Patient Support in DCTs

Introduction

Decentralized clinical trials (#DCT) are currently a much discussed approach to clinical trials. DCTs differ from ‘traditional’ trials in several ways:

because patients are not required to visit a site as often, there is reduced reliance on the investigator and site personnel to serve as the hub of activity for the trial
there is increased use by patients of technical appliances: wearables, monitors, trackers, etc. These provide more continuous data about the patient, as well as metadata about the patient and her activities
trial procedures require the introduction of visiting nurse services to meet patients in their homes and complete activities that previously handled via site visits
additional support services to lower the burden and overhead on patients enrolled in a trial

Several factors have driven the current heightened interest in DCTs:

Technical advances that make reliable remote data monitoring and capture feasible
The growing patient-centric movement in healthcare which enables patients to take more ownership of their healthcare journey, and provides improved access to and protection of their health data.
Acknowledgement that patient non-adherence in clinical trials is a significant issue and that the cause of non-adherence includes factors such as trial complexity, frequent site visits, logistics, and complicated procedures.
COVID-19 restrictions that severely limited the ability of patients to visit investigative sites.
The idea that reducing the need for patients to visit investigator sites would enable recruiting from larger geographic areas.

Implications of DCTs

The case for DCTs is logical and seems to make good common sense. It would be nice if there were more objective evidence to support its proposed benefits. However, even taking those advantages at face value, the likelihood is that the transition to DCTs will encounter unanticipated obstacles. To prepare for the roadblocks that may arise, it would seem prudent to evaluate the main changes DCTs introduce, along with the risks those changes present.

Key areas impacted by DCTs are outlined below.

Adherence – while it seems evident that the critical features of DCT design, outlined above, will positively affect patient adherence, they will not altogether remove the factors that cause non-adherence. Also, it is possible that DCT features may contribute to non-adherence. Some possible causes are: new wearable and monitoring device technology, including smartphones to transmit data, extension of clinical supply chain and delivery to the patient’s location, logistics
Patient Support – traditionally, patients relied on investigative sites for support, often addressed during the site visit. DCTs reduce the number of physical interactions between a patient and site personnel, with longer durations between visits, which decreases the ability for site personnel to build a trust relationship with the patient. The introduction of new technological devices for patients to manage adds to the list of items the patient is asked to manage. Even devices designed to be autonomous may require occasional patient interaction.
Data Management – more reliance on automatic data generation and collection via eSource fixtures such as eCOA, ePRO, and device data, and less on EDC from site visits and medical records. Monitoring and managing data quality from these new data sources will differ from traditional methods. Data queries and source doc verification will be less prevalent and will be replaced by technical and logistical risks that may impact data quality.
Drug supply – since patients in DCTs are not required to make as many site visits, where they would normally receive the investigational drug; it will be necessary to create and manage delivery processes to the patient or the patient’s locale (for example, a local pharmacy). These new requirements for drug delivery introduce new challenges that must be managed.
Monitoring – on one hand, DCTs will enhance the capabilities for remote and central monitoring due to greater use of eSource and wearable devices and monitors. On the other hand, traditional monitoring is focused a CRA/Monitor and an investigative site, where the majority of procedures occur and the data resides. Interactions between a monitor and a patient, while they may occur, are not typical. The Sponsor/CRO, represented by the CRA, also has a contractual/financial agreement with the site. When issues arise that require the monitor to remediate site behavior, that relationship can be key to successful remediation. When sites are less involved in the trial – as in DCTs – and patients are given greater direct control of their trial participation, it begs the question, how will monitoring and remediation occur in this scenario?

In general, DCTs will introduce new risks by reducing clinical site involvement and increasing the dependence on individual patients. The key variables of a clinical trial: disease state/indication, patient population, intervention, trial complexity, clinical technologies utilized, and others, will all contribute to the risk profile of a DCT. But dependence on patient involvement will tend to be a prominent and cross-functional risk.

Mitigation

Given the greater dependence on patients to drive more trial events and the attendant reduction in investigative site interaction with the trial and with patients, it would seem that a new or enhanced service is needed. The emergence of a new class of CRO – Virtual CRO – that provides a single (virtual) site to manage the trial for a sponsor – will alleviate a portion of the issues. However, if a DCT is to be truly patient-centric it seems imperative that concierge-level support will be necessary to assist patients in all aspects of their role in a trial.

The service, which may be based on current help desk and call center operations, will need to go beyond typical capabilities. Knowledgeable responsiveness in local language will be a core requirement, as will operators trained in empathetic communication, who are well-squinted with the protocol, the disease, the patient profile and their typical obstacles. They must also be able to solve technical issues with devices, smart phones, monitors, etc.

It’s possible that this service could be one channel of communication to implement remediation for a patient that has been identified as non-compliant. This service desk could then be the first point of contact to gather information from the patient regarding the identified issue.

Ideally, responsibility for support of a given trial would be assigned to small team, or pod, of agents who are trained in all aspects of the protocol, the patients, devices, and procedures. Second and third levels of support could be provided by HCPs, study nurses, PIs, etc., the technology vendors, clinical operations, etc.

Provisioning such a service desk will require a significant investment, represent an update in roles and responsibilities that must be handled via change management, and will modify the economics of study operations. However, making patients responsible for significantly larger portions of a trial without providing robust support and backup, may negate the perceived benefits of DCT.