Impact of Decentralized Elements on Site-Level Enrollment Velocity
Published February 2026 — Analysis of 18 studies incorporating hybrid decentralized elements shows a 15% increase in enrollment velocity at sites offering remote consent and telehealth visits, with no statistically significant difference in data quality metrics.
Decentralized Clinical Trials and Enrollment Performance
The adoption of decentralized clinical trial (DCT) elements has accelerated dramatically since 2020, driven initially by pandemic necessity and sustained by demonstrated patient-centricity benefits. However, the industry has lacked rigorous, multi-study data on how specific decentralized elements impact site-level enrollment velocity — the rate at which individual sites convert screened patients into enrolled participants over a defined time period.
This research brief presents findings from a cross-study analysis of 18 clinical trials conducted between 2023 and 2025 that incorporated varying degrees of decentralized elements within a hybrid site-based model. The analysis isolates the enrollment impact of specific DCT components — including remote informed consent, telehealth visits, direct-to-patient drug shipment, and wearable-based data collection — while controlling for therapeutic area, trial phase, and site characteristics.
The central finding is clear: sites offering remote consent and telehealth screening visits achieved a 15% increase in enrollment velocity compared to matched sites conducting fully in-person processes, with no statistically significant difference in protocol deviation rates, data query volumes, or overall data quality scores. This finding has direct implications for how sponsors design enrollment strategies and how sites allocate resources for hybrid trial execution.
Key Findings
Our analysis across 18 hybrid decentralized trials encompassing 142 sites and over 4,200 enrolled patients reveals consistent patterns in how DCT elements affect enrollment dynamics.
Sites offering remote consent and telehealth screening visits enrolled patients at a rate 15% faster than matched control sites using fully in-person processes, measured as patients enrolled per site per month during the active enrollment window.
The difference in composite data quality scores between hybrid DCT sites and traditional sites was 0.3% — well within the margin of statistical noise and confirming that decentralized elements do not compromise data integrity.
Sites offering telehealth visits drew patients from a 23% larger geographic radius compared to in-person-only sites, expanding the accessible patient population without requiring additional site locations.
The median time from initial patient contact to completed enrollment was 31% shorter at hybrid DCT sites, driven primarily by the elimination of scheduling delays for in-person consent visits.
Methodology
The analysis employed a matched-pair design across 18 multi-site clinical trials that offered hybrid DCT elements at a subset of participating sites while maintaining traditional in-person processes at others. This natural variation within studies allowed controlled comparison while eliminating inter-study confounders.
Study Selection and Classification
From the Clinitiative network database, 18 studies were identified that met the inclusion criteria: multi-site design with at least 6 participating sites, hybrid DCT implementation where at least 30% of sites offered decentralized elements while the remainder operated traditionally, completed or substantially completed enrollment (minimum 80% of target), and availability of site-level enrollment data with sufficient granularity for velocity calculation. The 18 studies spanned five therapeutic areas: oncology (5 studies), immunology (4 studies), CNS/neurology (3 studies), cardiovascular (3 studies), and rare disease (3 studies). Trial phases included Phase II (7 studies), Phase III (9 studies), and Phase IIb/III adaptive designs (2 studies).
Matched-Pair Construction
Within each study, hybrid DCT sites were matched with traditional sites based on five balancing variables: geographic region (urban, suburban, rural), site type (academic medical center, community research center, independent research site), historical enrollment performance quartile, principal investigator experience tier, and catchment area population density. A total of 71 matched pairs were constructed across the 18 studies, with 71 hybrid DCT sites and 71 matched traditional sites. The remaining sites that could not be adequately matched were excluded from the primary analysis but included in sensitivity analyses.
DCT Element Categorization
Decentralized elements were categorized into four tiers based on the degree of remote activity: Tier 1 included remote informed consent only (eConsent with remote discussion); Tier 2 added telehealth screening and follow-up visits; Tier 3 added direct-to-patient investigational product shipment; and Tier 4 added wearable or sensor-based endpoint data collection. Among the 71 hybrid DCT sites, 18 implemented Tier 1 only, 29 implemented Tier 2, 16 implemented Tier 3, and 8 implemented Tier 4. This distribution enabled sub-analysis of the incremental enrollment impact of each additional decentralized element.
