Decentralized Clinical Trials (DCTs): Costs, Regulations, and Platform Selection

Key Takeaways — Decentralized Clinical Trials

Decentralized clinical trials (DCTs) use digital tools, remote visits, and other decentralized methods to conduct clinical research beyond traditional trial sites. This guide will explore what DCTs are, what they cost, the regulatory requirements, how to implement them, and what to consider when choosing the right DCT platform for your organization.

For teams evaluating their options, we will also explore how TrialKit’s unified eClinical platform supports each stage of a decentralized clinical trial.

What Are Decentralized Clinical Trials (DCTs)?

A decentralized clinical trial (DCT) is a clinical trial that includes decentralized elements, allowing trial-related activities to occur at locations other than traditional clinical trial sites. These elements can take place remotely or at locations convenient for participants, including through telehealth visits, in-home visits, or visits with local healthcare providers. 

Decentralization allows sponsors to incorporate the approaches that fit a particular study rather than treating decentralization as an all-or-nothing model.

Common decentralized elements include:

  • Telehealth and virtual visits: Investigators and trial personnel can conduct appropriate participant visits and follow-ups remotely using telehealth rather than requiring an in-person site visit. 
  • Wearables and remote monitoring: Digital health technologies can collect health and clinical data remotely from participants through connected devices and sensors.
  • Remote electronic consent: Participants can complete informed-consent forms digitally in some instances. This can happen when the approach meets the applicable requirements and appropriate oversight is provided.
  • ePRO on the participant’s device: Participants can report outcomes and data digitally from their own device. Many tablets, phones, and computers allow the use of ePRO, where participants can log their own information. This can help to reduce the need for dedicated hardware, as this software is available across various systems.
  • Home health visits: Qualified clinical trial staff can conduct certain assessments and other trial-related activities from the comfort of a participant’s own home or other convenient location.
  • Local laboratories: When permitted by the protocol, participants may complete appropriate laboratory testing at qualified local facilities, reducing the need to travel to a traditional research site for assessments that can be performed closer to home.
  • Direct shipment of investigational product: In certain circumstances, when appropriate for the study and investigational product (or IP), the IP can be packaged and shipped directly to participants rather than requiring collection at a trial site.

In practice, decentralization is increasingly approached as a flexible model in which sponsors can combine decentralized and traditional activities based on the needs of the study and its participants.

Decentralized Clinical Trial Capabilities in TrialKit

Because the FDA frames decentralization as a collection of elements, rather than as a separate trial type, sponsors should be conscious of how many of those elements can be supported by one system when evaluating which one to invest in. TrialKit brings together the core decentralized capabilities in one eClinical platform:

  • ePRO/eCOA: TrialKit supports remote collection of participant-reported and other clinical outcome assessment data through configurable forms, diaries, and visit schedules. Study teams can define when forms become available, completion windows, recurring diary intervals, and participant notifications, while participants can complete assigned activities through supported web and mobile experiences.
  • eConsent: TrialKit supports remote and on-site electronic consent within the same study environment, including participant self-consent, consent status and history tracking, site- and version-specific documents, and re-consent workflows. Studies can also accommodate a combination of electronic and paper consent when required.
  • Televisits: TrialKit Engage supports secure, virtual interactions between participants and study teams. It helps to bring remote visit workflows into the same eClinical environment as the rest of the trial.
  • Wearable Ingestion: TrialKit can collect supported health and activity data through Apple Health, Google Health Connect, and Fitbit, allowing participant-generated data to flow into the TrialKit study environment. Study teams can define the wearable data required for a study and incorporate those data into participant data-collection schedules alongside ePRO activities.
  • RTSM: TrialKit Randomization and Trial Supply Management (RTSM) supports direct-to-patient supply workflows. It connects randomization and supply management with the operational requirements of decentralized trials.
  • eSource: TrialKit eSource supports direct electronic capture of source data, including data collected during decentralized study activities. This can reduce reliance on paper source documents and subsequent transcription while keeping source data connected to the broader study environment.

TrialKit’s modules are built into one platform, rather than being separate products connected through APIs. This enables sponsors to build a decentralized clinical trial from the elements that truly suit their study’s goals, without the need to stitch together multiple solutions. Coordinators and participants alike can access TrialKit natively across iOS, Android, web, and macOS, allowing them to contribute and work together from wherever the trial requires, without a second login.

