Decentralised Clinical Trials
With the total CAPEX for an approved new drug estimated at $2.6 billion, more patient-centric clinical trial design and operation is a business imperative for sponsors and clinicians.
Decentralised Clinical Trials (DCTs) are seen as the future of medical product development and focus on bringing the trial to the patient instead of patients travelling to clinical investigations sites.
DCTs represent an innovative way to design trials and address several patients’ needs including
- reduced travel to investigation sites and associated cost of travel
- minimised disruption to patients’ daily lives
- more frequent assessments that can be conducted in the patients’ home
DCTs take into account the constraints and needs of all stakeholders, which in turn is likely to boost recruitment and study adherence, leading to better study outcomes and reduced time to market for sponsors.
Aparito’s digital health technology platform helps stakeholders decentralise their clinical trials and enables patients to engage with clinical trials via a user-friendly interface using iOS and Android devices.
DCTs and novel digital endpoints
DCTs are not new but the increase of decentralised trials has been amplified by the pandemic and a consensus emerging that it could remain a permanent shift in the clinical trials landscape (Changes for CT).
A clear advantage of DCTs is that patient enrollment and retention are expected to be much higher by using patient-centric features, especially for patients with rare conditions, especially when we consider that 55% of people state that site location is very important to them in a clinical trial.
Though not all parts of DCTs (e.g magnetic resonance imaging or neurological exams) can be decentralised and lend themselves more towards hybrid clinical trials, moving clinical trial activities closer to patients is enabled by a range of new technologies and services such as eConsent, electronic patient-reported outcomes (ePROs), remote patient monitoring (RMP), and electronic clinical outcome assessments (eCOAs).
From a patient’s and physician’s perspective, DCTs are considered an improvement in terms of practicality and convenience but not all patients favour this virtual approach (Survey on DCT and Hybrid), whereas, from a regulatory point of view, the current ICH guideline R6 (ICH guideline) on Good Clinical Practice (GCP) is being revised to incorporate additional considerations for non-traditional Interventional clinical trials (i.e. hybrid or decentralised trials) in consultation with industry, healthcare professionals and patients groups.
But with new tools and technologies come new challenges and apps, tools, and wearable devices must be fully validated — taking into account the latest regulatory guidance — to ensure that reproducible and reliable signals are generated for the key clinical endpoints.
Aparito and DCTs
At Aparito we navigate the challenges of DCTs by working with sponsors and clinicians to design and validate novel digital endpoints. Our clinical trial platform, coupled with the use of a wearable device, can reliably monitor the patients from their home settings, and the use of video assessments and telemedicine removes the need for clinical site visits where in-person assessments are not vital for the study.