When you participate in a clinical trial, researchers track medical and personal data gathered from each participant. You may naturally want to know what researchers do with your personal information.

What kinds of data do researchers collect?

In the last blog post, we discussed the different types of clinical research. What data is collected depends on the type of research. What data is collected and used depends on the type of research study. Often times the collected data includes information on demographics, such as age, gender and ethnicity of a participant. Other data may be gathered from such sources as physical exams, biologic specimens, lab tests, electrocardiograms, vital signs, imaging studies, vision, hearing, cardiac and pulmonary tests.

Who has access to the data collected?

Data collected from you as a participant is called individual participant data (IPD), that information is transformed into de-identified data when researchers do their analyses, meaning the ability to determine the identity of an individual participant is removed from the data.

Typically only the study sites, the study sponsor, statisticians, regulators and the study’s institutional review board have access to IPD. In other words, the data associated with your personal identification is only available to a select group of people charged with protecting that data. While there may be many people involved in conducting a study, only qualified investigators who meet certain criteria can request to analyze study data.

There are a number of regulations in the U.S. and around the world governing de-identification, the most familiar is the U.S. Health Insurance Portability and Accountability Act (HIPAA). In its Privacy Rule, HIPAA spells out two de-identification standards covered entities must use to ensure data is de-identified. The European Union also has a standard called the General Data Protection Regulation (GDPR) which also requires anonymization of data. ObvioHealth is both HIPAA and GDPR compliant.

What happens to the data after the study is over?

Once the study is complete, the data from the trial is not discarded. Most studies will store the data in a database or registry where other qualified investigators can access the data for what are called retrospective studies.

Often that study data may be added to data from other similar studies for meta-analyses to get a broader perspective over a larger population of participants. As a result, future researchers can use the information gained from your participation in a trial to further advance the understanding of illnesses and conditions.

Sources: National Institutes of Health Clinical Trials and You, and ClinicalTrials.gov