Direct-to-Patient Drug Shipments in Clinical Trials: From Emergency Solution to Routine Practice?

In the early days of the COVID-19 pandemic, the pharmaceutical industry had an urgent need to ensure that study drugs reached clinical trial participants who could not visit sites. A solution born of necessity – sending treatments directly to patients – prevented delays in dispensing visits and allowed many trials to continue without interruption.

As most of the early visit restrictions have eased with the availability of COVID-19 vaccines, many in the industry are contemplating the future use of direct-to-patient (DtP) drug shipments.

In advance of his participation in a live panel, “The Practicalities of DtP Shipments for Sites and Patients,” Calyx’s Craig Mooney contemplates if DtP is worth continuing beyond the context of the pandemic? Or is it a solution in search of a problem?

The Possible Upsides

DtP drug shipments in particular, and decentralized clinical trials (DCTs) more broadly, have many potential advantages over more traditional site-based trials that require patients to make visits to sites to receive the study drug. When travel to a site is not required, a broader base of patients may be able to participate in research, increasing the diversity of the study population. And, if patients see DtP shipment of treatments as a convenience, the option could increase the speed with which patients can be recruited into trials and the rate at which they remain participants. It could also make it easier for investigators to serve more patients.

Counter Considerations

On the other hand, there are potential downsides to shipping study treatments directly to patients, which is a major factor in enabling trials to be decentralized. What was necessary – and what people were willing to do – during a health crisis may not be indicative of what should or can continue under more business-as-usual conditions.

If investigators are responsible for distributing the study drug routinely (as was generally the case in the early days of the pandemic), the additional burden of having a logistics operation within their practice may be too much for investigators on a regular basis. At the same time, patients may not necessarily welcome a decentralized approach that minimizes, or even eliminates study visits. A survey conducted by James Lind Care in the UK and Denmark revealed that 24 percent of the patients who responded are concerned about missing face-to-face visits with specialized medical staff in DCTs.[1]

There are logistical complications to consider as well. If third parties (such as couriers) are involved in the drug distribution, controls must be put in place around their having personally identifiable information (PII). And what is permissible varies by region, so it may be necessary to have different approaches across regions.

Asking the Right Questions

Before embarking on a strategy of DtP drug shipments, and by extension some form of DCTs, sponsors should take the time to ask a number of key questions:

• Does this indication lend itself to this approach? Can the related evaluations be done without the patient going to the site?
• Are investigators in a position to support this?
• Will the target patient population welcome this?
• How would shipment failures be handled? (Think porch bandits.)
• Will the technology required for patient participation in a DCT be a barrier for certain patient populations?
• What is permissible in each geography?
• Is a hybrid solution necessary (by region, site, or even within a site)?
• Do we need to enlist the help of a third-party provider, or can we do this ourselves? How must we change our contracts, Master Service Agreements, etc?

As an industry, we’re still developing best practices around DTC trials in general and DtP drug shipments in particular. This is all the more reason for sponsors to undertake a more formal evaluation process and to confer with other stakeholders, carefully weighing the pros and cons of on a study-by-study basis.

[1] “The Patients’ Perspective on Decentralized Trials,” James Lind Care paper, March 2021.