LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck.
Although restrictions were lifted in May, only 45% of trials that were suspended had reopened to recruitment as of Sept. 9, new trials are not starting and there is increasing concern about progress.
Problems remain with patient recruitment, trial oversight, long waiting times for non-COVID referrals and a lack of research staff.
The concern is becoming more acute because a second wave of infection means cases of COVID-19 are on the rise again. That is threatening further disruption, according to the Association of the British Pharmaceutical Industry (ABPI), which is drawing attention to the problem as it publishes its second annual report on the state of clinical trials in the U.K.
Adding to the difficulty will be the rise in other respiratory illnesses and infections over the winter, and the uncertainties that remain over the terms on which the post-Brexit transition period will end when the U.K. cuts its ties with the EU on Dec. 31 this year.
“The U.K. performs well on the world stage in clinical trials, but COVID-19 is presenting us with many challenges,” said Richard Torbett, chief executive of ABPI. “It is crucial that the government has a plan for the safe and sustainable start of non-COVID trials.”
The decision to suspend clinical trials has had a “significant impact” on participating patients and their families, said Aisling Burnand, CEO of the Association of Medical Research Charities (AMRC), which represents charities that collectively fund 17,000 scientists and invest more than $1.6 billion per annum in research.
More than half of AMRC members had to delay clinical trials because of COVID-19, affecting 126,000 patients.
Burnand said AMRC has been working to get non-COVID studies restarted. “Some progress has been made, but it’s clear that a restart is very challenging,” she said.
The irony is that the U.K.’s response in starting and running COVID-19 clinical trials has been world leading. The government set up a process for nationally prioritizing, rapidly approving and opening studies.
The most notable of those is the randomized Recovery trial, which has recruited 13,268 patients in 176 hospitals and demonstrated the HIV/AIDS combination therapy lopinavir-ritonavir and the antimalarial drug hydroxychloroquine are not effective, while the corticosteroid dexamethasone is.
The Recovery results have led to changes in clinical guidelines worldwide.
ABPI said the new ways of working inspired by the pandemic need to be embedded to ensure the changes enable future clinical trials to be conducted more efficiently in all disease areas, including COVID-19.
The health crisis has led to long overdue improvements in how quickly trials can be set up, said Cheng-Hock Toh, vice president of the Royal College of Physicians. “But a key obstacle still holding back clinical research in the U.K. is clinicians not having the time to participate, despite their keenness to become more involved,” he said.
It is important not only to sustainably restart non-COVID-19 research, but to also open new studies, said John Williams, managing director of Birmingham Health Partners, which manages clinical research across Birmingham University and two hospitals in the city. “Through the pandemic, the National Health Service and the U.K.’s academic and industry researchers have shown the ability to rapidly mobilize new studies in the face of a novel disease, and we now have the opportunity to use that collective experience to reassess our approach to setting up and running clinical research,” Williams said.
That can only be achieved by designing in resilience. Contingency plans are needed across the board – for example, fewer physical visits by participants, electronic data collection and innovative trial designs.
Other examples of improvements in COVID-19 clinical trials include delivering trial medicines direct to patients’ homes and the use of digital consent forms.
The COVID-19 pandemic also has underlined the need to address the under-representation of black, Asian and ethnic minority groups in clinical research, said Haseeb Ahmad, president of ABPI, who is U.K. managing director of Novartis AG. “[They] have been disproportionately impacted by the disease,” Ahmad said. To improve participation, “we urgently need to rethink how we conduct research.”
The ABPI report shows what is at stake, with pharma companies investing £4.5 billion (US$5.8 billion) in research in the U.K. in 2018, and more than 1 million participants involved in clinical research in 2018-2019.
Early stage clinical research already was in decline before COVID-19, with 95 phase I studies starting in 2018, compared to 117 in 2017, and 150 in 2016. For phase II and III, the situation is relatively unchanged, with 268 phase II studies opening in 2018, compared to 281 in 2017, while 292 phase III trials began in 2018, up from 269 in 2017.
The U.K. ranked first in Europe for phases I and II, and third behind Germany and Spain in the number of phase III studies.
While those comparative data describe the pre-COVID 19 clinical research environment, “the areas for improvement remain the same, with the need for change merely amplified [by] the 2020 pandemic,” the ABPI report said.