If not properly managed and resolved, compliance issues can increase the risk that the promising new investigational intervention may not receive regulatory approval.
It is widely believed that trial participants who are managing one or more co-morbidities may affect the results of the trial, for a variety of reasons.
A blinded study helps to reduce conscious or subconscious bias from being introduced during data collection or analysis.
Clinical trial participants play a key role in the advancement of medicine and the health sciences, and new treatments cannot be developed without them.
Data integrity helps to safeguard the voluntary participants who have placed their trust in the clinical trial process and patients who will ultimately be taking the medications once they have received regulatory approval
It might be helpful to know a few things about what to expect in that first screening visit.
Participants are vital to the company or institution knowing whether their idea will work. But what should you consider before joining a study?
The better prepared you are with observations and questions, the more precise the doctor’s recommendation can be and the more informed your decision will be.
The typical FDA approval process takes place within a structured framework.
A lot of the money, time, and energy poured into a trial ultimately hinges on the ability of the participants to complete the requirements that will allow the researchers to analyze the trial results in a meaningful way.