Clinical trials done by CROs like Veristat are run under strict guidelines and protocols; these must be followed and documented accurately for the credibility of the trials. Among these is data integrity; like other fundamentals, it is aimed at protecting the trial by ensuring it is conducted ethically. This data must be documented regardless of whether or not it approves the trial’s hypothesis.
Since virtual clinical trials are aimed at improving human health and welfare, the data documented is used to analyze and justify the procedure and pharmaceuticals used in achieving the effectiveness of the trial. Lack of data integrity can result in a lot of harm to the trial volunteers. That’s why the integrity of the trial is crucial as it promotes the health and well-being of volunteers.
What is data integrity in clinical trials?
Data integrity is a dimension of data that contributes to the credibility of the systems and processes taken in data collection, capture, maintenance, and retention. Clinical trials are expected to maintain a form of trustworthiness in the data used to determine the efficiency and safety of the therapies used in the trial. This data also acts as a guideline and regulator to the practices and systems used to achieve an acceptable standard of data integrity. Therefore, it should be observed by all parties involved in the trials from the data collection to reporting stage. Since human errors do happen, they don’t always undermine the integrity of the trial. However, they must be addressed and documented immediately. This helps prevent similar errors in the future through a corrective and preventive action plan (CAPA).
Clinical trials should be conducted under the Good Clinical Practice guidelines. The purpose of this is to ensure the studies are protecting the rights of the patients and validation of the data used in scientific and ethical ways.
What can happen when data integrity is compromised?
The results of data integrity being compromised could be anything from imprisonment to death of patients. By law, the trial’s Principal Investigator can be imprisoned if they were found to have intended deception in the trial’s data integrity. Also, imprisonment would be followed by fines and repayment of grants. Imprisonment would see the PI lose their license of practice in clinical research and their reputation would be greatly tarnished. This also means there will be a loss of sales and revenue for different global medical and manufacturing companies affected by this compromise. The loss in sales would in turn result in either company closure or laying-off workers. Clinical trials are essential in making a breakthrough in the medical field and finding cures and treatments for chronic illnesses. Therefore, there is no room for data compromise.
Data integrity should be upheld in any clinical trial. Plus it’s the responsibility of everyone involved. Whether or not it agrees with the hypotheses, research trials should be well documented following the trails guidelines and protocols. This will ensure that the procedures and medical devices used in the trial are safe and effective. A compromise with the data would not only lead to the PI imprisonment but also place the large population in harm’s way.