GP Studies


Article by Jan Sleigh, Senior Research Nurse, work with a number of GP sites in the UK, which involves lots of travelling between sites to see patients. Regularly, on the same day, we would have patient visits at more than one site, across a number of different studies, which means keeping a close eye on your diary! Having to switch your mind set regularly to different protocols throughout the day is a challenge, but a necessary requirement of the role.

Generally, we cover clinical trials in phases II-IV.  These GP trials generally enrol patients aged 18 – 70, with each protocol having its specific inclusion/exclusion criteria, depending on the disease area. We work across most disease areas within Primary care, but some disease areas are not practical in Primary care, for example Oncology studies, and these are performed in the hospital setting.

The set up of each study is very involved and time consuming. It would involve piles of paperwork (including Ethics and Regulatory submissions) and lots of meetings. Usually, prior to the start of a study, an Investigator meeting will take place, which are extremely important for the smooth running of a study, good for networking, and not to mention fun!

We then have to trawl through database to identify any relevant patients, send out invitation letters, evaluate the replies and telephone each patient to make an appointment with them to discuss the study. The study itself may involves several patient visits of varying lengths of time, and may include blood sampling, ECG recording, vital signs, including blood pressure, heart rate, temperature, height and weight, and a full physical examination. After a patient has left, there is still plenty to do, including spinning and aliquoting bloods and organising the courier, and completing the paperwork which usually involves documenting the information in a number of places.

All the study information has to be recorded in the patient’s case record form (CRF) from the patient’s paper or electronic notes. If the study uses an eCRF, data collection will usually also involves paper for source, in addition to patient electronic notes and any other source that the sponsor company stipulates. We have to be competent on several computer systems to enable us to be able to source and record information effectively. Most sponsor companies have different web based eCRF’s or supply laptop systems for entry of data into the eCRF. Some surgeries also use different computer systems to each other, adding to the complication.  All these systems require different passwords that cannot be shared and are required to be changed regularly. There is a lot of information to remember!

Most patients are very keen to enter into a clinical trial for various reasons, including; being well looked after and having additional assessments to their standard care, their current disease is not properly controlled, future improved medications for themselves and their families, the feeling of contributing to the development of a new medicine, and not least a day out for a lot of the patients! Most studies are quite lengthy and a lot of patients enter into several studies over time, so you get to know them very well. As a Research Nurse, patients quite often want to tell you all their problems and so we have to be prepared to make time for these patients.

GP studies are extremely rewarding and I am privileged to be involved in this industry.

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