Patients can help design clinical trials to reflect the real world

Clinical trial sponsors need to work closely with patients to establish study designs that meet patient needs – from endpoints to what decentralization approaches are integrated.

Early understanding of the disease space is critical, as it can pave the way for shorter drug development timelines. There are diseases for which established clinical trial measures and designs may no longer reflect current patient needs. If landscape scoping is done earlier, any study design adjustments can be carried out sooner.  

Talking to advocacy groups is a critical step to understanding the disease landscape. That said, it is important to go beyond them to find everyday patients who may not have the same level of health literacy. Working with clinical trial service providers who are experienced in specific diseases and have pre-existing relationships within those communities is valuable.  

When co-creating a clinical trial with patients, it is imperative to build processes around them to make sure study planning and the study itself fit into their daily lives. Making the study as accessible as possible for all stakeholders – especially patients – help minimize delays.  

Qualitative interviews of trial participants before, during, and after the study can be useful in figuring out how clinical trials can be improved for future studies as well as finding new drug development opportunities. To improve patient engagement, pharma companies should streamline documents for patient consumption. It is critical for patients to understand the mission of the studies and the role they play in the research.  

If there is a product or idea that may not match the company’s current drug development strategy, it should not be abandoned entirely. Repurposing investigational assets is not unusual, especially when they may better fit an entirely different patient population. Repurposing is made easier if the sponsor has deep relationships with a wide array of patient community groups. 

Conversations between sponsors and patients can guide decisions on how to decentralize clinical trials. If technology is to be integrated into the clinical trial, it is key for patients to understand the role of the technology to prevent any execution issues. While certain technologies may suit certain patient cohorts, other cohorts may find them impractical, which underscores the importance of engaging with all types of patients.  

Study designs should be flexible to accommodate clinical trial patients with different preferences. While there are patients who would rather stay at home and participate in the trial using technology, there might still be patients who prefer to go to study sites. Even in decentralized trials, study sites can still facilitate smooth study operations and so should be a part of clinical trial strategy conversations. While regulatory bodies may appear to be stringent as to what technologies can be integrated into trials, these agencies are there to protect patients and their privacy, keep standards high, and safeguard the scientific process. 

Watch the Full Video Here. 

Actionable Insights: 

  • Patient-centric clinical trials can increase uptake engagement: Designing a study that best reflects the needs of patients can lead to shorter drug development timelines, speed up asset market entry and alleviate uptake issues 
  • Communication channels should also be patient-centric: While patient advocacy groups are valuable, pharma companies should go beyond to reach everyday patients. Communication documents need to match patients’ health literacy 
  • Decentralized approaches should integrate seamlessly into patients’ daily lives: While there are technologies that may make sense in theory, an approach that is not used optimally by trial participants would lead to poor results 

Industry Experts Who Contributed:  

All contributors are senior leaders within the pharmaceutical industry 

  • Vicky DiBiaso, Global Head, Patient Informed Development and Health Value Translation, Sanofi 
  • Stephen Lutsch, Director, Head of Revolutionize Clinical Trials, Leo Pharma 
  • Mischa Szpirt, User Insight Lead, Leo Pharma 
  • Christine Von Raesfeld, Founder and CEO, People with Empathy 
  • Fabio Gratton, Co-Founder and CEO, inVibe Labs, a division of THREAD 
  • Sophie Cleanthous, (formerly) Director, Mixed Methods, UK Team Lead, Modus Outcomes, a division of THREAD 
  • Moderator: John Reites, Co-Founder and CEO, THREAD