No matter how important the scientific value of a study, the amount of money a Sponsor has or how lucrative the contract, the cornerstone of a successful study starts and ends with recruitment and retention of the study participant. In any walk of life, people have the fundamental need to feel valued and safe in the hands of the people who care for them. Clinical trial volunteers are no exception. If we want study participants to stay the course, we as research nurses and study coordinators, must make them feel safe and valued.
A confident, well informed, friendly research nurse or coordinator, is usually the participant’s greatest support within the clinical trial setting. Forming a good rapport from the outset is imperative. Instilling confidence and trust begins at the first meeting.
In a structured research environment, this does not happen by chance.
My journey with the trial volunteer begins in advance of meeting them. I believe in the adage “fail to prepare, prepare to fail”. Therefore when I am allocated a study, I have a process I follow; this allows me to identify every aspect of the protocol and put systems in place, essential for protocol compliance. Protocol compliance equates to great care of the trial volunteer and quality data. Having protocol knowledge at my fingertips instils the participant’s confidence in me and our journey together is a positive experience from the outset.
My preparation is not a tick list of do’s and don’ts, rather it’s a systematic approach to allow me to effectively facilitate the 6 “R”s. The right participant, in the right place, at the right time, seeing the right people, for the right procedures and the right treatment.
The processes I work with are devised per protocol so will vary according to need. However, a starting point is to always read the protocol and make succinct referenced notes. Each protocol is on average 100+ pages, my notes are on average 4-6 pages. Sometimes looking at the schedule of events is not enough to inform the Research Nurse or Coordinator how procedures should be completed or any special instruction associated with those procedure. There are often finer details embedded into the body of protocol text that could be difficult to find or be aware of. Having notes that contain these details saves time if answers are needed. Even if you have a great CRA, it still takes longer to contact them than it does to look at the notes! This systematic approach to reading the protocol also allows me to identify if there are any questions the protocol doesn’t answer. This enables me to obtain answers from the sponsor prior to study start. If a question comes up when I’m with the subject, a large % of the time I will have the answer.
Once I have my study notes and answers to my questions, I’m ready for the “participant talk”. This “talk” is a list of the main points about the study that I discuss with the trial volunteer. I believe this is an important part of the consent process. It provides an opportunity for me to meet with the trial volunteer and significant other, enabling me to answer questions and concerns ahead of the consent visit with the Investigator. It also allows me to collect PMH and con meds. Because I have a working knowledge of the inclusion and exclusion criterion, I can also assess suitability for study.
The next procedure is to develop an aid memoir that advises when a visit is due, what’s required at the visit, how the data should be captured and in what order. It includes a reminder to ask participant if they are happy to continue in study, identifying continued consent. It provides information to inform subject of any preparation required for next visit, including the window. Ideally this would come from the Sponsor but in reality this is rare. The detail and accuracy of the aid memoir is extremely important for protocol compliance. Therefore, it takes a long time in its construction and utilises all information available i.e. protocol, eCRF and procedure manuals. This is time well spent and saves a significant amount of time when the study is open to recruitment. The document is quality controlled. It’s also version controlled so that it can be updated if there are amendments.
Protocol reading, taking notes, participant talk and aid memoir are central to every study, but other preparations can be helpful.
Essential documents, for example adverse event logs, if not provided by the Sponsor, can be adapted for the study to be used for each consultation with the subject. Collecting data in real time as far as possible, improves quality.
A time point tracker may be necessary to prevent the subject going out of study window if there are multiple windows for various procedures e.g. during screening, where no concessions are given, meaning a missed time point could exclude a subject from being randomized into trial.
It might be necessary to review the lab manual to ensure I have all the correct equipment and familiarize myself with processing requirement. I may create processing guidance per study visit, if the lab manual does not easily provide this information. At the visit, it may be necessary to leave the subject shortly after the blood draw. It’s important therefore for the subject to be aware of this requirement and provide the opportunity to discuss any concerns or questions before blood is collected. A well informed participant involved in their care, improves safety and subject retention.
Finally, if trial participants are seen by other departments, it’s necessary to identify any training needs as training may not be possible from the CRA. Training and systems will be put in place to ensure appropriate and timely data capture.
Having a randomization check list also helps save administration time and enables the subject to be randomized at earliest time point possible.
The amalgamation of these systems makes it easy for me to know each visit requirement, projecting confidence and knowledge, while allowing the trial volunteer to be fully informed of visit preparations and activities. This combination helps the participant to feel safe, valued and well cared for, ensuring retention.
During my 12 years as a research nurse I have worked for different employers, learning and developing my practice throughout this time. I believe the methods I use, now tried and tested, to be effective, accurate and efficient.
Written by Patricia Carter, Research Nurse, Haematology Clinical Research Group, Cancer Trials Unit, University Hospital of Wales, Cardiff, UK.
Check out our podcast with Patricia Carter where we flesh these questions and suggestions out.