Posted: 20 Feb. 2020 14 min. read

Want to improve clinical-trial retention and compliance? Make convenience a priority

by Dawn Anderson, managing director, Deloitte Consulting LLP                                                                                                

Back in the 1980s, the only way for me to deposit a check or withdraw money was to visit my local bank, stand in line, fill out a slip, and interact with a teller. Even something as simple as checking my balance required a trip to the bank. Most of us now use phones or ATMs to conduct financial transactions. Bringing this level of digital convenience to clinical trials could help encourage patients to follow treatment protocols and remain in the trial until it concludes.

My February 6 blog outlined strategies some pharmaceutical companies have used to improve patient recruitment. But recruitment is just the first part of the clinical-trial lifecycle. Completing the circle also requires that patients comply with all of the activities in the protocol and stay in the trial until it concludes. If patients don’t follow rules of the protocol, the data generated during a trial could be incomplete or invalid. About 85 percent of clinical trials wind up being discontinued because they fail to retain enough patients.1

An engaged patient is less likely to drop out of a trial and more likely to comply with the protocols. A new report from the Deloitte Center for Health Solutions looks at how life sciences companies are beginning to respond to the demands of increasingly empowered consumers. Meeting consumer demands could improve engagement.

 

Five strategies for helping improve retention and compliance

Retention and compliance are closely linked in clinical trials. About 40 percent of patients stop adhering to protocols 150 days into a trial.2 But few pharmaceutical companies have made more than incremental improvements in their ability to retain patients and ensure compliance. Here are five strategies pharmaceutical companies should consider for improving retention and compliance in clinical trials: 

Explain expectations early: Patients who understand the expectations of a clinical trial are more likely to comply with the protocols. They also want to know what to expect during each of those visits.3 Patients who complete a clinical trial might be willing to consider other trials in the future. I see this as a bridge that runs from the clinical trial to the commercial market, and then back to the clinical sector if the patient participates in another trial.

Improve transparency to build trust: According to the latest Deloitte survey of US health care consumers, only 39 percent of respondents said they would be willing to share blinded data with organizations that conduct health care research. Being transparent about how data will be used could help create a level of trust between researchers and patients. Research indicates that clinical-trial participants want to be treated as valued partners. They want to know about the steps involved in a trial and they want to provide input. Trial sponsors should consider focus groups and trial simulations as they design more patient-friendly protocols. One biopharma company is working to make its clinical trial website patient-friendly and is creating an alumni network so that participants can stay in touch after a trial ends or help inform future trial participants.

Provide real-time feedback: Communication between patients and clinicians could help improve patient engagement. Medication compliance among stroke victims increased by 50 percent when artificial intelligence was used to analyze cell-phone photos to determine whether patients were following protocols. Patients who were taking a medication incorrectly received an alert.4

Tap into behavioral science: We know that one in five prescriptions are never filled, and about half of prescription drugs are taken incorrectly.5 The same lack of medication adherence can happen in clinical trials. The use of gamification, nudges, and regular feedback could help encourage better compliance. Deloitte’s STEP-UP study demonstrated that competition improved compliance and had a lasting impact on trial participants. A video game called ReMission helps keep children engaged by teaching them about the drugs that are used to fight cancer.6

Consider remote data collection:  I recently facilitated a working session where we discussed how wearables and connected medical devices can improve patient retention and compliance during a clinical trial. Collecting digital data through connected medical devices can capture data more frequently than collecting a single result during the clinic visit. This longitudinal data can give investigators a more complete look at patient data in a real world setting. In addition, telemedicine could help investigators connect with patients more regularly to review test results, which could improve care. Completing tests remotely and transmitting data from home (via connected medical devices) while talking to a doctor via telemedicine could mean patients don’t have to travel to a medical facility as frequently, which could improve their willingness to stay in a trial to completion.

Connected medical devices and virtual clinical trials might help improve patient engagement, but moving data through the internet can raise data privacy and security issues. During a webinar last month, my colleague Mike Cunning outlined some of the cyber threats that should be considered. The first step is to determine who might pose a cyber threat, what they might be after, and which tactics they might use to gain entry. Cyber-attacks often rely on the simplest, least intrusive tactics to gain access to data. An app or connected at-home device with insecure platforms or vulnerabilities, for example, could be the weak link, he explained.

While cyber is a risk to any digital transformation, it should be one of many issues to consider when developing virtual clinical trials. Generally, cyber risks are elevated when participant personal health information is collected, transmitted, or aggregated. Virtual clinical trial leaders can better understand cyber risks when they apply a cyber risk lens across the ecosystem of their virtual clinical trials to identify potential risks. Addressing cyber risks can help a digital clinical-trial sponsor increase the reliability of the research and help achieve the promise of recruitment, compliance, and retention of a trial protocol.

Consumers have become accustomed to a world where everything from banking to shopping can be done through an app or a website. I can’t remember the last time I stood in line at a bank. Financial transactions that take place via the internet are generally seen as convenient and secure. But nearly 40 years after online banking emerged, clinical trials still rely heavily on face-to-face visits, paper printouts, and fax machines. Making clinical trials more digital could make them more convenient for clinical trial participants, which could improve recruitment, retention, and compliance. As a result, pharmaceutical companies could have more opportunity to bring drugs to market sooner to improve patient health.

Endnotes

1. Considerations for Improving Patient Recruitment Into Clinical Trials, Clinical Leader, March 23, 2012

2. Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost, Applied Clinical Trials, April 24, 2017

3. What do clinical trial participants want?, TransCelerate BioPharma Inc., 2017

4. Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy, National Center for Biotechnology, May 2017

5. Improving Medication Adherence for Chronic Disease Management—Innovations and Opportunities, US Centers for Disease Control and Prevention, November 17, 2017

6. https://www.re-mission2.org/

At the SCOPE Summit 2020 in February, ConvergeHEALTH by Deloitte launched its patient-centered digital health platform to support global clinical trials. Learn more about MyPath for Clinical.

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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.