Posted: 18 Aug. 2020 12 min. read

Changing patient expectations could lead to more patient-centric clinical trials

By Dawn Anderson, managing director, and Ryan Myers, principal, Deloitte Consulting LLP

The COVID-19 pandemic is highlighting the importance of patient centricity in clinical trials. Patient centricity is the idea of including the patient perspective to ensure a better experience and, potentially, better outcomes. Trial sponsors that understand the patient, their condition, and the burden of participation could improve recruitment, retention, and the value of data generated by clinical trials.

COVID-19 introduced new barriers to recruiting and retaining patients for clinical trials. Even before the pandemic, time and burden related to traveling to a medical facility were the main reasons patients dropped out of trials. Today, a patient who has a compromised immune system, for example, might be even less willing to travel to a medical facility and risk being exposed to the virus.

Through conversations with our clients, we estimate that between 25% and 40% of all clinical trials were put on hold due to COVID-19. In the early days of the pandemic, some trial sponsors added a telehealth component to keep the trials moving. Some also turned to health aides—who travel to the patient’s home (wearing personal protective equipment)—to take clinical readings or take blood or urine samples.

Will patients be willing to return to the pre-pandemic approach to clinical trials once the threat of the virus is over? We think it’s unlikely. Since the pandemic began, much of the population has grown even more comfortable with shopping, conducting business, socializing, and getting health care virtually. We don’t expect clinical trials will ever be fully decentralized or completely virtual, but some aspects are likely to become more patient centric and virtual, as Dawn has noted in previous blogs.

Six strategies to make clinical trials more patient-centric

The Deloitte Center for Health Solutions interviewed 27 executives from life sciences companies (primarily biopharmaceutical companies, and several medtech companies) and patient advocacy/disease research organizations. We learned about what patient centricity means throughout the phases of therapeutic development—from research and development (R&D) to the commercialization of a new therapy.

A life sciences company that understands the patient journey might be better positioned to design therapies that can improve and enhance a patient’s quality of life. Results generated by clinical trials will likely be more valuable if the trial sponsor understands what is important to the patient, and how to reduce barriers to trial participation.

Here are six strategies to consider:

1.   Identify elements that can be conducted in the patient’s home: People who have recently participated in a video conference with a physician, or met with a home health aide, might wonder why they need to travel to a medical facility as their trial continues. Clinical trials often include certain data-collection activities that could be done at home. Consent forms and surveys are low-hanging fruit and generally don’t need to be done in a clinical setting. But there might also be opportunities for remote monitoring where connected medical devices provide robust data insights into the daily lives of trial participants.

2.   Help patients feel safe if they need to go to a medical facility: Since the COVID-19 outbreak, many health care facilities have turned to strategies such as contact-free check-ins and texting patients who are waiting in their cars instead of sitting in a waiting room. Clinical-trial sponsors should understand that many patients are beginning to expect these types of accommodations.

3.   Consider quality-of-life metrics: While a clinical trial might determine that a drug is safe and effective, the drug might not improve the patient’s quality of life. Quality of life might be more important to the patient than the medical outcome. During our research, many pharma company leaders told us about examples where R&D teams neglected to focus on areas that were important to patients. A therapy that allows a patient to live longer without the disease progressing might not viewed as successful if side effects—such as debilitating neuropathy—affect their quality of life.

4.   Improve ethnic and socio-economic diversity: A focus on patient centricity could make data more valuable if clinical trials include typically under-represented populations. Someone who earns an hourly wage, for example, might not be willing to take a day off of work to participate in a trial. Removing the burden of having to travel to a medical facility could make participation easier. We know that a lack of diversity in clinical trials can lead to problems once a drug becomes commercial and is used in a larger more diverse population. 

5.   Consider the patient’s condition and needs: A clinical trial that requires patients to traverse a medical center for various tests might be difficult for someone who has trouble walking. Pediatric appointments that require parents to pull a child out of school or leave work could reduce participation. A patient-centric trial will evaluate each participant’s needs and find ways to reduce barriers. Minimizing the burden on patients could improve retention.

6.   Offer innovative incentives for participating: Recruiting patients to participate in a clinical trial has always been challenging, but it has been particularly difficult since the pandemic. Patients can’t be paid for their participation because it could create bias. But incentives don’t need to be financial to be effective. An incentive is anything that the patient values. Personalized educational material about the condition, for example, might help the patient understand the disease and treatment. 

Patient expectations have changed, and clinical-trial sponsors need to accommodate those expectations to stay relevant. Once a patient agrees to participate, it’s important that they continue for the duration of the trial. If they drop out early, they have to be replaced with new patients…and the cycle continues.

There will be challenges getting trials back on track, but virtual health and increased patient centricity could help us get there. We experienced two or three years of digital transformation in just two or three months. Virtual health might be new territory for many clinicians who are accustomed to putting their hands on a patient to assess them. But patient preferences could push clinicians, and clinical-trial sponsors, to rethink their processes.

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Dawn Anderson

Dawn Anderson

Managing Director | R&D Life Sciences Consulting

Dawn is a managing director in Deloitte Consulting LLP’s life sciences consulting practice. She has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with biopharma and CRO clients to design and deploy global operating strategy, performance improvement, and technology implementations across drug development. Over the past 10 years, Dawn has led strategy and operations solutions including a focus on clinical transformation, and clinical innovation, operating model optimization, organizational redesign, process re-engineering, insourcing/outsourcing strategy, vendor performance management, digital, advanced analytics, cognitive automation and artificial intelligence, and the design and implementation of enterprise clinical system solutions. Dawn is a frequent speaker on CROs, clinical transformation and the future of clinical trials including topics around adaptive design, protocol complexity, risk assessments and technology: virtual trials, digital, mHealth, clinical analytics platforms, and cognitive automation.