In the clinical research industry, safety norms and processes should be applied to every aspect, starting from drug development to post-marketing use of approved drugs, keep in mind patient safety and data credibility at every stage of clinical development.
Patient safety requires collaborative effort of the regulatory system, healthcare system, and the sponsor. Equally important is the need for effective communication to patients by the regulatory bodies and health care systems to maintain transparency. Such communication also help in instilling confidence in patients about the scientific credibility of the trial. For instance, the Central Drugs Standard Control Organization (CDSCO), India uses information technology to keep the public aware about ongoing and completed trials. All data starting from filing of application to the trial results are available on the website. Sponsors, clinical research organizations, as well as ethics committees are required to furnish their details on the website. Data safety and monitoring boards (DSMB) are also formed to monitor trials, especially large trials, for safety and reliability of data. DSMBs play a significant role in letting the public know if the investigational drug poses any threat as well as to ensure that the sponsor does not purport the results to be unbelievably beneficial to the targeted patient population.
Emphasis should also be laid on novel and practical-oriented training programs for students in the health care profession to expose them to real-world situations. Students should understand the importance of having risk assessment, risk management, and risk mitigation plans in place to improve patient safety. Periodic assessment and continuing medical education programs for medical professionals are also pivotal in ensuring that they remain competent in their respective fields and prioritize patient safety and moral ethics in their profession.
The successful implementation of patient safety and data integrity is a multidisciplinary approach that requires sincere and diligent effort of each individual and organization involved in the conduct of clinical trials.
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