What Is a Hybrid Clinical Trial, and How Does It Compare?

A hybrid clinical trial is a clinical trial that combines on-site clinical activities with some decentralized elements. Through a hybrid trial, some parts of the study are carried out in person, and other parts are executed remotely. Which parts take place in person and which parts are carried out digitally across more convenient, remote locations depends entirely on the study itself. Hybrid trials offer a flexible approach that allows sponsors to retain in-person procedures when clinically necessary, while moving suitable activities to locations that better suit participants.

The decision to form a hybrid trial rather than a fully site-based one is generally dependent on the requirements of each protocol activity. Some procedures, such as certain imaging, infusions, complex assessments, or intensive sampling, may still require appropriately equipped clinical facilities or direct investigator involvement. This is because they require the use of clinical trial facilities, specialized equipment, or direct assessment. In contrast, questionnaires, symptom diaries, follow-ups, and connected-device vital signs can be executed remotely.

This selective approach makes hybrid trials a popular real-world model for decentralization. Rather than aiming to decentralize every aspect of a protocol, sponsors can choose the elements that provide the greatest benefit to participants and study operations, helping to reduce participant travel and the number of required site visits while retaining the on-site capabilities the protocol requires.

The three approaches of traditional, hybrid, and fully decentralized differ primarily in where trial activities take place and how much of the study is supported by decentralized technology.

Traditional vs Hybrid vs Fully Decentralized Clinical Trials

Trial model comparison

Traditional vs. hybrid vs. fully decentralized clinical trials

The three approaches differ primarily in where trial activities take place and how much of the study is supported by decentralized technology.

Comparing traditional, hybrid, and fully decentralized clinical trial models across six operational dimensions.
Dimension TraditionalSite-based HybridSite-based + remote Fully decentralizedRemote / local
Where activities happen Most visits and assessments at centralized trial sites Site-based care combined with remote activities Most activities remotely or at locations convenient to participants
Informed consent Typically completed in person Electronic or in person Electronic consent
Primary data sources Site-based assessments and source documentation Site visits plus ePRO, connected devices and wearables, telehealth, and home visits Remote data capture, connected devices, telehealth, home health, local laboratories, direct-to-patient supply
Best suited to Studies needing frequent physical examinations, specialized procedures, or substantial on-site infrastructure Studies with procedures that must happen in person alongside assessments that can safely be performed remotely Studies where most protocol-specified assessments can move off-site without affecting endpoint validity
Geographic reach Limited by catchment Increased Greatest
Main limitation Frequent participant travel can restrict reach and risk incomplete data from missed visits On-site and remote activity can generate data in separate systems that must be reconciled Greater reliance on technology, remote logistics, data quality, and decentralized operational processes

How to choose: the decision depends on which activities genuinely need to take place in person, and which can be performed remotely without compromising participant safety, data quality, or the integrity of the study.

The choice between these approaches ultimately depends on which activities genuinely need to take place in person, and which can be performed remotely without compromising participant safety, data quality, or integrity of the study.

Supporting Hybrid Study Workflows in TrialKit

Hybrid trials can create an operational challenge. On-site assessments and remote assessments often lead to data being generated and stored in different systems, leaving sponsors to reconcile information across platforms after the study has been conducted. 

TrialKit allows on-site and remote workflows to be configured within the same study environment. Data entered by site staff and data submitted remotely by participants can be managed within the same study database and participant record, with applicable audit trails and study controls maintained within the platform. Because the mix of on-site and remote activities is defined through study configuration, sponsors can accommodate different workflows across visits, sites, or regions without introducing a separate system solely for the decentralized components.

What’s the Difference Between Decentralized, Virtual, Remote, and Siteless Trials?

Decentralized, virtual, remote, and siteless trials are sometimes described interchangeably, and their usage is not fully standardized across the industry. “Decentralized clinical trial” or “clinical trial with decentralized elements” is now the more precise regulatory terminology. “Virtual,” “remote,” and “siteless” may still appear in industry discussions, but their meaning can vary depending on context. 

