Medical products are safer and more effective for everyone when clinical research includes diverse populations. Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race...
To many, the term informed consent is mistakenly viewed as the same as getting a research participant’s signature on the consent form. FDA believes that obtaining a research participant’s verbal or written informed consent is only part of the process....
Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research. Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or...
