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5 Policy Considerations
Pages 51-64

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From page 51...
... (McGraw) • Recent developments in privacy laws, such as California's Con sumer Privacy Act and the European Union's Global Data Protection Regulation, require more explicit consent and set a higher bar for data to be considered "de-identified." This is not as large of a concern for primary data collection in a clinical trial setting as it is for onward secondary uses, such as replica tion of results or additional studies.
From page 52...
... , discussed her organization's decentralized clinical trials project. Deven McGraw, general counsel and chief regulatory officer at Ciitizen Corporation, spoke about privacy protections for virtual trials, and Matthew McIntyre, senior scientist for data collection at 23andMe, discussed considerations for informed consent in relation to passive data collection and its associated paradata.
From page 53...
... These opportunities will require policies and regulations to address patient safety, privacy, the integrity of the data that remote technologies produce, and the responsibilities of the investigators involved in technology-enabled decentralized trials. Decentralized clinical trials are not new, said Sacks, but recent advances in communication, data capture, and transmission technologies have created ­ opportunities to conduct decentralized trials better -- as has the recognition of local health care providers' value in performing trial-related functions.
From page 54...
... Lastly, Sacks emphasized that the accuracy and precision of remote biosensors are critical to prevent false-positive readings. Participant Safety Ensuring participant safety in a decentralized trial is no different than in a traditional clinical trial, said Sacks.
From page 55...
... CLINICAL TRIALS TRANSFORMATION INITIATIVE: DECENTRALIZED CLINICAL TRIALS PROJECT Leanne Madre, Director of Strategy, Clinical Trials Transformation Initiative CTTI, explained Leanne Madre, is a public–private partnership cofounded by Duke University and FDA. Currently, more than 80 members, representing stakeholders from academia, biotech companies, pharmaceutical companies, patient groups, regulators, and others, are working to "develop and drive adoption of practices that will increase the quality and efficiency of clinical trials" (Madre, 2018)
From page 56...
... Key benefits of a decentralized clinical trial that CTTI was able to identify included those that previous speakers discussed: faster trial participant recruitment; improved retention; greater control, convenience, and comfort for participants; and increased participant diversity. To achieve these benefits, CTTI issued recommendations that fell into six categories: protocol design, telemedicine state licensing laws, mobile health care providers, drug supply chain, investigator delegation and oversight, and safety monitoring.
From page 57...
... m Mobile Health Care Providers As a decentralized clinical trial can cover a wide geographic area, it might be necessary to use mobile health care providers -- or health care providers who can travel to participants for protocol contributions. Activities can include blood draws, administration of the investigational products, clinical assessments, and in-home compliance checks.
From page 58...
... PRIVACY PROTECTIONS FOR VIRTUAL CLINICAL TRIALS Deven McGraw, General Counsel and Chief Regulatory Officer, Ciitizen Corporation McGraw discussed the importance of protecting participant privacy and data generated by participants, as well as policy mechanisms used in the United States and in Europe to protect privacy. Privacy protections matter, emphasized McGraw, because they build trust and help ensure that people will seek health care and enroll in clinical trials.
From page 59...
... 8 and the European Union's Global Data Protection Regulation (GDPR) ,9 are now requiring more explicit consent and set a higher bar for data to be considered "de-identified." This is not as large of a concern for primary data collection in a clinical trial setting as it is for onward secondary uses, such as replication of results or additional studies, noted McGraw, because CCPA contains exceptions for regulated clinical trials.
From page 60...
... McGraw said privacy is a hot topic and Congress could engage in this area more actively in the future. INFORMED CONSENT FOR PASSIVE DATA COLLECTION Matthew McIntyre, Senior Scientist, Data Collection, 23andMe McIntyre discussed the particular policy and regulatory challenges in developing informed consent processes for remote studies in which data will be collected passively.
From page 61...
... DISCUSSION Raj Sharma, chief executive officer of Health Wizz, started the discussion by explaining that his company has developed a user interface for clinical trial participants that resembles a video game, with badges, prizes, leaderboards, and milestones related to a clinical trial -- an approach termed "gamification." His question was whether this approach was too extreme to be useful in the clinical trials environment. McGraw replied that in her opinion, an appropriate approach is to first develop a clinical trial with its desired outcomes and endpoints, and only then find the technology tool that will help the trial meet its goals, as opposed to developing a tool and then looking for a clinical trial that would benefit from that tool.
From page 62...
... John Burch from the Mid-America Angels Investment Group asked Madre if she could talk about the CTTI Registry Trials project.12 Madre replied that this project issued recommendations that addressed two issues on how to conduct clinical trials embedded in registries. First, if the trial uses an existing registry, it is important to ensure that the data can meet regulatory requirements for a clinical trial.
From page 63...
... McGraw noted that a scientific hypothesis derived from analyzing aggregated data could count as an inference under CCPA, although if that analysis was conducted in the context of a clinical trial subjected to one of the law's exceptions, the inference would not be subject to the law. McGraw also highlighted the importance of dealing with passively collected data, such as geolocation data, that are collected by digital health technology, but not as part of the trial during the consent process.
From page 64...
... Sacks responded that safety monitoring is not a task appropriately delegated to automation. A clinician's responsibilities, he said, are to react to adverse events and stop a drug when it is causing toxicity.


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