Real-Time Site Feedback Guides Sponsor Decisions

Could telemedicine help sites resume trials disrupted by COVID-19?

The global pandemic created situations for which no one was prepared. With lockdowns, restricted movement, and healthcare professional preoccupied with treating COVID-19 patients, clinical trial operations were halted and enrollment paused.

Months later as lockdowns eased, there was then uncertainty on how to safely resume operations. A Top 30 global pharma decided to get direct site feedback on the situation using Teckro Survey. The results gave the study team insights into how sites viewed telemedicine and whether it could help to resume operations.

When Guessing Isn’t Good Enough

Nearly two years into the four-year study, COVID-19 presented an obstacle as research sites halted enrollment for this Phase III study. Months later, this Top 30 sponsor needed to validate whether telemedicine would be of interest to its sites and how feasible it would be to get the technology approved for use at the institutions.

Here is what the sponsor learned:

  • More than half of sites reopened enrollment and more than 60% of respondents said their site had taken alternative action for follow up visits.
  • Furthermore, 69% said their institution offered a telemedicine and 57% of respondents said they weren’t interested if this sponsor offered a telemedicine option.
  • And even if home visits were approved, 79% said it would take more than four weeks to get approval.

In testing its theory, the study team concluded that telemedicine wasn’t something that would benefit its sites and it wouldn’t be useful to get the study back on track.

Designing for Maximum Response

With advice from our team, the sponsor designed the survey to get a quick return.

  1. The survey was simple. It included 10 questions with simply worded questions and short answers. All of the questions except for one provided two choices, such as “yes” or “no” with the option for respondents to provide extra comments to expand on their answers. The only question that didn’t follow this formula was one that provided four options on how long it would take for a telemedicine system to be approved by the site.
  2. Target list of respondents was carefully selected. The study team focused on those sites and users active on Teckro. They created three groups based on geography so as to analyze responses among the US, Europe and Asia Pacific. They also focused on key roles of site coordinators, principal and sub investigators, and extended site staff. Not surprising, site coordinators responded the most, representing 71% of the total.
  3. The objective was clear. The purpose of the survey was clear and relevant to the target audience. The questions were easy to understand and the recipients would know the answers without much thought. It was also obvious to participants that the purpose was to test whether they could benefit from telemedicine as a method to get the study back on track.

Response Rate that Exceeded Expectations

CRAs were instrumental in reaching site staff; CRAs for all of the sites selected were notified via a Teckro alert about the survey so they could encourage their sites to participate.

The initial survey was open for just one week, so the window to respond was quite short. With such a light touch, the study team was pleasantly surprised, particularly with a 31% response rate from the US team.

The selection of sites and individuals based on their usage of Teckro could be one explanation for the strong response rate. These individuals were already regularly consulting Teckro for study answers, including eligibility criteria for enrollment and visit schedules. Therefore, it was logical that they should also provide feedback via Teckro.

Delivering Results with Teckro Survey

To capture feedback, it needs to be simple, quick and easy for the user. And the request for feedback should come from a familiar source that is relevant to the user. In this case, Teckro Survey checked all of the boxes.

Users are directed to the online survey through alerts from Teckro. They complete the survey from any web-enabled device. Sponsors can view the responses through a Teckro dashboard or download as a spreadsheet for further analysis.

Built on the Teckro platform, sponsors can decide to add Teckro Survey to their study. A simple wizard interface walks them through the process of creating of a survey. For users, they simply receive alerts when surveys are sent to them, there is nothing extra that needs to be added or installed.

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