I have completed reading the article “Can You Answer Patients’ Questions About Clinical Trials” by Maureen Habel in the Feb. 7, 2011, edition of Nursing Spectrum. I feel compelled to make a couple of comments/observations regarding this article and its relationship to clinical trials under Federal (FDA) purview concerning medical device trials.
On page 23, the general statement is made in the highlighted box that “Clinical trials occur in four phases” and it elaborates the phases. While this is true of drug clinical trials, this is incorrect concerning device trials which generally consist of 1. a pilot phase or feasibility study, 2. a pivotal study and 3. post approval studies. The mentioning of device studies as a Phase I study is incorrect.
Below the highlighted block the author states that “A phase I tests a drug or a device for the first time.” Again this is a basic generality concerning drug but not device studies since again device trials are not comprised of phases. It is of note that regulations for drug clinical trials are identified in Title 21 Code of Federal Regulations Part 312 (21 CFR 312) while device regulations concerning clinical trials are found in 21 CFR 812.
In addition biologics have to adhere to one or the other depending upon the biologic involved. All have to conform to 21 CFR Part 50 (Protection of Human Subjects), Part 54 Financial Disclosure by Clinical Investigators, and Part 56 (Institutional Review Board) as appropriately identified in the article. In addition 21 CFR Part 11 concerning Electronic Records must also be kept in mind.
The remainder of the article is accurate as it discusses the interrelationship of the clinical investigator, clinical research coordinator, IRB, study protocols, inclusion/exclusion criteria, study monitoring, informed consent, human subject protection issues, and other aspects of clinical studies.
Device studies cannot, however be lumped into a single category with drug studies as they have other considerations which must be accounted for such as significant risk/non-significant risk determinations and difficulty in performing single or double blind studies.
The bottom line is as the author points out is that as patient advocates, nurses have an ethical responsibility to advise potential subjects of their rights when they participate in a clinical trial. In addition, the staff participating in clinical trials have a responsibility to both the subjects and the study to perform it according to the established clinical protocol and study plan.