Reasons for Bad Patient Recruitment
Medically speaking, the statement: "Patient recruitment doesn’t work." just describes a symptom. The causes for this, however, can be manifold:
- The wrong patient clientele is addressed.
If patients eligible for the study according to the in- and exclusion criteria can’t integrate the study visits or a washout of their normal medication at the beginning of the study into their daily routines, one will not be able to win these patients for the study.
- The clinical trial is not attractive to patients.
Patients most often do not benefit personally from their participation in a clinical study. Therefore it is crucial whether the sponsor succeeds in designing the information to patients in a way that they can recognise the social value of the study and the possible added benefit of the medication or medical product to be approved. And it is important that the investigator can explain the study to his patients accordingly.
- The clinical study is scientifically not relevant.
For physicians at university hospitals their scientific research has priority. Therefore they favour collaborating in studies with an interesting scientific research question that matches with their research topics and offers the prospect of the results being published.
- The study sites do not fit with the study in regard to patient clientele, infrastructure or experience.
Besides the number of patients with the study indication that the study sites are seeing, it is crucial how many of these patients can be recruited for the study. This not only depends on whether they fulfill the inclusion and exclusion criteria, but on various other conditions: Are the study sites experienced with patients with this indication and the infrastructure required for the study? What effort does the study participation mean for the patients? Are there unpleasant or even painful study procedures? Can the investigator motivate the patients to participate?
- The study is not sufficiently paid.
The study fees must be fair and correspond to the effort to be yielded, so that the study sites have will be paid for the time needed to prepare for the study, even if later on they are not selected for the study. It has to be ensured that other studies, which the study sites collaborate in, are not better rewarded.
- Instructions for technical devices are difficult to understand.
The instructions for equipment to be used in the study must be clear and as simple as possible to be understood by the study team, and the study team must be trained in the use of these devices. It is recommended that the clinical monitors try out the equipment and the instructions, so that they can train the study team how to use them. If the instructions are difficult to understand, especially if they were written by the developers of the devices, they should be redacted by the sponsor and the redacted versions must be reviewed by the manufacturers. The study teams will not grapple with devices that do not function right away, and would rather be likely to attend another study which is less elaborate.
- The study processes are difficult to integrate into the workflows of the study sites.
The study teams must be able to integrate the study processes into their daily routines. It is a good investment in the success of a clinical study to deal with the study sites’ processes. In most cases, however, these are unknown to the clinical monitors.