Five key questions pharma companies ask about DTP

6 April 2021 (Last Updated April 6th, 2021 13:08)

Sponsored by World Courier Sponsored by Visit Company
Five key questions pharma companies ask about DTP

A year has passed since the WHO declared the Covid-19 outbreak a global pandemic, and with slow (yet steady) global vaccination progress and infection rates on the rise again in parts of Europe, a third wave could now be upon us, according to many government and science bodies.

Lockdowns and safety concerns have caused significant disruption to clinical trials, with slow to progress in Europe due to an understandable nervousness to covid, despite it being both legal and safe to do so. Many pharmaceutical companies have found a viable way of continuing trials with the decentralised model, which involves treatment being delivered direct-to-patient (DTP) and gathering data from the patient in-home.

As the troubling Covid outlook suggests ‘business as normal’ is unlikely anytime soon, more companies will find themselves considering this approach.

But what is the best way to crack DTP?

World Courier, a global speciality logistics company that has a 99% delivery success rate for pharma deliveries, has shared with Pharmaceutical Technology what their customers are most often ask when they begin exploring the DTP model.

Is DTP scalable?

Over the course of2020, the uptake of decentralised studies has grown from a nascent idea in the US and Europe to a globally viable solution that the majority of trial sponsors have engaged with. By May 2020, World Courier had reported its DTP consignments to have quadrupled from the pre-pandemic average.

Concerns that DTP would not be scalable were quashed, with both pharmaceutical companies and logistics businesses rising to the challenge, sharpening their processes and efficiently delivering an unprecedented number of products to patients.

How do regulators approach DTP in the markets we operate in?

DTP presents a few concerns that regulators need to address. Questions regarding whether the treatment can be delivered within the correct temperature range and in accordance with dosing schedules must be worked through. In addition, directives regarding at-home treatment differ across regions. Some territories mandate a physician to administer the treatment, while in others intravenous treatments cannot be done at the patient’s home.

Overall, though, reports World Courier, regulatory bodies showed considerable acceptance towards decentralised trials. The FDA and EMEA have both published detailed guidance on the model, meanwhile, some South American and Asian countries have also demonstrated approval.

How receptive are patients to the DTP experience?

During the pandemic, patients have preferred participating in remote trials due to the lowered risk of Covid-19 exposure. Decentralised trials have also been well-accepted for their convenience, therefore patient demand for DTP is likely to remain high long after the pandemic’s end. Catering to this demand could mean improved patient recruitment, engagement and retention.

Is DTP a short term play or a long-term model we should adopt now during and post-Covid?

Sponsors have plenty of reasons to retain their use of DTP. Improved recruitment is particularly significant for trials of rare disease treatments, which often struggle to meet recruitment numbers due to a limited pool of potential participants. Widening this pool with an expanded catchment area and a more accessible trial not only solves this problem but also allows for more rigorous selection criteria to be applied. Improved patient retention is another distinct advantage, enabling studies to be completed faster and at lower costs. A US Department of Health study reported that in-home testing could reduce per-trial costs by $0.8m in Phase 1, $4.3m in Phase 2 and $9.1m in Phase 3.

What technology is available to ensure we can make DTP reliable and successful?

There is a wide range of technology that has truly enabled at-home trials, from mobile technologies to wearables, in-home devices and sensors that provide regular updates. These technologies are expected to be enhanced as the adoption of DTP continues, helping to further improve the trials’ quality and the patient experience.

DTP is new to a lot of organisations, but it is here to stay. Lots of lessons have been learned, and you can find out how World Courier has answered the questions above and more with the whitepaper below.

Free Whitepaper

Direct-to-Patient and the pandemic: navigating 2021 Five lessons from the first wave – and why DTP is here to stay

While many clinical trials in Europe have halted during the pandemic, it is still both legal and possible to conduct clinical trials in a safe manner. One of the many ways this can be done is by direct-to-patient (DTP) shipping via speciality logistics providers, who are clinically savvy and know how clinical trials are run.

World Courier, a subsidiary of AmeriSource Bergen, has shared its top five lessons learned from the first wave of shipping life-saving medications as well as helping clinical trials to continue running. In addition, the whitepaper contains the top five questions that pharma, sponsor and biotech clients have when first approaching and then implementing DTP.

To learn more how to safely and efficiently continue clinical trials with a speciality logistics provider, download the free whitepaper below.

 

By clicking the “Submit” button above, you accept the Terms & Conditions and acknowledge that your data will be used as described in the AmerisourceBergen Corporation Privacy Policy.

We will also collect and use the information you provide for carefully considered and specific purposes, where we believe we have a legitimate interest in doing so, for example to send you communications about similar products and services we offer. We will always give you an option to opt out of any future communications from us. You can find out more about our legitimate interest activity in our privacy policy here. ‘We’ includes Verdict Media Limited and other GlobalData brands as detailed here.