For regulatory documents, the FDA’s preferred phrasing is “clinical trials with decentralized elements”. This reflects that decentralization is a set of trial activities, as opposed to a separate trial category. This distinction helps sponsors to describe their study design precisely and align terminology with regulatory expectations.

Does TrialKit Support BYOD and Remote Participant Access?

TrialKit supports both BYOD and remote participant access, so your team can create diverse trials tailored specifically to your needs. Native iOS and Android apps, together with browser access, allow participants to use a personal smartphone, a provisioned device, or a tablet at a local clinic, all from the same study environment.

The biggest challenge with BYOD is typically not app availability, but instead, potential issues with validation and control. Sponsors need confidence that data captured across different devices remains controlled, traceable, and compliant. TrialKit supports participant data collection across personal and provisioned devices while keeping the study configuration, forms, participant records, and associated data within the TrialKit environment. Participants can access assigned study activities through supported mobile and web experiences, allowing sponsors to use BYOD where appropriate without creating a separate data collection workflow solely for participant-owned devices.

How Much Do Decentralized Clinical Trials Cost?

There is no single price for a decentralized clinical trial, and a DCT should not be interpreted as being automatically cheaper than a traditional trial just because it is not being held at one particular site. Decentralized approaches can shift some costs toward technology, home health services, devices, and participant logistics rather than simply eliminating traditional trial costs. Potential downstream savings may come from reduced participant travel and on-site activity, broader geographic recruitment, more efficient enrollment, and shorter study cycle times, depending on the protocol and decentralized elements used.

A useful DCT cost model should account for the full operational picture:

  • Platform licensing and study build: The cost of the eClinical platform, configuration, validation, and study-specific setup.
  • Device strategy: Whether participants use their own devices through a BYOD setup, or receive provisioned devices such as tablets and wearables, as well as other equipment.
  • Home health networks: The cost of coordinating qualified healthcare professionals for visits and assessments conducted outside of traditional clinical trial sites.
  • Local laboratory setup: Establishing and managing local lab options where participants would otherwise need to travel to a study site.
  • Direct-to-patient logistics: Costs associated with packing, shipping, tracking, and managing supplies sent directly to participants. This includes the costs of randomization and the investigational product (IP) when applicable.
  • IP accountability: There are also costs associated with maintaining the appropriate records and oversight for the investigational product throughout decentralized distribution and use.
  • Participant support: Providing technical, logistical, and study support when participants are completing activities remotely.
  • Integration and validation: Connecting separate systems and validating the flow of data between them when different vendors provide different parts of the decentralized workflow.

Every additional point solution can introduce integration, validation, data reconciliation, user management, and support costs that may not appear on any individual vendor’s quote. A trial using separate systems for eConsent, ePRO, telehealth, wearables, and supply management may therefore have a substantially higher total cost than the individual licensing prices may initially suggest.

Because of these hidden costs of fragmentation, decentralization is not automatically the more economical choice. For example, trials with intensive in-clinic procedures may have limited scope for moving activities remotely, leaving much of the traditional site cost intact while adding decentralized technology and logistics. Similarly, small studies can also be difficult to justify from an economic perspective, because their fixed setup and technology costs are spread across a relatively small participant population.

Instead of thinking, “How much does a DCT cost?” your organization should instead be asking, “What does the decentralized model cost compared with the operational savings it can generate?” in order to find the most appropriate and cost-effective trial setup choice for your study.

What Is the ROI of a Decentralized Clinical Trial?

There is no fixed ROI of a decentralized clinical trial, but there are some strong, peer-reviewed estimates. Notably, a Tufts Center for the Study of Drug Development study by DiMasi et al. found that applying decentralized clinical trial methods across Phase II and Phase III could increase expected net present value by approximately $20 million per drug entering Phase II. This represents roughly a seven-fold return on investment. The study was commissioned by a DCT vendor and used that vendor’s project data, which sponsors should weigh when applying the figures.

Cycle-time reduction was the largest contributor to the net benefit, making faster study execution a more important part of the DCT business case than any single operational saving. Sponsors should be sure to model the variables that drive their own economics in individual studies. This could include factors such as enrollment duration, screen failure rate, amendment count, monitoring visit volume, and the dropout rate of participants. These inputs can help determine whether the upfront cost of decentralization is likely to translate into a meaningful return.

