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Takeaways from Inaugural Patients as Partners Europe Meeting


  • February 15, 2017

  • The Conference Forum held the inaugural Patients as Partners Europe (Patients EU) conference in London on February 6-7, 2017, in response to requests from European attendees at the previous Patients as Partners US events to bring the conference abroad.

    Patients as Partners is Patients Included-accredited and the research is driven equally by patients and advocacy alongside industry, government and academia. The Patients as Partners conference, both in the EU and the US, is devoted to understanding and incorporating the patient’s voice in designing clinical trials and developing a clinical endpoint, as well as vastly improving the patient’s entire experience in a clinical trial.

    Through the on-site activities, including the Patient Engagement Toolbox, each attendee walked away with a “toolbox” full of strategies to continue to support their patient involvement initiatives. Listed below are many takeaways discussed during Patients EU. We look forward to seeing everyone again for the 2nd annual event in 2018!

    Day One takeaways:

    • The interests of patients are best served when industry and patient groups work in partnership
    • Key to the success of such partnerships are trust and transparency
    • Several examples exist that exemplify best practice that should give confidence to those about to embark on such a partnership
    • Engaging with Patients;
      • Helps bridge the gap between clinical trial data and real world data which ultimately leads to more meaningful outcomes for all concerned
      • Increases transparency and trust in the system
    • Engagement should be mutually beneficial; use a flexible step-by-step approach, to learn together what format works best
    • Provide support – define roles – manage expectations – give feedback
    • Everyone benefits from knowledge sharing
    • Opportunities to engage patients exist across all aspects of drug development and the patient journey
    • To improve drug and device development the patient voice should be routinely solicited
    • Patient involvement in medicines development and assessment is essential to ensure that the added value of a new medicine to patients is clearly understood
    • Patients have unique experiential knowledge about living with the condition that can inform clinical trial design to ensure the outcomes that matter most to patients are studied
    • Patient organizations can invest in research and contribute to comparative effectiveness programs to fill evidence gaps or uncertainties in value assessments.
    • It is critical to assess outcomes defined by patients living with the disease and its treatment
    • Considering “Patient-Centered Outcomes” requires us to have a comprehensive understanding of patients’ needs and priorities. This information can be coupled with the needs of others to develop an outcomes measurement plan that evaluates outcomes that matter
    • Outcomes may include concepts that are best measured using patient-reported outcome measures (PROMs), but not all patient-centered outcomes are best-measured in this way.
    • Engaging in and implementing a novel patient-centric service requires commitment, dedicated time, cooperation, collaboration and investment by sponsor and partner vendors
    • Results can be fruitful-ambulant care at-home visits can reduce the burden on study participants by making it more convenient and comfortable for them and their families- ultimately resulting in faster enrollment, better compliance and higher retention and higher satisfaction for all parties
    • Feedback to patients is essential to encouraging data sharing
    • Transparency about how data are shared and giving patients control will reveal new possibilities

    Day Two takeaways:

    • Patient organizations can help you find patients to work with and offer guidance and support to develop meaningful involvement.
    • Patient engagement should be as early as possible, preferably before a clinical trial protocol has been finalized.
    • Patient groups tend to have the best databases of patient details, which is essential for rare disease trials.
    • Build trust & manage expectations (a new drug with maximum efficacy and no side effects is rarely a realistic goal)
    • Set aside enough funds for patient travel and subsistence and remember some of us need careers too. Allow time to explain things. Slowly and clearly. And probably twice.
    • Keep patients engaged. Tell us what’s happening with the study (and why), tell us the outcomes, and tell us what difference we made (if any).
    • Identify the joint goals (=mutual values) through open & transparent discussion. This will create a win/win situation.
    • Need to listen to and communicate with the patient(s)
    • Culture change – we need to continue to evolve and work beyond constraints of “the process”
    • Strive to “remove barriers” for effective patient engagement
    • Patients get ruled out by one of many hurdles to cross, not lack of interest
    • Empower the patient
    • The culture of the treating institution is central to how likely patients are to volunteer
    • Many patients would welcome general information at diagnosis about clinical trials so that treatment planning includes consideration of developing options
    • The most crucial element of the Informed Consent Process is interaction between investigator and patient
    • The investigators need to be made aware of the relevance of an optimized IC process
    • A complete overhaul of the IC preparation process is needed
    • The proposed “10 IC Steps to Success” Plan should be implemented as new standard in clinical trials
    • Informed Consent is a window of opportunity for researchers
    • Write with target audience in mind
    • Involve patient organizations from start
    • Informed Consent process needs input from multiple stakeholders
    • Sponsors have a role to play and should utilize the available guidance, best practice and shared knowledge to support the process that ultimately benefit the patient
    • EFPIA support reinforcement of the elements for “10 IC Steps to Success”, in particular:
      • Putting efforts in simplification
      • Utilizing modern technology
      • Taking patients on board