Decentralized Clinical Trials and Contract Research Organizations in 2023
Decentralized Clinical Trials for the CRO
Decentralized clinical trials (DCTs) are a relatively new concept in the world of clinical research, but they are quickly becoming more popular. In 2023, DCTs are expected to become even more widely used as the technology and infrastructure needed to support them continues to develop.
A decentralized clinical trial is one that is centered around patient needs and improves the patient experience by allowing them to participate from their own homes or local healthcare providers. This type of trial eliminates the need for patients to physically access hospital-based trial sites, which can be difficult for some people due to distance or other factors. It also allows for greater flexibility in terms of scheduling and data collection, as well as improved accuracy of results due to fewer potential sources of error.
In addition to these guidelines from the FDA, there are several ethical considerations that must be taken into account when conducting a decentralized clinical trial. These include ensuring patient privacy and confidentiality, providing informed consent forms that clearly explain the risks associated with participating in a DCT, and ensuring that all participants have access to appropriate medical care if needed during the course of the study.
How CROS can Implement DCTs
Contract research organizations (CROs) can implement decentralized clinical trials by modifying their protocol to incorporate remote data collection, patient-centric protocols, and virtual engagement between trial participants and CRO personnel. Remote data collection allows for the capture of participant-generated data outside of a traditional clinical setting via digital devices. Patient-centric protocols allow for a more personal approach to clinical trials by allowing patients to participate in activities such as self-reporting on symptom severity, digitally submitting medical images and lab results, and engaging with physicians from the comfort of their own home. Virtual engagement between trial participants and CRO personnel can be facilitated through secure video conferencing tools that enable real-time interactions.
Further modifications to the CRO protocols could also include integrating artificial intelligence technology into the trial process such as automated monitoring of patient behavior, prioritizations of interventions based on individual risk profiles, and remote health guidance by virtual nurses or other healthcare professionals. Mobile applications could also be used to remind participants about upcoming appointments or events related to the study as well as remind them about taking medication or completing questionnaires. Incorporating these types of technologies would ensure that decentralized clinical trials are conducted efficiently while providing participants with an enhanced user experience throughout every step of the trial process.
Five Steps to Implementing Decentralized Clinical Trials
1.Educate Project Managers: Contract research organizations (CROs) should ensure that their project managers are educated about the benefits of decentralized clinical trials and how to go about implementing them. This could include learning about the technology, regulations, data privacy, and other important elements related to this type of trial design.
2. Establish Data Security Measures: Before conducting a decentralized clinical trial, CROs should have strong data security measures in place to protect participants’ information and ensure that it is secure throughout the study duration. This includes accessing participant data only with permission and using encryption protocols when transmitting or storing any sensitive information.
3.Evaluate eClinical Platforms: A key part of implementing decentralized clinical trials is choosing the right eClinical platform for your study design. CROs should evaluate the various eClinical platforms available to them and select one that meets their needs for a successful trial, such as being user friendly for participants, having features such as remote monitoring capabilities, offering robust reporting capabilities, and providing easy access to data from multiple sites.
4.Utilize Mobile Technologies: To make a decentralized clinical trial successful, leveraging mobile technologies can be extremely helpful for CROs to communicate with volunteers remotely, manage participant engagement in real-time, collect patient-reported outcomes quickly and accurately from anywhere, track compliance with protocols on site visits or assessments done remotely, etc., reducing the need for face-to-face visits whenever possible.
5. Create Protocols: Having clear protocols in place is essential if a CRO wants to successfully implement decentralized clinical trials as they help ensure consistency across different sites by setting expectations around communication between sites and central teams; supervision of staff; quality control procedures; safety reporting; use of investigational drugs; collection of patient data; follow up on withdrawals or lost patients; etc., throughout the duration of the trial
Decentralized clinical trials offer a variety of benefits to CROs, such as reduced costs associated with traditional on-site trials, improved patient recruitment, faster data collection and analysis, and greater efficiency.
Decentralized clinical trials (DCTs) offer a promising new model for contract research organizations (CROs). By leveraging decentralized technologies such as blockchain and distributed ledger technology, DCTs provide a secure, efficient, and cost-effective alternative to traditional CRO models.
The key advantages of DCTs for CROs include enhanced security and data integrity, improved consent management, faster and more secure patient recruitment, and greater visibility into the trial process. With DCTs, CROs can leverage existing research infrastructure while streamlining processes such as data management and quality control.
