Clinical trial professionals are more committed than ever before to increasing the inclusivity of their trials. Succeeding in that mission requires a multifaceted approach, including ensuring patient-forward communications at every level are crafted in an array of languages.
Michael Smyth, president of life sciences solutions at TransPerfect, connected with Outsourcing-Pharma to discuss barriers for trial participation, the importance of elevated health literacy, and how to ensure adequate multilingual support.
OSP: Could you please share the ‘elevator presentation’ description of TransPerfect—who you are, what you do, and what sets you apart from companies operating in this field?
MS: For almost 30 years, TransPerfect Life Sciences has specialized in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. TransPerfect currently has 60+ products, including the Trial Interactive eClinical Platform, across industries and global markets, with the knowledge of relevant best practices, compliance, information management, and data considerations all baked in.
Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that a global launch makes a global impact. Through decades of delivering language services solutions, TransPerfect amassed deep institutional knowledge surrounding business content from operational documentation to commercial communications, which has cultivated a superpower for business process innovation.
OSP: Conversations about the importance of patient-centricity, and the inclusivity of clinical research, have been on the rise in recent years. Can you share your perspective on the progress that’s been made, and where there are still gaps between what’s done and what’s needed?
MS: It is imperative that sponsors and CROs put themselves into the patient’s shoes. Thankfully, we’re seeing more patient-centricity as technologies and operational processes evolve to support this. Based on our experience, companies that have orphan products with a limited patient population have generally done a better job at this as they have been forced to be more patient-centric to get study participants through trial completion.
Understanding the patient journey is a must. In a typical clinical trial, there are dozens of digital and in-person touchpoints. Patients are being asked to consume and interact with content across multiple digital and physical channels. It’s our collective responsibility to ensure a predictable, seamless experience, and that all content is perceivable, inclusive, and accessible.
OSP: What, in your view, are the most common barriers to clinical trial participation?
MS: The COVID pandemic has forced companies to better understand some of the hurdles patients face in participating in clinical studies. Some of these hurdles are somewhat surprising, yet very basic when you consider a typical “day in the life” of prospective study participants. Depending on the patient profile, some patients may have to take time away from work or for caregiving for elders or children in order to travel to a site.
For some, the reimbursement process related to personal expenses can be overwhelming. Digital and health literacy continue to be huge barriers. In some cases, patients are required to visit sites as well as to pick up investigational materials, creating even more appointments and travel.
Digital accessibility also contains big hurdles. According to the CDC, 26% of American adults manage at least one disability, whether visual, auditory, mobility, cognitive, etc. That’s 61 million people in the US alone. Estimates are higher outside of the US yet are harder to pinpoint due to privacy laws and people’s reluctance to disclose.
And finally, there is a lot of data to support that patients prefer to consume and process medical-related information in their native language. Again, ensuring an integrated and inclusive patient experience is key. One example of a common challenge is a site that has translated an Informed Consent Form (ICF) but does not have staff that speaks multiple languages to engage in Q&A or conduct a study visit.
All of this has forced the industry to rethink how they conduct studies, and this is backed by FDA guidance that was released in November 2020.
OSP: What types of tools and trial design features have study professionals used to help increase diversity/inclusivity?
MS: Partially in response to this, we are seeing an explosion of virtual clinical trial companies emerging on the scene, which is an exciting development. Along with this comes a healthy level of M&A with some of the traditional sponsors and CROs participating.
Virtual clinical trials can be more inclusive, as they reduce (or eliminate) the need for physical site visits. However, they present other challenges regarding digital accessibility and literacy.
We are also seeing an increase in the use of web portals, social media, and online patient communities, which can lend to inclusivity and “belongingness,” assuming the patient population is digitally literate enough to access it and the content is presented in the patient’s preferred language.
OSP: What types of patient ID, recruitment, and engagement tools have been effective, and which are less effective?
OSP: Most reading this article appreciate that an estimated 20% of clinical trials fail due to low patient engagement, and this percentage can be higher for certain therapeutic areas, such as oncology.
There are a number of methodologies to support patient recruitment, and one of the most effective is to partner with patient advocacy groups that have credibility and connectedness in their respective communities.
Electronic medical records have also helped but this has been slower to evolve in subject identification. Targeted social media and digital ads in regions where these are allowed can be very effective when paired with a multilingual contact center to screen subjects and transfer them to the most appropriate global site.
Automated visit reminders and patient diaries communicated via text, phone, or email also support patient engagement throughout the study. Again, this assumes that patients can conveniently access and interact with the content.
OSP: Could you please talk about the importance of health literacy, both for the overall good of communities and when it comes to clinical trial participation?
MS: Health literacy paves the way for communities to facilitate learning and sharing with one other. While a country-wide program on health literacy may have some effect, communities and patient advocacy groups are far superior in improving health literacy, as there is a greater sense of trust at that level.
OSP: Please share your thoughts on the need for multilingual components of a trial. How can sites and sponsors ensure they’re offering the right resources?
MS: Multilingual information is and will always be a necessary part of a clinical trial, and it’s a critical element of the inclusive patient journey. Unfortunately, we often see some sponsors stop at translating only the ICF for the study, which is not effective and does not serve to establish trust nor that necessary sense of “belongingness” as the patient—and their family—embarks on this journey.
Rather than thinking of this information as “components,” we encourage our clients to consider the entire journey or experience, and the relevant participants, which include the patients themselves, family members, caregivers, physicians, etc.
At a practical level, sponsors could improve what is offered to patients (in English and any language). This includes content delivered in compelling “snackable” videos rather than documents to explain study procedures and ongoing trial updates. Perhaps consider study completion in a lay summary format.
OSP: How specifically can a company like TransPerfect help with inclusive patient recruitment and engagement—do you come in at the design stage, the kickoff of recruitment efforts, or during the trial?
MS: TransPerfect can assist at the planning stages, especially with digital accessibility and multilingual aspects of the study. We have experience supporting global clinical trials for 30 years and offer much more than just language services.
We can develop digital media campaigns, leverage our multilingual contact centers to screen and engage patients, provide medical writing and learning solutions in lay summary formats, and offer web-based technologies (such as portals or mobile apps) —all with digital accessibility and language at the core—streamlining the entire study execution and ensuring diversity and inclusivity.