Our first decentralised clinical trial (DCT) Adoption Tracker update delved into clinical trial decentralisation trends in Q1 2022, followed by an analysis of top therapy areas using a decentralisation approach. We now look at seven decentralisation categories across 10 different therapy areas to explore emerging decentralisation archetypes.
The analysis reveals that, with some exceptions, robust disease area-specific decentralisation archetypes are yet to emerge. Some of the virtual components, such as telemedicine, are easier to implement into a clinical trial design due to their previous use in healthcare settings.
While some therapy areas may lend themselves better to a near-fully decentralised approach, the hybrid model opens itself up to a lot more diseases, says Rachael Scott, chief commercial officer at Lightship. She adds that, over the next few years, more therapy areas will come on board and grow their decentralisation capabilities.
Clinical Trials Arena has established an exclusive taxonomic approach involving the review of thousands of drug trial public records from the last 12 years to categorise different decentralised elements per therapy area, as curated in the Clinical Trials Database by GlobalData, the parent company of Clinical Trials Arena.
Telemedicine and remote monitoring dominate in most therapy areas
Telemedicine and remote monitoring via sensor, device, or tracker, were the most prominent decentralisation components across most of the analysed therapy areas. These elements are more straightforward to implement in a clinical trial and some therapy areas already had a head start of using them as a part of the standard of care clinical setting, says Sepehr Shojaei, vice president of design solutions at Lightship. Metabolic disorders were the only therapy area where telemedicine did not dominate.
The Covid-19 pandemic also accelerated the use of telemedicine. Scott says that this component was already available for the industry to use but was underutilised, and once the pandemic began, it became a tool to save the ongoing and planned clinical trials.
Clinical Trials Arena previously reported that telemedicine is yet to catch up in dermatology due to poor video quality and lack of personal assessment. Virtual assessments can be impacted by the lighting in the room where the patient is sitting in, says Paul O’Donohoe, senior director of eCOA product and science at Medidata Solutions. However, telemedicine technology is improving in dermatology through the use of image-capturing solutions instead of video visits. The analysis shows that nearly 24% of dermatology DCTs incorporated this virtual component.
Even though dermatology is trying to standardise imagining components, some assessments need to be completed in person because they are not validated on telemedicine, Shojaei says. Sponsors should consider offering patients decentralisation to home option with clinical staff completing assessments in person to overcome technical challenges, he adds.
In terms of remote monitoring via sensor, device, or tracker, wearables have become a common part of people’s lives, and it is easy to incorporate them into a study design, Shojaei says. Clinical Trials Arena previously reported on the rise of remote monitoring in clinical trials.
However, the exact role and purpose of such devices is yet to be determined, as some sponsors are including them in an exploratory way, O’Donohoe notes. “Wearables are a significant aspect of the future of clinical trials, but I think we're still very much in our infancy in regard to figuring out how to use them,” he adds.
For example, activity tracking is easy to add to the trial design, but it can be unclear what that data actually translates to. While patients might be used to wearables such as smartwatches, it is a massive change for data analysts on the other side of the device, O’Donohoe says. “If the patient’s activity level increased by a certain amount, is it a bad or a good thing? Are they pacing because they are in more pain or not?” he explains.
Variability in digital outcomes
The use of electronic clinical outcome assessment (eCOA), electronic patient-reported outcome (ePRO), and eDiaries varies significantly across therapy areas, with the lowest percentage in oncology, cardiovascular, and metabolic disorder clinical trials. Dermatology has the highest proportion of trials utilising ePRO, eCOA, and eDiary components.
This is likely due to the complexity of the disease that doesn’t allow the easy use of some technology, Shojaei notes. However, eDiaries and eCOAs are now incorporated more into patients’ journeys. Such a trend is seen in oncology, as these patients have many clinic visits and weekly follow-ups, so incorporating some sort of digital component at home can ease that burden, he adds.
On the other hand, it is less about the complexity of the trial and more about the importance of the eCOA data, O’Donohoe says. Therapy areas like cardiovascular and metabolic disorders are more driven by physiological measurements and use less of the “how are you feeling?” aspect, he explains. O’Donohoe notes that it is still important to ask the patient about their well-being, regardless of the therapy area and key endpoints.
O’Donohoe points out that there is an overlap of terminology between digital data collection and eCOA, as the latter can be seen as a subset of digital data collection. “We are still getting our heads around how to talk about this in a very clear way,” he adds. Indeed, the lack of common language across DCT stakeholders has always been a challenge.
In this analysis, digital data collection refers to a collection of information or data that are not directly related to an outcome in the trial protocol but refers more generally to the collection mechanism or technology such as mobile devices and digital communication channels. These decentralisation elements are most commonly mentioned in oncology, central nervous system (CNS), and infectious disease trials.
While the analysis did not reveal disease area-specific trends, the use of eConsent was consistently and relatively low across all therapy areas. The slow uptake of this approach to the consent process is likely due to different procedures around consent across various types of sites and, as a result, sponsors cannot force sites to use it, Shojaei says.
Another challenge is the acceptability of the eConsent from a regulatory perspective that varies country by country, especially when it comes to electronic signatures (eSignatures), O’Donohoe adds. This results in uncertainty from the sponsors’ side and if they sense potential hurdles, they default back to paper documents which can be perceived as a risk-free solution. However, paper is not risk-free, especially when it comes to the logistics of managing and storing it, reconsenting, and making sure they have the right version of the document, he explains.
Some clinical trials have more complex and complicated consents that need to be reviewed in person with a physician. While the technology is available for use, sponsors need to ensure that patients understand what they are consenting to, Scott says. If consenting happens at the patient’s home, there should be a nurse with the participant and a physician attending via telemedicine to assist the person if they have any questions, she adds.
One way to improve the implementation of eConsent is by making it user-friendly and interactive, and it should act as a “knowledge-check”, Shojaei notes. This way, sponsors can be safe in knowing that the patient has understood the protocol and they are consenting in the right manner.
eConsent can be used just as a learning tool for the patient to learn more about the study but the signature is done on paper, O’Donohoe says. “We can still use the technology in a way that ultimately benefits patients, but if there are concerns about the eSignature, we can then support that paper signature process,” he explains.
Currently, eConsent is not standardised across sites and sponsors, Shojaei says. It is very broken up in terms of who uses what, so having some level of standardisation will help increase the use of this technology, he adds.
Trials at home
The proportion of trials using decentralisation to the participant’s home or alternative site approaches such as mobile sites is the highest in infectious diseases, genetic disorders, and haematological disorders. However, Scott notes that there is an increasing interest for home delivery in cardiovascular, metabolic, and respiratory therapy areas.
Also, oncology companies are seeking solutions around the hybrid-decentralisation model to ease the patient burden, Scott notes. “The most important thing is patient safety and if data can be collected in an appropriate manner,” she adds. Clinical Trials Arena previously reported on ways to bring the clinical trial to the patient’s doorstep by using sites on wheels as an alternative decentralisation approach.
More insights on DCT adoption trends:
Clinical Trials Arena reviews the burgeoning trend on remote monitoring and looks into regulatory know-how needed to ensure success.
Clear regulatory guidance, existing healthcare infrastructure, and local culture are key influencers for swift decentralisation uptake.
As the clinical trials sector sets records for vacancies for jobs focusing on decentralisation, Clinical Trials Arena investigates professional pathways into DCT.
Clinical Trials Arena investigate which paediatric disease spaces are using decentralisation the most and why.
A remote revolution is transforming how clinical research is devised – but ambiguity in decentralisation approaches can curb adoption.
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