To further explore the potential of DCTs, it's helpful to look at some recent developments in the industry. In 2018, Decentralized Clinical Trials LLC partnered with Johnson & Johnson to create JLABS@TMCx to develop innovative digital health solutions for clinical trials. This collaboration unveiled two major projects that leverage decentralized technologies: Project Catalyst and Project Ovenbird.
Project Catalyst seeks to develop a system of protocols that will allow researchers to securely exchange information in real-time. The project is currently focused on developing decentralized application (dApp) versions of standard protocols and applications used in clinical trials. Meanwhile, Project Ovenbird seeks to create an enterprise-grade distributed data platform that will enable researchers to collect structured data from decentralized sources while maintaining privacy standards comparable to those set by HIPAA.
In addition to these projects with J&J, Decentralized Clinical Trials LLC has also partnered with Microsoft Corporation on a pilot program called "Verified Credentials." This program leverages blockchain technology to ensure accurate identity verification during patient recruitment processes for clinical trials.
For CROs interested in exploring DCTs further, there are several resources available online that can help provide a better understanding of their benefits, applications, and potential challenges. The National Institutes of Health recently launched the Decentralized Clinical Trials Hub (DCThub), which provides educational materials about DCTs for research professionals. Additionally, several companies offer products tailored specifically for DCTs such as TrialX from OptumIQ or Oneyield from Castor EDC Solutions Ltd., both of which are designed to support decentralized clinical trial design and implementation workflows.
Types of Remote Monitoring in DCTs
Decentralized clinical trials are conducted using remote monitoring technology to capture data from patients rather than requiring them to come into a physical research site. This allows for more flexible trial designs that can be tailored to specific patient populations and geographic locations. In addition, patients can more easily participate in a trial without having to travel or take time off from their daily lives. For example, virtual visits through telemedicine can be used for initial screening and assessments, reducing the number of visits required at an on-site research facility.
Data collected from decentralized clinical trials is often more accurate than what is typically collected in traditional on-site trials due to the use of continuous wearables, mobile devices and other innovative digital technologies that provide real-time monitoring of health parameters such as blood pressure or glucose levels. This increases the quality and granularity of information available to researchers while decreasing the amount of labor required for data collection. Additionally, electronic health records (EHRs) can be integrated with decentralized trial platforms allowing for rich longitudinal datasets that enable deeper insights into patient outcomes over time.
One example of a decentralized clinical trial is the use of telemedicine to support remote monitoring. This could involve providing video conferencing for patient-physician visits and using smartphones for tracking vital signs. In addition, telemedicine can enable doctors to monitor patients with chronic conditions remotely, by collecting medical data from sensors that have been placed on the patient’s body. This type of monitoring allows doctors to keep track of changes in health parameters without requiring an in-person visit, significantly reducing both costs and risks associated with traveling for treatment.
Another example is direct-to-patient (DTP) trials, in which medication is shipped directly to a patient's home instead of them having to travel to a clinic. In this case, study coordinators can monitor the progress remotely via phone calls or text messages while also providing support when needed. This approach has enabled researchers to conduct studies involving large numbers of participants located around the world who would otherwise not have been able to participate due to geographic distance or lack of transportation resources.
Finally, wearable devices are also being used increasingly in decentralized clinical trials as they allow researchers to collect more accurate data about activity levels and other health metrics over long periods of time without needing frequent interventions from healthcare personnel. It is possible for these devices to be connected directly with electronic data capture systems so that the collected information can be analyzed quickly and accurately by researchers.
Larger Patient Engagement
The decentralization of clinical research also opens up new opportunities for CROs to reach larger populations by enabling simultaneous studies across multiple sites around the world and removing many logistical barriers related to travel or geographical distance between participants and study sites. Additionally, leveraging social media platforms for recruiting further expands access potential outside of traditional recruitment networks and offers ways to engage with potential participants more directly than before.
Decentralized clinical trials, also called virtual studies or remote research, have the potential to revolutionize the way clinical studies are conducted. A decentralized clinical trial is a type of clinical study where participants are distributed across geographical and other boundaries, allowing them to participate from their own homes or from one of many remote sites.
