial and research platform is utilized throughout the participant experience with Digital ITAP. Key features of the platform—multi-modal (email, text, QR code, in-person) enrollment, screening tool, eConsent, and ePROs—facilitated Digital ITAP’s reduced lead time, widespread recruitment, and test distribution needs.

Shortened lead time

MyDataHelps™ is an easy-to-configure platform, with straightforward creation and revision of eConsent and ePRO modules including automated version control. The platform also allows for an agile development process that makes module updates immediately available for user testing. This configuration model reduces study lead time, or the time between study conception or approval and launch. For Digital ITAP, following a 3-month protocol development period, the lead time was a remarkably short 2 weeks between protocol approval and study launch.

Participant recruitment, screening, and eConsent

To kickstart enrollment while at the beginning of the study, recruitment currently leverages re-engagement of participants who have shown interest in previous research studies, including TUAH. The digital nature of the study allows participant recruitment across the country through a number of settings, though, including but not limited to community testing sites, healthcare organizations, community events, places of worship, public transportation hubs, and social media. MyDataHelps™ enables this widespread recruitment through html email invitations, publicly shareable QR codes, and coordinator-entered eligibility surveys.

ITAP screen

ITAP consent screen

ITAP assent screen

Upon recruitment, participants download the MyDataHelps app and are prompted to complete a survey to determine their eligibility for the clinical study. This survey also includes demographic and health history information. The UMass team created this eligibility survey using the advanced branching and conditional logic within MyDataHelps to ensure only eligible participants are invited to complete the eConsent. There were 5 major revisions to the screening survey, which were easily managed through MyDataHelps version control.

If considered an eligible participant, they are prompted to complete eConsent within the app. If they are not currently eligible to participate, they may be added to a waiting list. To date, there have been five rounds of curated pulls from the waitlist based on state, vaccination status, and previous interest in other programs. MyDataHelps also allows for an assent form that enables simple pediatric enrollment.

Beyond general eligibility, the MyDataHelps robust screening tool also enabled a second tier of criteria for enrollment, indicating “preferred” participants. These preferred criteria are easily adapted to changing circumstances without requiring additional IRB approval, allowing the study team to target specific demographic groups (e.g., unvaccinated, close contact) or specific geographies. To date, the preferred criteria for Digital ITAP have been adjusted live three times.

ePROs and adherence notifications

After enrollment, participants use the MyDataHelps app to submit ePROs, specifically their symptoms on the days of testing, and to trigger testing kits be sent to their home. Further, instructions for PCR sample collection and prompts for logging test results, including uploading photos of test results if requested, are both provided through the app. Automated SMS and push notifications are also used to promote adherence to the testing protocol. So far, 72% of Digital ITAP participants have completed all steps of the protocol.

Next steps

To date, Digital ITAP has launched with two investigational OTC tests and is in the early stages of participation. Thus, participant recruitment and enrollment will continue as the studies gather sufficient data to evaluate the sensitivity and specificity of the tests. As a robust digital clinical trial and research platform, MyDataHelps is also poised for scaling Digital ITAP to evaluate more investigational OTC tests, pending UMass Chan’s partnership with additional test manufacturers.

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