DocMe DCT: stepping up Decentralised Clinical Trials with AI
Biomedical sciences and technology fuel the opportunity to transform R&D for new drug development. However, clinical trials, fundamentally, are about patients and their journey. Therefore, we should strive to see the process through their eyes and put them at the centre of what we do. If not, we’re doing them a disservice. We must challenge ourselves to learn from our experiences during the pandemic and continue to deliver innovations for the patients.
Studies show that 70 per cent of potential participants live more than two hours from trial sites, half of clinical trials participants find it difficult to stay enrolled due to poor health, and 85 per cent of trials fail to retain enough patients.
Conventional clinical trials impede the speed and resource efficiency of pharmaceutical drug development processes and manufacturing productivity.
Fully decentralised or hybrid (a mix of site and home-based activities) clinical trials have huge potential to positively impact clinical trial.
There is a considerable advance in electronic communication tools, data transmission, digital technology, and development in the field of biosensors. These developments open new possibilities for information exchange between investigators and patients. The goal of the DCT is to make clinical trials easier for patients by reducing or eliminating the need to travel to research sites. This approach has shown to reduce drop-out rates, increase study effectiveness, and ultimately get life-altering drugs to market faster — saving sponsors billions.
One of the first peer-reviewed as- sessments of a fully DCT — the DeTAP study - saw rapid recruitment (94% in 12 days), high engagement and im- proved medication adherence from 85% to 96%.
Decentralisation broadens trial access to reach a larger number and potentially a more diverse pool of patients.
DocMe is proud to be part of an important transition from traditional clinical trials to decentralised ones. DCTs are new, innovative and exciting ways to bring benefit to patients in trials. DCTs allow for more efficient data generation and analysis than traditional clinical trials which means better treatments can be developed faster. This saves time and money which can then be spent on developing new drugs rather than repeating old ones which have already been tested but failed because no one knows why they didn’t work!
DocMe and DCTs
DocMe is a patient-centric data platform that enables patients, researchers and healthcare providers to collaborate on the creation of real evidence for better healthcare (Fig 1).
DocMe’s innovative DCT platform is the first AI-powered solution for DCTs. The DocMe platform has the potential to improve trial participation, diversity, engagement and efficiency at scale.
DocMe’s aim and the DCT challenge
DocMe is a computer vision-based AI platform that enables measuring health vitals from a face video, data sharing and the exchange of information in clinical trials.
DocMe uses existing photosensors in smartphones to run RGB analysis of images captured during a 30-second face video. Photosensors paired with light-sensitive photodiodes detect the amount of blood flowing through different regions of interest from the video footage. By repeating these measurements hundreds of times per second, DocMe algorithms can calculate the number of times the heart beats each minute, heart rate variability, respiratory rate, blood pressure and, in time, other physiological assessments. Also, our algorithm is designed to compensate for low signal levels by increasing both resolutions of the image and the sampling rate.
Furthermore, the DocMe DCT platform offers an all-inclusive solution for data collection, management and analysis for researchers and medical professionals. DocMe aims to help clinical trial participants to share their data with researchers and scientists in a secure manner by allowing them to anonymously undergo tests at home or work without having to travel long distances or wait for appointments at clinics or hospitals.
In recent years there has been an increasing focus on how technology can improve standards of healthcare delivery worldwide but still many challenges remain regarding decentralised clinical trials. The main reason why DCTs have not been widely adopted yet lies in their complexity when compared to traditional ones: they require complex data collection protocols due to remote patient recruitment while ensuring compliance with regulatory requirements; they raise privacy concerns among patients who may not wish others know about their participation; they generate high volumes of unstructured data which need proper storage solutions; they involve multiple parties such as trial sponsors, investigators etc.; last but not least — it takes time before results are obtained!
From the lab to the patient’s bedside
A decentralised clinical trial (DCT) is one in which the study treatment is made available to participants at multiple centres, rather than only at a central site. As you might imagine, this has some benefits over traditional trials:
- Subjects can receive treatment closer to home and participate in research while they are experiencing an acute episode that may otherwise make it difficult or impossible for them to travel. The workload on staff at each centre is also reduced since there’s no need for them all to come together during treatment sessions or data collection.
- Placing participants in different locations enables researchers to test whether results vary depending on geography (say, whether cold-related symptoms clear up faster in one country as compared another).
However, decentralisation comes with challenges too: it requires new systems and protocols so that participants can be enrolled across multiple sites; there may be differences from one place to another when it comes down to how well a given medication works; and even though patients might be able to get their dose more conveniently through DCTs, the extra effort involved means that compliance rates could drop off because of convenience issues or other problems related directly back into clinical trial design itself — these are just some examples out of many possibilities!
DCTs are a great alternative for patients
DCTs have a strong potential to drive health security and patient benefit, demonstrating improved productivity and reduced time to market, de-risk the use of transformative digital and automated data collection technologies, address net zero and sustainability goals through novel manufacturing technology, showing how digital and automated data collection technologies can improve resource efficiency, and support equality, diversity and inclusion via project initiatives and project outcomes.
DocMe’s solution for DCTs
The DocMe DCT platform is a patient-centric health technology platform (an app for patients and a Web portal for researchers) that supports decentralised and hybrid clinical trials and can help bring effective treatments to patients faster.
The DocMe DCT App will be available on Android and iOS. It will be available in multiple languages, including English, French, Spanish and Chinese (Simplified). The app will allow patients to access the DocMe network and make appointments with participating doctors so they can get an accurate assessments.
Researchers will be able to verify e-Consent, check the eligibility of the patient and enrol patients virtually. Furthermore, the DocMe WebApp will allow the clinical research team to perform rapid data analysis in real-time and request more data from patients if needed. They will be able to generate e-CRF. Finally, sponsors of clinical trials (i.e., pharmaceutical companies) will be able to close-out the study and carry out post-study surveys totally virtually.
DocMe is proud to be part of an important transition from traditional clinical trials to decentralised ones.
DocMe aims to make clinical trials more accessible for patients by providing a novel patient-centric DCT platform. In addition, DocMe makes it easier for researchers by providing support systems that automate much of their workload so they can focus on caring for their patients during their appointments.
Three core tenets differentiate DocMe from the other innovations:
- Simplicity: DocMe keeps tasks for patients as simple as possible. The DocMe app helps patients to measure and record health vitals accurately by simply taking a selfie on their smartphones.
- Accessibility: DocMeuse technology that’s easy to use and intuitive to learn. DocMe’s award-winning app fits seamlessly into patients’ daily lives and is acces- sible on devices they already use and are familiar with.
- Reliability: DocMe makes sure the tools and processes have been thoroughly tested. The DocMe app is soon to be approved as a Class IIb medical device — the world’sfirst to detect hypertension from a face video. Also, DocMe will have the ability to use patient feedback to continually improve the processes and reliability throughout the lifecycle of the trial.
DocMe DCT aims to measurably increase the speed and resource efficiency of pharmaceutical process development and manufacturing productivity.
Conclusion
DocMe is embracing a new era of clinical trials with decentralised data collection. We believe that this will bring huge benefits to patients and make it possible for more people around the world to participate in trials.
If you want to learn more about how DocMe is stepping up DCTs, come and say hi at the BioTechX Europe conference between 8–10 November 2022 at Basel Congress Center, Switzerland. We’re a Start-up at #BioTechX 2022, Europe’s largest congress covering diagnostics, precision medicine and digital transformation in pharmaceutical development and healthcare, bringing together 2,000+ industry experts.
