What Do Clinical Trials Test For? What Is a Clinical Trial? Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or
What Is A Retrospective Case-control Study? A case-control study is designed to help determine if an exposure is associated with an outcome (i.e., disease or condition of interest). … By definition, a case-control study is always retrospective because it starts with an outcome then traces back to investigate exposures. What is the difference between a
What Is A Follow Up Research? Follow-up is generally done to increase the overall effectiveness of the research effort. … Or, it could even be conducted subsequent to the original research to ascertain if an intervention has changed the lives of the study participants. Regardless of its purpose, follow-up always has cost implications. What is
What Is An Informed Consent In Research? Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. A central part of the informed consent process is the informed consent document. Why is informed consent important research? Informed consent is a
What Is Blinding Masking? Blinding (or masking) refers to withholding knowledge about treatment assignment from subjects and/or investigators in order to prevent bias in assessment of subjective outcomes, such as pain relief. What is blinding and masking in clinical trials? Masking (or blinding) of treatment assignment is routinely implemented in classical randomized clinical trials (RCTs)
What Is A Phase 0 Study? Phase 0 studies use only a few small doses of a new drug in a few people. They might test whether the drug reaches the tumor, how the drug acts in the human body, and how cancer cells in the human body respond to the drug. … They’re not
What Is Blinding In A Study? (BLINE-ded STUH-dee) A type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not know which drug or treatment is being given. The opposite of a blinded study is an open label study. Why is blinding used in studies? The purpose of ‘blinding’
What Is Blinding In Research? If you’ve done a taste test and selected ‘Cola X’ over ‘Cola Y,’ then you’ve already experienced what scientists call “blinding.” Blinding, in research, refers to a practice where study participants are prevented from knowing certain information that may somehow influence them—thereby tainting the results. What is the blinding method?
What Is A Recommended Strategy For IRBs To Minimize Therapeutic Misconception? Strategies to minimize therapeutic misconception include giving a clear description of the research procedures and goals (e.g. explaining study design, treatment allocation and the possibility of receiving a placebo since the allocation is randomized) and having a comprehensive discussion, with the subject, about the
What Is A Clinical Trial Authorisation? Clinical Trial Authorization means any issued or pending Permit required to be obtained from, as applicable, a Governmental Authority or IRB, in order to conduct a Clinical Trial under applicable Law, including, an IND. What is a CTN submission? Documents for Clinical Trial Notification (CTN) A statement that scientifically