Investigator site
An important task of the investigator site is the recruitment of patients. Unfortunately, 2 out of 3 sites fail to meet the patient enrolment requirements. Adding a high drop-out rate, due to variable reasons, such as schedule conflicts, inconvenient location, forgetting visits, family matters, etc., results in a low percentage of 25% of all screened patients who actually make it to the end of the trial.
According to a research conducted by the Centre for Information & Study on Clinical Research Participation (CISCRP), the 5 most common reasons for patients to leave a trial are all associated with the inconvenience of having to go to a physical location.
As a consequence, nearly one out of five clinical trials are shut down early due to insufficient participants. Therefore, introducing home visits during a clinical trial, could facilitate the recruitment process. This will then leave the site with more time to focus on patient recruitment.
A clinical trial can put a lot of strain on the staff of the investigator site. Not only can the patient recruitment take up a lot of time, the site is also burdened by the many on site visits and the associated administration. Home visits can therefore remove some of the work pressure.
Sponsor
As mentioned before, patients should be considered as an essential stakeholder. Therefore, recruitment and retention can determine the success of a clinical trial. Unfortunately, many sponsors experience difficulties in this area. The consequence of imposing a complex multi-visit trail on busy or unwell patients, can lead to dropout rates up to 60%, leading to costly delays and missing data, compromising the integrity and results of the study.
Furthermore, the exclusion of certain patients due to geographical location, can lead to a less representative patient population. Therefore, making trials more convenient and accessible to patients, will lead to a positive outcome for the sponsor:
higher enrolment and retention rates will ultimately have a significant impact on the results, costs and timelines of a study, which eventually will help with getting the product to the market faster. Furthermore, contrary to popular believe, home visits have proven to be cost neutral.
Aside from higher recruitment and retention rates, the compliance is also boosted. Having the same nurse come to the patient’s home every so often, will lead to a personal connection, which will make participants feel more valued and heard.
