Fan Gao, PhD, MS, is part of the ZS R&D excellence leadership team. She leads the digital and DCT vertical in clinical development.

Fan Gao, PhD, MS

By now, the pharmaceutical industry knows decentralized clinical trials (DCTs) are here to stay. DCTs offer many benefits, including helping sponsors reach broader and more diverse patient populations. In an article published last year in 

, we noted ZS’s DCT database shows the number of DCTs reported on clinicaltrials.gov increased by 77% between 2019 and 2020—and grew another 34% between 2020 and 2021. We also discussed that multiple studies have demonstrated that DCTs can improve enrollment and retention rates.

While DCT growth accelerated during the pandemic, this trend will outlast COVID-19. ZS’s patient burden collaboration with the Tufts Center for the Study of Drug Development showed that most patients indicated decentralized trial services such as home nurses and home technology will reduce trial burden. And in our March 2021 industry roundtable, most sponsors suggested that decentralized or hybrid clinical trials will become mainstream in three to five years.

clinical trial sites are not expected to fade away

. Rather, they will play a critical role in the decentralization process and are evolving through investment in DCT services such as home health and direct-to-patient investigational products, and in supporting technologies such as eConsent, ePRO, telemedicine platforms and wearables.

Transforming site selection is imperative for successful DCTs

Though sites are adapting to DCTs, the levels of experience and capabilities they offer can vary significantly. A 2021 Society for Clinical Research Sites (SCRS) survey indicated that only approximately one in four sites offered each type of decentralized service. This means there are few one-stop-shop sites for DCTs, and sponsors will need to rely on a robust site selection process to find sites with the right DCT capabilities and experience to meet their needs. Furthermore, they will need to segment sites by capability and experience to understand which sites would need training, resources and additional sponsor support during activation.

Without the ability to identify sites with the right experience, capabilities and willingness to conduct DCTs, studies could be time-consuming, costly or prone to fail. Additionally, sponsors could miss out on partnering with sites that are a good fit for the trial. For example, in our recent analysis of sites suitable for decentralized Parkinson’s disease trials, we identified two institutes that were similar in the traditional sense, each having more than 20 years of clinical trial experience in the disease area. However, only one had participated in trials in which home health, eCOA, ePRO, eConsent or remote monitoring were offered. In a traditional site selection process, sponsors would have similarly ranked both sites, but with additional insight, it’s clear these sites would perform very differently in a DCT.

Unfortunately, some sponsors are experiencing pitfalls. Some do not have visibility into site readiness for DCTs and are taking the same approach to site selection for DCTs as they would for traditional clinical studies. In one case, we saw a major pharma sponsor plan a fully decentralized study but then err by selecting traditional sites without the proper DCT experience. Not surprisingly, this presented major obstacles during the study. The sponsor likely is not alone, making it imperative that sponsors act now to modernize their site selection processes.

Considerations for enhancing DCT site selection processes

For sponsors to identify and select the right sites for their DCTs, a critical first step is to look holistically at how the strategic planning and site selection processes can be “DCT-compatible.”

First, sponsors must layer a DCT readiness analysis into the existing site selection process and include metrics that assess a site’s willingness, experience and capabilities to conduct DCTs. While traditional site selection metrics look mostly at physician and patient access, therapeutic area experience and site enrollment performance, sponsors will need to augment these metrics with ones specific for DCTs.

Sponsors also should update weighting to account for the importance of the new metrics. For example, if emerging sites are heavily equipped for DCTs but have not had a chance to demonstrate their capabilities in trials, they will not receive a fair chance if too much weight is placed on historic indicators. Thus, any DCT metrics added must include the option to put more or less weight on key metrics so that site scoring is aligned with the objective of the analysis.

While we expect there will be “must-partner” sites with both strong DCT and traditional readiness, sponsors will need to determine how to use less-than-optimal sites to meet specific patient population needs and study goals such as improvement in enrollment rates, patient experience, diversity, equity and inclusion.