To explore further options regarding DCTs and related technologies, interested parties may consult companies such as Medidata Solutions (www.medidatasolutionsinc.com), IMS Health (www.imshealth.com), HRA Pharma (www.hrapharma) or IQVIA (www.iqvia). These firms specialize in providing comprehensive services related to DCT implementation, ranging from development and customization of software solutions through full project management services that cover all aspects of a clinical trial operation from start-up through completion – including training protocols for implementing these new technologies at each site visited during study duration and beyond..
Overall, decentralized clinical trials represent a significant opportunity for CROs looking to move away from costly on-site studies in favor of more cost effective approaches that offer equally robust data sets but require fewer resources from both researchers and participants alike. As technology continues to advance so too will our collective ability to take advantage of decentralized trial designs for bigger impact studies without sacrificing quality or rigor.
Decentralized clinical trials offer many advantages over traditional site-based studies. They provide greater convenience for patients while still maintaining high levels of safety and efficacy standards. As technology continues to advance in 2023, we can expect even more opportunities for DCTs to become available.
More Examples on Decentralized Clinical Trials:
In the past decade, the advent of blockchain and other technologies have made it possible for clinical trials to be conducted in a decentralized manner. Here are five examples of decentralized clinical trials currently taking place across the world.
1. Mediledger Clinical Trial Supply Chain: This trial is being managed by MediLedger, a healthcare-focused blockchain consortium. The goal of this trial is to use blockchain technology to streamline and secure the global movement and tracking of drugs within the supply chain. The solution will enable parties to share data about patient safety, drug expiration dates, and more in real-time – all while remaining compliant with regulatory standards.
2. CardiLynx Smart Phone ECG Readings: This study is being conducted by CardiLynx, a healthcare technology company that specializes in mobile health applications that measure electrocardiograms (ECGs). The aim of this trial is to use an app on a smartphone to accurately detect heart arrhythmias in patients over time, as well as identify early symptoms and risk factors associated with cardiovascular diseases like stroke and heart attack.
3. Cogstate Cognitive Testing Trial: This study is sponsored by Cogstate, an AI-powered cognitive assessment platform that uses computer games to measure cognitive performance across multiple disciplines such as memory, attention and executive functioning. The purpose of this trial is to evaluate how well Cogstate’s technology can accurately detect changes in cognition over time in various patient populations and disease states.
4. Takeda Whole Genome Sequencing Study: This research project is sponsored by Takeda Pharmaceuticals, one of the world’s largest pharmaceutical companies. In this project, researchers are using whole genome sequencing technology to increase our knowledge about genetic mutations related to certain diseases such as hemoglobinopathies or rare blood disorders. They are also trying to identify new treatment options based on these mutations that could help improve patient outcomes overall.
5. Verily Life Sciences Patient Health Monitoring Project: This project involves Verily Life Sciences working with healthcare providers, payers and employers on an initiative called “Project Baseline” which uses wearables and other devices such as Fitbits or Apple watches to monitor patients’ health data in real-time while they go about their daily lives outside of a clinical setting. Through this project, Verily aims to understand how different lifestyle behaviors can influence health outcomes; enhance patient engagement; reduce healthcare costs; and ultimately improve population health management globally
6. GlaxoSmithKline’s digital platform trial: GlaxoSmithKline developed an innovative digital platform to conduct a clinical trial of its new asthma drug, mepolizumab, in the United States. The trial involved recruiting participants through a web-based interface, using secure electronic data capture (EDC) tools to collect and store data in real time, and utilizing mobile devices for remote patient monitoring. This decentralized clinical trial was able to reduce the traditional costs associated with running a large-scale clinical trial because it eliminated many of the steps required for enrollment and data collection. Additionally, it enabled GSK to recruit more geographically diverse participants who would not have been able to take part in a conventional trial setting.
7. Merck's MyEHRConnected study: Merck conducted the MyEHRConnected study, which sought to evaluate the efficacy and safety of its diabetes medication Januvia (sitagliptin). This was an international phase III study that utilized electronic health records (EHRs) from more than 60 sites located throughout Europe, Asia Pacific, Latin America and Canada in order to identify eligible patients with type 2 diabetes. The EHRs enabled Merck to recruit participants quickly without requiring physical visits or extensive paperwork. Furthermore, researchers could securely access patient data stored within the EHR system during the duration of the study for analysis and evaluation purposes—a process that would have been impossible with paper-based records.
