April 25, 2022
A Glimpse Into The Clinical Trial Participant Experience As Designed By The Pharmaceutical Industry
by Francesca Properzi with Carlos Capella and Dominic Tyer
Participant experiences influence clinical trial enrollment and retention and thus are a key indicator of the performance of these studies. To understand how well pharmaceutical firms contribute to positive clinical trial participant experiences, we surveyed patients across Europe and the US – in collaboration with Carenity, part of EvidentIQ” – and found that there is ample room for improvement. In the long term, pharma companies must adopt a structured approach to ensure that the clinical organization puts the patient at the center of everything they do—but there are also solutions that firms can adopt in the short term to get started.
Measuring the Clinical Trial Experience Matters
Drug development is a challenging process: only one in ten drugs successfully gain market approval.1 One of the main problems is getting enough patients to enroll in and complete clinical studies of those drugs; having a sufficient number of trial participants is essential to generating the high-quality evidence required by regulatory bodies. We have found that:
- Four in five studies don’t enroll enough participants. Globally, more than 80% of trials fail to recruit enough participants on time, prolonging studies and increasing their costs by requiring firms to add new study sites and channels.2 The situation is even worse for Phase III and IV trials, with an average enrollment efficiency below 40%. One prominent cause of recruitment problems is a lack of awareness of ongoing studies, which hints at a disconnect between participants and companies around the marketing of trials. Another is the complexity of study protocols, which make potential participants uneasy about signing informed consent forms.
- Six in seven studies are affected by patients dropping out. Fully 40% of participants are non- adherent 150 days into a clinical trial, and just 7% complete trials.3 This severely compromises the statistical relevance of data collected during the trial, leading to inaccurate assessments of drug safety and effectiveness. A patient’s decision to leave an ongoing trial or not adhere to protocols can have many reasons and vary by trial type and geography.
- Dropouts drive up overall clinical trial costs. A recent study found that the average cost per clinical trial participant is more than $40,000.4 Multiplying this by the number of new participants a trial must recruit to offset dropouts so the study can achieve statistical relevance indicates that sponsors can save millions of dollars in trial costs if they provide great participant experiences.
Understanding The Difference Between Participants’ Expectations And Actual Experiences
The lack of understanding of the factors influencing clinical trial patient behavior and engagement is clearly limiting progress in clinical research effectiveness. To shed light on this, we conducted research focusing on how the principles of customer experience (CX) management—used successfully in other industries as well as on the commercial side of pharma—relate to drug development processes. The key CX management principle is that customers view their experiences through the lens of their expectations. The resulting perceptions lead to certain—hopefully desirable—behavior, which in the context of clinical trials would be to continue participating until the end of the trial. Our research took place in three stages:
- Field an online survey. We partnered with Carenity, a leading digital patient platform, to field an online survey to patients who were actively participating in a clinical trial or had recently done so. We conducted the survey from July to November 2021 in the US and Europe’s five largest countries, covering trials in cardiology, dermatology, endocrinology, gastroenterology, pulmonology, and rheumatology (see Figure 1).
- Determine clinical trial patient expectations. We compiled an exhaustive list of the various ways that clinical trial organizations communicate with patients and provide them with information and services. Participants could select up to three of these and use them to gauge their overall expectation of the organization that managed the communication between them and the pharma company.
- Assess participants’ ratings of interactions based on their expectations. Most participant interactions involve trying to complete a given task in a certain channel. Tasks included completing surveys, filling in consent forms, asking questions and getting answers, consulting with doctors and researchers, requesting trial information, and compiling patient diaries; channels included online, website, telephone, and face-to-face interactions. We asked survey participants to rate interactions against each of their chosen expectations on a seven-point scale and aggregated these ratings to create a Customer Experience Quotient® (CXQ®) score that compares people’s expectations of clinical trial interactions to how well providers—in this case, large pharma firms—meet them.
Figure 1: The Customer Experience Quotient® Survey, Clinical Trial Participants
A Glimpse Into the State of Clinical Trial Participant experiences
Equipped with a measurement methodology, we collected and analyzed the responses of 85 patients who were either participating in a clinical trial or had recently done so. We found that:
- Participants primarily want medical support and high-quality information. First and foremost, clinical trial participants expect pharma firms to deliver high-quality medical support throughout the trial (see Figure 2 and Figure 3). They also expect to be treated as unique, valued individuals and say that it’s important for the trial to provide appropriate levels of information and service. Interestingly, participants’ primary expectations don’t vary significantly across therapy areas or countries.
- Current perceptions of interactions with pharma are good. Based on respondents’ ratings, we calculated a CXQ® score of 63 (see Figure 4). This falls into the lower end of the “good” range, meaning that there is plenty of room to improve participant experiences—and thus to improve enrollment and retention rates.