What Do Regulators Require for Decentralized Clinical Trials?

There are three major regulatory frameworks that shape decentralized clinical trials. These are FDA guidance, European guidance, and ICH Good Clinical Practice. They broadly converge on the principles for decentralized elements, but are not fully harmonized, and national requirements within the EU still vary.

Regulatory timeline

Key DCT regulatory milestones and what takes effect next

Three frameworks shape decentralized clinical trials — FDA guidance, European guidance, and ICH Good Clinical Practice. They broadly converge on principles for decentralized elements, but are not fully harmonized, and national requirements within the EU still vary.

December 2023 In effect

FDA guidance on digital health technologies for remote data acquisition

Sets additional expectations for the use of DHTs to collect trial data remotely in clinical investigations.

18 September 2024 In effect

FDA final guidance — Conducting Clinical Trials With Decentralized Elements

Covers trial design, remote data acquisition, sponsor and investigator responsibilities, delegation to local healthcare professionals, investigational product accountability, and safety monitoring. Non-binding, but the sponsor remains ultimately responsible for the trial, including delegated activities.

23 July 2025 In effect

ICH E6(R3) principles and Annex 1 become effective in the EU

The revised Good Clinical Practice principles and Annex 1 take effect.

1 October 2025 In effect

EC / EMA / HMA recommendation paper updated to V02

Provides a European framework for incorporating decentralized elements. Sponsors still need to account for practical differences in requirements and implementation across individual member states.

3 June 2026 Adopted

ICH E6(R3) Annex 2 adopted

Annex 2 covers decentralized and pragmatic clinical trial elements and real-world data. It reached Step 4 on ICH adoption, followed by CHMP adoption on 25 June 2026.

15 January 2027 Upcoming

ICH E6(R3) Annex 2 takes effect in the EU

Before Annex 2 takes effect, sponsors should review SOPs, validation, vendor qualifications, and training records so that decentralized processes and supporting systems are prepared for the updated requirements. Adoption timelines outside the EU vary by region, so sponsors running global studies should confirm the applicable date in each jurisdiction.

Preparing for Annex 2? TrialKit supports 21 CFR Part 11 alongside requirements relevant to HIPAA and GDPR, and keeps decentralized data capture inside one validated environment with timestamped, user-attributed audit trails.

  • FDA final guidance – Conducting Clinical Trials With Decentralized Elements: Issued on September 18th, 2024, this FDA guidance covers trial design, remote data acquisition, sponsor and investigator responsibilities, delegation to local healthcare professionals, investigational product accountability, and safety monitoring. The guidance is non-binding, but the sponsor remains ultimately responsible for the trial, including any associated activities delegated to other parties.
  • European Commission/EMA/HMA recommendation paper – Decentralized Elements in Clinical Trials: The European recommendations were updated to V02 on the 1st October 2025. They provide a European framework for incorporating decentralized elements, but sponsors still need to account for practical differences in requirements and implementation across individual member states.
  • ICH E6(R3): The revised Good Clinical Practice principles and Annex 1 became effective on July 23rd, 2025, in the EU. Annex 2, covering decentralized and pragmatic clinical trial elements, was adopted in June 2026 and is scheduled to become effective on the 15th January 2027.

Before ICH E6(R3) Annex 2 takes effect, sponsors should be sure to review SOPs, validation, vendor qualifications, and training records. By doing this, they can ensure their decentralized processes and supporting systems are prepared for the updated requirements.

Sponsors should also consider the FDA’s December 2023 guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This provides additional expectations for the use of DHTs to collect trial data remotely.

Do 21 CFR Part 11 Requirements Apply to Remote Data Capture?

Yes. 21 CFR Part 11 requirements can apply to regulated electronic records and electronic signatures captured remotely, including through BYOD approaches. Where Part 11 applies, collecting data on a participant-owned device does not remove the sponsor’s responsibility to ensure appropriate controls over the electronic record and the system used to capture it. 

Having participants use their own devices (BYOD) does not remove those requirements. When a device is owned by the participant rather than provisioned by the sponsor, the sponsor still needs to control the validated application and the way the study data is captured, transmitted, protected, and retained, rather than relying on control of the physical device itself.

