One of the many casualties of the Covid-19 pandemic was the upheaval it caused to global clinical research, with lockdown measures making it difficult for patients to attend site visits.
Many patients were reluctant to participate due to a fear of infection, which was particularly significant among clinically vulnerable groups. Those still happy to participate may have become incapacitated as infection and mortality rates grew. As a result of all this, slow enrolment and high dropout rates caused delays in planned and ongoing studies, in some cases leading to cancellations.
To continue the safe running of clinical research in this challenging environment, sponsors started to embrace a way of conducting trials remotely where the medicine is sent directly to the patient’s home and data is collected through telemedicine and wearables.
“Virtual trials weren’t a new thing, but they were accelerated by the pandemic,” explains Ian Hoban, business development director at Aposave, the pharmaceutical services division of Abacus Medicine. “Some of the regulatory barriers around those remote trial setups were pragmatically looked at by the authorities to enable trials to go ahead and get patients treated.”
Impact on clinical supplies
Meanwhile, clinical trial supplies were also impacted. Firstly, logistical issues struck when certain governments banned exports in the early months of the pandemic, cancelling pending orders of comparators.
Medicine shortages also occurred. Many governments decided to widen their lists of critical medicines that must be kept in stock, making these harder to source for clinical trials. At the same time, many anti-viral drugs suddenly became candidates for Covid-19 treatment, leading to restrictions on their use in research.
Other trials had already secured their comparator stock, but this became a concern too. According to Hoban, many sponsors suddenly realised they had more inventory than patients. Due to the finite shelf life of the comparators, the potential for large amounts of medicine to go to waste presented a big problem that Aposave, a leading company for clinical trial comparator solutions, already had the perfect solution for.
“We were able to help those companies by utilising our analytics and the fact we’re part of the Abacus Medicine group,” explains Hoban. “If the medicine was purchased in the European Union and it hasn’t been decommissioned, we could potentially buy it back from clients, repurpose it, and enable our parent company to sell it to pharmacy and hospital customers across Europe.
“This stops wastage and enables that client to recoup some or all of the losses they might have for the excessive stock they were sitting on. It also gives more patients access to medicines in markets where the costs are typically higher.”
With the successful rollout of the vaccine, enrolment is likely to pick up. However, quarantine rules could continue to impact site visits as countries like the UK enter the ‘pingdemic’ stage of infection control.
And even now, there may continue to be pressure on medicine supplies. “Over the last 18 months, the treatment of ongoing regular illness outside of Covid has been severely reduced. As health systems catch up, I can foresee a scenario where there will be pressure on certain medicines that sponsors might be looking to source for their clinical trials. That could cause problems as a knock-on consequence,” explains Hoban.
A fresh approach
As we adjust to life in a pandemic, a new approach may be needed in the clinical trials community, but Hoban believes it should be one that doesn’t cast aside all that’s been achieved. “There was a lot of collaboration and sharing of information that helped in the development of Covid treatments and vaccines. This could be left behind again as competitive drivers start to have more of an impact on how organisations behave.”
The future is uncertain, and the industry must keep evolving as the situation changes. Companies need to be looking one step ahead to ensure their operations are fit for the future. For Aposave, this is important. “As we move into a post-Covid world, we’ll continue to keep our eye on the supply chain demands to make sure we’re not providing a pre-Covid service for the post-Covid environment,” says Hoban.
“We’ll also continue to drive forward our way of working, which is that every trial and sourcing project is different. We will continue to be inquisitive and have detailed conversations to understand where our clients have had problems in the past, then come up with solutions and backup plans that avoid or minimise those issues. We’ll also keep challenging clients to make sure what they think they need is what’s best for what they’re trying to achieve.”