Article: How Are Our Customers Reacting to the Ongoing Impact of COVID-19?

By World Courier

Increased Decentralization and use of Direct-to-Patient Models

The impact of the COVID-19 pandemic continues to resonate in every sector. Biopharma is no exception. Supply chains have been strained to breaking point. Clinical trials have been suspended or reconfigured. The assumptions underpinning distribution models have been overturned.

Early on in the pandemic, World Courier surveyed its customer base – with 132 responses, and 9 interviews – to better understand the effect COVID-19 has had on clinical trials and wider biopharma distribution. The results are discussed in our on-demand webinar, DtP – The Future of Clinical Trials?, which is accompanied by a full report.

Chief among our findings are a major shift to decentralized trials, and a possible permanent move away from just-in-time distribution.

Trials have moved to patients’ homes

46% of respondents had moved clinical trials from hospital sites to patients’ homes. Of those, 52% said they would continue with a DtP model until restrictions were lifted. 24% said they would use DtP even after restrictions were lifted.

The move to DtP was precipitated primarily by site closures – falling under the ‘non-essential’ government category – and patients being unwilling or unable to visit hospitals during the pandemic. Other reasons given were travel restrictions impeding access to trial sites, and some patients being stranded while travelling or abroad.

A visiting nurse talks to a man and a woman in their home.

Direct to Patient may continue after restrictions are lifted

The move to DtP may have been pragmatic, but it already appears to have instigated a industry shift that may remain long after restrictions ease.  37% of respondents said it’s more likely they will design trials using DtP in the future, driven in part by concern that patients may be unwilling to visit clinical settings even outside of lockdown – a concern shared by 63% of respondents.

Indeed, 27% have had patient feedback expressing a preference for DtP over attending trials on-site. Having experienced the convenience of home-based trials and telemedicine, many will be unwilling to return to the status quo. However, while regulators have shown laudable flexibility during disruptive times, it’s unclear whether concessions will remain in ‘normal’ circumstances. DtP will also not always be appropriate. Some therapies need to be administered by trained staff, and some patients do prefer the reassurance of visiting clinical sites. And there are data protection hurdles to overcome, as explored in our whitepaper, Decentralized Clinical Trials and Data Protection.

The watchwords of the future are flexibility and patient-centricity. As David Spillett, Key Account Director at World Courier put it in our Maintaining Business Continuity whitepaper, “Allowing patients to participate in the way they would like to participate… giving them the option of coming into the site, if that’s viable, or even being treated at home, if that’s viable”.

COVID-19 may have a lasting effect on biopharma distribution models

Moving beyond clinical trials, World Courier’s research questioned customers about how their storage and distribution models were changing in light of COVID-19. 68% of respondents believe their IMPs, APIs, and approved products to be well distributed in case of another outbreak. Having been stress tested, supply networks have proven capable of the necessary flexibility to navigate disruption.

However, 39% still plan to review their storage and distribution arrangements as a result of COVID-19. Although supply chains were broadly resilient, weaknesses were revealed. For instance, Europe has always been assumed to be centralized, but there was difficulty moving products between Germany and France. That may necessitate more regional and in-country storage to pre-empt further lockdowns.  

Just-in-time distribution may also be coming to an end, with many respondents now stocking 3-6 months in advance. As one participant put it, “We will see lean manufacture fall by the wayside… For the next few years the world isn’t going to be as instant and available. There will be more stock on shelves that covers 80% risk.”

Take part in our phase two research

The pandemic shows no signs of abating soon. Even once vaccines are distributed, the impact of COVID-19 will reverberate for years.

We are now conducting a new survey, to measure the ongoing effect of COVID-19 on clinical trials and logistics within the wider biopharma sector. With this understanding, we hope to better adapt our own services, to facilitate the evolving needs of our customer base and provide the best possible support.