Investigational drug studies must have an IND granted by the FDA before they begin. Unsurprisingly in this regulated world, the definition of “investigational drug” can vary, but in summary, if a study needs an IND, it better have one before it gets started.
Figuring out what needs an IND and what doesn’t is tricky, tricky business. Many, many years ago, the IRB Blog Central team was at a conference where a speaker who worked in regulatory affairs shared slides describing various clinical studies done at his institution. He asked the audience our opinion about which of these studies required an IND, per the FDA. In summary, we had no idea. The decision about what needed an IND might as well have been random, even for studies that looked very similar, with the FDA deciding one needed an IND and the other didn’t. The speaker, a man with a slight build, a bald head, and a good sense of humor said that when he started this job, he weighed 300 pounds and had a full head of hair and now we knew why all that had changed.
So, it’s best to leave the “does my study need an IND” determination to trained professionals. At UAMS, the Office of Research Regulatory Affairs serves this role for sponsor-investigators.
One investigator in Texas apparently tried to go it alone re that decision and things didn’t work out so well for her, according to a recent warning letter posted on the FDA’s website. The FDA noted other issues too; they didn’t think, for example, that handing people a laminated copy of the consent form prior to the procedure really counted as informed consent.
We also take note of what the FDA letter describes as what constitutes a clinical investigation, as opposed to patient care: “FDA has long held that when an investigator limits his choices, his patients’ choices, and the choices of the people working for him in the treatment of those patients, he is conducting a clinical investigation.“
Click the link above to read the full letter.