Protecting patient privacy when sharing patient-level data from clinical trials

Abstract

BackgroundGreater transparency and, in particular, sharing of patient-level data for further scientific research is an increasingly important topic for the pharmaceutical industry and other organisations who sponsor and conduct clinical trials as well as generally in the interests of patients participating in studies. A concern remains, however, over how to appropriately prepare and share clinical trial data with third party researchers, whilst maintaining patient confidentiality. Clinical trial datasets contain very detailed information on each participant. Risk to patient privacy can be mitigated by data reduction techniques. However, retention of data utility is important in order to allow meaningful scientific research. In addition, for clinical trial data, an excessive application of such techniques may pose a public health risk if misleading results are produced. After considering existing guidance, this article makes recommendations with the aim of promoting an approach that balances data utility and privacy risk and is applicable across clinical trial data holders.DiscussionOur key recommendations are as follows:Data anonymisation/de-identification: Data holders are responsible for generating de-identified datasets which are intended to offer increased protection for patient privacy through masking or generalisation of direct and some indirect identifiers.Controlled access to data, including use of a data sharing agreement: A legally binding data sharing agreement should be in place, including agreements not to download or further share data and not to attempt to seek to identify patients. Appropriate levels of security should be used for transferring data or providing access; one solution is use of a secure ‘locked box’ system which provides additional safeguards.SummaryThis article provides recommendations on best practices to de-identify/anonymise clinical trial data for sharing with third-party researchers, as well as controlled access to data and data sharing agreements. The recommendations are applicable to all clinical trial data holders. Further work will be needed to identify and evaluate competing possibilities as regulations, attitudes to risk and technologies evolve.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…Osobito je važno držati na umu inherentni rizik od prekomjerne interpretacije rezultata na temelju mnogobrojnih analiza podgrupa 33 . Također su razvijeni i dokumenti koji propisuju najbolju praksu za anonimizaciju podataka 34 . Statističari bi trebali biti upoznati i s tom metodologijom.…”

“…In addition, legally binding data sharing agreements should include a compromise not to attempt to identify patients 34 . In particular, it is recommended ni podataka trebali bi uključivati i kompromis da se pacijente neće pokušati identificirati 34 . Osobito se preporučuje da ugovore o korištenju podatcima potpisuju i vlasnik podataka i istraživači.…”

“…Konačno, treba uvesti visoku razinu sigurnosti pri prijenosu podataka. Sredstva, troškovi i trud koji su potrebni da bi se podatci na razini pacijenata učini-li dostupnima za druga istraživanja mogu biti znatni pa stoga treba organizirati i prikladna novčana sredstva 34 .…”

“…Finally, high security levels should be implemented for data transferring. Resources, costs and effort required to make patient-level data available for third party research may be considerable and, therefore, adequate funding should be organized 34 .…”

“…Data holders are responsible for generating de-identified datasets to offer protection for patient privacy through masking or generalization of main identifiers. In addition, legally binding data sharing agreements should include a compromise not to attempt to identify patients 34 . In particular, it is recommended ni podataka trebali bi uključivati i kompromis da se pacijente neće pokušati identificirati 34 .…”