The findings of clinical trials are integral to the practice of evidence based cancer care.19, 20
The purpose of clinical trials is to evaluate the safety, effectiveness and toxicities of new agents and combinations of agents or interventions in humans. Clinical trials involve the following four phases of research or evaluation of a biomedical intervention:22
- Phase I trials involve testing of a new biomedical intervention for the first time in a small group of people (e.g. 20-80) to evaluate safety (e.g. determine a safe dosage range and identify side effects).
- Phase II trials study an intervention in a larger group of people (several hundred) to determine efficacy (whether it works as intended) and to further evaluate its safety.
- Phase III trials study the efficacy of an intervention in large groups of trial participants (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions (or to non-interventional standard care) as well as to monitor adverse effects and to collect information that will allow the intervention to be used safely.
- Phase IV trials are done after an intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use over longer periods of time.
A review of cooperative clinical trials in cancer in Australia found that fewer than 3% of new adult cases each year enter a clinical trial. It has been suggested that at least twice as many adults with cancer would benefit from trial entry.20
Barriers to access and enrolment to trials are:22
- system barriers (particularly limited funding for clinical trials)
- healthcare provider barriers (protocol complexity, general lack of knowledge)
- participant barriers (discomfort about the research process, fear of potential side effects).
Clinical Trials. Australian Government. National Health and Medical Research Council. 2014
Discuss the benefits and risks of cancer clinical trials for individuals affected by cancer; the community; and health professionals.
Access the Priority driven research web page on the Cancer Australia website and summarise the organisation's current research priorities.
Access the NHMRC Clinical Trials website, and:
- Describe the four different phases of a clinical trial.
- Outline the essential elements of a clinical trial protocol.
Access the Australian and New Zealand Clinical Trials Registry23, and:
- Identify the purpose of the registry.
- Select one type of cancer common to your area of practice and search for current clinical trials relevant to this cancer.
Access the National Statement on Ethical Conduct in Human Research24 and:
- Summarise the values and principles underpinning clinical research.
- Summarise the guidelines outlining the general requirements for consent.
The SCN's role in research and clinical trials
SCNs can contribute to many aspects of the clinical trial process, including: 25
- conceptualising and designing studies as part of a multidisciplinary team
- providing information to people affected by cancer
- assessing and monitoring people involved in clinical trials
- implementing treatments as part of a clinical trial protocol
- ensuring adherence to ethical principles associated with clinical trials.
The SCN also has a key role in providing continuity of care, advocating for the person affected by cancer, interacting with the research team, and documenting care provided.25
Competencies for SCNs
Specific competencies for SCNs in relation to the conduct of clinical trials may include:26
- protocol assessment
- planning for study initiation
- subject recruitment
- participation in the informed consent process
- provision of education to learn about the investigational product
- implementation of the study and continual evaluation for adverse events
- data management
- professional nursing activities such as supporting the discussion of ethical issues relating to the trial and the training of new research staff.
Access a current text and the following websites to answer the questions below.
- National Cancer Institute: Educational materials about clinical trials27
- Clinical Trials website. NHMRC
- Provide a detailed explanation of the roles of the clinical trials nurse / research nurse.
- Outline the complementary roles and role overlap between the SCN and the clinical trials nurse.
A person newly diagnosed with cancer asks you if they should enroll in a clinical trial. Discuss how you would respond.
Identify a clinical trial currently underway within your health care facility. Where possible, discuss this trial with the research nurse or data manager. Outline the purpose and process of this trial.
Discuss the effects of 'patient outcome' studies on the practice of nursing. Provide cancer control examples.