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Clinical trials have long been plagued by two well-known challenges: They don’t recruit enough people and they fail to reflect the diversity of the patients who will ultimately be taking the medications being studied. Yet the industry has been slow to adopt patient-centric approaches that would enable more patients to participate in clinical trials.
Decentralised clinical trials (DCTs) are helping to overcome these challenges. The Covid-19 pandemic quickly pushed DCTs to the forefront as companies sought innovative methods to maintain clinical trial continuity amid site closures, business lockdowns and social distancing measures. Patients have responded positively to this trend, and companies are now integrating decentralised clinical trials into their clinical trial designs from the beginning rather than considering them as an afterthought.
Why decentralised clinical trials?
Research clearly shows that patients’ perceived burden of participating is an important factor contributing to low enrollment and retention in clinical trials.
Decentralized clinical trials help alleviate this burden by bringing studies into patient’s homes and local communities rather than requiring patients to visit study sites. Using telemedicine visits, wearable devices, smart-pill dispensors, direct-to-patient drug shipments, home health nursing and other remote approaches, decentralized clinical trials cater to the patients' convenience, availability, compliance and preferences for how and when they receive care.
As a result, patients who otherwise could not participate due to scheduling conflicts, work commitments, childcare, transportation to study sites, cost and other logistical factors can now participate from their homes. This allows more people – and more diverse populations – to join clinical trials.
Diversity is a critically important factor in ensuring that new medications are being evaluated in the populations who will ultimately be using them. For example, testing a diabetes drug in Caucasian men may not reveal its real-world efficacy in Asian women, while testing a drug in younger people may not reflect its safety and efficacy in older adults.
DCT tools and technology
The future of clinical research is virtual and digital. Every day, the industry is introducing new sensors, devices and digital apps that connect patients to healthcare providers and transmit data directly to the cloud. Patients can even obtain their own blood samples using a novel home device that allows simple collection and shipment to a site or lab.
The benefits of decentralized clinical trials are being combined with the use of real-world data (RWD) - information that is gathered from from a variety of external sources independent of clinical trials, such as wearable devices, electronic medical records, pharmacy data, disease registries, patient surveys and much more. Integrating real-world data into clinical trials can dramatically accelerate trial timelines by creating a more holistic view of patient outcomes using data collected from multiple disparate sources. Hence, real-world data enriches both the quantity and quality of of data to better inform the drug development process and fill in existing data gaps.
Clinical monitoring for decentralized clinical trials
Decentralized clinical trials are proving equally beneficial for study teams. Clinical research associates have increasingly shifted to remote site monitoring instead of in-person monitoring, using purpose-built technology platforms that provide safe and secure access to patient data, such as electronic medical records, and the seamless transmission of data between research sites, the clinical research organisation and the sponsor. Remote monitoring also enables real-time data surveillance and adaptive monitoring so that users can to swiftly analyze data using risk-based and workload assessment techniques. This approach allocates monitoring resources more effectively and efficiently to save time and cost.
Clinical trial logistics and automation
One of the most essential – and perhaps least recognized – components of clinical trials is known as RTSM or IRT— randomization trial supplies management (RTSM) system or interactive response technology (IRT). This automated system randomizes subjects in a trial, documents patient visits, allocates medication to patients, and automates supplies and resupply to depots and sites.
In short, randomization trial supplies management systems are customized for each respective trial to ensure the right medication gets to the right patient at the right time. Because it uses a forecasting algorithm to manage different methods of shipping, RTSM systems can instantly respond to new input and adjust trial logistics accordingly. Intelligent packages with sensors help monitor and transmit critical data like temperature and drug consumption by sensor, resulting in robust compliance data and accurate real-time tracking. During the pandemic, RTSMs were quickly reprogrammed to divert supplies and shipments to patients instead of sites, while also sending PPE to home health nurses and early phase units.
Virtual trial process – the patient journey
Patients are at the centre of every step in the decentralized clinical trial journey:
• Patient-centric protocol optimization (PCPO) – Study designs increasingly incorporate patient and caregiver perspectives to ensure that timing and frequency and of study visits are feasible; study procedures aren’t excessively burdensome; and study endpoints address disease challenges that are meaningful to the patient experience.
• Patient recruitment and retention platform (PRR) and eConsent – Geography is no longer a barrier to patient recruitment, as site visits are dramatically reduced or eliminated in decentralized trials.
• Home nursing and patient apps – Home nurse visits replace some or all of the study site visits, while wearable devices and smart-phone apps collect and upload patient data information and support on patients’ phones or provisioned smartphones.
• Direct to patient drug shipments (DTP) – RTSM systems are customized for each respective trial and can instantly respond to new input and adjust trial logistics to ensure the right medication gets to the right patient at the right time.
• Electronic clinical outcomes assessment (eCOA) – Patients capture and report their data directly using eDiaries and patient apps, while medical devices continuously or periodically collect and record objective measures such as motor, sensory and cognition. Caregivers and home nurses also collect and report data electronically.
• Regulatory approvals – Regulatory authorities are increasingly accepting innovative trial models that utilize remotely collected and real-world data to mimic randomized control arms, which is speeding trial timelines and in turn, drug approvals. For example, sponsors can now apply in parallel to the US FDA and EMA for orphan drug designation using the same data and a single common form, and the Eurasian Economic Union (EAEU)’s new guidelines allow the five member states to operate a national medicines market in a single space.
Future of decentralised clinical trials
Decentralised clinical trials offer multiple advantages to sites, clinical research organisations and sponsors, including expanded access to more diverse patients independent of geography; increased efficiencies; seamless data transmission, and continuous remote patient engagement techniques.
Similarly, patients are embracing decentralized approaches because they reduce their burden of trial participation. In February 2020, prior to the Covid-19 pandemic taking hold in the US, Parexel commissioned independent research to identify the biopharmaceutical industry’s perspectives on the benefits and barriers of decentralised clinical trials. According to respondents, the biggest benefits were improved patient experience; less burden for travel, especially for patients who do not live close to a study site; less disruption of daily work and school life; and improved patient recruitment and retention.
During the pandemic, these benefits have played an essential role in clinical trial continuity for patients whose medical conditions cannot wait for the pandemic to end. When it comes to decentralized trials, the future is now, and there’s no going back.
(Author is senior Vice President, India Country Head & Managing Director of Parexel)
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