The 9th European Medical Writers Association (EMWA) symposium, entitled ‘Clinical Trials – New Trends’ took place on 6 May. The symposium explored the latest trends in the design, conduct and reporting of clinical trials over 3 sessions, focusing on insights relevant to medical writers and communicators.
A summary of session 3 of the symposium is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did.
Session 3: Does the clinical trial wheel need reinventing?
The third and final session of the symposium was chaired by Art Gertel (MedSciCom) and looked at innovation in clinical trials. The panel covered the genesis of recent innovations in clinical trial conduct in the context of the COVID-19 pandemic. They considered which innovations had occurred as a direct result of COVID-19, which only required the imposition of the pandemic to accelerate their adoption, and whether innovation in clinical trials would persist once the pandemic subsides.
Nowadays, simply testing is not enough
Rick Galli (St. Michael’s Hospital, Toronto, Canada) kicked off the talks with a review of an innovative study of a blood-based human immunodeficiency virus (HIV) self-test conducted in Canada. Culminating in the imminent launch of the I’m Ready telehealth platform, what began as a routine diagnostic device trial turned into anything but when the COVID-19 pandemic emerged. COVID-19-related policies implemented at clinical sites meant numerous protocol amendments were required to overcome challenges such as:
- a 50% reduction in clinical site visits
- need for monitoring of study participants on site
- time restrictions for visits
- limits on the number of participants allowed in the study centre
- reluctance among participants to return to the centre to obtain results, with the anonymisation process limiting the ability to contact participants afterwards
- enrolment halted short of the intended recruitment target.
COVID-19-related policies implemented at clinical sites meant numerous protocol amendments were required to overcome challenges.
Despite these challenges, the study was able to proceed and show that the HIV self-test performed well in usability testing and provided valid results. However, per the title of the talk, simply testing is not enough. The next innovative step of the programme is to combine the self-test with the telehealth platform to increase access to HIV testing – particularly for undiagnosed and marginalised populations – and allow people to make use of mobile and online platforms to gain access to appropriate care.
COVID-19 and its implications on how we conduct clinical trials
Robert Malone (RW Malone MD) continued the proceedings, elaborating on the implications of COVID-19 for conducting clinical trials. As Simon Page had done earlier in the day, Malone referred to the ‘hierarchy of evidence’ to demonstrate how COVID-19 has emphasised the potential shortcomings of different types of medical evidence. At the base of the hierarchy, Malone noted that the excess of expert opinion pieces during the COVID-19 pandemic has led to some ‘flip flopping’ of opinions as new data are published and interpreted.
The excess of expert opinion pieces during the COVID-19 pandemic has led to some ‘flip flopping’ of opinions as new data are published and interpreted.
Regarding some journals’ reluctance to publish case series and case control studies for fear of further retractions, Malone encouraged reviewers and editors to keep faith with the peer review process and help the authors of well conducted, robust studies to present their data accurately and with integrity. Even study types towards the top of the hierarchy of evidence reliability (such as cohort studies and randomised controlled trials) have been affected. Accurate matching in cohort studies has been difficult to achieve when the relevant risk factors are not well understood, while politicisation of institutional review board and regulatory processes has the potential to hinder the conduct of randomised controlled trials.
While COVID-19 has brought with it a variety of practical challenges to overcome, not least protecting staff and patients from virus transmission during the conduct of trials, the pandemic has also created opportunities to innovate. Malone identified virtual trials, with their potential to increase and diversify participation in clinical research, as one area for innovation along with increased use of public health databases and other sources of real world evidence.
The pandemic has also created opportunities to innovate. Malone identified virtual trials, with their potential to increase and diversify participation in clinical research, as one area for innovation.
Decentralised clinical trials: collaboration to accelerate adoption and Challenges of virtual trials, data integrity and patient privacy protection
In the final two talks of the session, Craig Lipset (Clinical Innovation Partners) and Steve Raymond (Personal Health Insights) spoke in greater detail on the topic of virtual trials. Whether referred to as decentralised, virtual, remote, or siteless, the devolved approach to trial conduct has been around for a number of years prior to COVID-19. However, in recent times, such approaches have been increasingly used, with 79% of sponsors and contract research organisations (CROs) using decentralised, virtual or hybrid trial designs. In addition, 90% of trial participants have experienced a change associated with decentralisation, including use of telemedicine and smartphone apps, a virtual clinic visit, or study medication being delivered directly to their homes. Lipset expects this situation to persist, with around three-quarters of sites expecting to use telemedicine beyond the pandemic and 76% of industry respondents to a survey noting that the pandemic had sped up their adoption of decentralised trial methods.
90% of trial participants have experienced a change associated with decentralisation, including use of telemedicine and smartphone apps.
Raymond then described how the logistical challenges of running virtual trials – such as remote sample collection, medication administration, and oversight of procedures and patient wellbeing – have been met to date. Regulatory compliance is also a challenge in the virtual trial environment, particularly where safety oversight and administration of sensitive assessments are concerned (ie situations typically requiring physicians to be near the patient). Along with these challenges, the key to further successful adoption of decentralised trials is pairing the appropriate decentralised research methods and tools with the specific requirements of each study. It is hoped that the payoff for doing so will be greater choice and flexibility for research participants and wider engagement of sites and investigators.
The key to further successful adoption of decentralised trials is pairing the appropriate decentralised research methods and tools with the specific requirements of each study.
In the discussion session following the talks, the panel concluded that the COVID-19 pandemic has had the effect of fast tracking the adoption of innovative approaches to clinical trial conduct. The pandemic necessitated an openness to virtual solutions and regulators have been able to accelerate their response to facilitate the adoption of such approaches. Post-pandemic, it will be important to consider which innovations have been a boon and should be adopted more generally and which have simply served their purpose in a time of need. In all of this, the medical writer is uniquely placed to be a point of influence. As a nexus between subject area experts, regulatory bodies, journals, editors, industry scientists and patients, the medical writer is on the front line of science communication, ideally positioned to provide balanced counsel and maintain perspective.
The panel concluded that the COVID-19 pandemic has had the effect of fast tracking the adoption of innovative approaches to clinical trial conduct.
Written as part of a Media Partnership between EMWA and The Publication Plan.