As the organization of home visits can be quite complex, some clinical research organizations (CRO) have specialized in offering services specifically tailored to home visits during clinical trials. These services can include:
- The transportation, preparation and administration of the investigational product
- Training and education of the caregiver and/or patient
- Observation
- Parameters, taking blood samples, ECG’s, …
- Obtaining Informed Consent
- The collection, preparation, packaging and shipping of samples
- Reporting adverse events (AE)
- Reporting patient outcome measures and carrying out a questionnaire
The most obvious and probably most important advantage for the patient is time, as it is finite and precious. Due to frequent mandatory visits at the hospital, the often-long time spent at the site, the travel time, disruption of their daily schedule, …, a clinical trial takes up a lot of a participant’s time. Especially certain patient groups, such as severely ill patients for whom visits at the hospital can be difficult, patients with a rare disease for whom the distance to the hospital is often quite far, children whose participation takes a high toll on their parents, patient who move regularly and are participating in a long-term trial, patients who can’t miss work to attend hospital visits, patients with busy schedules, patients who fear hospitals,… , can really benefit from less on-site visits. According to Lopienski, 38% of patient who dropped out early, reported that the site visits were stressful, compared to only 16% of the patients who completed the trial. Furthermore, up to 70% of potential participants do not live near a research centre, leading to potential exclusion from participating in a trial due to geographical location. Therefore, they miss out on the opportunity to try a new, potentially beneficial, therapy.
Aside from the time aspect, participating in a trial often comes with costs. Although clinical trials shouldn’t bring any additional costs for the participants, they often do have to pay for parking, find childcare during each visit and miss out on work. However, these costs could all be diminished by implementing home visits. As patients have a say in when and where the visits will take place, they are less likely to have to miss work or pay for additional childcare or parking.
Lastly, in the long term, patients will also benefit from the shortened timelines of clinical trials. Due to higher enrolment rates, they will have faster access to new treatments. Furthermore, the shortened timeline can drive down the costs of a clinical trial, leading to a lower market price of the new therapy.