8. Sanofi's Telcare Diabetes Trial: Sanofi conducted a revolutionary telephone-based randomized control trial known as the Telcare Diabetes Trial (TDCAT), which aimed to assess the impact of telemedicine on diabetes care management among patients at risk for complications due to uncontrolled blood sugar levels. Patients were randomly divided into two groups—one group received standard care while another group received a combination of traditional care plus remote support provided by nurses through weekly phone calls over a period of six months. Results showed that those participants receiving telemedicine services had significantly better glycemic control than those who did not receive any telemedicine services at all—highlighting one powerful benefit of decentralizing clinical trials using technology such as telephone communication services.
9. Novartis’wearable device clinical trial: Novartis launched an ambitious clinical trial involving 20,000 individuals across nine countries in order to evaluate whether wearable devices such as smart watches can detect early signs of heart failure before medical symptoms appear. The decentralized nature of this study offered numerous advantages over traditional studies in terms of cost savings as well as recruitment speed; enabling Novartis to rapidly reach out potential participants worldwide instead of relying solely on localized recruitment methods used previously by other companies conducting similar trials with much smaller sample sizes due to limited resources or geographic restrictions
10. Eli Lilly & Company's eCOA Study: Eli Lilly & Company recently completed an innovative eCOA (electronic Clinical Outcomes Assessment) study that leveraged mobile applications and internet-connected devices in order to record patient outcomes over longer periods of time compared with traditional studies involving paper forms or periodic clinic visits alone. By using this decentralized approach, Lilly was able to gather more accurate data while reducing costs associated with running conventional trials; making it possible for them to enroll larger numbers of patients in shorter periods than ever before.
11. The IQVIA-sponsored study by the Alzheimer's Prevention Initiative (API). This study was designed to evaluate the effects of an investigational oral form of the drug solanezumab on the cognitive decline associated with early stage Alzheimer's disease. It was a decentralized trial conducted using remote monitoring, which allowed participants and clinical sites to interact online via web-based video visits, digital questionnaires and remote diagnostic testing. The trial collected data from over 800 participants at over 30 clinical sites in 12 countries.
12. A decentralized clinical trial launched by Durect Corporation to assess its investigational drug DUR-928 for the treatment of nonalcoholic steatohepatitis (NASH). The Durect NASH study was conducted across 16 countries and used innovative telemedicine technologies for patient monitoring and data collection. In addition to traditional site visits, remote video visits were performed with patients and caregivers to observe adverse events, review patient-reported outcomes, analyze lab results remotely and monitor compliance with the protocol.
13. The Institute for Qualitative Medicine’s (IQM) pilot study that evaluated an innovative approach to decentralizing clinical trials using mobile health technology (mHealth). The mHealth platform was used to connect participants remotely with healthcare professionals who monitored vital signs such as blood pressure, heart rate, respiratory rate, oxygen saturation level and body temperature using wireless medical devices connected directly to smartphones or computers. In addition, the platform included a chatbot that trained participants on how to use their medical device correctly or send real-time reminders when it was time for follow-up appointments or tests.
14. An analysis conducted by PPD Incorporated comparing decentralized vs centralised clinical trials for a Phase IIb study evaluating an investigational vaccine for malaria prevention in children aged 1–6 years old. They found that decentralizing the trial saved approximately 25% in total resources spent compared to a centralized approach and resulted in shorter recruitment times due to increased convenience for both investigators and participants alike compared with centralised approaches where people had to travel long distances for appointments or procedures.
15. A global Phase IIIa research program sponsored by GSK which evaluated an experimental shingles vaccine involving over 17000 elderly individuals across 11 countries in Europe and Latin America including Argentina, Brazil, Chile, Colombia, Germany Spain France Italy Netherlands Poland Portugal UK..The study incorporated various decentralized models such as virtual/remote clinic visits with self-administered questionnaires through smartphones/tablets; home delivery of intervention product; remote diagnostics; online physician/patient communication through video calls; collection of sample storage through kits sent remotely from local courier companies etc., thus enabling a truly distributed model of conducting clinical trials without relying solely on physical presence at site locations
Want to train your staff to run decentralized clinical trials? Enroll them in our in-depth clinical trial certification courses with hours of lectures focuses on remote monitoring alone.