DCT readiness assessments should help sponsors select the right sites and help them segment sites based on potential experience and capability gaps. During site activation, sponsors will have the opportunity to provide resources and support such as DCT training and relevant technology. This also will accelerate sites’ adoption of decentralized studies.

To further complicate the landscape, sites are partnering with new industry players to adopt novel operating models designed to bridge critical gaps in clinical trial operations. They’re aiming to reach highly qualified patients in a more targeted manner than what is offered by social media and traditional sites. They also want to offer better access to patients in remote areas or underserved populations.

One noteworthy model is the integrated research organization (IRO), which involves patients’ regular physicians in all stages of clinical research. This enables more targeted recruitment and retention of patients who are highly qualified for the trial. Furthermore, the IRO model also can lead to better patient diversity by leveraging the relationship between the physician and the patient if the IRO has a strong presence in institutions and community clinics in underserved areas. In our recent article, “

How to recruit more diverse clinical trial participants

,” more than half of underrepresented patients surveyed indicated they would be more comfortable if the trial principal investigators were the doctor they see regularly.

A decentralized research organization (DRO)—such as Care Access or Emvenio Research (previously Matrix Medical Network)—is another model that can improve recruitment, retention and diversity by bringing trials closer to target patients who were once considered inaccessible. This can be accomplished by using “sites on wheels,” which include mobile investigation teams, on-demand sites and local clinics and pharmacies.

While emerging site operating models are vastly different, one similarity is that most sponsors are not assessing the benefit-to-cost ratios of partnering with these organizations for a trial. This could lead to two scenarios, neither of which are optimal. The first is underusing these new site models, which could possibly cause enrollment, retention and diversity metrics to fall short and bring about less effective patient targeting. The second is overusing trials that do not necessitate these services to meet their recruitment needs, which could lead to unnecessary cost increases.

Sponsor considerations for site selection

While we expect most clinical trial sites will continue to be chosen through a site selection process adapted for DCTs and hybrids, we also anticipate a growing percentage of sites will come from partnerships with organizations such as IROs and DROs. Sponsors will need to keep important considerations in mind as they navigate this more complex site landscape.

The first is site strategy. Sponsors must look holistically at their strategic planning processes and site strategy frameworks to ensure they are current and able to assess if novel services should be utilized. It’s critical for sponsors to cover both of the following scenarios as part of their assessment:

Sponsors should explore partnerships with new organizations such as IROs and DROs to recruit and enroll patients as a supplement to enrollment from the sites identified in traditional site selection analyses.

 Sponsors should think about reducing the number of traditional sites needed and replacing them with sites provided by DRO and IRO services.

For each scenario of the site strategy, sponsors must assess the benefit-to-cost ratio of increasing the percentage of sites chosen through IRO and DRO partnerships for trials. For example, through correlations of how IROs and DROs quantitatively benefit enrollment, retention and diversity, estimate the ratio of quantifiable benefit against any cost premiums.

With DCTs and emerging operating models such as IROs and DROs, the future of clinical trials is here. Now is the time for sponsors to update their site selection strategies to realize the benefits of these new site offerings. For sponsors wondering where to begin and how to ensure success in modernizing site strategies, the following considerations are critical to success.

First, a good starting point is to understand what data is available to provide the insights needed for transformation. For example, does in-house and third-party public data exist to identify trials and sites that have leveraged DCT technologies? What pricing information and correlations between new site operating models and patient recruitment, retention and diversity are available?

Another consideration is how this data will inform budgets and resourcing for DCTs and hybrid trials. It is common for sponsors to assume that both patient facing and non-patient facing hours for sites will decrease with DCTs and hybrid trials, but this is not always the case. According to the 2021 SCRS site survey, sites cited adverse event reporting, screening failures and start-up costs as the top underfunded areas in the trial budget. This data would be critical, for example, to accurately assess the benefit-to-cost ratios of DCTs and hybrid trials, and to inform the trial budget.

