By: Deepu Joseph – Vice President and Global Head of Clinical Data Management – Quanticate
The transition of clinical trials away from investigator sites and into volunteer homes offer a more patient-centric approach and reduces the burden on caregivers. It also offers up great opportunities for the industry to capture more real time data. And as the world adjusts to the reality of a prolonged global pandemic and the difficulties of asking volunteers to make physical visits to sites, decentralized and hybrid clinical trials have become a pertinent solution.
Decentralized clinical trials are an entirely different approach with a transformational philosophy. As the COVID-19 pandemic took hold in 2020, CROs reported that sites were becoming inaccessible or non-functional due to travel limitations for both patients and monitors and also because of the decrease in available health workers in the hospitals to support research. Many trials were put on hold and planned trials postponed due to the crisis, the response from the industry was to pivot to virtual trial models or hybrid models to start or continue the research. The industry was already exploring how virtual models could improve patient participation and their experience during trials, the pandemic however accelerated this change.
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Enabling Technologies
The burden on patients on having to travel great distances and comply with study protocols has always affected recruitment and retention. The idea behind decentralized trials is to diminish some of the burden and costs of traditional methods for patients and sponsors alike. The primary goal of many companies is to make clinical trial participation as easy as possible so patients can continue with their day-to-day lives with minimal disruption. The technologies we now commonly use to interact with trial patients directly in the comfort of their homes at their convenience have been around for some time but more broadly adopted in the past year or so.
eRecruitment
Innovative solutions utilizing Artificial Intelligence (AI) help match patients to appropriate clinical trials. AI is used to analyze structured and unstructured clinical data into new clinical data which is used to match clinical trial criteria. Post analysis, it makes it easier for investigators to identify and contact potential patients for the clinical trials. Platforms that integrate electronic recruitment capabilities with downstream processes of electronic screening, consenting and even data collection for patient-reported outcomes and televisits assist with patient engagement, from recruitment to study completion.
eConsent
Informed consent is a vital ethical consideration in clinical trials. Performing the entire process of consenting remotely has always been a challenge to address but it is now possible for trial participants to consent from virtually any location and have that consent tied directly to their own data, all in compliance with 21 CRF Part 11 or GDPR requirements. When used remotely, eConsent gives patients more time to consider important trial information and make informed decisions. The technology can be seamlessly integrated with Electronic Data Capture (EDC) systems and even Electronic Medical Records and Electronic Health Records (EMR/EHRs) making it easier for site staff to track the process. It also eliminates the paper-based workflows enhancing the productivity of site staff.
Electronic Patient Reported Outcome (ePRO)
Collecting data directly from patients as part of patient-reported outcome assessments electronically is an efficient way to improve the quality of data collected. These platforms are also integrated with EDC which helps site and data management teams to track the completion and adherence on a real-time basis. The user-friendly design of such tools aims to help patients provide accurate data without any ambiguity even if they are not technology savvy. The Bring Your Own Device (BYOD) model helps patients to use their own devices to conveniently access the platforms, increasing compliance and engagement.
Use Case
In a program Quanticate is supporting, the sponsor was measuring the amount of ‘itch’ that a particular patient group may be experiencing. The protocol allowed patients to submit data via a wearable device through the night, helping the sponsor understand the impact on sleep and track the amount of itching experience. Historically, this would likely have to have been performed in a sleep clinic at a notable cost to the sponsors and inconvenience to the patient.
Direct Data Capture (eSource)
Traditional paper-based clinical processes are cumbersome, a lot of time, resources, and budget can be spent on things that have little to do with the actual process of collecting and managing data. By eliminating paper and enabling remote monitoring, Direct Data Capture (DDC) reduces costs and resource dependence, enabling trial sites to work faster and increase the trial volume. For hybrid and decentralized clinical models, especially in lower economic geographies, DDC could be of real help for study coordinators who can ‘visit’ patients at remote areas to collect data. Many times, connectivity would be an issue at such places and DDC tools allow the collection of data offline and once connectivity is restored, it integrates.
