Using a Direct to Patient (DTP) strategy is an approach that is gaining traction – but how do you know if it makes sense for your trial?
Simply put, a DTP trial eliminates the need to visit an investigator site which increases patient convenience and takes away any cost associated with travel expenses. Because of this significant patient benefit, the pharmaceutical / biotech industry has observed that a DTP strategy can positively impact patient enrollment and retention. Given the challenges sponsors face in these two areas, the demand for DTP trials has seen significant increase in recent years.
Characteristics of the ideal profile for a Direct to Patient trial
Using a DTP strategy has its opportunities and challenges. Choosing the right time to deploy this strategy is critical. Some of the ideal characteristics include:
- A non-interventional study that does not require diagnostic testing prior to taking the study drug
- A remote-study approach
- A long-term outcomes study
- Non-ambulatory situations
- Rare diseases
- Therapeutic areas that demand data collection from various stakeholders
How should a sponsor proceed with their evaluation?
Sponsors first must ensure that dispensing DTP is legal in the countries named in the protocol. Details of DTP distribution must be included in the clinical trial application (CTA) submission. For countries that present import challenges or delays in clearing shipments through Customs, Fisher Clinical Services recommends that the sponsor consider using local depots.
The next step in the evaluation requires addressing the following questions:
- Does a licensed healthcare provider need to be present to receive and administer the medication?
- How can the sponsor ensure that temperature specifications are maintained once the medication is delivered to a patient’s home?
- What is the process for collating data?
- How will the shipments to and from patient’s home be managed?