Home visits as part of clinical research have accelerated in recent years as we strive to find the right balance between facilitating study participation while accommodating participant’s busy everyday lives.  Clinical trials in rare diseases are even more challenging than trials in other diseases due to a number of factors:

  • Small number of eligible trial participants
  • Complicated by heterogeneity among rare disease patients
  • Most have no cure and manifest at a young age
  • Less than 10% of rare diseases have a specific treatment
  • Many have other debilitating conditions / physical limitations making it difficult to attend frequent study visits

The combination of home study visits and the right technology removes barriers to optimal patient recruitment, compliance and retention.

In this evolving process of moving away from on site visits to patient centric services, there are limitations to consider. The CRO and Sponsor have to determine the acceptable risk parameters for the study. Portable equipment for collecting study assessments has to be easily managed by one person with an upper limit of 30-40 pounds and the research activity is within the scope of the nurse administering the product. A decade earlier, home visits were limited to infusions and specimen sampling. Today there are more ways to administer products: infusion, injection, orally, inhalation and topical and study staff are dosing, testing and coaching patients. If needed, specialty couriers can deliver the IMP [investigational medicinal product] and send blood samples to the central labs. Even visits requiring  8-12 or 24 hour PKs that might otherwise make a subject have an in-patient hospital stay, can be conducted by an in-home study nurse. Essentially, a patient centricity approach supports patients wherever they may be.

Bringing clinical trials to the 21st century requires an innovative spirit and can-do attitude to successfully achieve more, faster and better. The use of eCOA [electronic clinical outcome assessments], image collection for central review such as photographs, physical assessment at the patient’s location, collection of samples for central lab analysis, and EDC entry increase higher quality, consistent data which saves time and money.  This solution leverages investigator site and home technology. Home visits are the best use case for technology and the human touch for the most fragile patients and their already stressed caregivers. Leveraging technology delivers dignity and peace. An array of devices support the effort from project team communications to tablets and wearables. This is technology and human interaction at work.