The acceptance of telehealth and the incorporation of digital technologies have led to the rapid evolution of the infrastructure and delivery for conducting clinical trials, providing a unique opportunity to address social disparities in trial participation.
Why oncology pharma companies should care about Decentralized Clinical Trials (DCTs).
With FDA’s recent initiative to promote and advance Decentralized Clinical Trials (DCT) in Oncology, and FDA’s Oncology Center for Excellence (OCE) supporting efforts to modernize modalities for clinical trials evidence generation, pharma companies need to be well set to ride the new wave of carrying out innovative trial designs in oncology.
More importantly, the viral pandemic provided an added impetus and a proof-of-concept for pharma companies and regulatory agencies to incorporate the utility of DCT in future trial designs.
DCTs: What’s it all about? Promising or challenging?
Earlier, we had provided insights on Unconventional Trial designs, including information about DCT, and highlighted their key advantages.
DCTs reduce geographic barriers and patient drop-out rates. At the same time, they enhance patient convenience, increase patient diversity and ensure social equity in treatment access. Also, they bring faster trial recruitment and accelerate the study timelines.
DCT involves, among others, remote trial data collection after having obtained electronic patients’ consent, remote patient monitoring using connected device(s), electronic clinical outcome assessments (eCOAs), and electronic Patient-Reported-Outcomes (ePRO).
Proper functionality and intrinsic limitations of these new-age strategies play a key role in determining the successful adoption of DCTs.
Even with the advantages mentioned above, unknown challenges raise questions and barriers.
- Will geriatric and pediatric patients welcome digital access?
- How receptive will stakeholders be to digital tools’ variability, sensors, and data reproducibility?
- Who will pay the additional resource allocation cost to support representative clinical trial participants? (such as delivery of digital wearables, home visits for treatment, dispersed data management, etc.)
Despite these challenges, major pharma players have begun to show their increased interest in conducting DCTs in oncology.
For example, Novartis recently initiated a P2 pilot trial, TELEPIK (start date: Mar’22; primary endpoint completion date: Jul’23), evaluating the safety and utility of a hybrid DCT approach employing telemedicine platform for HR+/HER2- advanced breast cancer patients with a PIK3CA mutation, that can be treated with an approved Alpelisib (Piqray; PI3Ki) in combination with fulvestrant (ER antagonist).
The trial is specifically designed to identify and register observations and experiences regarding planning and implementing decentralized, patient-centered clinical trials at a geographic distance with digital/virtual elements.
Similarly, another key player, Roche/Genentech has a P2 study planned (start date: Sep’22; primary endpoint completion date: Sep’25), that will evaluate atezolizumab (aPD-L1) in combination with recombinant human hyaluronidase (rHuPH20), as a subcutaneous formulation in NSCLC patients using a DCT model.
The primary objective is to determine safety and feasibility of atezolizumab/rHuPH20 co-formulation’s home administration by a healthcare provider (HCP) and mobile nursing.
Also, investigators will report patient satisfaction and the feasibility of a cancer clinical trial conducted under a decentralized model with telehealth assessments as secondary objectives.
As part of their long-term strategy and to determine the futility of DCTs with approved drug combinations, Novartis and Roche/Genentech are expected to conduct prospective interventional clinical studies for pipeline oncology drugs. We expect the outcomes of these recently initiated trials to transform how clinical oncology trials are conducted.
Another unique example, is the recently initiated(start date: Jul’22; primary endpoint completion date: Jul’25), non-interventional, non-randomized, decentralized bio-specimen collection study SPARK, sponsored by Addario Lung Cancer Medical Institute (ALCMI) – US aimed to identify resistance mechanisms in KRAS-driven cancers.
The study will incorporate a web-based remote patient consent. Blood collection kits having necessary materials for local draws will be delivered to patients at their residences. Collected specimens will then be sent to the Dana-Farber Cancer Institute (DFCI), and rerouted to the central laboratory at Foundation Medicine, Inc. (FMI) for plasma-Next Generation Sequencing (NGS). FoundationOne® Liquid CDx will be utilized to perform NGS, while specimens will be eventually stored at ALCMI.
The goal of this remote participation plasma NGS study is to characterize resistance mechanisms arising in KRAS-mutant cancers among individuals experiencing disease progression while being on a KRAS-targeting therapy. Moreover, the trial intends to provide personalized subsequent therapy tailored to individual patients, based on the results of plasma NGS testing.
DCTs: state of the art and an inevitable necessity in the post-pandemic world
Increasing evidence of designing clinical trials with a unique DCT-approach points to a future paradigm, where academic institutes, new-age CROs, Digital Health companies, and tech-based start-ups work in close association with legacy pharma companies. These strategic partnerships would primarily aim to provide patient-centric, cost-effective and more inclusive solutions in future.
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Sources:
FDA – Advancing Oncology Decentralized Trials
Lucid Quest Ventures Insight – Unconventional Trial Designs explained in 5 minutes