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Digital endpoints in clinical trials: DHTs. Game changer or not?

Digital endpoints in clinical trials

Digital health technologies (DHTs) like mobile applications, wearable sensors, telehealth, and health information technology represent the convergence of technology, health data, and advanced analytics. DHTs offer great potential and opportunities to transform diagnostics, drug development, and patient healthcare access. 

As we are moving from traditional trial models towards Unconventional Trial Designs, digital endpoints are being explored as primary and secondary (endpoints) across multiple clinical trials. They have accounted for ~63 of 225 trials in the Digital Medicine Society (DiMe) database until 2021. These digital tools utilize novel and validated technologies to prevent, manage and treat diseases complementing or replacing current treatments.

The diagram below (adapted by Parla Işıl Yüksel et al in Digitalisation in Clinical Trials from Utrecht University) shows the growth of trials registered in the library of endpoints between 2005 and 2021. 

Figure 1: Τrials registered in the library of digital endpoints (DiMe)

DHTs: What is their potential?

Multiple companies are trying to leverage DHTs to improve their existing endpoints or identify novel digital ones that we could not measure before. For instance, now we can use DHTs to investigate the burden of sleep disturbance, identify cognitive behavior in patients with mental disorders or monitor blood glucose levels in diabetics in the comfort of the patient’s home.

The development of novel digital measures of clinical indications will significantly impact drug development. It will assist in generating newer critical insights around diseases, the efficacy and safety during preclinical and clinical development, and the real-world effectiveness of already approved products.

Current regulatory DHTs landscape 

In December 2021, the US FDA published for the first-time draft guidance on data acquisition through digital tools during clinical investigations. This indicated how serious the regulatory authorities were in accepting digital endpoints to support drug approval procedures. We expect complete guidelines from the US FDA within the next period. 

The draft guidance provides details on DHTs check, validation, and assessment regarding their usability in a clinical trial. Trial sponsors need to ensure DHTs’ accuracy and validation to support their use during the trial and after the study. We expect validation studies in different backgrounds like gender, age, ethnicity, and geography.

Collaborations and alliances in DHTs space change the game.

Since no regulatory guidelines clearly define the use of DHTs in clinical applications, professional groups and industry-wide collaborations are emerging to drive their use in healthcare innovation. The development of high-quality, evidence-based digital products and services for clinical use is now being supported by the Digital Medicine Society (DiMe) and Digital Therapeutic Alliance (DTA). 

DiMe was founded in 2019 and was the first organization to bring together professionals from multiple disciplines in the diverse field of digital medicine. DiMe introduced a toolkit for 3Ps of digital endpoint value, namely patients, pharma, and payers, to ease the inclusion of digital endpoints as evidence for payers during reimbursement decisions. This toolkit was created over 2-3 years in partnership with multiple companies active in the field.

DiMe has an open-access library of digital endpoints for clinical trials of new drugs or medical products. This collection of unique digital endpoints reportedly has expanded by ~790% since 2019, with multiple sponsor organizations turning to these measures to answer new research questions on medical products

The Digital Therapeutics Alliance (DTA) is an association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics. It recently published the first guidance on digital therapeutics best practices called ‘Value Assessment & Integration Guide. The guide was developed through a collaborative process incorporating insights from payors, clinicians, and manufacturers to ensure applicability across settings. The guide is updated regularly and serves as a leading framework for evaluating and implementing DHTs.

DHTs current trends: Strategic investments, growth, and new players

DHTs are now becoming an integration of information systems and healthcare processes aiming to simplify the tasks of healthcare providers to improve patient experiences. Therefore, rising demands for technological adoption in healthcare are likely to increase the DHT market performance. The current trends that are shaping the DHT space are: 

Top digital therapeutics companies

Currently, the key players in the DHT market leaders are primarily focused on acquisitions or partnerships with other companies working in the space. There is a considerable number of companies and startups working on new approaches and new product launches. 

Prominent companies that have a significant customer base are:  

Future prospects and challenges of digital endpoints

While the digital transformation of healthcare is disruptive, it comes with the challenges we discuss below. 

After addressing these challenges, we see data exchange as a key parameter for the creation of a continuum of care having the potential to enhance health outcomes. And digital health can become a priority benefiting people in an equitable, scalable, and sustainable way. 

 

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#digitalendpoints #DHT #Digitalhealthtechnologies #clinicaltrials #DCTs #digitalhealth #wearables

 

Sources:

https://www.iqvia.com/solutions/research-and-development/decentralized-trials

https://medcitynews.com/2022/05/digital-endpoints-global-opportunities-and-clinical-data-protection-and-other-challenges/

https://www.dimesociety.org/about-us/

https://www.clinicalleader.com/doc/when-how-to-develop-a-novel-digital-endpoint-in-clinical-research-0001

https://www.clinicalleader.com/doc/fda-releases-guidance-on-digital-health-data-acquisition-in-clinical-investigations-0001

https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs

https://www.outsourcing-pharma.com/Article/2022/08/01/curavit-swing-team-up-on-fibromyalgia-therapeutic-trial

https://www.prnewswire.com/news-releases/fulcrum-phase-3-fshd-clinical-trial-using-amra-medicals-whole-body-mri-measurements-as-a-key-secondary-endpoint-301585824.html

https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs

https://www.clinicalleader.com/doc/fda-releases-guidance-on-digital-health-data-acquisition-in-clinical-investigations-0001

https://www.clinicalleader.com/doc/when-how-to-develop-a-novel-digital-endpoint-in-clinical-research-0001

https://www.dimesociety.org/tours-of-duty/v3/

 

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