There is a quiet but growing discussion in the world of clinical research that has the potential to reinvigorate the recruiting process and alleviate disparities in study participation. The conversation around the topic of decentralization of clinical trials has steadily gained attention over the last few years. The idea has gained significant momentum recently because of the ground-breaking advances in the available technologies, infrastructure, and the increasing shift to remote life. Moreover, under-enrollment in traditional clinical trials remains a considerable challenge. According to one study, around 82.9% of the oncology patients enrolled in clinical trials conducted between the years 2001 to 2010 were white, while only 17.1% of the participants belonged to racial and ethnic minorities. Decentralized trials promise to help close that gap by bringing research closer to larger parts of the population, thereby eliminating some of the obstacles, e.g., the need to own a car or have access to public transportation, which stand in the way of participating.
What are decentralized clinical trials (DCTs)?
Virtual, remote, site-less, direct-to-patient, and patient-centered clinical trials are some of the terms that can be used to describe the concept of decentralized clinical trials (DCTs). DCTs are trials that are conducted using new technologies and methodologies, which differ from the traditional clinical trial models, such as telemedicine and mobile/local healthcare providers.
These trials eliminate the need to have patients regularly travel to a physical clinical trial site and allow the trial participants to be enrolled and participate in clinical research from anywhere. Networked wearables, medical devices, mobile applications, web-based portals, and surveys are some of the means that can be used to collect data from the participants. Numerous virtual clinical trials have either been completed or are ongoing. There are many more trials using the decentralized approach in sponsors’ pipelines. It has been forecasted that the size of the global virtual clinical trials market would approach 10 billion dollars by the year 2026, rising at a compound annual growth rate of 6.5%.
What are the advantages of decentralized trials?
Decentralized clinical trials have a tremendous potential to positively influence clinical trial development. Some of the advantages of DCTs in comparison to traditional clinical trials are:
- Faster patient recruitment: It has been estimated that around 86% of traditional clinical trials fail to recruit the target number of patients within their specified timeframe. Similarly, according to a systematic review, 19% of the trials registered as newly closed in 2011 had an early termination due to recruitment failure or were completed with less than 85% of their expected enrolment target. With a more extensive geographical footprint, DCTs allow access to a larger population. The investigators can recruit from a wider pool of patients, and this results in faster rates of recruitment.
- Improved participant retention: Compared to traditional site-based trials, decentralized trials require less frequent visits to physical trial sites. The autonomy provided by the technology allows participants to be more informed and engaged in the trial, from the comfort of their own homes. This patient-centric approach also eases participants’ burden by reducing travel costs and other logistical demands and makes them more willing to participate in the trials, thus enhancing participant recruitment and retention.
- Increased participant diversity: In traditional trials, participant recruitment is usually limited to those who reside within a reasonable distance of a trial site. By reducing or eliminating the need to travel to one specific physical site, decentralized clinical trials allow investigators to recruit patients regardless of their geographical location, thereby increasing the diversity of enrolled participants.
- Improved data collection and accuracy: The data collection is limited by the duration and frequency of site visits in the traditional clinical trials model.
The use of mobile technologies in DCTs allows remote monitoring of the patients in real-time and helps collect a greater quantity of data over time. It also helps keep the data safe and organized, as opposed to the site-centric trials, where the data is typically stored in paper format, prone to damage or loss.
What are the things to consider when setting up a decentralized trial?
The Clinical Trials Transformation Initiative (CTTI) is a partnership between the United States Food and Drug Administration (FDA) and Duke University, which has released recommendations regarding decentralized clinical trial approaches and protocol design. Some of their key recommendations are:
- Early engagement with the stakeholders: CTTI recommends that the sponsors should engage with the appropriate stakeholders, such as the FDA, state medical boards, IRBs, investigators, CROs, and technology providers, early in the trial planning and design process. During these meetings, the concerns from these various stakeholders can be discussed and standard operating procedures (SOPs) can be developed to address any process-related concerns.
- Adherence to a fit-for-purpose protocol design: A DCT will require a trial-specific protocol design and it is important to determine if there are any additional requirements to maintain protocol compliance. For example, additional trial-specific training and trial participant safeguards and the creation of supplemental education materials.
- Planning for technological support: A clear plan must be devised to ensure that the required technical support is available at all times to all the parties involved in the trial, including the trial participants and telehealth providers.
- Mapping data flow: Specific actions should be taken by the sponsors/CROs and third parties who manage data flow and storage to ensure participant privacy is protected and personally identifying data isn’t mishandled.
- Consulting telemedicine providers in protocol development: During the protocol development process, sponsors and stakeholders should consult experienced telemedicine providers. These professionals have successfully integrated their services in clinical trials and have a thorough understanding of the use of telemedicine in clinical areas.
What are the challenges associated with conducting decentralized trials?
Despite the dramatic changes resulting from the introduction of modern technology in healthcare, the adoption of a decentralized approach to running clinical trials has been slow and variable. Some of the significant barriers that may be causing reluctance in the clinical trials industry to accept decentralization are:
- Limited experience: A general lack of awareness regarding decentralized clinical trials may be one of the primary reasons for the slow adoption of this approach. Sponsors, investigators, and other stakeholders may have concerns regarding legal and regulatory compliance, and thus, may be tempted to choose the more risk-averse, traditional approach of conducting clinical trials.
- Concerns regarding data privacy: The reliance on remote communications and collecting a high volume of data through mobile devices in decentralized trials means that the sponsors and site staff must pay additional attention to maintaining compliance with data privacy and security regulations. This may be of particular concern while outsourcing the technology services.
- Finding reliable technology vendors: It may be challenging, especially in the early stages of adopting digital technologies, to select the right vendor that offers the best technology, protects patient data, and promptly provides the data in a suitable format so as not to delay or disrupt the trial progression.
How can these challenges be overcome?
The United States Food and Drug Administration (FDA) has been working closely with the research industry to assess the role of decentralized trials and the use of mobile technologies. Under a project named the Decentralized Clinical Trials project, CTTI has issued several recommendations to encourage broader utilization of decentralized clinical trials and successfully achieve the benefits of executing clinical trials outside of traditional brick-and-mortar clinical trial sites.
It is also important to note that state-of-the-art digital technologies required for the seamless execution of decentralized clinical trials are becoming more readily available. These validated virtual technologies can provide all the support that the DCT operators need while ensuring accurate data collection and analysis and keeping the data secure. The use of these technology services can help tackle some of the significant challenges that the industry faces in adopting DCTs.
Clinical.ly – We can help you decentralize!
Clinical.ly is a technology solutions provider that is focused on investing in the future of efficient clinical research. By providing accessible, easy-to-use, and reliable technology services, we can help you stay ahead of the clinical trials industry’s evolving demands.
Reach out to us to see how you can leverage our technological expertise to harness the power of decentralization and make clinical trials more patient-centric.