In a clinical trial, there is a bigger burden of implementing digital tools on the contract research organisation (CRO) than the principal investigator, but the latter has a bigger responsibility regarding data collection, said John Zibert, CMO of the Swedish biotech Coegin Pharma at a recent talk on decentralised clinical trials (DCTs).
Zibert was emphasising the importance of patient safety and investigator responsibility during a talk at the 12th Annual Outsourcing in Clinical Trials & Clinical Trial Supply Nordics meeting that took place in Copenhagen, Denmark, 1–2 October.
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In a DCT, the CRO’s responsibilities include technology support and evaluation, and online outreach, said Zibert. Additionally, it is important that principal investigators are involved in pre-screening and oversight from the beginning, he added. All through this process, Zibert stressed the importance of educating a patient on how to use digital elements in a clinical trial.
Patient education when using digital tools in clinical trials is crucial. Utilising e-learning via YouTube, emails, or texts to provide information on the indication, facts about treatment, and study protocol improves patient autonomy and holds the potential to reduce staff workload and guarantee patient safety in the trial, said Zibert.
When discussing the advantages and disadvantages of digital tools in medical setting, Zibert highlighted that there is an increased risk of human error when participants are operating sensors and machines such as blood pressure devices remotely. He added that data accuracy might be reduced, since “data is generated offsite and collected through processes that have not been solidified as reputable yet”. Until more studies have shown consistency and reliability in virtual trials, many sponsors may not back this type of clinical study, said Zibert.
However, in many cases, the advantages override the cons. Studies show that nearly 49% of the original set of participants in a study will not make it through the entire timeline and drop out due to transportation and daily life issues, said Zibert. Transport to and from sites is one of the main reasons people drop out of clinical trials, so DCTs (with remote monitoring) can lead to less patient turnover, he explained. With a DCT, capturing data more consistently and in real time makes the study’s timeline more efficient and allows for better safety and measurement opportunities, he added. When turnover rates are lowered, ultimately operating costs are reduced due to the reduced manhours, which is one of the most expensive aspects of clinical trials, said Zibert.
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