Confidentiality In Clinical Research Paper

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 terms 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 …show more content…
Early trials may produce some records of data. The results from 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 sponsors 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