The industry provides endless methods in crafting solutions for patients.
Due to the timing of the industry’s gradual shift to more decentralized clinical trial (DCT) models, when COVID pushed trials outside of sites, Rho was already able to adapt quickly and adapt. focus on developing technology solutions that capture efficiency and high-quality data in a virtual environment.
To seize the right opportunities, we had to remain flexible in our approach. This adaptability is the driving force behind Rho’s development of a robust Risk-Based Quality Management (RBQM) framework. The custom framework has allowed many sponsors to navigate and implement decentralized solutions for their clinical trials and programs. While focusing on potentially critical risks, the framework helps you identify the right monitoring strategies for your trial. Rather than spending more time and money onsite, the streamlined approach delivers the most value without sacrificing data quality.
Due to the ICH E6r2 requirement for sponsors (or CRO delegates) to implement clinical trial quality risk management, it is more important than ever to direct our attention to highly effective technological advances. A federally registered revision of ICH E6 (R2) makes explicit the sponsor’s responsibility to understand and actively manage quality risks in clinical trials using a quality risk management (QRM) approach.
Based on our experience helping sponsors navigate and implement decentralized solutions for their clinical trials and programs, we believe that the best decentralized solutions are patient-centric, personalized and anchored in a robust management framework. risk-based quality (RBQM). Rho’s methodology was developed in partnership with a consultant from PharmaInitiatives and is directly derived from ICH E6R2. Other tools Rho used to develop its RBQM framework include resources and tools available from Transcelerate and the Metrics Champion Consortium, now part of the WCG Avoca Group.
Here are some considerations for successfully implementing effective decentralized solutions:
- Risk analysis
- Patient-centeredness and study logistics
- Continuous assessment
- Updating study plans/protocols
Risk analysis—A formal risk analysis is the basis for implementing a decentralized solution. A data-driven RBQM process that allows you to identify and assess risks early, monitor those risks, and provide insights to adjust throughout your trial is essential. A robust RBQM process led by an experienced CRO will help determine the type of decentralized solution needed for your clinical trial (eg, fully virtual or hybrid). It will also help you make decisions about the most appropriate use of monitoring strategies, including risk-based monitoring, central monitoring, offsite monitoring, and targeted source data verification (TSDV), as well as to provide insight into other critical considerations for the topic. data security and integrity.
Patient-centeredness and study logistics“The patient must be at the center of any decentralized solution. This includes considerations for study safety, engagement, and logistics. When clinical sites are closed and/or travel to sites is a burden on patients, it is important to consider the following:
- Telemedicine visits—Many of our sites have implemented telemedicine visits to assess subject safety throughout a decentralized trial. During a telemedicine visit, clinical site personnel communicate with the patient by phone or web conference to assess new and/or ongoing adverse events and any changes to the patient’s medications.
- Lab prints“It’s important not to overlook a local lab as an option for some blood drives. Allowing a patient to have blood drawn at a lab closer to home can reduce patient burden. We have also partnered with a supplier who offers the patient the option of collecting blood, urine, saliva and stool samples at home and sending them directly to the laboratory for analysis.
- Direct-to-Patient (DTP) Shipments of Investigational Products (IP)“We have developed strategies for IP dispensation, such as door-to-door delivery or using courier services to ship IP directly to patients’ homes. To ensure that IP maintains a specific temperature in transit, our shipping partners use a temperature-controlled shipper and temperature tracking device.
- Offsite Monitoring“We have many types of offsite monitoring processes in place to meet the needs of specific decentralized clinical trials. These solutions have included tailored approaches and levels of risk-based monitoring, off-site monitoring and targeted site data verification (TSDV). The right combination of these solutions for your clinical trial will depend on the risks identified in the RBQM process, as well as the status of your clinical trial or program (for example, a new study that has not yet started versus an ongoing study). underway and needs to implement a decentralized solution along the way), and the level of access to your clinical sites.
- Centralized monitoring and data visualization—Remote assessment of clinical data (eg, centralized monitoring) is an essential part of any decentralized solution, and it becomes more important as direct access to clinical sites and patients is reduced. Centralized monitoring is used to identify trends in clinical data, including information relevant to site management activities and data related to security events. Our teams have centralized monitoring tools to quickly identify key quality and risk indicators and monitor them throughout the study to provide actionable and timely insights that will help manage your decentralized clinical trial.
Technology—Technology is a key component of most decentralized solutions. At Rho, we have implemented eCOA and ePRO solutions, as well as devices and wearables that capture data directly from patients. Technological solutions have the potential to significantly reduce patient burden and increase patient engagement if properly implemented. It is important to develop a strategy early in the process, which includes solid plans for site and patient training. It’s also important to make sure that the CRO you’re working with has developed strong partnerships with any technology vendors they offer.
Continuous assessment“Research site conditions and patient availability have changed rapidly over the past few years. Therefore, it is even more important to have a decentralized approach based on a robust RBQM framework, which can provide data and triggers to determine when a change in approach is needed.
Updating study plans/protocols—To document potential modifications to your decentralized strategy, be sure to update study plans and protocols throughout your trial or program. Study plans include, but are not limited to, the project management plan, clinical monitoring plan, and statistical analysis and data management plans. Up-to-date plans and protocols will ensure compliance and result in reliable data that supports endpoints.
Looking ahead, DCTs are here to stay. However, these decentralized solutions are not universal. The right solution for your trial or program should be determined and managed using a robust risk assessment process, which will identify risks in advance and monitor them throughout to let you know when changes need to be made. be brought.
To fully leverage all the advantages and benefits of a truly decentralized approach, it is essential to partner with a reliable and experienced CRO to implement and run your decentralized solution. While there are no set guidelines to define the future of clinical trials, our industry stands at a unique point with limitless opportunities to design adaptable solutions that best serve our patients.
Marina Acosta EnslenDirector, Clinical Management, Rho