DPHARM2023 – Five key themes impacting clinical trials today
Beautiful Boston was the host for a fascinating three days of conference. Throughout all the sessions some key themes emerged that are impacting study teams and the effectiveness of their clinical trials on a daily basis.
Hybrid trials bring many benefits.
Decentralised trials (DCTs) are here to stay, but there were several interesting discussions around how all DCTs could and should be hybrid.
The overall advice was to try and include hybrid elements into your trial and that virtual or decentralised sites should be treated the same as any other site, with their success measured accordingly.
Whilst the benefits of decentralisation are clear, with remote participation encouraging diversity and allowing for accessibility – senior leaders questioned if their sponsors are prepared to bear the cost and logistical responsibilities of fully DCTs, as we continue to move away from pandemic ways of working.
The hybrid model seems most likely, where traditional trial sites will continue to play a vital role in the success of the study, and a proportion of participants will join remotely as part of a distributed or virtual study site.
It was also noted that pharma companies continue to work on their approaches to “bring your own device” models for remote patient monitoring, and as such are shipping devices and monitoring equipment to remote nurses or direct to patients for them to monitor their progress as a part of the trial. There is room for innovation here as more convenient options are explored that are friendlier for patients.
Marginal gains can make huge impacts.
Trial sponsors are looking for ways to reduce overheads and create efficiencies where possible.
This comes as no surprise, as the industry reacts to the current global economic conditions. However, the most interesting threads of this conversation came in the ways in which pharma businesses are looking for innovation from outside partners to drive efficiency.
These innovations seem to be largely focused on operational savings and the reduction of overheads and time slippage. One of the key issues surrounding cost increases coming right in the early stages, with recruitment continuing to be a challenge. Shaving even a couple of weeks off the time taken to fully recruit a study can have an enormous impact on cost saving. Innovation around recruitment will be key in the coming months as trials look for suitable patient populations in a climate where trust in medical research is generally understood to be low.
Recruitment challenges and engaging patients.
This increased distrust since the pandemic, is consequently making recruitment even more difficult, and without intervention, this will not change.
However, there are lots of opportunities to rebuild this trust and develop relationships with patients, helping them to understand and access the many benefits that come from being part of a clinical trial.
Patient centricity remains a key talking point.
It was great to see it’s now widely understood that we need to engage with patients and advocacy groups as a part of the study design process, and most importantly find ways to measure if therapies improve the lives of patients. A crucial step in improving recruitment and retention.
Technology on its own is not enough, integration and human elements are key.
Finally, we saw lots of mentions of the importance of digital health tech and the role it can play in the future of clinical trials. However, the role the human element of healthcare plays cannot be underestimated.
Whilst remote patient monitoring tools provide additional data and opportunities to collect evidence of efficacy, the enhanced care that patients receive just by being part of a study continues to be a big contributor of HCP referrals. Keeping a focus on the overall patient experience when becoming a participant, from recruitment through to sharing the trial results, will be vital in the coming years.
