Patient recruitment is one of the most important aspects of the clinical trial process, for both the hospital and the sponsor. At study set-up a feasibility assessment is undertaken, and the specific question of how many patients can be recruited is discussed. If a hospital regularly over-estimates its capacity to recruit and doesn’t hit targets, that doesn’t look good for future study site selection. If the sponsor doesn’t have enough patients recruited, it makes it difficult to make a strong case for the validity of the drug. So, good recruitment is essential.
The ease of recruitment is totally dependent on the study protocol. If there are many invasive assessments involved it can be a challenge to meet patient recruitment targets. Another factor that can influence your recruitment numbers is the severity of the disease under investigation. For example, if you have a patient with severe emphysema and is being offered a drug or device that may improve their breathlessness, that is sometimes easier to recruit for compared to a patient with mild asthma. The patient with emphysema is sometimes willing to try anything to improve their quality of life.
Patient recruitment methods can vary from study to study. The big and well funded trials can have internet adverts, directing potential patients to a website where they register their interest. I’d periodically log in to the database, contact the patients and pre-screen them for eligibility. Typically, patients are recruited directly from hospital clinics. So, on a weekly basis I receive a list of names from the doctor of who they think would be suitable for the trials they are involved with. Again, I make contact with the patient, discuss the trial with them, and if they seem interested I forward a patient information sheet for them to read.
As part of the recruitment process, there are certain things that need to be clearly explained to study participants. Firstly, it is made clear to patients that this is a clinical trial and that it runs parallel to their regular clinical care. Secondly, that they are under no obligation to participate in the trial and that their decision to not to take part will not affect their regular clinical care. Thirdly, the level of commitment required on the part of the study participant (e.g. the number of study visits) is clarified before taking part.
When it comes to patient retention, the success or failure of a trial is dependent on your ability to pre-screen patients. Although you want to help as many patients as possible get onto the trial, it may not a manageable commitment. There can be significant factors to consider: How far away do they live? Are there transports costs in the study budget? If not, is it financially viable to attend monthly visits for the next 18 months? Do they have mobility issues? These are reasons you could lose patients to follow-up. However, if you are able to recruit the patient on to the study, it becomes about building a rapport and, sometimes, managing expectations. Some patients love coming to the study visits, and can’t wait to tell you about their upcoming holiday or their nieces graduation they attended at the weekend. You do begin to build a bond with some patients. On the other hand, some patients can get down hearted when they don’t notice a change in their health and perceive they’re on the placebo. That can be a challenge.
Furthermore, the frequency the patient comes in and the tests that are undertaken is obviously dependant on the study protocol. Typically patients come in monthly, and have a series of tests done. Visits can take up to five hours, so it’s a long day for the patients. Participating in a trial can require a large commitment from the patients.
Here at the Royal Brompton Hospital we recognise the commitment required by the patients when participating in these studies. We therefore hold regular patient meetings to discuss how to improve the experience of being involved in a trial, aiming to enhance the experience of patients who take part and increase recruitment as a result.
*Dingani Mpoko is a Clinical Trial Coordinator at The Royal Brompton & Harefield NHS Foundation Trust in London