Some time ago, the idea of bringing a clinical trial to the patient’s home was unthinkable, but recently more and more research companies are convinced of the benefits. The overall goal of a clinical trial is to develop new and better treatments for the patient. Therefore, each development that contributes to achieving this goal faster, should be considered. As more and more pharmaceutical companies are getting familiar with patient-centricity, home visits, as opposed to on-site visits, are gaining a lot of interest.
It would be impossible to relocate a whole trial to a patient’s home. A more realistic approach is to combine on site visits with at home visits. For example, body assessment, vital signs, blood collection, questionnaire collection, administration of investigational product, etc. are all procedures that can be performed by a trained nurse at home. However, on site visits are still important when a physician or instrumentation, such as an MRI, is required.
Many different steps are necessary to bring home visits to a good end. There are many different stakeholders and vendors involved, leading to a complex organizational structure.
- Study protocol approved by the Ethics Committee and authorities defines the scope of the home visits
- Study site includes patients
- The site sends a request to the company providing home visits
- The company trains a local homecare nurse and a back-up if necessary
- The principal investigator delegates tasks using the Authorization Log
- The company provides all necessary equipment to the nurse
- The nurse visits the patient at home and performs the tasks as described in the protocol
- The nurse records all important information on a worksheet and sends this document to the company for quality control. Afterwards, the corrected worksheet is sent to the site.
- In case of any symptoms or unexpected events, the site is notified immediately
- Ultimately, the medical responsibility stays with the site
Although this might seem like a lot of hassle, home visits are worth the investment, as they will increase the possibility of patient inclusion.