Are you considering Direct-To-Patient Supply Strategies for your clinical trial?
If your answer is YES, remember to start conversations early.
Early conversations should include:
- Reaching out to clinical sites during the feasibility stage and ask about their DTP experience.
- Educating DTP-inexperienced sites on the processes and logistics needed.
- Engaging regulatory agencies early with a documented DTP process in your protocol or distribution manual, as many regulatory agencies around the world do not have a clear process set up for DTP.
Want more in-depth information? This paper is your Direct-To-Patient Clinical Supply Cheat Sheet.
What the experts have to say about Direct-To-Patient
During our Sherpa Summer Seminar we had a panel of experts from across the clinical trial community give their thoughts on Direct-To-Patient. This panel included:
- Reddy Sama, PhD, Sr. Clinical Trial Manager, Alnylam Pharmaceuticals
- Kimberly Finn, VP Global Homecare & DTP US Services, Marken
- Melissa Fassbender, US Editor, Outsourcing-Pharma
- Sascha Sonnenberg, Vice President Commercial Operations America and EMEA, Marken
1) The Definition of Direct-To-Patient
"I think the term, in general, is a little bit misleading because it could imply that you, as a sponsor, ship directly to a patient. That’s not the case. What we see at the moment, which is the common model, is that you actually ship from an investigator site to the patient. In the US you can ship also from a depot location to the patient location." - Sascha Sonnenberg
2) What role does home healthcare play in Direct-To-Patient?
"Home healthcare is also increasing as much as Direct-To-Patient is over the past years and especially as we move in to hybrid and virtual trials. It can be used with Direct-To-Patient. If you are shipping your study medications directly to a patient’s home, you may want a home healthcare nurse to be on site with the patient, one, to receive the medication, but also to administer it and/or even to help train the patient or their caregiver on the administration of the medication." - Kimberly Finn
3) What are the regulatory issues that need to be planned for if a Direct-To-Patient study is going to move forward?
"With all the GDPRs (General Data Protection Regulation) and HIPAA (Health Insurance Portability and Accountability Act) becoming an issue, we were actually facing some challenges in the sense that the process is not clear to these agencies or even sites. If you’re considering these services, my recommendation is that provide as detailed information as possible upfront to these agencies. Provide the patient information, their contact, their names, home addresses, phone numbers." - Reddy Sama
"Direct-To-Patient in many countries is kind of a gray area. You might find regulations for commercial pharmaceutical products, but not necessarily for clinical trials. So it’s important to clearly define and outline the benefits for the patient.
You might have a patient suddenly located in the country where the trial is not running. So this is something that you need to address. Approach the local MOH (Medical Officer for Health), in the country where the trial wasn’t actually set up, explaining the situation to them. You provide them additional support so that you can import the drug into the country and you can deliver to the patient." - Sascha Sonnenberg
Next week, check back for our list of Direct-To-Patient pros and cons.