Importance of Data Integrity
The scientific community has been a witness to some of the worst tragedies in the history of clinical trials data integrity. From the year 2015 till date, The Journal of the American Medical Association (JAMA) and the JAMA network journals have published at least 18 notices citing concern over data error and/or falsification of data.(Bauchner H et ael., 2018) For instance, the trials conducted by a Japanese anesthesiologist and researcher, to treat post-operative nausea and vomiting, were reviewed by the Japanese Society of Anesthesiologists (JSA) in the year 2012 to find startling revelations. The data obtained from the trials were either totally fabricated or fraudulent and approximately 210 papers published by the anesthesiologist had falsified data.(George SL et al., 2015) Lapses in data integrity causes significant loss of revenue with the direct costs estimated to be close to 525,000 US dollars while indirect costs amounting to approximately 1.3 million US dollars.(Michalek AM et al., 2018)
Such scientific misconducts served as a wake-up call to tighten regulations and laws to monitor drug development and drug use. Scientists acknowledged the need for data integrity at every stage to safeguard human subjects, starting from pre-clinical development to pharmacovigilance.