Remote trials can also expand the privacy and data-protection landscape. HIPAA may apply to protected health information handled by covered entities and their business associates, while GDPR can apply to personal data within its scope. Adding home-health providers, local laboratories, shipping providers, and other logistics vendors can also expand the processor and third-party data environment that sponsors need to assess, contract with, and oversee.

How to Incorporate Decentralized Elements Into a Clinical Trial Protocol

Decentralization is an operational redesign, not a technology purchase. Treating it as procurement can leave sponsors with more apps, more integrations, and more work for coordinators, all without meaningfully reducing the burden on participants.

A practical approach is to evaluate each protocol activity individually, determining where decentralized methods are appropriate while accounting for endpoint integrity, participant safety, oversight, and regional requirements:

  1. Inventory every protocol-specified assessment: List every visit, assessment, procedure, data collection point, and participant interaction.
  2. Classify each activity: Tag each activity as ‘must be onsite’, ‘could be remote’, or ‘already remote’.
  3. Protect endpoint validity: Be sure to rule out remote approaches wherever they could compromise the validity, reliability, or interpretation of an endpoint.
  4. Map eligible activities to a modality: Determine whether each activity is best handled through telehealth, ePRO, connected devices, home health, local laboratories, eConsent, or another decentralized method.
  5. Define oversight and delegation: Establish which activities can be delegated to local healthcare professionals and how investigators will retain appropriate oversight.
  6. Confirm regional acceptability: Check that the proposed decentralized activities, vendors, data flows, and delegation arrangements are acceptable in each relevant jurisdiction.
  7. Rebuild the schedule of assessments: Once the remote and on-site activities are defined, redesign the study schedule around the new operating model rather than simply adding technology to the existing workflow.

Once decentralized activities have been identified, sponsors should define the operational controls, responsibilities, and supporting processes required to implement them. Key considerations include: 

  • Local HCP responsibilities and documentation: Define the activities performed by local healthcare providers, confirm appropriate qualifications where required, and maintain records consistent with applicable regulatory and protocol requirements.
  • IRB-approved eConsent workflow: Ensure the electronic consent process is approved and configured before participant enrollment.
  • Device strategy and support model: Define whether participants use BYOD, provisioned devices, or both, and how technical issues will be handled.
  • Data flow and system architecture: Map where every decentralized data stream originates, travels, and ultimately resides.
  • Part 11 validation documentation: Maintain evidence that systems handling regulated electronic records and signatures have been appropriately validated.
  • Participant helpdesk coverage: Provide a clear route for participants to resolve technical and logistical issues without relying on site coordinators for every problem.
  • IP accountability: Define how the investigational product (IP) is shipped, received, tracked, reconciled, and accounted for when it moves outside of the traditional site.
  • Remote AE reporting pathway: Establish how participants and remote providers report adverse events and how those reports reach the investigator and study team.
  • Site and coordinator training: Train sites on the revised workflows, including how to oversee activities performed remotely or by delegated local providers.

Decentralization can also change the criteria used for site selection. Geographic catchment may become less restrictive for some study activities, while investigator capacity to oversee decentralized workflows, coordinator readiness, local infrastructure, and participant support requirements may take on greater importance.

If decentralization is introduced after a study has already begun, sponsors should also account for the need to amend the protocol. They should weigh the operational benefits of the change against the cost and disruption of amending the study.

How Do You Choose a Decentralized Clinical Trial Platform?

Integration and validation burden can be just as important to a DCT platform decision as the feature checklist. Sponsors should therefore consider how well the platform’s capabilities work together, whether it meets the regulatory requirements of the study, and whether it supports the devices and operating systems participants and study teams will use.

The time required to build a study and bring a validated database live also matters, particularly when sponsors need to make changes without relying on vendor change orders. Participant experience, including languages, accessibility, BYOD, and support, should all be considered alongside the commercial model and the total cost of running the technology.

Point solutions can offer greater depth in a particular modality. In contrast, a unified platform can reduce integration, validation, reconciliation, and vendor-management overhead by keeping multiple capabilities within one environment. 

