Clinical trials have traditionally revolved around specific clinical sites where study participants visit and the bulk of trial activities take place. Designed to increase patient convenience and bolster the enrollment process, decentralized clinical trials (DCTs) use a virtual-first approach to bring the study to patients, wherever they are.
While the decentralized approach isn’t new, recent advancements in technology and new digital tools have made DCTs more feasible to run. But it’s the COVID-19 crisis that expedited its adoption and hastened regulatory acceptance. When stay-at-home orders ground the world to a halt, there was no choice but to implement alternatives to site visits. As patients and physicians have embraced the convenience and effectiveness of telehealth, more pharma companies have embraced virtual solutions for clinical trials. At McKinsey’s 2020 Clinical Operations Roundtable, 89% of surveyed pharma and contract research organizations expected to run a trial with most activities conducted in participants’ homes, versus 48% surveyed in 2019 by Industry Standard Research1. DCTs have been gaining ground, and experts agree they are here to stay, with or without a pandemic.
Benefits and challenges of decentralized clinical trials
Shedding the geographical constraints that limit a sponsor’s pool of suitable participants is among the top benefits of a DCT. According to the Center for Information and Study on Clinical Research Participation, 75% of those surveyed were willing to participate in relevant trials2. Yet industry resources approximate that 70% of potential participants live more than two hours away from a research site, deterring many from enrollment. With trial activities taking place at participants’ homes or other convenient locations, a decentralized trial eliminates or reduces the travel burden, resulting in faster enrollment and a more diverse study population.
In addition, study data can be collected at a faster rate in a DCT than a traditional trial. Many options are available for capturing participant responses and metrics, such as having patients answer questions via smartphone, attend telehealth appointments, or wear a web-enabled health monitor. Sponsors may also gain more insights from participants when they can take their time and answer questions in the comfort of their own home. Ultimately this can lead to better outcomes for patients and sponsors.
For all their distinct advantages, DCTs do have unique challenges: Regulations vary between countries, and some countries are slower to accept DCTs than others; data protection and patient authentication need to be considered; supply tracking and patient data processing may require changes; integrating new technology can be complicated for patients, sites, and others concerned; building a compatible infrastructure for DCTs involves buy-in from multiple stakeholders, some of whom may be difficult to persuade; placing the patient at center of supply chain entails specialized logistics planning, especially for global studies or temperature-controlled products.
However, regulations, technology, people, and processes are adapting. Also, decentralized doesn’t necessarily mean “fully virtual” or “site-less.” Most DCTs are a hybrid of virtual and site-based elements. Different approaches can be designed for different drugs and various populations. And sponsors transitioning to more decentralized trials don’t need to make sweeping changes overnight (although many did during the pandemic), but can work on building their DCT capabilities and technologies on select trials. Nor must sponsors tackle supply chain logistics and regulations on their own. They can partner with a contract packaging organization (CPO) experienced in flexible, global distribution, including direct-to-patient (DtP) shipments.
How the right CPO can help your decentralized trial
A good CPO will create a seamless experience for all parties involved in the clinical trial, no matter how the study protocol is designed. As a global CPO, Xerimis has provided packaging, labeling, storage, and distribution of supplies for traditional and decentralized trials worldwide. We can support your DCT in the following ways:
- Adapt our processes to your decentralized approach
- Help you identify the right supply chain lanes for your decentralized trial
- Coordinate DtP shipments of clinical supplies anywhere in the world through qualified couriers
- Direct couriers on any in-transit handling requirements specific to your supplies
- Leverage our strategically located GMP warehouses and partner depots to ensure your supplies are always available for the demand of a decentralized trial
- Advise on regulations and provide import services where necessary
- Follow strict procedures to safeguard patient privacy and data integrity in all countries where we ship your supplies
- Use inventory control systems and IRT for tracking your supplies
- Offer solutions for returns and accountability of unused or expired trial product
- Make the same commitment to quality, flexibility, reliability, and responsiveness that we make for any trial we support
By removing common enrollment barriers and speeding up data collection, a decentralized approach to clinical trials is a big win for investigators, sponsors, research coordinators, participants, and the advancement of medicine overall. DCTs require different processes and technologies than traditional trials. An agile supply chain partner is also critical. Xerimis knows how to seamlessly orchestrate all the moving parts of DCT logistics. From packaging to safe and compliant distribution of supplies, we’re ready to help your DCT succeed.