Great Experiences Drive Participants’ Willingness To Complete A Study
We asked respondents to provide other details about their clinical trial experience, including their preferred channels to interact with pharma and participants’ attitudes to clinical trials after a positive or negative clinical trial experience. We found that:
- Healthcare professionals create clinical trial awareness. Three-quarters of participants learned about their clinical trial from a hospital, GP, or specialist (see Figure 5). Very few found trials via their own research. Face-to-face visits create the most awareness, followed by social media; this is also consistent across countries and therapy areas. Most tasks related to clinical trial enrollment and completion are performed during a face-to-face visit or via email (see Figure 6). Despite low adoption levels, telehealth tools and online audio or video calls had the highest CXQ® scores (see Figure 7).5 The channels that participants prefer are the ones they currently rely on: face-to-face visits and email (see Figure 8).
- Good communication is fundamental to patient retention. Nearly 70% of respondents who are participating in a trial or did so in the past year intend(ed) to complete it; 19% said that they left a trial or had no intention of completing it. CXQ® scores are much higher among respondents who completed or want to complete their trial and much lower with those who didn’t or don’t (see Figure 9). Communication with researchers and medical staff and clarity on the progress of the research drive participants’ willingness to remain in the study and complete it (see Figure 10). Travel distance and being monitored and visited at home were selected least often.
- A great patient experience fuels retention and positive views of health research. We asked trial participants how their overall clinical trial experience affected their perception of a range of topics. Three of these topics stood out as positive: a sense of making a contribution to science and healthcare; a stronger willingness to complete the study and participate in future studies; and greater willingness to use health management tools to support their condition (see Figure 11).
Figure 2: Trial participants expect high-quality medical support, personalized treatment, information, and service
Figure 3: Drivers of the Customer Experience Quotient® for clinical trial participants
Figure 4: Interactions between clinical trial participants and pharma have room for improvement
Figure 5: Face-to-face visits with healthcare professionals drive participants’ awareness of clinical trials
Figure 6: Most interactions that trial participants have with clinical sites occur face to face or via email
Figure 7: Telehealth tools, mobile apps, and online calls are little used but get the highest CXQ® scores
Figure 8: Trial participants prefer to communicate face to face and via email
Figure 9: The CXQ® score is a good predictor of participant trial completion
Figure 10: Effective communication and clarity on research progress are key to participants retention
Figure 11: Trial experiences positively influence participants’ view of science and willingness to finish the study
Improve CX With Early Successes and Transformational Change
There are many activities that firms can pursue to improve clinical trial participant experiences and CXQ® scores—but their time and resources are limited. Companies need to balance initiatives that provide short-term benefits and fix pressing issues with a more structured CX improvement program that aims to prevent CX flaws from arising in the future.
- Early successes: review and improve what is live. AstraZeneca reviewed the protocols of 90 trials and found that 70% of them could collect data remotely, which would reduce the effort needed to participate and thus improve the overall experience.6 The volume or complexity of questionnaires, checklists, or other screening tools that sponsors use to check eligibility criteria can be unnecessary barriers to patient enrollment. A CISCRP study found that one-third of patients who dropped out of a study found the consent document difficult to understand.7 Participant interviews, CX reviews, and social media monitoring are easy initiatives that provide insights quickly on these matters. And getting from insights to action in a heavily regulated environment is not a showstopper: making eConsent forms or recruitment websites more engaging via rich media, pop-up definitions, quizzes, audio, and infographics all contribute to making it easier and more comfortable to enroll in a trial with lower approval barriers than other, protocol-related interventions.
- Transformational change: embed key CX design principles throughout the trial lifecycle. To systematically prevent participants from having bad experiences and reduce the risk of expensive dropouts, firms need to drive excellence centrally with an approach based on three key principles of CX design: thoroughly understanding participant motivations and needs in trial recruitment; incorporating the voice of the participant in trial design; and demonstrating empathy during and after trial completion (see Figure 12). While systematic adherence to CX principles is a complex, multifaceted organizational transformation journey, its orchestration has been tried and tested. To get started, we recommend appointing someone to a senior role looking after experience design to bring together an organization that focuses on the design process, technology, and governance around best practices in clinical trial recruitment and completion.
Figure 12: The key principles of CX design to deliver excellent clinical trial participant experience
DT Consulting’s Customer Experience Quotient® (CXQ®), Patient Interactions 2021 study is an online survey fielded in conjunction with Carenity, part of EvidentIQ, from July to November 2021. The survey included 628 patients whose primary condition was in oncology, dermatology, gastroenterology, cardiology, pulmonology, rheumatology, endocrinology, or neurology. Of these, 85 patients indicated that they were participating in a clinical trial at the time of the survey or had participated in one in the past 12 months. We sent an email invitation to patients who use Carenity to take the online survey. Respondents came from France, Germany, Italy, Spain, the UK, and the US. The Clinical Trial CXQ® ranking was calculated considering the first three drivers selected by patients. Please note that respondents who use online networks, are triggered by email, and participate in online surveys have more digital experience and are more likely and confident to interact with companies digitally than those with less experience.
Learn more about Carenity at: www.carenity.us
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