During the global pandemic, an unsurprising 84% of biopharmaceutical companies reported that they implemented new approaches due to COVID-19. The most popular of which were:

• eConsent

• EHR

• Remote Monitoring

• Video/Phone Visits

The shift towards De-Centralized Trials (DCT) enabled trials to keep (or start) running without the need for patients to visit a trial site. The benefits of this are not only relevant in the COVID-19 world, but have huge benefits for orphan drugs, trials with immobile patients, those who may have challenges visiting the site for a host of different reasons. However, the benefits for recruitment and retention are a headache for those supplying the trial participants. The rise of Direct-to-Patient (DtP) supply was accelerated, and became a buzz in the industry.

DtP is pretty standard in the commercial arena, with millions of prescriptions shipped direct to patients in many countries each month. However for Investigational Medial Products (IMPs) it is a relatively new phenomenon. There are many facets to the clinical supply chain that may have varying requirements for DtP vs ship to site: packaging, cold chain needs, logistical challenges (including last mile). Perhaps the drug supply sector is in need of some greater regulatory governance specific to DtP trials where GMP and GCP play an enhanced role over traditional clinical site administrators.

Even with a physical trials site, there are still patient recruitment and cost and wastage benefits to DtP shipping, which indicates that the approach is here to stay, and process and improvements will come over time. On-demand packaging is one such development, enabling not only reduced waste but the ability to pool drugs across trial protocols and the ability to add or remove countries with relative ease. In an industry where overall trial budgets are escalating, the need to find incremental savings is high, and the rewards significant. Trial timelines are also reduced by using an on-demand packaging DtP model, enabling patient kits to arrive with patients faster.

Ultimately, the key decision for any trial sponsor when considering DtP as an option is how to implement for the trial participants; all or only some patients, all or only some shipments, or in an emergency only. Perhaps with the rise of greater guidance and/or regulations around the impact on trial protocol and when the retention and recruitment benefits have more indications, we may see an all patients all-of-the-time world.