The advantages of the Direct-to-Patient model for clinical trials
In the recent years, the tendency to provide medical care services at home has increased for clinical trials. Services and treatments provided in the framework of the medical center or clinic are transferred to the patient’s home, in the patient’s natural environment, at their convenient times and without depending on the flexibility and availability of the medical system at the investigational site.
The Health Care Providers in Israel offer several services in many domains – beginning with the occasional doctor visit or routine blood tests, up to prolonged treatment for which nursing services are required.
Home-care treatment can be challenging and complicated in terms of the logistics. The coordination of the medical care as well as the supply of the required medicines direct to patient home requires a qualified sub-contractor with suitable licenses and logistics capabilities.
The benefits of home care are obvious. Researches supports the fact that a familiar environment for the patient improves the patient recovery. When a doctor provides home-care treatment, the exclusive attention given to that patient in addition to the accuracy of the diagnose/treatment concerning the time frame the doctor has, is immeasurably greater than the attention, patience or time the doctor has in the hospital or clinic.
Another benefit is that non-hospitalization reduces the number of infections in which the patient risks under hospitalization, saving excessive costs (hospital beds) and maintaining the continuity of the treatment.
In addition, home care services for clinical trials have many advantages for pharma companies who have implemented this model in the study. For example, side effects are immediately reported, patient compliance significantly rise as there is a beneficent influence on adherence to the doctor’s instructions.
Israel is considered a suitable choice for conducting clinical trials for many reasons. One reasons being is the small geographical size, which is very convenient for managing the required logistic operation. In addition, Israel has a high level of health care services with a suitable technological platform to perform studies.
A conceptual change of mind is required in order to encourage more companies to conduct their clinical studies with this influential model , this fact is as opposed to what is actually requires for including this service in clinical trials design: to submit it for approval to the Ethics Committee.
The Ethics Committee approval should include in the request form an approval to perform part of the treatment, including the delivery of the drug, to the patient’s home. After gaining the approval a contract needs to be signed between the parties (sponsor, medical center & service provider) defining the responsibilities of each party and assuring the compliance to the study protocol to GCP requirements.
When choosing the adequate clinical supply chain supplier and distribution partner for home care services, one should ensure that the suppliers are in compliance with GCP/GDP and local regulations, flexible and of course have a service-oriented approach. IMP has built a suitable supply chain platform to provide solutions for clinical trial logistics in the fundamental trend of Direct-to-Patient Models.
The platform for providing drug products in adequate conditions to patients home is accessible. It is clear today that all medical services are moving forward and implementing this important service and it is only a matter of time before it will become the common practice.