How TrialKit Maps to These Criteria

These criteria give your organization a practical way to compare DCT platforms beyond a simple feature checklist. The questions are not just whether a platform offers a particular function, but whether those functions can work together in one study, meet the requirements for regulated research, support the devices participants actually use, and can be configured without adding unnecessary systems or delays. Here is how TrialKit maps to each of the above criteria:

  • Module breadth: TrialKit’s core eClinical modules are built within a single platform rather than assembled as separate point solutions. EDC, ePRO/eCOA, eConsent, RTSM, virtual visits, eTMF, medical coding, imaging, and other capabilities can be configured as part of the same study environment, reducing the need to build and validate integrations between separate systems for each function.
  • Regulatory posture: TrialKit supports 21 CFR Part 11, along with other requirements relevant to HIPAA and GDPR.
  • Device coverage: TrialKit provides native iOS and Android apps, alongside web and macOS access. 
  • Study build model: TrialKit gives authorized study teams direct access to configure forms, visit schedules, workflows, permissions, ePRO activities, consent, notifications, and other study settings within the platform. This allows sponsors and CROs to manage routine study configuration and changes without relying on a separate design environment.
  • Study startup and change management: Because TrialKit’s study configuration and core modules reside within the same platform, teams can configure interconnected workflows without separately implementing an individual system for each function. Authorized teams can also manage study configuration and versioning within TrialKit as requirements change.
  • Participant experience: Participants can access assigned forms, diaries, consent activities, schedules, and virtual visits through TrialKit’s supported web and mobile experiences. Configurable email, SMS, and push notifications can remind participants when study activities become due, while BYOD support allows eligible studies to use participants’ own devices rather than requiring provisioned hardware for every participant.
  • Commercial model: TrialKit uses a platform license agreement (PLA) model, with pricing provided directly, in relation to sponsors’ needs, rather than published online.

Together, these capabilities allow sponsors to manage multiple core technology components of a decentralized trial within one study environment, reducing the need to implement separate platforms for each individual function.

What Are the Biggest Challenges in Decentralized and Hybrid Trials?

Many of the challenges associated with decentralized and hybrid trials are operational as well as technical. Participants may have limited digital literacy, unreliable internet access, or no suitable smartphone or device to use. BYOD can create equity issues when participants have different devices or operating systems. Provisioned devices, on the other hand, can add purchasing, shipping, replacement, and support costs. Digital-first recruitment strategies can also introduce selection bias if they disproportionately reach participants who are more comfortable with technology, potentially affecting the representativeness of the enrolled population.

Data security and privacy also become more complex as more parties handle the trial data. Organizations such as home health providers, local laboratories, shipping companies, and other logistics vendors can expand the number of organizations with access to patient information. For this reason, sponsors need clear responsibilities, contracts, access controls, and data flows across the full process.

Device and platform fragmentation can create another practical problem. Different BYOD devices, operating systems, wearables, and point solutions can produce data in different formats and systems, creating extra work to integrate and reconcile information. The cost isn’t just the integration itself, but coordinators may need to check multiple systems, resolve mismatched records, and investigate missing or duplicated data.

Sponsors also need to maintain oversight and data provenance when study activities are taking place away from the traditional site. They should be able to establish who performed an activity, what was done, and when and where it happened. A decentralized workflow therefore needs clear records and audit trails that preserve the history of an activity just as reliably as a site-based workflow.

Reducing Technology and Data Fragmentation With TrialKit

TrialKit is designed to reduce the practical barriers participants may face with decentralized trials. Both its mobile and web interfaces are designed specifically to be straightforward for participants to use. With participant support available and the option for multiple languages, there are accommodations made for different participants with varying levels of digital experience.

TrialKit incorporates security and privacy controls, such as encrypted data transmission, multi-factor authentication, role-based access, and audit trails. Additional information about TrialKit’s security, privacy, and compliance practices is available through the Trust Center to support sponsor evaluation and vendor qualification.

For global studies, TrialKit can be configured for different regional requirements within a single system. This allows sponsors to support sites across multiple regions without needing to create separate technology environments. Bringing EDC, ePRO, eConsent, imaging, and virtual visits into one platform also reduces fragmentation and the need to reconcile data between different vendors.

TrialKit also maintains data provenance by recording entries and changes with timestamps and user attribution. This allows study teams to see who performed an activity and when it occurred, regardless of where the data originated.

