A traditional clinical trial is carried out at an investigational site, with all patients traveling to and from sites for receiving the investigational treatment and being examined for safety and efficacy.
This traditional approach was restricted due to the covid-19 pandemic, and studies around the world were placed in jeopardy.
The traditional format of the clinical trials was challenged and led sponsors to look for advanced solutions to overcome and enable clinical operations continuity.
Decentralized clinical trials offer a hybrid approach and include solutions that enable more flexibility to patients, clinical staff, and sponsors alike. So, what are decentralized trials, and what advantages do they bring?
- What is a decentralized clinical trial?
- How and why did DCTs become popular?
- What are the different types of decentralized trials?
- What are the advantages of decentralized clinical trials?
- What are the challenges of decentralized clinical trials?
- The future of clinical trials
- Clinical trials with Gsap
What is a decentralized clinical trial?
A decentralized clinical trial is a modern evolving approach that includes different levels of integration of technological solutions that enable activities and assessments to be performed virtually such as electronic informed consent, video and telemedicine visits, home health, supply chain extensions, and basic remote monitoring.
This approach and solutions enable the improvement of data collection flow, recruitment, and patient compliance.
How and why did DCTs become popular?
A major factor for the increase in popularity of decentralized clinical trials was the COVID-19 pandemic. The nature of the global pandemic forced society to find alternative ways to function, and clinical trials were no different. Although decentralized trials were already operating before the COVID-19 pandemic (Pfizer completed its first decentralized clinical trial in 2011), this type of trial became much more popular in response to the global pandemic.
What are the different types of decentralized trials?
Decentralization can be split into two categories:
Fully remote
A fully remote clinical trial is conducted virtually, using mobile devices, remote monitoring software, and apps. Sometimes, home visits are also offered, or patients are required to travel to labs located near their homes. Fully remote clinical trials take advantage of recent advances in telemedicine, and there is no defined “study site” to speak of.
Hybrid
As the name suggests, hybrid clinical trials combine traditional, on-site clinical trials with remote clinical trials. Some activities are conducted remotely, using the technologies described above, while other activities occur at designated study sites. This model is becoming increasingly popular with study sponsors across a wide range of fields and industries.
What are the advantages of decentralized clinical trials?
Decentralization comes with many advantages, including the following:
● Flexibility. Because the model reduces the need to physically travel to a designated study site, a DCT offers much more flexibility for patients. Using telehealth and wearables, data can be submitted from anywhere, at any time.
● Ease of participation. Reducing the need to travel to a study site makes it much easier for patients to participate in clinical trials. The option to participate remotely reduces a major barrier and allows more participants to enroll in a trial.
● Saves time. Recent research has shown that decentralized phase 2 clinical trials can be completed one to three months faster than traditional trials, with phase 3 trials also saving time compared to their traditional counterparts.
● Better generalizability of trial results. With fewer barriers, more patients can enroll in decentralized trials. This makes it easier for trials to enroll a more diverse patient population, which allows for fewer caveats and greater generalizability of the overall results of the trial.
● Improved patient engagement. Patient engagement is higher, and patients are more likely to participate in a clinical trial for the entire duration if the “patient burden” is reduced. The flexibility of decentralization significantly reduces the patient burden, improving patient engagement.
● Authenticity and reliability of data. Due to the use of technology such as wearables and real-time monitoring devices, decentralized trials often lead to more robust data.
● Improves enrollment potential. Transportation is a major barrier to trial enrollment. With decentralized clinical trials, this barrier is largely removed, which improves the potential patient pool.
● Real-time study overview. Collecting data remotely, and in real-time, means that the study team can identify missing data or deviations that must be addressed immediately. Real-time monitoring is especially advantageous for safety data, as any adverse events can be acted upon immediately.
What are the challenges of decentralized clinical trials?
While decentralization offers several advantages, there are also some challenges associated with this newer trial format, including:
● Infrastructure. Clinical trials require a great deal of infrastructure, including financial support, information systems, technology, staff, and more. Coordinating this remotely, and ensuring that all patients receive and administer medications appropriately is a significant logistical challenge.
● Technological skills needed by participants. DCTs often involve patients administering their medication, or affixing their own wearable devices. This requires patients to have some skills in these areas or risks the integrity of trial data.
● Design and planning. DCTs require comprehensive planning to promise smooth execution. The DCT approach requires interaction and interface of many factors and the process needs to be well planned, validated, and documented
● Data quality. Some decentralized clinical trials rely on self-reported data, which may increase certain forms of bias and not be as accurate as data collected from a traditional trial site.
● Patient safety. Patient safety needs to be carefully considered in DCTs. As patients are often not required to report to a trial site, stringent trial monitoring needs to be in place to ensure that all patients are appropriately and frequently assessed for adverse events.
● Regulations. As patients are given more freedom with a DCT, trial staff must ensure that regulations are adhered to despite the reduced patient contact and interaction.
The future of clinical trials
The technological development landscape and regulatory approach towards DCT enable the integration of advanced solutions to improve main parameters in the execution of clinical trials, in particular aspects of recruitment, duration, and cost. Yet, the full integration of applicable solutions should be considered and built in the early stages of the trial design.
Gsap CRO supports sponsors during the planning phase and clinical trial protocol development to promise appropriate integration of the relevant DCT solutions into their operation. This increases the value to the sponsor, improving data authenticity and reducing patient burden.
Clinical trials with Gsap
Gsap is a boutique Contract Research Organization (CRO) with vast experience across a wide range of industries. Gsap’s full-service CRO services will help ensure your trial runs smoothly from start to finish. Whether you are running a traditional clinical trial, a hybrid trial, or a fully-remote clinical trial, Gsap has the professionals on staff to make it a success.
A boutique CRO offering personalized support
The team at Gsap ensures that you have much more than an organization to plan and execute all facets of your clinical trial. Gsap acts as a partner, providing personalized services based on your trial’s specific needs.
Gsap has helped hundreds of clients execute clinical trials across cell and gene therapy, medical cannabis, medical devices, digital health, and beyond. The Gsap holistic approach to CRO services helps to ensure the success of your clinical trial.
Contact Gsap today to discuss your upcoming clinical trial.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
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