Guest Column | December 3, 2019

Shared Decision Making & Its Impact On Clinical Trial Consideration

By Marla Clayman (American Institutes for Research), Nisith Kumar (Pfizer), Mary Murray (Bristol-Myers Squibb), Wilson Mok (Merck), and TJ Sharpe (patient advisor)

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Patient participation forms the backbone of clinical research. Surveys reveal that up to 80 percent of patients say they are “somewhat or very willing” to join a clinical trial, yet enrollment levels remain low. For example, only 8 percent of cancer patients ever enroll in a clinical trial, despite substantial resources and efforts being invested in clinical trial advertising, transportation support, and other recruitment and retention activities. What are we missing? Might sponsors have greater success bringing trials to patients if we explore patient engagement practices used in clinical care, rather than those used in clinical research?

Healthcare practice is moving in the direction of participatory medicine, with an increasing focus on patient experience and satisfaction alongside clinical outcomes over time. One discipline from participatory medicine is shared decision-making (SDM), a collaborative healthcare communication between patients and their care providers. SDM engages patients in their care decisions using tools and techniques to provide balanced, evidence-based information on all options while simultaneously eliciting patients’ values, preferences, and goals relative to each option. Early research has indicated that SDM has the potential to improve patients’ consideration of clinical trials, but integrating clinical research options into the overall care conversation is complex. Clinical trials should consider aspects of the patient’s decision journey as well as healthcare professional (HCP) practices that offer several barriers and opportunities for SDM in the research setting.

The Patient’s Decision Journey

“Participation in a clinical trial is a very individual choice. . . You really have to examine why you are doing it.”- Linnea Olson, lung cancer survivor1

Patients often make decisions about whether to participate in clinical trials when the emotional and physical stakes are high. They are seeking answers to these clinical, financial, and convenience questions to arrive at a decision about research participation:2

  1. Do I qualify?
  2. Do I have access to a site?
  3. Do I have the time and financial means?

Patients seek to answer these questions as fully as possible relative to available standards of care, not only to determine which option is best suited for them at a given point in time, but also to remain engaged in their care planning as both disease status and available options evolve.3,4 These priorities are consistent with those reported in more general research about healthcare consumer decision-making.5

Further, a systematic review of 33 cancer clinical studies with 6,000 patients identified the following clinical trial decision factors among patients:

  1. concerns with the trial setting
  2. dislike of randomization
  3. general discomfort with the research process
  4. complexity and stringency of the protocol
  5. discomfort with presence of a placebo or no-treatment group
  6. potential side effects
  7. lack of awareness of trial opportunities
  8. preconceived notion that clinical trials are not appropriate for serious diseases
  9. fear that trial involvement would have a negative effect on the relationship with their physicians
  10. their physicians’ attitudes toward the trial.6

This list demonstrates that patients need better information, more effective methods of communication, and a framework to weigh the risks, benefits, and personal values when considering clinical trial participation.

HCP Practices

“There is a lot of debate about ‘is this patient healthy enough for my clinical trial?’ and I actually was kind of skeptical because I thought, ‘she’s coming from hospice, she’s got a lot of other illnesses,’ but her family, and the patient, wanted something better for her, and so I took a little bit of a risk and put her on a clinical trial…”- Dr. Brian Druker, Director of the OHSU Knight Cancer Institute7

HCPs face barriers to introducing clinical trial options to potentially eligible and interested patients. First, clinical trials are not available at all clinical sites.8 Second, HCPs may lack adequate time to gather, evaluate, and discuss clinical trial information for trials that may be appropriate for individual patients.9 Third, HCPs may be selective about which patients to introduce to the idea of clinical trial participation.10 Fourth, some HCPs perceive discussion of clinical trials as intrusive to the patient-provider relationship.11 Current practice in real-world decision-making for patients often falls short, as patients may not be presented with all relevant options in a way that accounts for patient values and preferences.12

Current State Of SDM Tools And Techniques To Support Clinical Trial Conversations

An international survey conducted by CISCRP in 2017 found that over half of the 12,000 participants indicated they would begin their search for a clinical trial by asking their doctors.13 This reinforces the notion that doctors are patients’ trusted resources and that successful communication between the two parties is essential to address the unique needs during each individual patient’s decision-making process. Reviewing the literature for potential ways to pair SDM with the patient journey in the clinical trial setting reveals how little has been done, the unique set of information and support needs described by patients, and gaps that could become opportunities to improve existing approaches.

