Pharmaceutical body says faster and more open trials could be good for patients and research
The Covid-19 crisis has already led to new ways of conducting clinical trials that could be applied to other diseases in future, according to the executive director of research and innovation at the Association of the British Pharmaceutical Industry.
“What we are seeing is some speed of doing things and new ways of doing things which are potentially really good for patients and good for research overall,” Sheuli Porkess told Research Professional News.
“What I am really keen to do is to think about how we then apply that across all disease areas when the time is right to do so.”
New ways of conducting trials which have emerged during the current crisis include the delivery of clinical trial beds and medicines to patients’ homes instead of them having to go to hospital to receive treatment. Medical teams are also monitoring patients remotely via video or telephone.
“That’s a really good [way] to keep trials going but also something to think about for the future,” said Porkess.
Lessons can also be learned from the speed at which trials are taking place in the UK during the current crisis, she added, pointing out that companies make decisions on the location of a clinical trial based on how quickly they can get it up and running in a particular country.
“We are now seeing Covid-related trials being approved very quickly by the Medicines and Healthcare Products Regulatory Agency and the Health Research Authority (HRA). We have examples where it has been done in a matter of days.
“What would be really helpful once we get through Covid is to ask: ‘What is it that enabled those trials to be approved so quickly and how can we learn from that?’”
The pandemic has also led to the rapid recruitment of patients to trials, which has been aided by the UK’s four chief medical officers sending letters to every NHS trust asking them to help enrol patients into Covid-related clinical trials.
“That national support for research is very important and is getting results,” said Porkess, adding that the Randomised Evaluation of Covid-19 Therapy trial led by the University of Oxford, known as Recovery, managed to recruit over 5,000 patients in 163 centres in just three weeks.
She believes there are also lessons to be learned around the openness and transparency of data.
“We are seeing the HRA providing researcher summaries to ensure immediate transparency,” she said. “It is something that’s very important, making sure that we’ve got higher transparency standards.”
However, Porkess is adamant that the quality of research or patient care should not be compromised in the rush to get trials underway.
“What is really important here is that we make sure the research is robust and that whatever answers come out of the research are reliable,” said Porkess. “It’s incredibly important that, with the pressure for intense speed and results that we do not actually lose the reliability and the robustness here.”