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.
Enrollment figures confirm what the study team hoped would happen: When the study protocol is immediately on hand, it is easier to confirm eligibility criteria and therefore sites would enroll participants faster. This is exactly what happened. Leading up to the COVID-19 pandemic, the trial was ahead of its recruitment targets, which the study team attributes, at least in part, to making it easier for research staff to look up inclusion and exclusion criteria from a digital device when they are with a patient. The main interface to the protocol is Teckro, though site coordinators could request a PDF copy of the protocol for their sites. Still, the vast majority of sites use Teckro. The result is that sites that are active on Teckro randomized 3x more participants than those not using Teckro. In fact, sites not using Teckro at all only contributed 15% of the total number of participants randomized.
The fact that the protocol is only distributed via Teckro helped increase site adoption and usage. It also saved time and effort as no FAQs are manually maintained. More than 80% of all sites invited registered on the platform and 90% of CRAs are active. The feedback to the study team from both CRAs and site staff is overwhelmingly positive as they are happy to replace the habit of retrieving paper with their mobile phone. Not only does it save time, it also makes investigators, study coordinators and the CRAs more likely to look up information more often. This not only supports their decision making for enrollment, it also reduces errors.
Given the number of sites, the study team didn’t want to ship paper or update documents in a portal for each new version. Since the launch of the study, there have been four protocol amendments and two versions of the pharmacy manual. However, study information in Teckro is always the correct, current documents, so the study team doesn’t have to worry about version control. Looking at the usage patterns, it confirms that research staff want study information on the go as 75% of site staff access Teckro from a mobile device. And not surprising, eligibility and screening are among the Top 5 searches.
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.