Decentralized clinical trials (DCTs) are changing the way we collect data from patients. This method of data collection also introduces new challenges for keeping data safe. To be compliant and adhere to regulatory standards and guidance, sponsors and sites need to redefine workflows for managing data collection, ensuring data privacy, and proving compliance to data privacy standards and regulations are being met.

IQVIA recently hosted a panel discussion in this topic, titled Patient Centricity Through DCT Technology: How Decentralized Clinical Trials Converge GCP and Privacy Compliance. The panel included Jill Bähring, a DCT privacy expert at IQVIA, Eric Klaver, DCT regulatory director at IQVIA, and Dr. Viviënne van de Walle, co-founder of PreCare Trial & Recruitment (PT&R), an independent research site. The panel was moderated by Owen Corbin, IQVA’s senior director of DCT Regulatory and Data Privacy.

In the conversation, these experts discussed the many challenges trials face managing huge volumes of data while adhering to global and local data privacy rules, and the best practices sponsors can use to adapt.

Investigators lead the way

The DCT environment is lauded for reducing the burden on patients. But sponsors also need to consider how it changes the role of investigators, and what insights they can bring to the data collection process. “We talk a lot about involving participants in developing DCT protocols and trial designs, but investigators play an equally important role in balancing regulatory compliance with patient centricity,” Corbin said.

Most investigators will have limited experience with DCTs, particularly at smaller sites that don’t run a lot of trials. The use of telehealth and remote technologies to capture data will be new to them, and they need to be confident that these processes will maintain their patients’ safety and data privacy, van de Walle said. “It is their name and clinic that will be attached to that trial, so having open conversations with them is crucial.”

Investigators also have the most knowledge about what patients value in the trial experience, where they may face fears, and where they are likely to become disengaged with the study or data collection process. Those insights can help sponsors identify potential risks in the data collection strategy and achieve a balance between ease of use and compliance.

For example, requiring additional log-in steps may add data security, but it may damage the user experience and increase attrition, Bähring said. “It could be the best privacy solution that has ever existed, but if it's too complicated and it takes too long, people will not use it.” By involving investigators in these planning decisions, sponsors can identify better solutions based on the protocols, patient preferences, and privacy requirements.

Missing data

Investigators can also review where data collection strategies may face unintended risks.

When an investigator sees patients face-to-face they have the flexibility to ask follow up questions, and dig into issues that emerge. But if the trial relies on ediaries and other self-managed data collection tools, those nuances can be lost. For example, a questionnaire may ask about minor medical events, but fail to ask follow up questions about what over-the- counter meds or supplements a patients used. “Sponsors need input from sites and patients to make sure what they are setting-up is feasible, and that they are not missing crucial information,” van de Walle said. Investigators can point out these shortcomings during planning to ensure the collection process will result in complete and representative data.

They can also provide sponsors with insights about the local community, and what expectations they are likely to bring to the trial. “Many communities feel strongly about the culture of privacy and their concerns can be a hidden barrier to trial participation,” Bähring said.

If patients worry that their data won’t be protected, or don’t fully understand the reasoning for providing such personal data, it can lead to a lowered level of trust with the investigator, the site, and the overall clinical research experience. Addressing these issues up front can eliminate recruiting obstacles and build a data collection environment enhances the patient experience while ensuring rigorous data privacy.

Tech support is not our job

Though sponsors should be clear that investigators are not tech experts – and they shouldn’t expect the site team to take ownership of the data privacy process, or the technology that enables it. “You cannot just throw a technical solution at a site without any guidance or support,” Klaver said. “Sponsors are responsible for making sure sites are supported in setting-up and managing the technology.”

This is a common misunderstanding among sponsors new to DCTs. They assume that by choosing a DCT model, the sites will naturally take on the role of help desk support, seamlessly integrating digital data collection into their care offering. But unless sponsors provide study administrators the help to set up the technology, training to use it, and help desk teams when things go wrong the trial won’t run smoothly, and sites won’t be happy. “Patients may come to the site staff first when they have technical problems, and the sites need to be supported in supporting their participants,” Klaver said.

Data privacy learning curve

Operationalizing data privacy for global DCTs where every country has different rules won’t be easy. Engaging investigators and patients in the planning process, and working with partners who have expertise delivering patient-centric DCTs around the world can ease these risks, and help sponsors create studies that adhere to all data privacy demands.

“We need to be willing to do the work to ensure the solutions we provide to our investigators support their work and protect their participants,” Klaver concluded. “Because we all have the same aim: to get a drug on the market and to our patients as quickly and as safely as possible.”

To hear the full panel discussion, check out Patient Centricity Through DCT Technology: How DCT's Converge GCP and Privacy Compliance.