Importance Of Data Confidentiality In Clinical Trials!
Clinical trials involve the production of large quantities of information that need to be recorded in order to analyze them for adverse events, patient profile, etc. Electronic record keeping has changed the manner in which information about trials and patients are stored and accessed. Electronic records also serve as a means for researchers to access information about previous trials in order to find if there is any data that had been overlooked but might be of use. The term data and information used here are interchangeable and include numeric data files, qualitative files like interview transcripts, field notes, and research files in audio and video formats among others.
Confidentiality in clinical research in the US is covered by the “Privacy Rule” that are a set of regulations provided by the department of health and human services (HSS) as a response to a congressional mandate in the Health Insurance Portability and Accountability Act of 1996 (HIPAA). All entities in clinical research covered by the department were to comply with the regulations of the Privacy Rule by April 14, 2003. The Privacy Rule primarily acts as a legal guardian to the potential misuse of individual health information. When a covered entity conducts clinical research, the researchers involved need to be aware of the Privacy Rule regulations in accessing protected health information (PHI).
Confidentiality protection applies to PHI obtained:
- prior to research like eligibility assessment of prospective patients, medical condition of patients, etc
- during the course of trials like data about patient responses, adverse event reports, etc
- post the trial phase
Researchers are responsible for adhering to standards needed to comply to institutional review board (IRB) approved researcher-participant agreements and protect participants from suffering from the after effects of any confidentiality breaches like loss of employment, societal isolation, psychological effects, etc.
Another concern of protecting confidentiality that is not related to patients directly or completely is the issue of releasing interim data. Early trials may produce some records of data. The results of such data might not be encouraging, but pharmaceutical companies routinely cite security concerns and maintain secrecy to prevent them from being exposed. Alternatively, if the early trial data is positive, the sponsors might reveal them earlier and thus bias the regulators into giving approval. Also, patients might want to stop participating in trials if early trial data showed negative results, this can cost sponsor’s money and require them to search for replacements which can be time-consuming and expensive, to say the least.
Regulators like the Food and Drugs Administration recommended that some secrecy was necessary to be maintained with respect to interim data. This was because they wished for the scientific question of whether the drug is useful or not to be established, fully rather than stop the trial on the basis of a small suspect in the safety of the drug. Their positions on the topic have been shown to be tilting towards giving patient safety the first priority by releasing interim data of early trials rather than allowing damaging early trial info from being kept in secrecy.
