Clinical Trials Design in Operative and Non Operative Invasive Procedures by Kamal M.F. Itani & Domenic J. Reda

Author:Kamal M.F. Itani & Domenic J. Reda
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

Conclusion

When testing a new intervention, principal investigators have a responsibility to evaluate the learning curve and the status of each investigator on the learning curve. Participating subjects should be informed of the expertise level of the investigator caring for them. Lack of equipoise among investigators or bias against a new procedure by patients may be introduced based on the learning curve of the investigator. Frequent monitoring and auditing should be in place to avoid exposing patients to risk and compromise the results of the trial. Various statistical tools are also available to address variability resulting from the learning curve.

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