For many people the summer holidays are the ideal moment to dust off the suitcases and enjoy relaxing or exploring abroad.  But is this possible while participating in a clinical trial? Often, medication has to be administered on a regular basis or certain parameters need to be measured, making it difficult to plan a trip.
Although home visits are associated with a lot of important benefits, some challenges should also be noted. Sponsors often link home visits to a higher risk.  Although this is not necessarily the case, certain precautions should be considered. For example data security needs to be a priority.  As many sensitive patient data is transmitted over
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
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,
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
Advantages of home visits during clinical trials - Delta Healthcare Consulting
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally,

What is a clinical trial?

The National Institute of Health (NIH) defines a clinical trial as: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes.” Many different types of clinical trials exist: Phase 0-IV Descriptive vs