Clinical Trials 101: Basics and Insights

November 6, 2012

With access to clinical trials growing in a variety of clinical settings, nurses increasingly need to develop core skills and knowledge to safely, effectively, and appropriately care for enrolled patients.

With access to clinical trials growing in a variety of clinical settings, nurses increasingly need to develop core skills and knowledge to safely, effectively, and appropriately care for enrolled patients.


In this video, Denise Friesema, MS, RN, OCN, discusses assessing responses and adverse events in clinical trials

A special session during the 37th annual ONS Congress, “Clinical Trials: What Every Nurse Needs to Know,” provided basic information and key insights. It was presented by Denise Friesema, MS, RN, OCN, director of clinical research operations at the University of Chicago Medical Center (UCMC), and Elizabeth Ness, RN, MS, a nurse educator and director of staff development at the National Cancer Institute’s (NCIs) Center for Cancer Research. Some of the discussion points are highlighted here.

Clinical trials have two key aspects, the presenters emphasized: adherence to strict scientific principles, to ensure valid results; and adherence to strict ethical standards, to protect patients.


Protocols, Ms. Friesema said, are clinical trial “recipes” outlining the study purpose, (primary and secondary) objectives, and plan of care and follow-up. Eligibility criteria ensure patient similarity within a study or specific subgroups. They can include age, sex, stage of disease, laboratory values (clues to the patient’s physical/physiologic status, specific conditions), prior treatment, and other health factors. The statistical power of a trial to reliably assess effects of an agent/intervention is influenced by the number of participants, appropriate duration, and specific patient characteristics. Protocols are generally developed by the principal investigator and/or industry sponsor. If a protocol is violated, the FDA submits a 483 form outlining the violations, which are part of the public record; investigators must provide an action plan to address the deviation(s) before the trial can be continued.

Conflicts of Interest and Avoiding Bias

Trial management teams must have plans to address potential conflicts of interest, for example when a principal investigator has stock in or is compensated by the company sponsoring the trial. In such cases, the principal investigator may not be allowed to obtain informed consent from patients or a different principal investigator must be selected.

Random assignment of patients into study groups, and conduction of single-blind (patients unaware of group assignments) and double-blind (physicians and patients unaware) trials are ways to avoid bias.

Informed Consent and Eligibility Criteria

Informed consent is essential for proper conduct of a clinical trial. Informed consent documents have grown in scope, often consisting of detailed 10- to 20-page documents that need to be reviewed with patients. Risks discussed as part of informed consent should include all risks related to treatment in the clinical trial, not just those posed by the drugs that will be tested (eg, risk of bruising if many venipunctures will be performed, risk of hypersensitivity reactions if contrast dyes will be used, etc).

Participants must sign an informed consent document before screening for eligibility can take place.

In screening for eligibility, review of baseline physical health (eg, ECOG status), past medical history, and concomitant medications is key. Depending upon the potential toxicity profile for the intervention protocol, patients must meet certain criteria to be eligible such as: acceptable cardiac (with QTc assessment) and liver function. A sufficient amount of time needs to elapse between prior treatment and any treatment administered for a clinical trial.

Institutional Review Boards (IRBs)

IRBs review trial protocol appropriateness and assess risks/benefits to study participants; trials considered ethical have an acceptable risk/benefit ratio.

A “local” IRB provides review only for the researchers of its organization. A multisite trial may use an “independent” IRB that serves as the “central” IRB and provides review services for multiple sites. Detailed information about IRBs can be found on the websites of the FDA and the Consortium of Independent Review Boards.

Non-nurse study coordinators (clinical research coordinators) cannot dispense medication and should not be assigned clinical trial roles that require licensure. However, IRBs may not always know whether a registered nurse or a clinical research coordinators is coordinating the study. “Institutions need to be reminded that the IRB leaves the responsibility to the institution (the principal investigator) to select the appropriate people to coordinate the trial,” Ms. Friesema said.

Blood Draws and Infusions

An important objective of phase I trials is to collect blood samples for information about drug pharmacokinetics/pharmacodynamics. Patients need to be told they might have to be in the laboratory all day for blood draws, and that many blood draws may need to be taken through a central line, Ms. Friesema explained.

It is critical, she added, that blood draws be taken at approximately the same time(s) each day, that no sampling time is missed, that each sample is complete (ie, same amounts of blood taken at each draw), and that all samples are processed appropriately at all steps (from centrifuging through handling and storage).

When performing drug/other infusions, start and stop times must be documented.

Assessing Responses and Adverse Events (AEs)

RECIST criteria are published standards for assessing improvement, stable disease, and progression of solid tumors in patients  participating in a clinical trial. The original criteria were published in February 2000 through a collaboration between NCI, the NCIC Clinical Trials Group, and the EORTC. They were updated in 2009. Standards for hematologic malignancies are also used to assess response in a clinical trial.

Documentation of AEs is essential to patient safety during the trial and its follow-up period. Identifying and monitoring patterns of AEs informs research teams about unanticipated and/or multiple occurrences of a given event (eg, Stevens-Johnson syndrome), and facilitates medical intervention to prevent or address the AE. Commonly encountered AEs include nausea/vomiting, diarrhea, neutropenia, and thrombocytopenia. The FDA provides guidelines on occurrences that constitute a serious AE. All serious AEs must be reported to the FDA. Enrolled patients must contact the research team if they are hospitalized or receive emergency care.

Clinical Trials Software


In this video, Denise Friesema, MS, RN, OCN, discusses electronic medical records software for clinical trials

UCMC has developed a standardized form for patients in trials to complete at every visit. Clinical trials software from eVelos (Oracle) is used at UCMC; it can generate checklists, and it prompts for data (eg, ECOG status, grading/attribution of toxicities) that are not consistently captured by paper checklists. eVelos also uses “hard stops” to prevent clinicians from proceeding with data entry online if specific requested data are not provided. UCMC will soon begin tailoring Epic (Epic Systems Corporation) electronic medical records software for their clinical trials.


Good clinical trials information can be found online at NCI’s Clinical Trials home page; the National Library of Medicine’s database; NIH’s “Research Trials and You,” which provides resources for healthcare providers; and NCI’s AccrualNet. NCI’s website also offers help with reimbursement questions.

ONS and the International Society of Nurses in Cancer Care will offer an online course “Clinical Trial Awareness on a Global Level,” beginning this month.

While the clinical trial nurse and principal investigator are the go-to resources for critical clinical trials information, all nurses, including clinical nurse specialists and nurse educators, need to have a knowledge base in clinical trials.