It’s conference season in the life sciences world, and we at RWS couldn’t be happier. Last week, our Linguistic Validation team attended and exhibited at ISPOR Europe in Vienna, Austria, the leading European conference for Health Economics and Outcomes Research (HEOR). We’re always delighted to connect with clients and industry professionals and join the many robust discussions around healthcare trends at ISPOR.
This year’s event focused on cross-border collaboration and the use of evidence to enable access. The conference sessions explored multiple fascinating and important trends and topics, and we found three areas particularly interesting and relevant to our work. We left the conference excited about the takeaways we’d gleaned from attending various sessions on clinical outcomes, patient-centered research, and study approaches. The overlap among these different themes characterizes so much of what we do every day, and it’s inspiring to see that these areas are front-of-mind for so many professionals in the industry.
Here are a few key takeaways related to these topics.
Selecting the right instrument is critical—both for data accuracy and to improve the patient experience
As COA experts, we know the importance of selecting (and translating) the right instrument in order to assess clinical outcomes. We were interested in attending EuroQol’s session on Pediatric Quality of Life instruments, which highlighted the difficulties sponsors face in selecting the appropriate and relevant instruments for pediatric patients. That difficulty is impacting both the quality of data collected in pediatric trials and the experience for pediatric patients and their caregivers. A poor selection of instruments used for children can dilute the accuracy of the data, and it can also place undue burden on parents.
Our takeaway? It’s critical to establish consistently effective ways to cognitively debrief a patient population that is growing and undergoing more changes than an adult population would. Doing so can help provide feedback on the quality of instruments used, can improve the patient's experience, and can ultimately lead to more accurate study data.
Being patient-centric means focusing on caregivers, too
Patient-centricity has rightly taken the clinical trial world by storm and these days, there is no doubt that trials would not happen without patients. To their credit, sponsors around the world realize that the patient is the most important person in the clinical trial, and sponsors are taking steps to improve and enhance the experience for these trial VIPs.
Many patients involved in clinical trials depend on caregivers to help them enroll in, complete, and provide feedback on the trial. It’s just as important to include the caregiver’s perspective when assessing trial components as it is to focus on the patient.
Patient-centricity and diversity go hand-in-hand
We’re encouraged to witness how committed multiple industry parties are to enhancing diversity and inclusion efforts across their trials. We know that certain patient populations are currently underrepresented in the healthcare system, and it’s important to engage patients from these populations in clinical trials. Doing so is a matter of more than marketing: effectively recruiting diverse patient populations requires trust, empathy, and demonstrated understanding of different cultures, languages, and values.
We see it as our mandate to constantly evaluate how language could serve as either a barrier or a point of connection between trial sponsors and patients. We will continue to partner with sponsor clients to help them include diverse patients and overcome language barriers for all populations, while trying to keep the impact to those sponsors as low as possible.
Technology can help - or hinder - the patient experience
The fast-approaching EU CTR has heightened trial sponsors’ reliance on technology providers, such as eCOA vendors and linguistic validation providers, to work together as efficiently as possible. Ever-evolving technology will continue to play an important role in the clinical trial landscape. To date, however, the impact of technology implementation has been mixed. eCOA vendors will be the group most heavily impacted by the CTR and will need to modernize, adapt, and seek efficiency where it does not currently exist in order to make simultaneous European submissions a possibility.
Technology shapes the entire linguistic validation process. As electronic administration becomes more common and the Bring Your Own Device (BYOD) trend grows, RWS is committed to working with all technology providers to ensure that collaboration is efficient and delivers questionnaires to patients as quickly as possible.
It’s our duty to continue pursuing excellence in technology implementation with both patients and sponsors. We know that electronic implementation of COAs (eCOAs) can significantly improve the patient's experience—but deployed improperly, such tools can create confusion and delays for sponsors and patients alike. We’re committed to working closely with sponsors and vendors to ensure timely, effective collaboration regardless of the technology used.
Let’s keep the discussion going
Solving the challenges trial sponsors face regarding patient-centricity, improved outcomes, and study approaches won’t happen overnight. We’re glad to be part of a community that places such value on these areas, and from which we can continue to learn.
If you’re interested in learning more about our role in clinical trials and how we can support sponsors to get to market first, reach out today.
Blog has been written by Sarah and Jonathan Norman, Associate Director of LV Quality and Purchasing at RWS.