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Shared Decision Making Summit 2018

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Topics at the Summit

The Summit is more discussion and brainstorming than prepared presentations.  The theme is high-level: how can healthcare stakeholders work collectively to enable and support Shared Decision Making broadly.  Hence, the pre-identified topics below have been articulated more as an aid to identify who should attend, than as rigid discussion guardrails.  Accordingly, while these topics will be "teed up" by experienced SDM professionals, attendees have the liberty to take the discussion where it would be most fruitful.

Topic 1:  

Shared Decision Making and Clinical Trial Enrollment

The decision to enroll or not in a clinical trial can be overwhelming, complex, and unclear for patients. Decision theory strongly suggests that if people are unclear, they don't enroll. Accordingly, some patients likely miss out on treatments that might be the best option for them. Furthermore, this leads to slower enrollment, poor adherence to therapy, and slows the development of new drugs. If we can achieve greater clarity, patients, sites, and the pharmaceutical industry might all "win”.

Questions to be discussed include:
    • What are the best ways to help trial sites adopt Shared Decision-Making, focusing on patients’ decision-making, in addition to trial protocol?
    • While some answers to the above question will be trial-specific, others can be much broader, for example training health care professionals at sites to become decision facilitators. How might various stakeholders enable this more broadly?
    • To what extent is the current research onboarding and consenting process the right one for patients? What can be done better ensure that patients’ needs are being met?
    • What can be learned from PCORI methods for involving patients in the research process? To what extent is co-creation possible, how could it become a systematic, new way of conducting trials?
Recommended Attendees:
    • Executive Directors / VPs of clinical trial operations from pharmaceutical companies
    • FDA representatives focused on these issues
    • NIH representatives and academic researchers doing cutting edge work specifically in this area
Topic 2:

From Averages to Individuals: Patient-Centered Data and Prescribing, Paying, and Adherence Decisions

Even when a clinical trial is not on the potential treatment list, making a medical treatment decision is still often an overwhelming and complex process for patients. There are often many treatment options, including medications that might be good alternatives. Patients want information about how medications work on their specific body. Will this drug work for my body given my personal situation, genetics, and other conditions? What is the likelihood that my body will experience adverse events? Which will I experience, and how bad will they be? Traditionally pharmaceutical companies conduct research studies that provide data about how medications perform on average. While an appropriate frame for a regulatory agency’s decision to approve a drug or not, this leaves ambiguity for providers, payers, and patients.

Questions to be discussed include:
    • With the medication adherence rate for chronic disease therapies averaging 50%, patients are a critical consumer of the information about products. What would it take to conduct research specifically to meet patients’ needs for information not built on averages?  How could traditional study types and methodologies be re-imagined to to meet patient needs for individualized information?
    • What else would be needed to systematize this type of research to a similar extent as the traditional research for established audiences such as regulatory agencies, payers and providers?
    • How might the results of this research be communicated? In what ways might this be integrated with the label, patient materials and risk communication? How would the structure of the studies change if a new way of communicating the information was pre-envisioned? What is best practice around risk communication and labelling for shared decision making?
Recommended Attendees:
    • Executive Directors / VPs of clinical Trial Operations, Epidemiology and Outcomes Research from pharma companies
    • FDA, NIH, and PCORI representatives
    • Academics doing cutting edge work specifically in this area
Topic 3:

Creating a Cultural Shift: Patients as Empowered Decision Makers

Shared decision-making is intended to be a two-way conversation; however, research shows that many patients do not actively cultivate ongoing discussions with their health care providers about their adherence to medications, medical treatment options, questions, and concerns. In what ways could stakeholders better support the efforts of independent organizations that are working to empower patients as consumers and equip them to participate fully in shared decision-making?

Questions to be discussed include:
    • What roles can different stakeholders (nurses, physicians, pharmacists, pharma companies, etc) play in order to spur and support this cultural shift?
    • What kind of support do the independent organizations need to scale up their efforts?
    • What environmental and regulatory changes might need to be updated to allow for greater support for these organizations?
Topic 4:

Encouraging and Equipping Providers to Become Decision Facilitators

A patient's health care providers (including the prescriber, but also the extended care team – nurses, pharmacists etc) play a significant role in the shared decision making process, from communicating available options/risks/benefits to eliciting a patients values and preferences. Several of those skills are new to many providers and something they must learn.  In what ways could stakeholders (pharmaceutical industry, payers, etc) better support the efforts of independent organizations that are working to train current and future healthcare providers and equip them to participate fully in shared decision-making within the constraints of their workflow?

Questions to be discussed include:
    • What roles can different stakeholders (nurses, physicians, pharmacists, pharma companies, etc) play in order to spur and support this cultural shift?
    • What kind of support do the independent organizations need to scale up their efforts?
    • What environmental and regulatory changes might need to be updated to allow for greater support for these organizations?

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