se of Direct-to-Patient (DTP) shipments of investigational products and study treatments has received increasing attention since the COVID-19 pandemic began in 2020. DTP shipments are generally defined as any method of investigational treatment delivery directly to a trial participant’s home. Two strategies are common: Site-to-Patient (STP) shipments and Warehouse-to-Patient (WTP) shipments. The STP method involves shipping investigational treatment from the investigative site to the patient’s home—excluding one-time shipments that are not part of the study design (i.e., one-off or ad hoc shipments made to accommodate a patient’s specific limitations, but not included in the study design). The WTP approach is the shipment of investigational treatment from a warehouse, depot, or central pharmacy directly to the patient’s home.

Study Methods

The Tufts CSDD research team developed two surveys following the American Association for Public Opinion Research (AAPOR) guidelines—one targeting clinical trial participants, and another aimed at investigative sites. The analysis included descriptive statistics, frequency comparisons, analysis of mean response values, subgroup stratification, and significance testing. Data cleaning and analysis was conducted in R (Version 4.4.1).

The survey on clinical trial participants was fielded between June and July of 2024 and received 301 responses; 166 (55%) reported having experience with DTP shipments. This survey was administered by the nonprofit patient advocacy organization CISCRP (Center for Information and Study on Clinical Research Participation) to a panel of adult clinical trial participants in the US, stratified by age, gender, educational achievement, race and ethnicity, housing situation, and proximity to trial site. Data on experience and receptivity by study parameters was also collected, including length of the clinical trial, frequency of drug administration, frequency of study visits, and distance from the site. The survey received Institutional Review Board (IRB) approval, and all respondents provided electronic consent to participate. Table 1 presents the demographic characteristics of survey respondents, demonstrating broad representation across diverse groups. The analysis focuses on the 166 clinical trial participants who reported having had a recent personal experience with DTP in a clinical trial.

Table 1: Clinical Trial Participant Respondent Characteristics.

The survey on investigative sites, deployed between July and October of 2024, collected 160 responses from site representatives; 112 (70%) reported having experience with DTP shipments. This survey was administered via direct email invitation by Tufts CSDD to approximately 10,000 of the entire list of US investigative site contacts drawn from listings in www.clinicaltrials.gov. The survey received IRB approval, and all respondents provided electronic consent to participate. Most respondents were site directors (40%) or clinical research coordinators (39%), and 19% were principal investigators. Most (85%) respondents had fewer than 8 years of clinical research experience. Approximately half (51%) of the investigative site respondents were based within Academic Medical Centers (AMCs) and nonprofit settings; the other half were based within for-profit networks, hospitals, and community-based practices. See Table 2.

Table 2: Investigative Sites—Sample Characteristics

Clinical Trial Participants Report Positive Experiences and Greater Willingness to Join and Remain Enrolled in Trials with DTP Shipments.

Our study evaluated six areas of DTP shipment experience among clinical trial participants: (1) convenience, (2) impact on willingness to enroll in a future trial, (3) impact on retention, (4) satisfaction with logistics and instructions, (5) helpfulness of solutions often paired with DTP shipments, and (6) issues encountered.

Most (93%) clinical trial participants who had received DTP deliveries found that these shipments made their clinical trial experience more convenient across demographic factors and study parameters. When assessing the impact of DTP shipments on willingness to enroll in trials, 86% of clinical trial participants in the sample indicated they would be more likely to participate in a trial if DTP shipments were offered. A similarly high percentage (90%) reported that DTP shipments positively impacted their ability to stay enrolled in the clinical trial (see Figure 1).

Figure 1: Clinical Trial Participant Perspectives on DTP Shipments (% of total DTP-experienced Participants, N = 166).

A higher proportion of trial participants in the 18-30 and 31-50 age groups—87% and 89% respectively—were more likely to participate in a trial offering DTP shipments, compared to 69% in the 51+ group. A higher relative percentage of those in the 51+ group indicated that DTP shipments would have no effect on their willingness to participate. Males (94.9%) were slightly more likely than females (91.9%) to report that shipments were more convenient. The vast majority (98%) of those living in apartment buildings and 86% of those in single-family homes indicated that DTP shipments would increase their willingness to participate in trials. In contrast, a lower 67% of those living in mobile or nursing homes said DTP shipments would increase their willingness to participate (see Table 3).