Evidence on Decentralized Trial Adoption and Outcomes

The evidence base for decentralized clinical trials is growing, but it remains uneven and a significant share of published research is vendor-sponsored. That context matters when interpreting the figures. DCTs show promising results, but there is no single set of outcomes that applies to every study or protocol.

Data concerning adoption suggests that selective decentralization is the dominant or most popular model. Tufts CSDD and the PACT Consortium covered 69 trials. They found electronic outcome assessments to be the most commonly used DCT solution supporting study visits, appearing in approximately 85% of the trials analyzed. Also in this research, changes were found in some measures of participant diversity. Asian participation was also higher — 20.9% compared to 14.2% at traditional sites. American Indian or Alaska Native participation almost quadrupled, increasing from just 0.5% to 1.9%. Female representation also increased from 49% to 55.7%. However, Black or African American participants still accounted for only 7.3% of enrollees, indicating that improved representation in some groups doesn’t necessarily translate into broader diversity across all populations.

There is also no reliable single DCT retention rate to report. Instead, retention varies by protocol, population, intervention, and the specific decentralized elements used. Sponsors should be sure to evaluate each of these, and the retention evidence at the study level, rather than look at an unreliable headline or DCT-wide figure.

TrialKit for Decentralized Trials at a Glance

TrialKit supports decentralized and hybrid studies within the same eClinical environment used for site-based study activities. EDC, eCOA/ePRO, eConsent, virtual visits, wearable data, RTSM, PACS, adjudication, medical coding, eTMF, reporting and analytics, AI, and API integrations are available within the broader TrialKit platform.

This architecture allows sponsors to select the decentralized elements appropriate for a particular protocol without building a separate technology stack around them. Participant-facing activities and site-based data collection can remain connected to the broader study environment, reducing the number of separate systems that teams may otherwise need to configure, validate, access, and reconcile.

Decentralizing a clinical trial is a change to how the study is run, not simply a software purchase. The important question is whether the technology keeps the study in one connected environment or spreads it across disparate systems that create additional integration and reconciliation work. Request a personalized demo of TrialKit to see how it can support your decentralized or hybrid study.

FAQs About Decentralized Clinical Trials

What Is the FDA’s Guidance on Decentralized Clinical Trials?

FDA issued final guidance titled Conducting Clinical Trials With Decentralized Elements on September 18, 2024. It covers trial design, remote data acquisition using digital health technologies, sponsor and investigator roles, delegation of trial activities to local healthcare providers, investigational product accountability, and safety monitoring. The guidance is non-binding — it reflects FDA’s current thinking rather than enforceable requirements — but it signals clear agency support for well-designed decentralized approaches.

When Does ICH E6(R3) Annex 2 Take Effect?

ICH E6(R3) principles and Annex 1 came into effect in the EU on 23 July 2025. Annex 2, which addresses decentralized elements, pragmatic elements, and real-world data, was adopted in June 2026 and comes into effect on 15 January 2027. Sponsors planning decentralized studies should review SOPs, system validation, vendor qualification, and training records against Annex 2 ahead of that date.

Do 21 CFR Part 11 Requirements Apply to Data Collected on a Patient’s Own Device?

Yes. Part 11 requirements can apply to regulated electronic records and electronic signatures captured through participant-owned devices. Where Part 11 applies, using BYOD does not remove the need for appropriate controls over the electronic record and the system used to capture, transmit, protect, and retain it.

What Should You Look For in a Decentralized Clinical Trial Platform?

Evaluate module breadth, integration architecture, regulatory posture across 21 CFR Part 11 and GCP, device and operating system coverage, whether your team can configure study builds without vendor change orders, time to database go-live, participant experience and language support, and the commercial model. Sponsors should also account for the integration, validation, reconciliation, and vendor-management burden that can result from using multiple point solutions.

Do Decentralized Trials Improve Diversity in Clinical Research?

Evidence suggests decentralized approaches may be associated with improved representation among some historically underrepresented groups, although results are not consistent across populations. PACT Consortium research across 69 trials found higher representation of Asian participants (20.9% vs. 14.2%), nearly quadrupled enrollment of American Indian or Alaska Native participants, and female representation rising from 49.0% to 55.7%. However, Black or African American participants still represented only 7.3% of enrollees, demonstrating that decentralization alone does not necessarily improve representation across all populations.