Decentralized Clinical Trials: A Patient-First Approach with Central Lab Expertise 

Decentralized Clinical Trials (DCTs) are more than just a technological advancement – they represent a fundamental shift in how clinical research engages with patients. At their core, DCTs are designed to make trial participation more accessible, inclusive, and tailored to individual needs. Rather than requiring patients to travel to a clinical site, DCTs aim to bring the trial to the patient. 

At the Core of Decentralized Clinical Trials: Designed Around the Patient

The defining feature of decentralized trials is their patient-centric design. Traditionally, clinical trial participation often required frequent visits to a central site – sometimes far from home and difficult to access. Decentralized Clinical Trials offer an alternative by enabling participation from the comfort of a patient’s home or a nearby healthcare facility. Whether through local blood-drawing points or home healthcare visits, this model reduces logistical burdens and prioritizes patient comfort. 

This approach does more than improve recruitment and retention. It enables participation from individuals who might otherwise be excluded due to mobility limitations, geographic barriers, or personal circumstances. It supports more diverse and representative patient populations. 

Technology plays an enabling role in this transformation. Digital platforms, wearable devices, and eConsent solutions help patients stay informed, report outcomes, and remain connected to the research team. However, the focus isn’t on the tools themselves – it’s on how they improve access, understanding, and engagement. 

The concept of a decentralized clinical trials has been a talking point in the industry for over 20 years, but it was the pandemic that forced clinical researchers to give it much more thought and to bring it from a niche solution into the forefront.   Despite of the recent developments in this field it is still a new topic and worth exploring or considering. – Tomasz Bohr , Associate Director, Business Development, Medicover Integrated Clinical Services 

Decentralization from a Central Lab Perspective 

While decentralized clinical trials are gaining momentum, the term “decentralized” can mean different things to different stakeholders. For some, it implies eliminating traditional trial sites altogether; for others, it means a hybrid approach blending remote and on-site elements. From the perspective of a central laboratory, it’s essential to clarify what decentralization means – particularly when it comes to ensuring data integrity and operational consistency. 

Some DCT models rely on local diagnostic facilities for sample collection and analysis. While this may increase patient access, it also introduces variability in how samples are handled and data are generated. In multi-country trials, this inconsistency can challenge standardization and complicate regulatory submissions. 

At Medicover Integrated Clinical Services, we experienced that successful Decentralized Clinical Trials maintain a level of central coordination – especially in laboratory processes. Sensitive and complex analyses still require centralized oversight to ensure scientific quality. Our model supports decentralization on the operational level while safeguarding the consistency and reliability of data. 

How It Works in Practice: Options for Sponsors 

There is no one-size-fits-all approach to decentralized clinical trials. Depending on the therapeutic area, patient demographics, regulatory requirements, and geographic scope, sponsors can select from a range of models or combine them to suit their study needs. 

Within our operations, we support various successful configurations, including: 

• Hybrid models: Remote sample collection paired with centralized laboratory analysis 

• Home visits: Coordinated logistics for direct-to-lab transport, ensuring timely and compliant sample handling 

• Local access points: Utilizing our network of Blood Drawing Points and partner sites to minimize patient travel while maintaining quality control 

Each option offers distinct advantages: 

• Hybrid models provide a balance between data integrity and operational flexibility – ideal for trials requiring both convenience and high-quality analytics. 

• Home visits accommodate patients with mobility issues or other constraints, while still ensuring high sample quality through trained personnel. 

• Local access points enhance turnaround times and support compliance with national regulations – particularly important in geographically dispersed studies. 

When selecting a DCT model, sponsors should consider: 

• Study endpoints – Does the trial require advanced biomarker analysis or is it primarily observational? 

• Patient population– Are participants in remote locations or likely to require tailored support? 

• Regulatory landscape – Are there local constraints on sample handling, transport, or data privacy? 

• Geographic spread – Is the study multinational, involving regions with varying infrastructure? 

• Trial complexity – Are hands-on interventions or frequent in-person assessments required? 

Choosing the right model ensures that each trial balances scientific rigor, patient accessibility, operational efficiency, and regulatory compliance. 

Inclusion and Sustainability: Broader Benefits of DCTs 

The value of decentralized clinical trials extends beyond convenience. By reducing geographic, logistical, and socioeconomic barriers, DCTs promote inclusivity. Patients from underrepresented regions or backgrounds gain greater access to clinical research, leading to more robust and representative data – and broader access to emerging treatments. 

DCTs also align with the growing sustainability goals of the clinical research sector. Fewer site visits and reduced travel for patients and study monitors help lower the trial’s carbon footprint. Digital documentation and leaner logistics contribute further to environmentally responsible practices.

Importantly, as regulatory bodies increasingly expect diversity and inclusion in clinical trial populations, DCTs provide a meaningful way to meet these expectations – while improving equity in access to care.

As the DCT model continues to evolve, one principle remains clear: success begins with a deep understanding of patients’ needs. Regardless of where patients are located, the consistency and reliability of trial data must remain the cornerstone of every decentralized strategy.

Frequently Asked Questions: Decentralized Clinical Trials and Central Lab Integration

References

1. Meeting Trial Participants Where They Are: Decentralized Clinical Trials as a Patient-Centered Paradigm; ASCO Publications, https://ascopubs.org/doi/10.1200/OP.22.00702, accessed: 10.04.2025
2. Decentralized clinical trials and digital health technologies, National Center for Biotechnology Information, https://www.ncbi.nlm.nih.gov/books/NBK609002/, accessed: 10.04.2025
3. Conducting Clinical Trials With Decentralized Elements, Food and Drug Administration, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements, accessed: 10.04.2025