Outcome Measures
The primary outcome was enrollment velocity, defined as the number of patients successfully enrolled per site per month during the active enrollment window (first patient screened to last patient enrolled at each site). Secondary outcomes included screen-to-enrollment conversion rate, geographic catchment radius (median distance from patient residence to site), patient demographic diversity index, composite data quality score (incorporating query rate, protocol deviation rate, and source data verification findings), and patient-reported satisfaction with the enrollment process where available.
Enrollment Impact by Therapeutic Area
The 15% overall enrollment velocity increase was not uniform across therapeutic areas. The magnitude of the DCT effect varied based on disease characteristics, patient mobility constraints, and visit burden profiles.
Oncology trials showed an 11% enrollment velocity increase with hybrid DCT elements. The relatively modest gain reflects the inherently site-dependent nature of oncology treatment administration. However, remote consent and telehealth pre-screening provided meaningful benefits by reducing the number of in-person visits required before enrollment confirmation, which is particularly valuable for patients managing treatment side effects or travel burden.
Immunology trials demonstrated the largest enrollment velocity increase at 22%, driven by the ability to conduct follow-up assessments via telehealth for conditions like atopic dermatitis and psoriasis where visual assessment can be reliably performed remotely. Patients in these trials reported significantly higher willingness to participate when telehealth visits reduced their time commitment by an average of 4.2 hours per visit cycle.
CNS trials showed a 14% enrollment velocity increase, with the benefit concentrated in conditions where cognitive or mobility impairments create barriers to site visits. For Alzheimer’s disease studies, telehealth caregiver interviews and remote cognitive screening reduced the pre-enrollment burden on both patients and their support networks, which are frequently cited as barriers to trial participation.
Cardiovascular trials achieved a 16% velocity increase, with wearable-based cardiac monitoring (Tier 4 sites) contributing a particularly strong incremental benefit. Sites using wearable ECG monitors for endpoint collection were able to extend their catchment radius to include patients in rural areas who otherwise would not have participated due to travel distance to cardiac monitoring facilities.
Rare disease trials showed the second-highest velocity increase at 19%. Given the inherently dispersed geographic distribution of rare disease patients, the ability to conduct screening, consent, and follow-up visits remotely expanded the practical catchment area from a median of 48 miles to 127 miles — a critical factor for diseases where eligible patients may number in the hundreds nationally.
Across all therapeutic areas, the enrollment velocity benefit was most pronounced during the first 60 days of enrollment — the period when scheduling bottlenecks and patient decision-making delays have the greatest impact. Sites that offered remote consent saw 28% faster first-patient-in timelines, suggesting that DCT elements are particularly valuable in the critical early enrollment window.
Data Quality and Regulatory Considerations
A primary concern among sponsors and regulatory stakeholders is whether decentralized elements compromise data quality or introduce new sources of variability. Our analysis directly addresses this question with site-level data quality comparisons across all 142 sites in the dataset.
The composite data quality score — which aggregates EDC query rate per data point, protocol deviation rate per patient-visit, source data verification concordance, and adverse event reporting completeness and timeliness — showed no statistically significant difference between hybrid DCT sites and traditional sites (p = 0.72). In fact, hybrid DCT sites demonstrated a marginally lower protocol deviation rate (3.1% vs. 3.4%), potentially attributable to the structured digital workflows that DCT platforms impose on consent and data collection processes.
From a regulatory perspective, the 18 studies in our dataset have collectively undergone 7 FDA inspections and 4 EMA inspections to date. No inspection findings related specifically to the use of decentralized elements have been reported. Sites that implemented remote consent using 21 CFR Part 11-compliant eConsent platforms had complete audit trails for every consent interaction, which inspectors noted as equivalent to or more thorough than paper-based consent documentation.
However, the analysis identified two areas requiring ongoing vigilance. First, telehealth visits for physical examination endpoints showed 8% higher inter-rater variability compared to in-person assessments, particularly for dermatological and musculoskeletal evaluations. Second, sites that adopted DCT elements without adequate staff training experienced a temporary 12% increase in technical support queries during the first 30 days, underscoring the importance of readiness assessment before implementation.
Patient Experience and Site Readiness
Beyond enrollment metrics, our analysis examined patient-reported experience data and site-level readiness factors that influence successful DCT implementation.
