Remote technology has quickly become a key element of clinical trials.According to June 2021 survey Research from WCG shows that 94% of research sites hope to use at least one form of remote technology in the future.
Remote technology allows research sites to easily transmit their clinical trial data to their sponsor, CRO or coordination center. However, when the treatment proves to be effective, sponsors who wish to publicly share phase IV clinical trial data can also use the technology. Although these advances are exciting, they raise many questions about how to share data.
Does clinical trial data sharing benefit public health, or will it eliminate research incentives by allowing organizations to use data collected by others? How to share data in an ethical manner while respecting the privacy and personal safety of participants? Which regulations guide data sharing, and should there be more?
Data sharing can help clinical trial sponsors determine which interventions are most effective. Ultimately, this will bring better results for patients. However, in order to achieve this goal, clinical research institutions need to understand the principles of sharing data in an ethical, safe, and private manner.
Benefits of data sharing in clinical trials
inside Clinical trial sharing guidelines dataThe National Center for Biotechnology Information released in 2015 stated that data sharing can “accelerate scientific progress and ultimately improve public health”. Since 2015, it has become easier for research sites to transfer data to their sponsors. It has also become easier for researchers or sponsors to publicly share their final data.
Published, peer-reviewed data enables doctors to better understand the benefits and risks of specific treatments so that they can make informed decisions about patient care. Sponsors can save time and money by not repeating trials already conducted by other sponsors or researchers, and participants do not have to participate in intervention trials that have been proven to be ineffective or too risky.
Data sharing can even increase public trust in clinical trials because participants will know how their data is used and what impact they will have on healthcare. In this era of remote or partial remote trials, sponsors and researchers should consider sharing their data.
Privacy and security risks in data sharing
Although data sharing can enhance public health, it creates challenges for participants, research sites, and sponsors. When adopting digital tools, clinical researchers must apply existing privacy and compliance regulations to the new environment. Some of these regulations have not been updated to reflect the widespread use of the technology, so compliance experts must explain how to apply them.
Leonard Sacks of the FDA raised this issue in a speech in November 2020. Virtual clinical trial seminar Sponsored by the National Academy of Sciences, Academy of Engineering, and School of Medicine.
For Sacks and others in the U.S., this means following FDA 21 CFR Part 11, But other countries/regions have their own regulatory guidelines that must be followed. As virtual or hybrid trials become more common, sponsors may conduct research in new countries and therefore may need to comply with multiple regulations.
Recent privacy regulations
It is also important that digital tools and workflows comply with privacy laws and protect participant data.Laws like this California Consumer Privacy Act (CCPA) and EU’s Global Data Protection Regulation (GDPR) requires explicit consent to data sharing, so websites are responsible for ensuring that their software platforms meet these requirements.
CCPA and GDPR also distinguish between data that contains personally identifiable information (PII) or protected health information (PHI) and “de-identified” data, that is, data whose personal identity cannot be determined. CCPA and GDPR have strict requirements on when to treat data as de-identified.
Both laws recognize that the regulations for medical clinical trials are different from those for private companies. Nevertheless, if the data is shared, the clinical research organization must carefully consider how to ensure its de-identification.
Protect vulnerable participants
Simultaneously November 2020 seminar Deven McGraw of the National Committee on Biotechnology Information, hosted by the National Academy of Sciences, Academy of Engineering, and School of Medicine, emphasized that privacy protection makes people more willing to participate in clinical trials. He pointed out that one in six people withhold health information for fear of confidentiality. On average, participants of color are more likely to worry about privacy issues than white participants. “
This Guidelines for Sharing Clinical Trial Data The statement from NCBI supports the claim that some clinical trial participants are more vulnerable than others. If clinical trial participants suffer from common diseases such as mental illness, HIV or drug addiction, they may be more harmed by data leakage.
Participants who are already members of disadvantaged groups may need additional privacy or confidentiality protection from research sites and sponsors. Clinical researchers should create comprehensive and accessible informed consent forms and discuss any data sharing plans for vulnerable groups with research participants, disease advocacy organizations, and community advisory committees.
Ensure that data is not stolen or misunderstood
Although protecting trial participants is always the first priority, participants are not the only ones at risk if shared data is abused or misunderstood. If another researcher or public figure analyzes the data incorrectly, it may cause unreasonable safety concerns or false beliefs to spread among the public.
Sharing data may also reduce the motivation of researchers and sponsors to conduct research. They may worry that their data will be taken and used by other researchers, so the time, money and intellectual capital they put in will not be rewarded.
Although sponsors will not (and should not) share confidential information about their products, they still need to control what data is shared, so no one can infer trade secrets from this data. Researchers must also carefully trust each other when using each other’s research data.
Without their permission, remote technology companies should not share data from sponsors or investigators. Although technology can enable data sharing, when and how to share data should always be determined by the sponsor and site conducting the research.
Establish ethical standards for data sharing
Many national laws and international guidelines specify when and how to share clinical data. But most clinical research institutions also need internal guidelines and SOPs (standard operating procedures) that specifically regulate data sharing.
Every organization needs to develop an SOP to help them advance scientific research while protecting the privacy of participants and product information. Investigators and sponsors should consider how participants and their communities can benefit from the data they collect without sacrificing confidentiality.
Key points about data sharing
The process of determining when and how to share data through remote technology is ongoing. However, research organizations can participate in ethical data sharing today by considering the privacy and security of participants and balancing the need to protect their business interests with the need to share enough data to benefit medical research.
Photo: Isinger Julian, Getty Images