It’s also important to understand how can sponsors use that data to improve their site selection decision-making. For example, what analytics and key performance indicators are needed to reveal the best sites for a sponsor’s trials? Is it easy to provide sound justification for partnerships with new research organizations? It’s critical to define study execution expectations and to identify and address potential risks for monitoring and capability gaps, so that sponsors can adequately support the sites with needed technologies and services to execute DCTs and hybrid trials.

Sponsors and sites are driven to improve the patient experience, operational efficiency and patient diversity in clinical trials. For these commitments to materialize, sponsors must enhance their approaches to site selection, engagement and partnerships. Let’s work together to enable a future where clinical trials include the right patients, and let’s meet them where they are.

, PhD, MS, is part of the ZS R&D excellence leadership team. She leads the digital and DCT vertical in clinical development.

 leads ZS’s global clinical development practice area.

 is a leader in ZS’s R&D excellence practice area and leads the development and global commercialization of ZS's DCT strategy and analytics solutions.

 is a leader in ZS’s R&D excellence practice area and leads strategy and analytics work in the areas of DCT and clinical feasibility.

 are consultants for ZS's R&D excellence team and members of the digital and DCT vertical in clinical development.

Articles

Sites not expected to fade away even as DCTs continue to grow past COVID-19.

Adapting Site Selection for Clinical Trial Decentralization and the Future Landscape

Clinical trials that incorporate decentralized components have graduated from experimental pilot projects to a mainstream priority for sponsors. According to ZS’s decentralized clinical trials (DCT) database, the number of industry sponsored DCTs jumped from a 15% compound annual growth rate in 2014-2020 to a 70% growth rate from 2020 to 2021. As the pharmaceutical industry increasingly focuses on scaling decentralized efforts and realizing the value of its investments, it will be critical to identify and address risks DCTs pose to good clinical practice (GCP) quality.

DCTs have moved GCP oversight outside of the investigative site and introduced new processes, technologies and stakeholders—like couriers, home healthcare providers and patients who collect their own data—who are now part of the overall clinical trial execution. Patients can now receive investigative medicinal products (IMP) at home, have procedures performed by home health services, capture data with wearable devices and connect with their physician via telemedicine. However, each of these modalities can raise new risks for GCP compliance. For example, for a patient receiving and self-administering IMPs at home, the product might not be stored in accordance with good manufacturing practice (GMP) if it is delivered late by a courier, stolen or delayed (see GCP Principle 2.12).

The considerable shift in the clinical landscape created by DCTs means sponsors need to reevaluate their practices and potentially implement new mitigation steps to continue to ensure the rights, safety, and well-being of trial subjects, as well as the integrity of clinical trial data. 

ZS sought to identify and provide insights into the array of perspectives on GCP quality and risk concerns across common DCT modalities. We undertook a survey in collaboration with senior clinical quality representatives from four top-20 pharmaceutical sponsor organizations. The goal of the survey was to understand sponsors’ perceptions of risk types, magnitude and potential mitigations for nine DCT modalities. Risk magnitude was assessed on a 6-point scale (from “no risk” to “very high risk”) and then converted into a linear numeric scale (0-5) for analysis.

Survey responses from 15 clinical quality representatives representing 11 large and mid-sized pharmaceutical organizations, as well as 14 therapeutic areas (TAs), were collected from November 2021 through January 2022. The survey responses yielded three key insights.

Insight one: There is no clear consensus on risk magnitude and risk type

As noted in Figure 1 below, more than 75% of the DCT modality and risk type combinations that sponsors were asked to assess rated between zero (no risk) and four (high risk). Even for combinations with the tightest consensus—like patient safety and welfare risk for local labs—sponsors’ responses still exhibited variability from zero (no risk) to two (low risk).

