Direct-to-patient (DtP) studies offer a compelling alternative to traditional clinical trials. Though the logistics in these studies seems daunting, challenges can be overcome by planning in advance.
In DtP trials, investigational medicinal products (IMPs), equipment, and supplies are delivered directly to patients. Homecare services may administer the IMP, collect patient outcomes and obtain biological samples.
As we’ve written before, it can be helpful to communicate with regulatory agencies earlier in the drug development process when designing a DtP. Logistics for DtP trials benefit from advanced planning too, since delivery of medication and equipment is to patients’ homes.
Advanced planning should involve logistics experts at the beginning of the trial planning phase. Clinical supply chain strategy experts with knowledge of local markets, regulatory expertise, and experience with couriers and home care companies, can assist in forecasting and simulating the final supply chain.
Planning DtP logistics involves packing and labeling, storage and distribution, drug supply, ancillary supplies, laboratory samples logistics, temperature monitoring, import/export control, and returns and destruction.
DtP logistics also involves the use of automated systems that facilitate processes (such as ordering / re-supply) , gather data, and provide transparency across the supply chain. This will lead to better quality control and data capture.
By planning their DtP logistics upfront, sponsors can reduce risk and surprises while enabling responsiveness and flexibility.
When all the pieces come together, you have a successful, comprehensive end-to-end solution that saves time, saves money and gets supplies to patients at the right time. After all, the ultimate goal is to get investigational product to the patient to advance clinical development and accelerate market access.
For more information on Direct to Patient clinical trials, download our white paper Assuring Success in Direct to Patient Studies: Key Considerations.