Table 3: Convenience, Willingness to Participate, and Retention in Clinical Trials with DTP Shipments by Age, Gender, and Housing Situation (% of Total DTP-experienced Participants).

Clinical trial participants reported very positive experiences with DTP shipments (see Figure 2). Nearly all (99%) rated “Receiving the study drug on time” as “Excellent” or “Very Good/Good.” Similarly, 98% rated both “The study drug arriving at the right temperature” and “General scheduling and delivery of the study drug” as “Excellent” or “Very Good/Good.” The clarity of instructions provided with shipments for taking and storing the investigational product, and the quality of translation of these instructions, were also very positively rated (all 98% or higher “Excellent” combined with “Very Good”/“Good”).

Figure 2: Clinical Trial Participant Experience with DTP Logistics and Instructions (% of total DTP-experienced Participants).

Nearly four out of 10 (39%) clinical trial participants reported an issue with at least one of their shipments. Of those who experienced an issue, 50% indicated that they had an issue with only one of their shipments. Approximately one in 10 (12%) reported having issues with all or most of their DTP shipments (see Figure 3).

Figure 3: Frequency of Issues with DTP Shipments per Trial (% of DTP-experienced Participants who reported issues with their shipments; N = 64).

The top issues reported were missing instructions (50%), trouble scheduling deliveries (45%), and shipment delays (43%). Some of the less common issues experienced included receiving a damaged shipment (15%), loss of the shipment (23%), the opening of the shipment by someone other than the clinical trial participant (29%), and being unable to properly refrigerate the study drug (28%) (see Figure 4).

Figure 4: Types of Issues Reported with DTP Shipments (% Yes; N = 64).

To resolve an issue, 77% of clinical trial participants contacted the site directly instead of contacting the sponsor or the emergency contact provided in the package and/or instructions. Nearly all (98%) reported that their issues were resolved.

In general, these results suggest that clinical trial participants are very receptive to direct-to-patient (DTP) shipments, citing improved convenience, enhanced retention, and a greater willingness to participate in future trials.

Investigative Sites are receptive to using DTP shipments, but express concerns about clinical trial participant adherence, safety, and privacy and the increased burden on site personnel to manage and support DTP.

The Tufts CSDD team examined six areas of DTP shipment experience among sites: (1) preferences and receptivity, (2) impact on clinical trial performance metrics, (3) impact on patient measures, (4) impact on site work effort, (5) challenges, and (6) opportunities.

Results show that 87% of sites were receptive to using DTP shipping options in industry-sponsored trials; however, 68% preferred delivering investigative treatments under the traditional model (in person at the primary site), and 21% prefer a hybrid model if given the choice. Nearly two-thirds (65%) of investigative sites responding to the survey reported prior experience with DTP shipments: 65% had experience with Site-to-Participant (STP) shipments, and 63% had experience with Warehouse-to-Participant (WTP) shipments (see Figure 5).

Figure 5: Investigational Treatment Delivery Models: Site Experience and Preferences (% of total; N = 160).

These preferences can be better understood by examining site perceptions related to the feasibility of these approaches and their impact on site workload, study participant experiences, and clinical trial implementation efficiency. Sites noted that investigational treatments administered orally or applied topically are the most compatible with DTP shipment approaches. Although parenteral injections are seen as somewhat feasible, the majority of sites view treatments that require more specialized administration, such as parenteral infusions and IV administration, as incompatible with DTP shipment approaches at this time (see Figure 6). This finding is consistent with the FDA’s 2024 guidance on decentralized elements in clinical trials.

Figure 6: Perceived Feasibility of DTP Shipments by Route of Administration (% of total; N = 160).

Three of five sites (61%) observed a positive impact on patients’ willingness to enroll in trials, with 63% citing a positive impact among individuals from racial and ethnic minority communities. Additionally, 78% of sites reported that having participants complete their first clinical trial visit in person contributed to a more positive overall experience with DTP shipments.

Most investigative sites surveyed perceived that STP and WTP shipments positively impact patient satisfaction (see Figure 7). Investigative sites conveyed mixed perceptions with respect to the impact of DTP approaches on patient adherence and privacy. A relatively high percentage of investigative sites (53%) perceive that DTP approaches negatively impact patient safety. This study did not inquire further into this, which is an area we would like to explore further in future research.

