Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.
According to GlobalData’s Clinical Trials Database[1] the number of clinical trials has increased sharply since the pandemic began, with the number of studies using DCTs rising each consecutive year, although this has now levelled off. However, numbers are still much higher than 2019, indicating the use of telemedicine is set to remain post-Covid.
The most used virtual components in DCTs, according to GlobalData’s Pharma Intelligence Center[2], are remote patient monitoring and telemedicine (39%); wearables such as glucose or heart monitors (26%); web-based technologies such as eConsent and eDiary (25%); mobile tech e.g., emails, text messaging and smart devices (18%); and in-home devices such as blood pressure monitors and oximeters (15%).
Overview of last year’s DCT activity
North America dominates DCT landscape
Analysis by GlobalData[3] shows that North America dominates industry and non-industry DCTs, with a total of 4,117 trials as of September 2022. This is followed by Europe (3,146 trials), Asia Pacific (2,460), Middle East and Africa (855), and South and Central America (600). Values for North America are particularly high due to the highest revenue pharmaceutical corporations being based in the US. Most of these sponsors are eager to use technology to streamline the clinical trial process, and incorporating virtual components into trials can help reduce costs and improve efficiency.
Phase II and III show most use of DCTs
In 2022[4] the majority of DCT trials were in Phase II (43.0%), followed by Phase III (25.0%), Phase IV (20.9%), and Phase I (10.9%). Phase II and Phase III trials have a higher number of trial participants, and DCTs can help ensure these trials are more accessible to participants, with faster data collection and analysis for larger participant groups. Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person.
Metabolic disorders are top therapy areas
Analysis curated by GlobalData[5] shows the top three therapy areas for DCT adoption in the first quarter of 2022 were metabolic disorders, followed by central nervous system (CNS) and genetic disorders. Metabolic disorders have remained the leading therapy area for DCT adoption for over five years, mainly due to the use of wearables, such as glucometers, and other smart devices. The therapy area with the fourth highest percentage of digital trials is infectious diseases. Initially accelerated by the pandemic, this growth continued into 2022 with infectious disease trials still ranking high in DCT adoption.
Hybrid DCTs cover more diseases
While some therapy areas can conduct trials on a near-fully digital approach, the hybrid model allows more diseases to be covered in clinical trials by at least some elements of telemedicine, most of which have been used already in healthcare settings. Remote monitoring platforms and wearable devices have become commonplace and easy to incorporate into a study design. For some therapy areas, such as dermatology, recent improvements in remote video capture quality allows more accurate virtual assessments, and analysis shows[6] that nearly 24% of dermatology DCTs now incorporate this virtual component.
Use of DCTs in regenerative medicine remains very low
Despite an increase of clinical trials for regenerative medicine, due in part to increased funding, this is the one area that remains behind the curve in terms of DCT use. DCTs in regenerative trials are restricted due to tighter controls of sample collection and administration of gene or cell therapy at home, such as stem cells, which can require injections into the spinal cord. However, there is still some use of remote patient monitoring technologies.
Projections for 2023
Digitalisation is key moving forward
Fully utilising digitalisation as part of a DCT can result in savings in both time and costs. In a 2022 poll for GlobalData[7] readers of Pharmaceutical Technology said they believed that wearable technologies and AI carried the promise of improving DCTs the most.
Alongside the use of patient Electronic Health Records (eHRS), eConsent is now often used to request, confirm, and document informed consent for trials, and electronic trial master file (eTMF) systems utilise both hardware and software to manage clinical trial data.
Recent developments in artificial intelligence (AI) and machine learning are being used in clinical trial recruitment by integrating information collected from wearables, eHRS and other medical devices into ‘matches,’ which are then recommended to doctors and patients. As this process can be conducted virtually, combined application of AI and wearable technologies could bring synergistic benefits to DCTs.
For instance, AI chatbots can review a patient’s symptoms and suggest next steps, such as an in-person follow-up. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022[8], and growing use is expected throughout 2023.