This lack of consensus among industry-leading professionals on GCP quality and risk for DCT modalities highlights the industry’s nascent understanding of this topic. There is a need for more industry-wide collaboration, education and research to improve collective understanding. Additionally, while our survey looked across all TAs, research to identify specific nuances of DCT quality and risk at the TA level will be important for application to specific trials.

 Minimum and maximum risk across respondents by DCT modality and risk type

Insight two: No DCT modalities are off limits, but none are without new risks

While different DCT modalities pose different risk types and magnitudes, respondents said on average that DCT modalities posed a very low to medium risk (see Figure 2 below). Such results suggest no modality poses a high enough risk to prevent use in DCTs, but almost all modalities have at least one risk type necessitating closer consideration.

Direct data capture and on-demand technology support for patients carry the lowest overall risk of the nine DCT modalities (see Figure 3 below), respondents said. Their responses indicate these modalities could serve as gateways into decentralization for less experienced sponsors. However, it would be important to define and mitigate the specific risk to data integrity and credibility identified by sponsors in the survey.

On the other hand, telemedicine, virtual visits and home health services are viewed as carrying the highest risk of the nine DCT modalities—but respondents still consider them “low risk.” The breadth of contributing risk types suggests the need for a more expansive risk assessment and mitigation process than other modalities in order to deploy these foundational elements of decentralization.

While incorporating decentralized modalities will bring about new risks, sponsors can integrate these modalities into protocols without fear that doing so will pose a significant risk. Leading sponsors can differentiate themselves by not dismissing a DCT modality at the prospect of any new risk, but by objectively comparing the potential benefits to the risk magnitude and required mitigations. This includes considering the dynamic nature of how risks may compound when multiple DCT modalities are used in a single visit or trial.

Insight three: Different risk types matter for different modalities

As seen in Figure 2, survey results show significant differences in risk types and magnitude for different DCT modalities. For sponsors, this highlights the importance of avoiding a “one size fits all” approach for assessing quality and risk. Not every modality poses each risk type—some modalities have specific risk types on which sponsors should focus, while others raise multiple risk concerns.

For remote patient monitoring and direct data capture, data integrity and credibility are the main risk posed; for electronic informed consent and digital communication, patient rights and privacy are the primary concern. In both cases, risk types are closely associated with the primarymodality purpose. For example, electronic informed consent is designed to ensure patients understand their rights in the research study. It’s not designed to collect endpoint data for demonstrating efficacy to a regulatory body. 

Modalities that involve clinical care or complex logistics are characterized by a broader set of risk concerns. For example, telemedicine and home health services each have four risk types with scores of at least two (low risk). For these instances, sponsors will need to consider and invest in broader mitigation approaches for multiple risk types.

Sponsors utilizing DCT modalities should evaluate and, as necessary, choose to track and mitigate additional risks created by DCT use. Effectively doing so will require investment in three areas: A DCT-specific risk assessment and categorization tool (RACT), analytics for risk signal detection and clinical stakeholder training.

Developing a DCT-specific RACT—which can identify, assess, monitor and mitigate risks that could affect data quality and patient safety—can serve as a starting point for sponsors to facilitate organizational discussion and consensus on DCT risks.Sponsors may also consider appointing a DCT risk management lead who can oversee the enterprise level DCT quality risk management plan.

There is a systematic three-step process that can enable organizations to make robust DCT risk assessments

The first step is to identify new potential risks associated with DCT modalities. Engaging with study teams who have experience deploying the modalities in practice can help inform this set of potential risks. The second step is to assess the likelihood, detectability and impact of risks to determine an overall risk score, which, alongside potential impact and cost, can be an input into an overall DCT modality implementation assessment

And the third step is todeploy mitigations for the highest-risk score categories.

The outputs of the DCT RACT process should be used to inform quality and risk management plan development for DCTs, while also determining which decentralized modalities can be lower-risk starting points for implementation. These risks should be communicated to study teams so they can include, track and mitigate the risks in their risk management plan.

