Rules of the Trade

Patient Centricity in Clinical Trials

terena-bell

Christophe Djaouani

Christophe Djaouani joined SDL in 2018 with the acquisition of Donnelley Language Solutions.
He successfully led the integration of the regulated industries team providing solutions to the financial, legal, life sciences, and investor relations markets.

Think about this: every time you reach into your medicine cabinet for some type of aid like headache relief or pain management, a clinical trial will have brought your medication to market.

Clinical trials have traditionally provided a controlled testing environment to ensure the safety and efficacy of any drug. Patients play an ever more important role in clinical trial design and execution. The ability to recruit, retain, and communicate effectively with clinical trial participants may make the difference in a drug’s approval.

And then came COVID-19, throwing a huge curveball into the drug development process, and leaving contract research organizations (CROs) scrambling to keep clinical trials up and running. Many clinical trials were paused or delayed given the safety challenges to enroll and dose participants. Investigative sites were disrupted, driven by staff furloughs, social-distancing protocols, and concerns over patient safety. According to the US National Institutes of Health, an estimated 80% of non-COVID trials were impacted by the pandemic, forcing clinical studies to develop flexible, innovative and patient centric approaches. With patient centricity on the rise, CROs are focused on patient engagement, communication, and the execution of clinical trials to remove physical, geographic, and communication barriers to adequately address the needs of patients. In a post-pandemic era, patient centricity has to become best practice as opposed to something that’s nice to have.

What is patient centricity?

Patient centricity is a holistic approach to treating patients as collaborators in the clinical research process. This trend pivots clinical trials from purely scientific to trials tailored to engage, retain patients and caregivers, with increased transparency. It can take many forms, from the actual trial design to setting realistic expectations on how patients might benefit from the therapy, to the overall patient experience in an effort to drive more effective patient-centric care.

Patients are consumers even when enrolled in a clinical trial and expect CROs and partner sites to deliver the best possible experience. Understanding what patients want and expect is the first step towards patient centricity. A high level of understanding and patient engagement can only be achieved by creating avenues for continuous communication and feedback which will ultimately benefit not only trial patients but the healthcare system as well. High quality therapy whether delivered in-person or remotely, must reduce patient burden and meet patients’ needs and expectations. And it’s not one size fits all. When you’re delivering care that is convenient for participants — whether it’s in-home visits, video chat via digital portals or in-person appointments — top priority is placed on patient comfort and needs.

“Content must engage, inform, and clearly communicate important information to patients throughout the entire clinical trial lifecycle.”

The emergence of virtual trials

Virtual or decentralized clinical trials are more of a necessity than ever. Traditional brick and mortar visits and monitoring can now be accomplished with advances in telehealth and telemedicine. A wide variety of patient-facing digital technologies have been developed to support virtual clinical studies. The ubiquity of mobile technologies like tablets, smartphones, and wearables, along with cloud technology, has eased the way for legitimate electronic data capture that can generate reliable clinical data. Data can be collected at home or wherever it’s convenient for the patient.

These patient-facing technologies add additional challenges where local or native language is required. This goes beyond the translation and localization of clinical trial documents normally used in a traditional randomized clinical trial. Now, consideration must be given to the various patient-facing interactions. This includes target language user interfaces, real-time virtual interpretation, translating documents for regulatory authorities, electronic informed consent forms, and other patient-related materials.

Language plays an even more important role when it comes to virtual clinical trials. Patients must adapt from face-to-face interactions to digital ones. The precise meaning of what’s being communicated is critically important to ensure that the captured data is accurate.

Including voice of the patient

Making sure therapies reach target patients starts with patient engagement during trial design. Proactive, bilateral patient communications are crucial for study retention and efficacy results. Content must engage, inform, and clearly communicate important information to patients throughout the entire clinical trial lifecycle.

Traditionally, quantitative measures have served to evaluate the safety and efficacy of clinical trials, but these approaches don’t directly address the voice of the patient. New method-ologies are being adopted that capture the patient experience through qualitative measures providing valuable patient feed-back on their experiences throughout the clinical trial process. Recently, the FDA produced guidance documents to address how patient experience data can be collected in a systematic approach. The output is a series of guidelines which address collecting patient input, methods to identify what is important to patients and developing fit-for-purpose clinical outcome assessments. By incorporating the voice of the patient in study design, it’s possible to minimize obstacles, improve efficiency, and trial outcomes.

Best practices for effective patient communication

Research shows that patients who are engaged and receive personalized care are more likely to stay in a clinical trial. Retaining patients means providing access to resources in a way that is convenient for each individual. Preferences may range from video check-ins to in-home visits to telephone calls. Physical limitations and technology accessibility must be considered to ensure therapy and patient monitoring can be adequately delivered during the trial.

For multilingual participants, cultural adaptation and linguistic accuracy must be incorporated across interactions and study materials. Working with native speakers who possess broad experience in clinical trial documentation in multiple therapeutics is critical for ensuring patient recruitment and retention — and ultimately clinical trial success.

Vision of a patient-centric future

This year has seen the emergence of patient-focused drug development (PFDD), an FDA Center for Drug Evaluation (DCER) approach for patient centricity. Top pharma organization are also implementing patient centric strategies for drug development, and hiring patient-focused leads.

These emerging initiatives support a unified vision where the patients’ experience, perspectives, needs, and priorities are put at the forefront, with detailed patient experience mapping and a comprehensive patient-focused story across all stakeholders. These guiding principles will only gain momentum in the coming year and drive new approaches in the future.