1. Dimsdale, Allison Walp RN, CCRN

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Exciting healthcare discoveries can debunk current guidelines, shatter closely held beliefs, and open our eyes to new treatments. These advances are achieved with clinical trials-and you can play a key role. In this article, I'll tell you how clinical trials are conducted, how to protect your patient's legal rights, and how to provide nursing care to a patient participating in a clinical trial.


Four phases

A clinical trial typically has four phases, although the sponsor and the FDA will stop a trial that doesn't show beneficence or if the risks to the study participants are too great.


* Phase I is the first test of a new drug or treatment in humans. The objectives of this phase are to determine drug safety and a safe dosage range, assess absorption and distribution in the body, and identify possible adverse effects. A limited number of healthy volunteers or patients-usually 20 to 80-participate in this initial phase, which may last from 9 to 18 months.


* Phase II evaluates preliminary safety, efficacy, and dosing schedules in the targeted population. Typically 100 to 300 subjects will be chosen, usually people who might benefit from the drug or treatment. They're likely to be hospitalized patients who can be closely monitored. Phase II may take 1 to 3 years to complete.


* Phase III involves the most extensive testing to fully assess safety, efficacy, and drug dosage in hundreds to thousands of patients and to compare the new treatment with either standard therapy or placebo. Much of the information that's used for package labeling and the drug package insert comes from information obtained at this phase, which usually lasts 2 to 5 years (or longer).


* Phase IV, or the surveillance stage, includes postmarketing studies. Follow-up may go on for years to ensure that a newly licensed and marketed drug is effective and safe.



As the bedside nurse, you may be involved in identifying a potential participant, verifying that she's been fully informed about the clinical trial, and helping to protect her rights.


Ensuring informed consent

No investigator may enroll a patient in a clinical trial without obtaining informed consent from her or her legally authorized representative (usually next of kin or someone with a healthcare power of attorney). Informed consent requires these three elements:


* The patient must be given information about the study, including all potential risks and benefits.


* She must comprehend the information.


* She must consent voluntarily and must not be coerced.



During the informed consent process, you must advocate for the patient and ensure that she's fully informed and isn't led to make a decision that she doesn't understand. Make sure she knows that study participation is entirely voluntary and that she's free to refuse to participate if she has any misgivings. She also has the right to withdraw from the study at any time.


Most informed consent forms are written at an eighth-grade reading level, with technical information left out. These forms educate the patient about the study and what her participation may entail, but you or the study coordinator may need to clarify this information.


If you believe that a patient's being pressured to enroll in a study, discuss your concerns with the study coordinator or principal investigator. If your concerns aren't resolved, contact the Institutional Review Board, which oversees the research process at your institution. Its primary role is to protect the patient.


Remember, informed consent is a process, not a paper. The consent form documents the consent process, but it doesn't replace the conversations that are needed.


Besides understanding what she's signing, your patient also must be alert enough to make an informed decision. Step in if you know her judgment or perception is impaired. For instance, if a research coordinator wants to obtain informed consent right after you've given your patient an opioid analgesic, ask him to return later. Likewise, if she needs her glasses to read the consent form, make sure she's wearing them.


Be in the know

If your facility conducts research, become familiar with its studies. You should know basic inclusion and exclusion criteria so that you can help screen patients for the study. If your patient asks about trials, tell her about those being conducted at your facility. You also can refer her to CenterWatch (, which lets her search for trials being conducted by medical condition.


Clinical trials are sometimes a last resort for seriously ill patients who've exhausted conventional medicine. By participating, they can sometimes obtain new drugs and treatments that aren't yet approved but that may be effective. Many outpatient trials provide free medication for patients who can't afford them. Even if a new treatment isn't like to save the patient's life, she may get satisfaction knowing that she's contributing to research that could help others.


When you receive report and learn that your patient is enrolled in a clinical trial, read the informed consent form in her medical record. It gives you a simple outline of the study plan and procedures. Look for notes in her medical record about any special nursing considerations.


If your patient is enrolled in a drug trial, the study coordinator should give you information about the drug being administered, such as expected effects and potential adverse reactions. Be sure to pass this information along in report so that you can answer any questions. Contact the study coordinator with any questions you can't answer. Most study coordinators are nurses experienced in fielding the most difficult questions.


Some trials require that you follow precise methods for obtaining and processing samples for lab studies. Make sure that you know who'll obtain the samples and where and how they'll be processed. The coordinator makes sure that study procedures are carried out exactly and will give you all the details you need.


This exciting time of discovery is your chance to shine by helping patients who are participating in clinical trials.




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