Clinical trials using "unsophisticated approaches" despite availability of newer technology

Clinical trials are using “unsophisticated approaches” to interact with protocols despite the availability of smartphones and tablets, new research shows.

Research conducted by the Tufts Center for the Study of Drug Development (CSDD), in collaboration with software company Teckro, highlights how the majority of clinical trials are still reliant on paper and desktop computers to reference protocol instructions. 

The study includes responses from 228 investigative site staff and looks at how and when they interact with the clinical trial protocol. The study found that the majority (87%) of respondents refer to paper versions of the protocol “very” or “somewhat often”. More so, 80% of investigative sites report relying on direct communications with the study monitor or clinical teams for protocol instructions, while 79% rely on static PDF versions of the protocol via desktop computers.

The research also found that smartphones and tablets are rarely used to access online versions of the protocol due to difficulty of navigating PDFS on smaller devices. The study found that only four in 10 refer to frequently asked questions via an online portal. 

For 80% of respondents, the primary way they receive protocol amendments is via email. Only 13% of respondents said they access updates via online portals.

“The study results indicate that the majority of investigative sites are using unsophisticated approaches when referring to the protocol to guide clinical trial administration. This is not surprising given the high proportion of sites that are inexperienced, with minimal infrastructure, and — in many cases — involved in clinical trials as a supplemental activity to their clinical practice,” says Ken Getz, deputy director of the Tufts CSDD. “As clinical trial activity becomes more virtual and remote, facilitated in part by the pandemic, we expect to see investigative sites using more mobile, flexible technology solutions offering dynamic data updated in real time.” 

The study indicates that clinical trials are using time intensive methods to get answers regarding protocol administration, with a high percentage turning to study monitors. Around six out of 10 (58) respondents report that it takes more than 20 minutes to get an answer. 

“What started with a question turned into a collaborative research project between Teckro and Tufts CSDD. The results point to ways we need to make it easier for research staff to conduct clinical trials,” says Brendan Buckley, Teckro chief medical officer. “It’s usual for people to do an online search or to ask Siri or Alexa when they have a question. Within an instant, they get access to hundreds, thousands or even millions of answers. Why isn’t it the same with clinical trials?”