The transformation of clinical trials – the Direct to Patient Model

On February the 15th, Stockholm Science City and World Courier is hosting a seminar focusing on clinical trials in a home environment. The topic is more relevant than ever in a changing pharmaceutical industry. One ongoing transformation is the shift towards becoming health companies, i.e. increasing the offering from “only” a drug provider to a wider offering. 

The extended offering can for example be of digital support covering informational aspects as well as digital tools to simplify or provide feedback in regard to the use of the medication. The trend is also a shift towards a patient-centric approach to a much higher degree. Together with increased access to information and technological tools this transformation further facilitates and enables a patient centered approach.

This paradigm shift also affects how clinical trials in drug development can be conducted putting the patient’s needs in center. With the direct-to-patient (DtP) clinical trials the drug therapy is administered in the patients home as well as performing additional testing required for the trial. Not all trials are suitable for these types of trials and the requirements on the sponsor is to have a coordinated approach engaging all stakeholders in the trial; from patient, nurses, the pharmacy, the logistic company, the investigational site and the central lab. In addition, there may be national regulations which needs to be taken into account in each specific country. Major benefits of the DtP trials are increase in patient recruitment by 60 percent or more, reduced on-site visit for patient for patients, and maintained patient retention at 95 percent or more. In the longer perspective, the DtP aim for better research results, improved healthcare for the patient and increased success for the sponsor.

During the seminar you will meet Christina Vinum from Klifo A/S, Chris Elston from the Medical Research Network and Gunilla Andrew-Nielsen from the Medical Products Agency who will participate in the panel discussions after the presentations. Different aspects of DtP clinical trials will be addressed and there will be plenty of time to network with the speakers.

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