The government, the FDA, and other agencies, for the benefit of public health, like to see to it that all pharmaceuticals are clinically tested prior to their release into the market. By doing so, they can alert potential users of the side-effects of the drug, ensuring that it does not cause death & that it works as desired. These organizations require a significant amount of research and data in order to approve the product, and therefore, pharmaceutical companies must contact monitoring agencies if they want their products to be successful.
During a clinical trial, a participant will be asked to participate in a study that requires them to take a recommended dose of a product while their health is monitored throughout the study. Safety measures are put into place to protect participants, and most commonly, members of the clinical research teams visit the participant on a regular basis. Communication between the participant and the monitoring associate may be done over e-mail, telephone or fax, but only in extremely rare and low-risk cases, all of the monitoring and communication will be done via telephone. Communication in the trial is of utmost priority for both accuracy and reduced risk.
Monitoring in Trials
The extent to which clinical monitoring is executed differs from case to case. In the early phases of moderate risk studies, the associate may legally need to be present for long periods of time of the participant’s treatment. In other cases, there will be little in-person interaction between the participant and the associate. Making sufficient arrangements with health taken into consideration is an important part of having a successful trial.
It will also differ from case to case how many associates will be monitoring the participant. In many cases, there is a sole associate, while in others, there are many. The research associate’s overall schedule for monitoring and means of communication should remain consistent for safety purposes.
Pharmaceuticals are commonly tested on participants who have diseases, so the nature of the disease will also affect the schedule of the monitoring.
What Monitoring Entails
Research associates should have compiled an educated checklist of what things will be monitored including symptoms, energy levels, pain levels, blood tests, et cetera. There should also be a very specific protocol that all associates must follow. Successful associates will get a feel for the trial and develop a sense of which factors are more important to monitor and where complications are likely to arise. The FDA does audit the sites of these trials, and therefore, if the associate is not successfully following protocol, keeping accurate records, reporting adversities, administering the right dosages, gathering consent, or anything similar, a deficiency will be reported.