Industry view on using technology to address clinical trial disruptions
According to ‘The Covid-19 Pandemic Impact on Clinical Trials’ survey tracker conducted by GlobalData between 2020-2022, remote patient monitoring and DCTs were selected as the two most common methods that companies used to address clinical trial disruptions. Rapid uptake of this trend towards DCTs has been accelerated by regulatory authority’s support of remote monitoring and virtual trials during the Covid-19 outbreak.
However, in a recent survey reported by GlobalData, Digital Transformation and Emerging Technology in the Healthcare Industry, 2022, 39% of surveyed industry stakeholders said that they are expecting to witness a decrease in investment in emerging technologies over the next 12 months, due to current economic conditions and financial disruptions.
However, in the same survey, a third of respondents said that they believed inflation would have no impact on investment with digital transformation. Indeed, over 75% of respondents claimed to be optimistic about digital transformation growth in their organisations during the next 12 months, with this result consistent across all business sizes and geographic regions.
The analyst’s view
Priya Nair, Senior Analyst, Clinical Trials, GlobalData, shares some of the DCT trends she expects to see for 2023.
Therapy areas
“In 2022, CNS and metabolic disorders had the highest counts for DCT usage, and I think this may remain the same, but there could be a slight shift towards DCT involvement in rare disease trials as it should be easier to conduct trials investigating rare disease populations.
Overall, I think trends will be similar to last year, with some indications more easily remotely monitored than others. For example, there may be fewer home measurement trackers or sensors in oncology compared to other indications, which may justify the reduced number in DCT trials for oncology. Some indications have more challenges to overcome, such as the administration of therapeutics (such as intravenous medication) or the need for in-person monitoring.”
Technology
“DCTs are still relatively new, with the influx of usage occurring between 2019-2021 due to Covid-19 restrictions, but now sponsors are aware of how useful they can be. For DCTs, even a small virtual component can make the trial somewhat decentralised. For example, the patient completing an e-diary.
When it comes to AI and digitalisation, these are already having a positive influence on DCTs, and I think this will continue. As different technologies evolve, incorporating them into the trials space will only help streamline the process and potentially aid in drug analysis.”
Looking ahead to 2023: Key takeaways
The next year is shaping up to be one of digital transformation, with increased use of data, combined with machine learning and AI for analysis. Sponsors are also starting to take a more data-driven approach to studies, using data and AI to model and use predictive analytics for trial design, leading to more ‘bespoke’ solutions.
Political aspects may also influence DCTs in the coming year. Geopolitical instabilities and the pandemic are still affecting global supply chains and with continuing travel restrictions, sponsors may move to using DCTs more in these areas.
Finally, the patient will become more centric, with greater engagement and active participation than perhaps ever before as sponsors incorporate virtual elements at all levels, from e-diaries to in-home devices.
Huma is a global healthcare company, spanning across multiple geographies and operating across four continents. Powering some of the world’s largest DCTs, Huma enables better research by remotely collecting real-world data. For further information, download the paper below.
[1] The Movement Towards Decentralized Clinical Trials, GlobalData, October 2022
[2] GlobalData_DigitalTransformationandEmergingTechnologyintheHealthcareIndustry2022_210223
[3] The Movement Towards Decentralized Clinical Trials, GlobalData, October 2022
[4] The Movement Towards Decentralized Clinical Trials, GlobalData, October 2022
[5] https://www.clinicaltrialsarena.com/analysis/dct-adoption-tracker-who-and-what-is-at-the-crest-of-the-trial-decentralisation-wave/
[6] https://www.clinicaltrialsarena.com/features/dct-adoption-archetype-therapy-area/
[7] GlobalData_DigitalTransformationandEmergingTechnologyintheHealthcareIndustry2022
[8] https://www.medicaldevice-network.com/comment/artificial-intelligence-medical/