Key risk indicators (KRIs), the clinical tools used to identify anomalous clinical data points by cross referencing and comparing study data across clinical trial dimensions, should be enhanced to also monitor potential risks associated with DCT-related modalities and vendors. This can mitigate the increased vendor oversight risk identified by survey respondents. In particular, statistical monitoring can be established to identify if there are statistically significant differences in clinical values across a range of home health providers, local labs or wearable technologies used in decentralization.

For example, a sponsor could establish KRIs for local labs used in a multi-country study. If one country’s average patient value for a specific trial data point was three times that of all other countries, this could suggest incorrect calibration of a local lab device or mismeasurement. This situation would warrant an investigation,appropriate corrective action by the sponsor and mitigation efforts to prevent future risks.

As the locus of control for a DCT moves outside of a conventional clinical site, it is key that sponsors provide training to a range of new stakeholders that are accountable for performing trial procedures and data collection—these include local imaging companies, couriers and home healthcare providers—to comply with GCP Principle 2.8, which states that each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). For example, an IMP courier must be made aware of the IMP’s proper storing conditions, so that it is stored and delivered in accordance with GMP standards. Additionally, training previously given to investigators and site staff will need to be augmented to account for the incorporation of DCT modalities and their associated processes.

Furthermore, in some DCTs, patients may now be involved in completing procedures previously performed by site staff, like measuring their own heart rate at home using a wearable device. This could expand the originally intended scope of GCP 2.8 to include the patient, who is now playing a role in conducting the trial. Sponsors need to ensure these participants have adequate training to perform tasks.

As an industry, it is important to align on the set of risks uniquely posed by DCTs (while not associating these risks with those that would also be present in a traditional site-based trial). As sponsors across the industry invest in and evaluate DCTs, we will gain greater insight into the actual—rather than perceived—DCT risks. Some risks may be greater than anticipated, and there could even be new, unanticipated risks. Other risks may be lower than anticipated or easily mitigated. This appears to be the case with telemedicine, for which sponsor-stated risk decreases with experience (see Figure 4 below).

 Sponsor telemedicine experience vs. risk score

Sponsors should also be aware of opportunities for DCTs to reduce quality and risk concerns when compared to traditional trials. For example, using an electronic patient-reported outcome (PRO) 

could improve data quality and provide more control

 over who completes data and when, in comparison to a traditional paper PRO completed at home. However, methodologies to reduce one risk may introduce new risks such as technology integration or software glitches.

As DCT use increases, it will become increasingly critical to have a clear understanding of the associated impact and required mitigations from a GCP quality and risk perspective in order to inform decentralized trial design choices and effective implementation. This can be accomplished by investing in uniting a DCT “lens” with existing tools and processes, like RACTs and KRIs, and establishing clear feedback loops to learn from study teams in practice.

It’s vital these teams share newfound insights across the industry and work to consolidate learnings to form greater consensus on DCT risks and effective mitigation approaches. This will ultimately ensure that patient safety and data integrity remain at the core of DCT approaches.

 We thank Grace Crawford, Patty Donnelly, Federico Feldstein and Kristel Van De Voorde for their advisory support and contribution to the study design.

These survey results were discussed with GCP quality and risk industry leading representatives at a panel discussion at SCOPE 2022 and

, PhD, MS,is part of the ZS R&D excellence leadership team. She leads the digital and DCT vertical in clinical development.

, PhD, MS, MA, has worked in the pharmaceutical industry across clinical, quality and corporate teams for over 25 years. He currently leads ZS’s clinical development quality, operations and risk management functions from the New York office.

 is a consultant for ZS's R&D excellence team and member of the digital and DCT vertical in clinical development.

 works within ZS’s clinical development quality, operations and risk management practice, and is a consultant at the Princeton, New Jersey, office.

 works within ZS’s digital and DCT vertical in clinical development and medical affairs practices, and is an associate consultant at the Evanston, Illinois, office.

