Discussion of Patient Recruitment and the Informed Consent Process in Clinical Drug Trials
Jerolee White

Jerolee White, MSN, FNP, RN, is Research Coordinator/Investigator and Primary Care Practitioner, Nephrology, Bluefield, WV.

As worldwide populations become older, more overweight, and more sedentary; cardiovascular disease, diabetes mellitus, and other life-threatening diseases are on the rise. These endemic diseases have been the major impetus for the aggressive research undertaken by pharmaceutical companies to find new and better drugs to prevent or mitigate the impact of these diseases on humans.

In their response, pharmaceutical researchers are busy in their labs developing new drugs or finding new uses for existing FDA approved drugs. In addition to pure laboratory research, massive, controlled studies are being undertaken to prove and improve the safety, efficacy, and dosage schedule of these drugs. As a study coordinator for drug research, I am excited to be a part of this amazing era of drug (re)discovery. I feel a certain pride that my participation, albeit it very small, in the investigational process will help further the research and speed valuable drugs to patients.

Challenges of Patient Recruitment and Consent

From my perspective as a study coordinator, and hence a member of the research team, I am aware of the challenges and difficulties that are encountered at all phases of the research process. All clinical trials progress through a series of steps that proceed from the initial design to termination and post-trial follow up. While there are many hurdles that must be faced, one major issue in the process of a clinical trial is patient recruitment. Another primary concern, and the focus of this writing, is the consent process. In an attempt to deal with the atrocities of World War II, the post-war Nuremberg Code, and indeed all subsequent codes, were explicit on the need for voluntary consent in experiments that entail risks to humans. Good Clinical Practice or GCP guidelines were born in the USA in the mid 1970s when the Food and Drug Administration (FDA) implemented guidelines for clinical investigators along with strict investigational new drug procedures (IND). In 1996, the International Conference on Harmonization was held. This meeting defined Good Clinical Practice guidelines, which would standardize research internationally (ICH GCP). These standards defined an international ethical and scientific quality standard for designing, conducting, and reporting of clinical trials.

The ICH-GCP guidelines require that investigators in drug studies “obtain the informed consent of each human subject to whom the drug is administered.” In effect, these guidelines work to ensure that subjects are given sufficient opportunity for the exchange of information between themselves and the investigator and have the opportunity to ask questions and receive comprehensive answers concerning both trial logistics and the drug under study. These guidelines require clear disclosure of reasonably foreseeable risks to the subject. However, the informed consent document should be primarily viewed as a teaching tool and not as a legal instrument. Ordinary language should replace technical terms or simplified definitions need to be included. Obtaining an informed consent needs to be an educational process that takes place with the prospective subject. What might a prospective subject think when they are handed a document that is generally somewhere between 10 and 20 pages long? Human nature is to be concerned that perhaps a lawyer is needed to review this form!

Somewhere in the translation of the above mentioned regulations, trial sponsors and approving agencies have taken the consent form to an extreme, many times including risks regardless of their relationship to the study drug or study procedures. Also included many times are everyday situations that are standard of care but are described at length because it is a research consent. For example, when was the last time a lab informed you that drawing your blood may cause bruising, infection or cause you to pass out? As the patient, this is so commonplace, it would make me think they must be doing something different! Similar issues are also evident when the research involves approved drugs that physicians may prescribe with minimal discussion of the most common and relevant side effects, yet in a research consent form this could be pages of risks listed.

Reform Is Needed!
Although designed to protect human subjects, the regulations, or interpretation of them , have become onerous. Obviously, validity of patients’ consent rests on the dissemination of factual information presented in a manner that provokes understanding rather than fear. Furthermore, patients must be allowed to make free choices based on informed consent. Nonetheless, when we consider the inconsistencies that allow for the use of a one-page consent form for life–threatening surgery while requiring a multi-page form for research studies, it is evident that reform is needed!