As CEO of UK patient recruitment company Innovative Trials, Kate Shaw highlights that a pause does not automatically mean a new medicine or vaccine is unsafe. But she says the public needs to understand what clinical research involves in order to avoid panic in the face of such events.
The responsibility of raising awareness of clinical research ultimately rests with everyone in the industry – and so the industry needs to work together to increase public understanding and awareness, says Shaw.
Clinical trial paused: What should your company say?
Temporary pauses during clinical trials are not unusal. “It's hard to know a definitive figure, but I estimate that it could affect around 10% of trials,” says Shaw. “Many treatments and vaccines can experience a pause during their development, even ones that are ultimately successful and brought to market.”
Providing information is important when it comes to dealing with patients, the media and the general public, says Shaw.
“I would advise companies to give as much information as they possibly can, particularly for the coronavirus trials that are so heavily in the spotlight and under media scrutiny,” she said.
“It would be helpful for the companies to provide the information in an educational way so that it does not lead to panic or fear among the general public and instead helps them understand the clinical trial process."
Shaw says there is a need for greater awareness of what clinical research involves – but isn’t this a big ask, given the complex and specialist nature of the area?
“Awareness of the clinical trial process is so important,” she says. “Recruiting people into clinical trials has always been challenging for the pharmaceutical industry and part of this problem is that general awareness of clinical research - why it is important and what it involves - is low. Clinical trials that do not recruit or retain enough participants are at risk of failing, so this is something that must be tackled.
“One of the key things is to engage effectively with potential trial participants, creating materials that gives them the information they need in a way that engages them best. This could be through written materials, animations or other mediums, using appropriate language and imagery. If handled well, those participants can become advocates for clinical research and help to spread the word."
Local initiatives should also be explored, adds Shaw. Innovative Trials is working with The Christie NHS Foundation Trust in Manchester to help speed up research by engaging with local communities and healthcare professionals, using a more personalised approach to encourage them into appropriate clinical trials.
"We will be doing this by spending time in local communities, creating bespoke and culturally appropriate materials designed to educate prospective clinical trial participants and work with clinical research delivery teams to make sure they are able to keep patients engaged for the duration of their trial.
“However, the responsibility of raising awareness of clinical research rests with all of us within the industry and I would like to see the industry coming together to look at how we can increase public knowledge and awareness of clinical trials.”
AstraZeneca's COVID-19 vaccine trial pause
AstraZeneca paused vaccination in all of its Oxford COVID-19 vaccine candidate trials globally on September 6, because of a ‘potentially unexplained illness’ in one of the trials. It said the trials were paused as a voluntary, routine response to an unexplained event to allow a review of safety data.
On September 14 it announced trials had resumed in the UK after the company received the green light from the country’s Medicines Health Regulatory Authority (MHRA). The status of trials in other countries is dependent on each country’s regulators.