Patient-Reported Experience
Among the 8 studies that collected patient experience surveys, participants at hybrid DCT sites reported significantly higher satisfaction scores across three domains: convenience of participation (4.3 vs. 3.6 on a 5-point scale), perceived respect for their time (4.5 vs. 3.8), and willingness to participate in future trials (89% vs. 74%). Notably, patients aged 65 and older reported the largest satisfaction gains from telehealth options, challenging the assumption that older populations prefer exclusively in-person interactions.
Technology Infrastructure Requirements
Successful DCT implementation required sites to have reliable broadband connectivity (minimum 25 Mbps), HIPAA-compliant telehealth platforms integrated with their clinical trial management systems, and staff trained in remote consent procedures. Among the 71 hybrid DCT sites, 14 required infrastructure upgrades before implementation, with an average investment of $12,000-$18,000 per site. These costs were recovered within 4 months through reduced per-patient visit costs and higher enrollment throughput.
Staff Training and Competency
Sites that completed a structured DCT readiness program — including platform training, simulated remote consent sessions, and troubleshooting protocols — achieved full operational competency in a median of 14 days. Sites that adopted DCT elements without structured training took 32 days to reach equivalent competency levels. The analysis found that coordinator confidence with technology was the single strongest predictor of successful DCT implementation, more predictive than site type, investigator experience, or therapeutic area.
Site Readiness Assessment Framework
Based on these findings, we developed a five-dimension site readiness assessment for DCT implementation covering technology infrastructure, staff digital literacy, institutional policy compatibility, patient population digital access, and regulatory documentation preparedness. Sites scoring above the 70th percentile on this assessment achieved the full 15% enrollment velocity benefit, while sites below the 40th percentile showed no statistically significant improvement, suggesting that DCT elements should be selectively deployed based on site capability rather than universally mandated.
Hybrid DCT Model Design Recommendations
The data do not support a binary choice between fully centralized and fully decentralized trial designs. Instead, the evidence points toward optimized hybrid models where specific DCT elements are deployed based on their demonstrated impact within each therapeutic context.
Remote informed consent delivered the highest return on investment across all therapeutic areas and should be considered a default element in hybrid trial design. The scheduling flexibility it provides eliminates one of the most common bottlenecks in the enrollment funnel — the 7-to-14-day delay between patient interest and an available in-person consent appointment. Sites offering remote consent achieved first-patient-in timelines an average of 19 days faster than matched traditional sites.
Telehealth visits for screening and non-procedural follow-up visits delivered strong benefits in immunology, CNS, and rare disease studies but should be carefully evaluated for conditions requiring physical examination endpoints. The recommendation is to implement telehealth visits for history-taking, questionnaire administration, and safety follow-ups while maintaining in-person visits for primary efficacy assessments that require physical examination or laboratory procedures.
Direct-to-patient drug shipment showed meaningful enrollment benefits only in studies with oral medications or self-administered injectables. For IV-infused therapies and complex administration regimens, the logistic and safety requirements of on-site administration outweigh the convenience gains of home delivery. Wearable-based data collection showed strong promise in cardiovascular and movement disorder studies but requires careful validation against site-based measurements during the study design phase to satisfy regulatory endpoint requirements.
Conclusions
This analysis of 18 hybrid decentralized clinical trials provides robust evidence that selective implementation of DCT elements — particularly remote consent and telehealth visits — delivers a meaningful 15% increase in site-level enrollment velocity without compromising data quality. The benefit is not uniform across therapeutic areas, but it is consistently positive when DCT elements are matched to the appropriate clinical context and deployed at sites with adequate readiness.
The implication for sponsors is straightforward: hybrid DCT elements should be evaluated as standard components of enrollment strategy rather than experimental add-ons. The 15% velocity improvement, combined with broader geographic reach and improved patient satisfaction, represents a competitive advantage in an environment where enrollment timelines directly impact drug development economics. For sites, the investment in DCT readiness — technology, training, and workflow adaptation — pays for itself within months through improved enrollment performance and patient retention.
Future research should focus on longer-term retention outcomes at hybrid DCT sites, the impact of decentralized elements on patient diversity, and the development of standardized readiness benchmarks that allow sponsors to efficiently identify DCT-capable sites during feasibility assessment.
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