There are two main components to shared decision-making for patients and HCPs:

  1. Having an array of options to consider for which the patient may be eligible along the care pathway
  2. An evaluation framework that helps patients consider the options according to their evolving set of values, preferences, and goals throughout the continuum of care.14,15

Physician workflow products exist to develop the options array, such as Roche’s NAVIFY Tumor Board, which integrates active clinical trials among the array of options physicians present to patients, and Cota’s Cota Nodal Address (CNA) system, which stratifies patients for treatment recommendations based on “prognostic attributes.”16,17

However, there are gaps in connecting these systems with tools to elicit and clarify patient values as they evolve with disease and treatment experiences.

  1. There is no decision aid or related SDM training that allows physicians to present patients with the full array of clinical treatment contemporaneously with relevant trial participation options.
  2. There is no decision support tool that enables patients to articulate and document their preferences about available trial options in their medical record and to determine the information they need to make informed decisions related to their clinical, financial, and other circumstances.
  3. There is no prior research pairing either a decision aid or a values clarification tool in a healthcare setting where clinical trials are among the options.
  4. Research sponsors are not consistently tracking patient and HCP satisfaction with their clinical trial participation decisions using validated outcome measures.

Call To Action

By focusing on the patient-provider conversation and decision support, sponsors may be able to include patient-centered outcome metrics related to patient experience alongside operational metrics such as enrollment. For example, “recruitment” materials may become “decision support materials,” containing not only the clinical but also the financial and convenience-based information patients are seeking. Sponsors, including industry, academic researchers, large healthcare organizations, or any researchers, can measure the impact of these materials not just on enrollment, but on the patients’ perception of the clinical trial consideration process with their HCPs, referral experience to the investigative site (if a clinical trial is selected), and subsequent decision satisfaction.

Potential outcome measures include validated instruments for decisional conflict prior to the patient’s decision and for decision regret at a post-decision time point.18,19 Systematically measuring these outcomes across populations and studies may help research sponsors and sites make operational decisions and develop communications that are better aligned with individual patient preferences.

Another opportunity is for sponsors to co-create with patients, HCPs, SDM experts, and others clinical trial patient decision aids that are compatible with electronic health records and clinical workflow systems. Integrating clinical trial options into decision aids may be difficult because they vary from institution to institution and change frequently via protocol amendments and site availability. One priority could be a tool that allows HCPs and/or patients themselves to regularly document their preferences and assessments of their options via free text and narrative functions within the patient’s electronic health record. This type of functionality would complement the institution’s clinical decision support system, ensuring that patients and HCPs are able to consider all options, including clinical trial participation, as they become available during the patient’s care and evaluate them for how well they meet the patient’s clinical circumstances and personal preferences. This effort would require multistakeholder collaboration, including patients, HCPs, trial sponsors, SDM experts, technology providers, and the healthcare industry.

Finally, sponsors can create incentives for sites and investigators to include SDM interventions among their patient counseling, referral, and care coordination services.4 Research sites could work with sponsors to identify and use validated decision-related outcome measures to study the impact of SDM interventions on overall patient experience and, specifically, the satisfaction of people offered clinical trial participation among their options. Research site staff can use SDM training to help patients explore and compare the potential benefits and risks associated with each available option, including clinical trial participation.

Where To Get More Information

SDM training, tools, and approaches are becoming more available in the United States and globally. The National Patient Advocate Foundation has a Shared Decision-making Roadmap and Toolkit that can be adapted to support clinical trial conversations. The Society for Participatory Medicine has resources related to SDM and measuring outcomes. The Center for Shared Decision-Making at Dartmouth-Hitchcock has SDM training, toolkits, and consultants. The Patient Centered Outcomes Research Institute offers SDM research and outcome measures.

Conclusions

Clinical trials have been and will continue to be fundamental in fostering the development of novel treatments in medicine and for understanding disease mechanisms. SDM is one of many levers that can be utilized to increase conversations about clinical trials, and the discipline is in line with the current movement toward a patient-centric drug development process. While patient experience data is not yet explicitly required by regulatory agencies, initiatives such as the FDA’s Patient Focused Drug Development (PFDD) encourage collection and use of this data in drug development operations. Practicing SDM in the research environment can provide information that is most important to patients about clinical trial risks and burden in a way that supports their decision-making20 and satisfaction and perhaps even facilitates enrollment.

Disclaimer: This work was commissioned by TransCelerate BioPharma.

References:

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Acknowledgements:

The authors gratefully acknowledge the support of TransCelerate BioPharma Inc, a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies, and the following members of the TransCelerate Clinical Research Awareness initiative team: Sima Balsara, Roche Products Ltd., Welwyn Garden City, U.K.; Catharine Clay, K8 Healthcare Consulting, Portland, Maine,; Elke Meyssen, Sanofi, Brussels, Belgium; Diana E. Pankevich, Ph.D., Pfizer Inc., New York, NY; and Sylvie Roulier, Sanofi, Chilly-Mazarin, France.