Identifying and providing clarity on the GCP quality and risk concerns associated with DCT modalities.

Survey Results: GCP Quality and Risks in Decentralized Clinical Trials 

For many pharmaceutical organizations, decentralized clinical trials (DCTs) have quickly become a strategic priority, one that is expected to endure long after the COVID-19 pandemic ends. Once viewed as nice-to-have pilot projects, DCTs—trials conducted remotely or through local healthcare providers to improve the patient experience—arrived when Pfizer launched a virtual trial

 in 2011. While drug-based interventional DCTs only experienced a 7% CAGR between 2014 and 2019, they jumped to 77% between the second halves of 2019 and 2020 after the onset of COVID-19, according to ZS’s DCT database, referencing data from more than 1,000 trials.

Decentralized trials offer a patient-centric approach, addressing various patient needs that often go unmet in traditional designs. DCTs benefit sponsors by accelerating clinical development, enabling more representative patient access and developing a stronger evidence package than traditional trials. Yet, DCT implementation doesn’t have to be all or nothing; trial decentralization can be viewed as a spectrum, with most DCTs combining in-person and remote activities to make clinical trial participation easier for patients. But one thing is certain: COVID-19 has shifted the balance of tradeoffs for the pharma industry, and despite operational challenges that may arise during decentralization, the benefits outweigh the investment. In the era of disruption, now is the time to take the risk.

Through our work with pharma clients, we have observed four primary drivers that suggest DCTs are here to stay, even in a post-pandemic society:

 As a result of COVID-19, regulatory agencies including the FDA and European Medicines Agency have clarified their guidance on key decentralized modalities, such as telemedicine across state lines, direct-to-patient investigational product shipments and more. The FDA’s new Digital Health Center of Excellence

 to advance the use of DCTs indicates a smoother regulatory landscape through 2021 and beyond.

 Evolving technology—fueled by record-level venture capital investments

 in digital health—is enabling trial decentralization. Furthermore, horizontal and vertical integration among technology solution providers is creating more end-to-end technology solutions to deliver DCTs.

Pharma investment and capability development:

 Pharma is creating focused DCT capability groups with dedicated leadership and investing in processes and technology to operate DCTs at scale.

 Patients’ increasing use of digital healthcare, such as telemedicine and digital pharmacies, have enhanced expectations of their clinical trial experience, which we don’t expect to revert moving forward.

DCTs offer patients a more streamlined experience, reduce the burden of time-consuming in-person visits and enable wider patient access, especially in rural and underrepresented communities.

Like patients, sponsors also benefit from DCTs. As of 2016, 85% of trials failed to finish on time, financially impacting sponsors by up to $8 million per day, according to Pharmafile.

Decentralization can reduce these hurdles for sponsors by speeding up recruitment, increasing compliance and reducing drop-out rates. Additionally, collecting high-quality clinical and real-world data through DCTs can build stronger evidence packages and better reflect the value created for patients. Sponsors can use novel digital endpoints to generate differentiated label claims through DCTs as well.

Still, decentralization—like most new innovations—adds complexity to the clinical trial process. It requires stakeholders to devote time and resources before the benefits can be realized. Sponsors must learn how to effectively and flexibly implement DCTs, as well as support patients and sites on their respective learning journeys. From a regulatory perspective, DCTs are still nascent and without consistent standards, meaning sponsors may have to initially focus on select priority markets. Lastly, while initial proof points to DCTs providing value are emerging—especially for increasing recruitment speed

—more work is needed to understand their impact. Sponsors should consider ways to benchmark DCT performance versus traditional trials to understand and capture the value of DCT.

Sponsors considering DCTs must root their approach in a deep understanding of patient needs and experiences. Designing approaches and solutions that reduce the patient burden and provide the right behavioral incentives for patients will lead to better patient engagement and improved trial performance. It’s also important to recognize that sites will remain key to patient experiences: As sponsors develop DCT solutions, providing options that are adaptive to site workflow and capability will be critical.