One of the key challenges with decentralized trials is that different therapeutic areas will require unique approaches - there isn’t a one-size-fits-all technology that meets the need of every trial. The right combination of technology needs to be paired with the trial development process. Interoperability and integrations between these technologies is the next hurdle and bringing all the data together in real-time to give a comprehensive and live view of the trial can be difficult.
Challenges in Decentralized Approaches
From a regulatory standpoint the data privacy requirements related to directly collecting from patients must be fully understood. Sponsors and trial sites must ensure they're collecting only the data that is required for the research purposes, and from the data, ensuring that appropriate data is added to patient healthcare records as well.
More pragmatically, there are notable organizational challenges when it comes to pivoting to a decentralized approach. Clinical institutions must have trained personnel to carry out what will be revised protocols and the use of smart technologies. The accessibility of the technology is also key - not everyone will have access to a device that can host an app. Whatever technology deployed must be easy to use, intuitive and fit seamlessly into the patient's daily routines. Reliability is also imperative, the tools and processes need to be thoroughly tested, and an awareness of any pitfalls that require any mitigation prior to the release of the study must be developed.
Public and Patient Reassurance
The public perception of a clinical trial is a study done in a controlled environment at an investigator site, usually, a clinical medical institution in which volunteers are required to visit and where medical professionals carry out all the testing taking samples collecting the data.
Despite the convenience to trial participants with a decentralized approach, there are understandable questions from the public about the safety and efficacy of virtual trials. In interventional trials for example, a common concern is whether patients can access local medical support. Firstly, there must be a process to ensure local medical support is accessible to the patient and as part of the overall conduct of the study. From a data perspective, decentralized approaches actually have an advantage here and it's important to see that sponsors are receiving data in real-time more than previously done. Technologies like wearables gather and communicate information in real-time, giving investigators the opportunity to analyze data in real-time, identify trends and understand safety concerns and respond back accordingly. In short, with decentralized approaches, patients are more consistently monitored and interventions such as local medical support and site visits are still available when required.
It’s also important to offer reassurances that, as is always the case with the pharma industry, patient safety which is enforced through robust regulatory compliance and approval is at the forefront of every trial.
The Future: Patient-Centricity
The full transition to a decentralized approach is not going to be straightforward as certain trials will still need site visits. For example, oncology therapies, which are a major focus of the development pipeline and are likely to be for the foreseeable future, may require investigators to measure the size of a tumor, which requires equipment that will only be available in a clinical environment. As such, hybrid models which retain site visits when they are essential but leverage technology wherever possible to reduce patient travel time and gather more data will soon be the norm.
The key challenge is to take patients through the journey of a trial so that they're very happy, confident and understand the protocols and how their data will be managed and used. It is possible to do this online, but a more human touch is likely to be required for years to come. As the industry moves forward and people become more confident with digital communication and platforms, and the technology supporting these approaches gets better and easier to use, hybrid trials will become more commonplace.
The decentralized approach also allows patients to interact more with their condition and the trial, having direct access to the data allows them to check if things are going well so long as they understand what the data means, whereas previously, they may have to wait until the next visit to get a picture of any progress.
Conclusion
In the past, the industry has put the comfort and convenience of patients second to the scientific endeavor of developing effective therapeutics. Pharmaceutical companies have come to realize that these softer factors significantly affect trials in a number of ways - from recruitment, thorough retention and even outcomes. By focusing on improving participation and gathering more and better data that reflects the patient’s life more accurately, sponsors are painting a more detailed picture of the efficacy of their drugs, leading to better treatments available to patients.
About the Author
Deepu Joseph is currently serving as Vice President and Global Head of Clinical Data Management with Quanticate. Joseph has over fifteen years of experience in managing and driving clinical data management operations delivery across major CROs.
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