It is estimated that the average cost of each patient in a Phase III trial is over $35,000. That means each patient who drops out of a trial can have a significant impact not only on development costs, by lengthening the time frame of a study, but also on the potential revenue generation a new therapy can deliver. As a result, the biopharmaceutical industry continues to explore new and better clinical trial processes to encourage patient recruitment and retention – such as the Direct-to-Patient (DTP) distribution model.
The “What” and “Why” of Direct-to-Patient (DTP) Logistics Model
With a DTP clinical trial, patients can reduce the number of site visits needed to participate by completing many of the required trial activities from the comfort of their own homes. Investigational drugs are delivered from central or local pharmacies, central depots or clinical sites with pharmacy licenses directly to the patient.
Drugs are administered and patient samples are collected at home by the patient or with the help of a home health care nurse, and sent back to a central lab for testing. This approach is ideal for pediatric and geriatric cohorts, as well as patients who are unwilling or are unable to travel to clinics – whether that means they live in remote areas or have debilitating diseases.
- More convenient for patients
- Improved communication with patients
- Easier recruitment and higher retention
- Faster trial completion
- Better data and improved compliance
- Reduced clinical supply costs
- Enhanced revenue potential
Orphan, Rare Disease and Blockbuster Drug Trials
Faster patient recruitment and higher retention rates mean a DTP clinical trial is perfect for orphan and rare disease drug development, where enrolling and retaining participants has been historically difficult. Additionally, blockbuster drug trials can benefit from DTP supply chain models, as their implementation has been known to shorten trial times. The incentive for completing a blockbuster trial early means that patients get access to a much needed therapy sooner. Plus, the biopharmaceutical company can take advantage of the estimated $3M/day in revenue that a blockbuster drug is able to generate when under exclusive patent.
With tangible benefits for both patients and the life sciences industry, it is not a matter of “if,” but rather when more pharmaceutical and biotech companies will implement their own DTP trials.
To read the entire article, go to: World Pharma Today Magazine