It’s easy to assume solely decentralizing trials and introducing new technology will improve the patient experience, but this isn’t necessarily true. In fact, a multitude of disjointed study apps may even increase the burden, while home nurse visits may be more stressful than visiting a community center. Sponsors must first listen to patients and understand their needs, and then create a more personalized trial experience that meets those needs. It’s important for sponsors with diverse clinical development pipelines to tailor this exercise to specific trial patient populations, endpoints and intervention modalities. Furthermore, within each trial, sponsors should strive to enable optionality for individual patients based on their engagement preferences.

Beyond the approach itself, sponsors also must ensure that decentralization options are considered early in clinical development planning, allowing sufficient time for patient research, endpoint validation and vendor selection activities. If decentralization is an operational afterthought, the process will be more difficult to incorporate and, moreover, the extent to which the trial can be decentralized will be constrained by traditional, site-centered protocols. Shifting this thinking upstream will enable study teams to assess how decentralization can improve the patient experience.

Developing the digital capabilities needed for DCTs is also critical. There are new types of data collected in DCTs and oftentimes new insight generation opportunities from continuous data collection. Digital solutions must enable a unified user experience and one source of truth for data integration. Additionally, while the infrastructure can be gradually built—with numerous digital solutions and providers in the market—sponsors must have an enterprise architecture blueprint to guide the development to enable connectivity and optionality. Developing the DCT infrastructure without a plan would lead to future challenges with technological integration and agility.

Finally, since DCTs are cross-functional in nature, they require collaboration across sponsors’ trial design, trial operations, regulatory, digital health and innovation functions. These teams must overcome functional silos and establish new ways of working to successfully drive DCTs. Sponsors must also establish consistent processes to facilitate scaling DCTs from a proof-of-concept to an organizational capability. One key step here is organizational knowledge sharing: applying learnings rapidly and efficiently across study teams.

For sponsors wondering where to begin or focus DCT efforts across a portfolio, a combination of their business needs and feasibility of decentralization between therapy areas can act as a guide. Some therapy areas are a better fit for decentralized trials, based on factors such as the investigational medicinal product’s administration route (e.g., oral vs. infusion), type of assessment procedure (e.g., non-invasive vs. invasive biopsy) and whether the condition being studied is chronic or acute. Although ZS’s DCT database found cardiovascular, neurology and diabetes as the most common therapy areas for DCTs, they can also be applied in other therapeutic areas. In fact, oncology and infectious diseases make up 5% and 4%, respectively, of all DCTs historically. That said, for many therapy areas, full decentralization may not be feasible or right for patients; instead, identifying specific procedures that can be decentralized or combined into a single visit can drive valuable improvements to the patient experience.

As DCTs become more common, they will raise the bar for patient experience and patient data collection. They offer an opportunity to fundamentally change how we perform clinical research. As pharma companies embark on this journey, they can’t do it alone. The good news is that patients, investigators, sites and regulators are prepared to make the change and unlock the value of moving clinical trials closer to patients.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer_conducts_first_virtual_clinical_trial_allowing_patients_to_participate_regardless_of_geography

https://www.fda.gov/news-events/press-announcements/fda-launches-digital-health-center-excellence

https://www.appropriations.senate.gov/imo/media/doc/AGRept.pdf

https://rockhealth.com/reports/2020-market-insights-report-chasing-a-new-equilibrium/

http://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss

https://www.sciencedirect.com/science/article/pii/S2451865420300740

https://www.sciencedirect.com/science/article/pii/S2451865418300358

Assessing the opportunities, considerations and implications of decentralized trials—and why they’re here to stay

Fan Gao, PhD, MS

Articles

Adapting Site Selection for Clinical Trial Decentralization and the Future Landscape

Survey Results: GCP Quality and Risks in Decentralized Clinical Trials

Why Decentralized Clinical Trials Are the Way of the Future