Meeting Patients Where They Are: Why Patient-Centric Trials Mean Assessing Your Protocol in New Ways

Author: Faith Holmes, M.D.

Many clinical trials struggle with patient enrollment and retention. To simplify enrollment challenges and reduce incidences of dropout, investigators, sponsors, and contract research organizations (CROs) have shifted their trial design and execution toward patient centricity, seeking to keep the patient’s needs, concerns, and perspectives front of mind throughout the entire clinical trial process.

The wider industry’s adoption and implementation of a patient-centric approach to clinical research — central to Elligo’s mission of providing that research as a care option to all patient populations — is a work in progress. But the community practice physicians who function as the Elligo network’s principal investigators during clinical studies know nothing but a patient-centric approach, as they care for patients on a daily basis. That existing physician-patient relationship allows the physician unique insight into patient-centric approach to study design.

If sponsors and CROs truly seek to build patient-centric protocols to improve clinical trial enrollment, retention, and the overall success of clinical research going forward, we must acknowledge the steps they must take. Creating effective solutions actualizing patient-centric clinical studies depends on:

  1. Connecting with patients. Communicating the importance of clinical research participation to patients cannot be a one-size-fits-all message. Each patient’s age, race, ethnicity, education level, and even where they live must all be considered. It is important to recognize that despite general advances in technology and connectivity, there are still individuals for whom electronic platforms are not accessible. These potential participants often overlap with demographics sought to increase diversity in clinical trials.
  2. Communicating results. Patients want to know the outcomes of the research they contributed to — to be treated like valued members of the research team, instead of being made to feel like test subjects. Making a commitment to keep the patient informed of progress, even after their trial participation is over, is a simple, inexpensive, important step for ongoing engagement.
  3. Increasing patient access to study drugs. What is the patient’s access to the study drug during and after the trial? For drugs which have early positive indicators for safety and efficacy, creating the opportunity for an open label, long-term extension of studies to enable access to the study drug for the placebo arm can be important for recruitment and retention. Another element of patient centricity involves when a drug reaches post-marketing. Facilitating access to a drug for which patients have contributed data leading to approval — but that they may be unable to afford once that drug is commercialized — could have an impact on recruitment and retention.
  4. Weighing placebo-controlled versus active comparator trials. What risks are you asking patients to take? For those disease processes for which there are safe and effective treatments available, and particularly for conditions in which an exacerbation can lead to not only acute but long-term consequences impacting ongoing quality of life, consider use of an active-control versus placebo-control study design.
  5. Understanding the patient journey. Participation in a clinical trial may place added burden not only on the patient, but on their caregivers as well. This needs to be recognized and considered when trials are designed. Proactive efforts in this arena may considerably enhance recruitment and retention.
  6. Realizing the challenges of the patient. Take the time to understand the patient you’re trying to recruit. What is their day-to-day like? What’s important to them? Invest the time to find out so patients feel valued as more than just research subjects. This outreach is critical to patient centricity.

With thoughtful and careful planning, we have a wonderful opportunity to not only conduct the research that answers the questions we need to answer, but to help all patients thrive. True patient centricity starts with us as researchers, sponsors, and CROs: design patient-friendly trials that address patients’ needs, welfare, and well-being throughout the entire clinical trial process.

For more information on how Elligo is bringing patient centricity to clinical research, read our white paper, Facilitating Patient-Led Research: How Increased Data Access Can Increase Patient Enrollment and Engagement.