As many as 85 percent of clinical trials are unable to keep patients enrolled long enough to confirm the efficacy of the trial treatment. It’s hard enough to recruit enough patients; losing them before completion is costly in terms of delays and results.
The reasons for dropping out of clinical trials are numerous, and some unpreventable. However, there’s one approach at least that helps retention. And that’s listening to patients from the outset. As Jean McCoy and Pam Garfield at Clinical Leader write, 97 percent of surveyed patients regard it as “important for pharma companies to include consumer input when designing trials.”
The obvious conclusion is that soliciting and implementing patient feedback can help improve trial design.
Knowing logistical concerns about transportation, location or scheduling conflicts, for instance, can allow trial researchers design better trials and “adjust specific clinical trial operational factors that have been identified to impact enrollment or retention,” they say.
It’s no wonder then that an increasing number of pharma companies and trial sponsors are seeing the value of patient feedback. By listening, sponsors learn where improvements can be made to processes and operations, while patients are more likely to stay enrolled and feel better about the experience.
Below we explore the reasons why patient feedback is valuable and suggests ways to obtain it.
He suggests soliciting feedback from both the patients that complete the trial and those that drop out before finishing. The latter group provides the information necessary to correct issues that affected the trial unfavourably. Examples might include a patient leaving the trial because adequate meals weren’t provided or they weren’t informed of how to take the medication.
An online survey of 1,621 patients found reasons for non-participation included “eligibility criteria, inconvenience of travel and concerns about side effects,” the research team at PatientsLikeMe.com reports.
Feedback also gives sponsors insight into the ways patients see their health conditions, which can differ significantly from the way trial researchers do. This understanding helps create a more empathetic environment.
“When trials understand their patients’ point of view, they can draw valuable connections between study requirements and the conditions they’re trying to treat, helping patients understand why they need to comply with instructions,” Stempel explains.
Patient feedback helps shape all stages of drug development, Amy Froment, global feasibility operations director at Amgen, writes. She says sponsors and researchers should “understand clinical disease management, identify unmet patient needs [and] obtain feedback on clinical trial design.”
Feedback can be sought through facilitated reviews, study simulations, patient panel, moderated discussions and building an online patient community.
Another source of patient feedback is patient-reported outcomes (PROs), which are reports from patients about their health conditions without interpretation from clinicians. Melissa Fassbender, editor at Outsourcing-Pharma.com, writes that the protocol was updated from the 2013 version by researchers at the University of Birmingham in the UK and at the University of Sydney, Australia.
Known as the SPIRIT-PRO checklist, it includes 16 PRO-specific items: trial rationale, objectives, eligibility criteria, assessment time points, PRO instrument selection and measurement properties, plans for data collection, translation, strategies to minimize missing data and determining whether PRO data will be monitored to make decisions on clinical care.
The aim of the protocol is to include more direct responses from patients to make clinical decisions that provide them with the best care.
A valuable resource for trial sponsors is patient organizations. Peter Kristensen, SVP and head of global development at Novo Nordisk, argues that trial sponsors need regulators and payers to listen to feedback from patients and patient organizations as this will help speed up the process of getting drugs to market.
Additionally, Kristensen says, a pharma company that partners with patients is more likely to become a “game-changer in clinical development, at both process and product level.”
By creating a shared goal or common purpose, trial sponsors and patients can gain more from the trial experience.
Rich Denness and Paul Welty, at management consultancy firm North Highland, argue that this approach will help to deliver a unique trial experience that facilitates better relationships and more loyal patients.
Having a shared purpose means trial sponsors regard “quality of life” as the driving feature of the trial and guides them to find better and more meaningful ways to engage patients. As Denness and Welty write, a common complaint for trial patients is the feeling they are not being listened to or that pharma companies are not committed to or invested in them.
Properly listening to patients and incorporating what they say helps to overcome patient attrition. But it also helps medications reach the market faster as trials are smoother and more streamlined when patient pain points are removed.
It’s not easy participating in a trial. Patients are there to seek treatment for what are often chronic medical issues and, despite regular updates from researchers, they can feel somewhat overwhelmed.
And what Marcia K. Horn, J.D, president and CEO of the International Cancer Advocacy Network, calls being “poked and prodded” can actually deter patients as can multiple visits to faraway trial sites. The entire process places a “heavy psychological burden” on patients and makes remaining in the trial seem a burden too great to bear. Add to that the cost, time and physical toll of traveling and patients are even less likely to stay committed to the trial.
It’s important to ascertain what patients are able and willing to commit to when it comes to trial participation. Listening to their feedback and incorporating that to manage a more patient-centric trial will improve data quality and patient retention.
While communicating with patients is aspirational and desirable, it is not easy.
This is why many pharma companies are fearful of saying the wrong thing to patients and “getting in trouble,” John Whyte, director of professional affairs and stakeholder engagement at the FDA, says.
Additionally, there is the risk of a limited understanding of patients’ health conditions and how those impact their lives on a daily basis. Patient suffering is more than a clinical trial endpoint, and it is vital that researchers do not assume they know the extent of a patient’s suffering.
Patient engagement, therefore, needs all of the healthcare community to participate, including patients, their caregivers and doctors, trial sponsors and researchers, and regulators and insurance companies.
Another way to improve patient feedback is to tap into social listening, which uses software to monitor digital conversations. This approach, according to patient recruitment agency Go Praxis, can improve clinical trials in several ways:
Patient attrition remains a significant problem for clinical trials. However, adopting a more patient-centric approach by listening to patients and by implementing their feedback, can help guide sponsors towards better trial designs. The important point to remember is that patients can and should become empowered and active participants in their health.
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