Introduction
The adoption of decentralized trials (DCTs) has rapidly soared due to the rush to conduct clinical trials during- and post-pandemic, with increased competition among biotech companies. Early 2020 saw a sharp increase in decentralized methods, mirroring the sharp increase in total trial activity driven by COVID-19 therapy and vaccine development. Additionally, the highest quarterly utilization of decentralized methods in Q4 2021 suggests that the industry continues to push into a new territory with this set of innovations1. The rise in popularity of DCTs may be seen as a game changer, so what are the key trends, considerations, and benefits of adopting DCTs?
Shift in DCT adoption in Asia Pacific
DCTs bring an increased proportion of a trial’s activities to patients2 through online medical consultations, digital devices for remote monitoring, assessments, and samples collection at the patients’ homes or local health services.
Australia started adopting DCTs in 2017 not only due to the vast size of the country, but also their early understanding of its potential. Other countries in JAPAC adopted DCTs due to the pandemic, resulting in the heightened development and operation of DCTs. Some emerging biopharmas (EBPs) have adopted DCTs as a contingency solution, while others have started implementing them at the planning stage of their studies.
Benefits of DCTs
One key benefit of DCTs is the patient centricity of the trial design. DCTs provide a convenient end-to-end patient experience that reduces patient burden, e.g. travelling times and cost, and improving patient engagement and satisfaction3. This leads to better patient compliance and retention, rapid trial completion and greater access to new patients who would not have otherwise participated.
DCTs can also decrease site burden by using technological platforms that act as better engagement channels and allow EBPs to gain access to real-time patient progress on demand. For example, the IQVIA Study Hub Platform provides a suite of tools to enable DCTs and support data collection. Investigators running DCTs are also provided with simple and customizable workflows that help to speed up the study execution.
Key DCT adoption considerations
There are three key considerations that EBPs need to take into account when setting up a DCT. Firstly, is the study fit for a traditional, decentralized, or hybrid approach?
- Does the drug have a well-known safety profile?
- Are the trial endpoints measurable through a DCT approach?
- What trial design phase is it in, so that the appropriate trial support tools can be adopted?
Secondly, does the regulatory environment support the required DCT elements e.g., tele- or home-visits, direct-to-patient investigational medicinal product (IMP) shipment, etc., in the chosen countries?
Thirdly, operational considerations to react to the fast-moving DCT landscape:
- Ensure a convenient end-to-end patient experience throughout the DCT process.
- Set up a site delegation log that details the roles and responsibilities and a simple but customizable workflow to speed up study execution.
- Ensure that regulators and the ethics committee are on board with the trial and stay updated on regulatory changes.
It is also helpful to engage an experienced Contract Research Organization (CRO) with a good track record to help with the set-up and audit process. The Parkville Clinical Trials Unit in Melbourne and the Border Medical Oncology Research Unit in Albury engaged IQVIA to audit their first tele -trial and was able to avoid compliance issues by ensuring that the methodology between the primary and satellite sites were being followed.
Key stakeholders, particularly patients, also need the right training and education to drive the success of DCTs. IQVIA Study Hub provides a platform for patients to interact with study team members, view and schedule upcoming visits, complete eDiaries, access study related documents, and tap into 24/7 support.
The future of DCTs in Asia Pacific
The pandemic has catalyzed the adoption of DCTs, which are now a permanent part of clinical research. A survey by IQVIA found that 68% of patients expect a trial to include decentralized options.4 However, there will always be a role for in-person trials as some patients feel more comfortable being examined by a clinician.
This is why hybrid models, that is, a mix of face-to-face interactions and technology access, are now a permanent fixture of the clinical trial landscape. In Australia, hybrid DCTs are available to people living in remote places, where they would have telehealth consultations with their physician at the primary care facility where their interaction is recorded.
With the increased adoption of DCTs, accuracy of reporting and data integrity will remain a priority to alleviate any data concerns. Rigorous training of trial staff and investigators on the new technological platforms are also crucial to ensure that they have an accurate view of the study progress for each patient.
Summary
DCTs are evidently gamechangers and are here to stay. They have greatly enhanced the clinical trial arena by bringing patient needs to the fore – from giving them greater access to trial participation, to driving clinical efficiencies and ensuring the drug to market process is ultimately accelerated for them. As the pandemic eases and normalcy returns, it is important for EBPs to engage the right CRO to ensure a smooth transition from either fully traditional clinical trials or DCTs into a hybrid model.
For more information on new approaches and trends in the biotech landscape, do listen to our mini four-episode podcast series, Through the Biotech Lens: Molecule to Market, for Emerging Biopharma where industry stalwarts give an insightful perspective on biomarker selection, innovative trial designs, decentralized trials and the value of digital to advance patient centricity.
IQVIA Biotech employs a flexible and adaptable approach to align with each customer’s needs. The process begins with the initial alignment meeting where we listen to our customer and have an open conversation in order to outline the approach and discuss the most efficient way to perform the study. This helps clarify the scope of the trial, allowing for the development of a sound strategy and to ensure the work is achieved in a timely, efficient manner. Our goal is to help our customers get their life-saving therapeutics to commercialization as efficiently and cost-effectively as possible so that patients can receive the treatments they need.
Contact us to discuss how we can help support your clinical trial.