Career advice

Making the trial run

Better approaches to screening, diagnosis, treatment and prevention of disease are made possible by the research findings from clinical trials.

Whether these trials are for a new drug, device or care delivery system, the reality is that nurses, not doctors or other clinicians, run them.

The success of clinical trials is judged by the quality of data collected, which depends to a great extent on the engagement of the participants – a responsibility that often falls to nurses. To ensure you meet this and the other requirements of clinical research, remember the following points.

Using the correct study methods for data collection is essential

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Nurses have three different roles during clinical trials:

Participants’ advocate.

Implementer.

Collaborator.

You need to be able clearly to identity your different roles in a clinical trial so that you can switch between them effectively.

As an advocate, the nurse is the patient’s source of information. It is his or her job to address any confusion the participant might have about the care received during the trial. This helps the patient define the purpose of their participation in the trial, which helps the research project to run smoothly.

As the implementer, the nurse must learn the relevant research methods and adhere to protocols. This enables you to provide accurate answers to questions from participants or other clinical staff members. Understanding protocol also encourages nurses to adhere to study methods when collecting data, which is essential to the validity of the trial.

Nurses can function better in clinical trials when they communicate with the whole research team, as a collaborator. As part of that team, you can play a role in tackling any issues that arise.

Clinical trials depend on quality data. Nurses can ensure data quality by maximising communication and making sure that important observations are recorded. Primarily, you should maintain records strictly, in order to protect the integrity of the study and patient safety.

When monitoring responses to treatment, documentation is key. You might be asked to use open-ended questions to evaluate participants’ tolerance to a treatment, however, this is not as straightforward as it sounds. For example, in some cultures, people do not report symptoms because they fear this will be seen as ‘complaining’. You can collect more accurate data when you understand the effect of culture on patient responses.

When patients are more open and engaged, nurses can collect quality data and therefore do their jobs better.

Patient involvement begins with the informed consent process, during which the patient and family members are informed of research goals and trial procedures before giving formal consent.

When patients and family members are well informed, you can proceed with the trial more efficiently and answer any questions that arise. You can also involve patients by identifying learning and counselling resources relevant to the disease or treatment being investigated in the trial.

Assisting with clinical trials can be a juggling act, but when you are aware of the research, protocol, documentation requirements and cultural implications, you can maintain the integrity of the study while at the same time protecting the interests of patients.

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