Vaccine clinical trials pose unique challenges with regards to duplicate research subjects or professional subjects.
Typically, large numbers of subjects are dosed at the first visit in a vaccine clinical trial. There is no way for a site or principal investigator to adequately check if the research subject is a duplicate or professional subject. Subjects are dosed multiple times, causing safety issues as well as problems with the placebo response. This can result in a clinical trial failure.
Verified Clinical Trials a global research subject database registry provides a cross-study and cross-sponsor solution to detecting and preventing duplicate subjects. VCT protects phase I through phase IV studies and has global dedicated support.
The detection occurs just at the time of screening, preventing, costly in eligible poor-quality subjects from joining the clinical trial. The protections continue the entire duration of the study, improving retention as well as research, subject, safety, and data quality.
Verified Clinical Trials also prevents numerous other potential protocol violations that help your clinical trial achieve success.
This is why the majority of the largest vaccine developers in the world have turned to Verified Clinical Trials to protect their studies and improve outcomes.
VCT operates globally and has a patented solution that is unlike any other solution in the industry.There are many obstacles to the success of a clinical trial and duplicate research subjects, or professional research subjects are unfortunately one of them. Duplicate subjects in clinical trials results in a myriad of poor outcomes. Ultimately duplicate research subjects can result in a clinical trial failing to meet its endpoints. And now with decentralized clinical trials or hybrid clinical trials, the risk is even greater as there is often diminished contact with the research site.
The incidence of duplicate subjects in research is not rare and ranges from 2% – 12% depending on the therapeutic indication, size of the trial, and where the study is being conducted. Certainly, these issues are very common and well known in phase I clinical trials, but data reveals that phase II – phase IV studies face the same issues. Moreover, the issue of professional subjects is a worldwide phenomenon.
Detecting duplicate research subjects is difficult if not impossible without the proper tool. Verified Clinical Trials is a global research subject database registry used across multiple therapeutic indications. Upwards of 18 potential protocol deviations or violations can be proactively detected and prevented using the Verified Clinical Trials system. It is important that these issues be known at the time of screening and that the protections continue the entire duration of the clinical trial.
Optimizing for success with improved data integrity in clinical trials can be significantly improved using the Verified Clinical Trials global research subject database registry.
