iSpeak Blog

Placing Patients at the Center with ‘Direct to Patient’ IMP Delivery

Charles W. Gentile
Marc Sotty, Pharm.D
Emmanuelle Quere, Pharm. D.
Placing Patients at the Center with ‘Direct to Patient’ IMP Delivery

The voice of one patient and a pandemic in South Korea in 2014 prompted a new approach to dispensing Investigational Medicine Products (IMP) -- bringing the medicine directly to the patient.

The approach is in alignment with Sanofi R&D’s Corporate Social Responsibility (CSR) effort known as ‘Trial Committed to Patient’ to develop trials that reduce or eradicate as much of the burden to trial participants as possible.

Direct to Patient offers more flexibility to patients and investigators and reduces recruitment time.

Next steps for the ‘Direct to Patient’ (DTP) approach would be to ship Investigational Medicine Products from a central pharmacy directly to patients issued from several sites which could strongly reduce the Investigational Medicine Products stocks at a site’s pharmacy.

Taking Action

In the case of the patient who requested home delivery, since Direct to Patient was not mentioned in the study protocol and Informed Consent Form (ICF), the hospital pharmacy decided to deliver the Investigational products to a pharmacy in the village close to the patient's location.

At the same time, Middle East Respiratory Syndrome (MERS) pandemic, emerged in South Korea. In order to avoid treatment discontinuation, local Health Authority (HA) companies requested to send investigational products directly to the homes of study patients.

Middle East Respiratory Syndrome is a viral respiratory illness that is new to humans. It was first reported in Saudi Arabia in 2012. Middle East Respiratory Syndrome is spread through a common Corona virus.

Then Sanofi decided to move forward with pilot trials in pulmonaria fibrosis with Direct to Patient option.

To be quality compliant, policies and procedures were developed, and audits were requested of providers that partner with Clinical Sciences & Operations (CSO) for Direct to Patient activities.

With respect to the audit, the main concerns were the legal questions and data privacy constraints related to the General Data Protection Regulation (GDPR) regarding information communicated from the investigator site to the courier for drug delivery.

To secure personal data, the courier uses encrypted tools to align with General Data Protection Regulation regulation.

Following positive feedback from pilot studies and faced with the many requests, Sanofi decided to be proactive moving ahead more deeply with Direct to Patient.

Internally, the decision was made to add the Direct to Patient option in all protocols and Informed Consent Form’s routinely to be prepared for emergency requests and/or demands from patients or investigators.

In parallel, for specific diseases (oncology, rare disease) it was decided that Sanofi would implement Direct to Patient for specific visits with regard to drug stability, specific population, and patient residence.

Based on patient centricity, new trials with Direct to Patient will offer home nurse support.

As of today, Sanofi has already performed about 400 Direct to Patient/Direct from Patient on 12 studies mainly in the US and Europe.

More recently the company has decided to move forward with digitalization and e-studies, and to do so, Sanofi will work closely with specific companies (Science 37) for electronic collection of data associated with Direct to Patient and Direct from Patient (DFP).

For some marketed products, Sanofi Industrial Affairs in the UK, decided to use Direct to Patient circuit instead of the formal one through wholesalers and pharmacies. Shipments are then directly sent to patient’s home or working office.