Why is drug infusion rate often controlled in clinical trial protocols?

Drug infusion rates are often controlled in clinical trial protocols to ensure that the study participants receive a consistent and safe dose of the drug being tested. This helps to minimize variability in the results of the trial and ensures that the data collected is accurate and reliable. In addition, controlling the infusion rate can help to prevent adverse events or other complications that may arise from administering the drug too quickly or at an incorrect dose. For example, if the drug is a vasodilator, it may cause blood pressure to drop too low if administered too quickly, which could be dangerous for the participant. If a clinical trial protocol requires that the infusion rate be controlled but it is not followed, there could be several potential consequences:
Inaccurate dosing: If the infusion rate is not controlled, it may result in inconsistent or incorrect dosing of the drug, which could lead to inaccurate or unreliable data being collected during the trial.
Adverse events: As mentioned earlier, administering the drug too quickly or at an incorrect dose can lead to adverse events or other complications. If the infusion rate is not controlled, these events may occur more frequently than they would if the protocol was followed.
Compliance with ethical guidelines: Failure to control the infusion rate may also violate ethical guidelines related to the protection of human subjects in research. These guidelines typically require that researchers take steps to minimize risk to study participants and ensure that their rights and welfare are protected.
Legal liability: In some cases, failure to follow a clinical trial protocol that includes specifications regarding infusion rate control may expose the researchers or institution running the trial to legal liability if an adverse event occurs as a result of the breach of protocol.