Figure 7: Perceived Impact of STP and WTP shipments on Patient Experience (% of total DTP-experienced Sites; N = 112).

The highest proportion of investigative sites perceived that DTP approaches had no impact on clinical trial durations (e.g., study start-up, enrollment and close-out timelines). Approximately one in five sites perceive that DTP approaches positively impacted study start-up and close-out timelines. Forty-seven percent and 63.4% of sites believe STP does not impact study start-up or close-out, respectively. Similarly, 60.0% and 68.8% of sites believe WTP does not impact study start-up or close-out, respectively. Nearly four out of 10 (38.2%) sites perceived that STP approaches accelerated enrollment timelines, and 21.2% perceived that WTP approaches did so. Small relative percentages of sites perceived that DTP approaches negatively impacted clinical trial timelines with one exception: 28.4% and 22.5% of sites perceived that STP and WTP approaches, respectively, negatively impacted study start-up timelines (see Figure 8). Six out of 10 sites (60%) reported that use of DTP shipments positively impacted study participant enrollment and completion rates (see Figure 9).

Figure 8: Perceived Impact of STP and WTP shipments on Clinical Trial Cycle Times (% of total DTP-experienced Sites; N = 112).

Figure 9: Perceived Impact of STP and WTP shipments on Clinical Trial Enrollment Measures (% of total DTP-experienced Sites; N = 112).

A high percentage of investigative sites (50%-60%) perceived that STP and WTP shipments increase site workload across a number of patient management areas including monitoring, adherence, and technical support associated with drug administration. Sites also reported increased burden with STP and WTP shipments due to the additional patient training and education required (see Figure 10).

Figure 10: Perceived Impact of STP and WTP Shipments on Site Work Effort Related to Patient Support Activities (% of total DTP-experienced Sites; N = 112).

Nearly half of investigative sites surveyed perceived that WTP shipments have a positive impact on drug dispensing, storing management, inventory control and oversight, and ordering and resupply (see Figure 11). A high proportion of sites perceived that both STP and WTP shipments have a negative effect on drug reconciliation, accountability, and study drug destruction activities.

Figure 11: Perceived Impact of STP and WTP shipments on Site Logistics and Training (% of total DTP-experienced Sites; N = 112).

Lastly, top concerns of sites with STP and WTP shipments included (1) the amount of time required to oversee and manage trial execution, (2) ensuring patient adherence, and (3) drug/investigational treatment accountability and reconciliation.

Improving Receptivity to DTP Shipments Among Clinical Trial Participants and Investigative Sites

Study participants offered the following primary suggestions to improve their experience with DTP shipments:

1. Being able to reschedule a study drug delivery
2. Receive shipments automatically—from a site or warehouse—instead of having to reorder replacements
3. Provide—by mail or in person—explicit, printed instructions on how to self-administer and store their study drug
4. Receive regular updates and alerts indicating when their study drug will arrive.

Investigative sites also offered several primary suggestions to improve their experience with, and the effectiveness of, DTP use in clinical trials:

1. Include site input into draft protocol designs that use DTP approaches
2. Offer training at the beginning of clinical trials to study participants and investigative sites alike
3. Provide better investigational product and treatment tracking systems.

Conclusions

The results of this study assessing study participant and investigative site receptivity to, and experience with, DTP shipments are informative and largely encouraging. Study participants appeared highly receptive to DTP shipments due to improved convenience and flexibility. They were also more likely to participate in future trials when DTP shipments are offered.

Investigative sites were also highly receptive to using DTP shipments—particularly of orally and topically administered treatments—and they perceived that these approaches improve participant enrollment and retention. In addition, sites noted that DTP shipments, whether site-to-patient (STP) or warehouse-to-patient (WTP), can accelerate clinical trial enrollment timelines. Investigative sites raised concerns about the increased burden associated with DTP approaches, particularly regarding patient monitoring, training, and support. They also expressed apprehension about participant safety and privacy.

Sponsors and other stakeholders looking to implement DTP shipments should actively address these concerns by improving site-level support, providing targeted training on privacy and safety, and integrating streamlined solutions for drug accountability and returns to ensure Good Clinical Practice compliance.

Together, these findings reinforce the dual imperative of embracing decentralized models like DTP to enhance participant enrollment and engagement while proactively addressing and supporting the operational needs and concerns of investigative sites to drive sustainable and scalable adoption.

References available upon request.