No More Paper, No More Portals
How a Top 10 Sponsor Exceeded Recruitment Targets with Teckro

It’s not a stretch to say that enrollment can make or break a clinical trial. Nearly half of all sites under enroll or fail to enroll a single participant, according to statistics from the Tufts Center for the Study of Drug Development. Without participants, trials are delayed. In some cases, eligibility criteria are amended. In more extreme cases, trials are cancelled because there aren’t enough people to participate.

For a Top 10 sponsor, the study team for a large respiratory clinical trial wanted to do as much as they could to help research staff quickly enroll participants. They decided to make the study protocol and related documents available via Teckro, forgoing paper shipments, PDFs in online portals, and manually-created FAQs. Site coordinators could optionally request a PDF of the protocol for their sites, but it was not encouraged by the study team. With Teckro Search, the current protocol – and therefore the current eligibility criteria – are always on hand from any digital device so that physicians can decide instantly whether the person in front of them is a candidate for the clinical trial.

Immediate answers at the point of care allow research staff to make better decisions throughout the study. Better than any “cheat sheet” or quick reference guide, Teckro puts the protocol plus any other supporting study documents in the hands of research personnel on their smartphones. Working with study teams, we ensure that the right documents are available for the right sites to reduce the risk of anyone following the wrong version of the protocol. Real time answers are always available to enroll the right patients, properly carry out the procedures for a given visit, and correctly assess how to respond to adverse events.

Looking at search trends gives the sponsor insights into the types of questions sites have. Keywords being searched can highlight areas where sites may need more information. Equally, high-risk terms could provide an early view into potential safety issues. Based on the stage of the study, search terms will naturally shift from eligibility to visit assessments and safety, such as reporting requirements for adverse events and dose modifications. All of this provides a wealth of information for the sponsor to understand what research staff are facing and take proactive action.

Search activity also gives the sponsor visibility into which sites are engaged with the trial. Those sites with more search activity, particularly during the enrollment phase, are more likely to meet recruitment targets than those sites without any activity. In this case, there is a stark difference in screening results for sites using Teckro to confirm eligibility compared with those sites not using Teckro. With immediate access to the protocol from their mobile phone, answers to help with eligibility decisions are just a couple of taps away.