Board of Governors Meeting via Teleconference/Webinar July 19, 2016 12:00-2:00 p.m. ET
Welcome and Introductions Grayson Norquist, MD, MSPH Chairperson, Board of Governors Joe Selby, MD, MPH Executive Director
Agenda Time Agenda Item 12:00 Call to Order, Roll Call, and Welcome 12:00 – Consider for Approval: Minutes of the June 21, 2016 Board 12:05 Meeting 12:05 – Consider for Approval: Proposed Slates for 4 Targeted PFA 1:05 Awards 1:05 – Consider for Approval: Proposed Slate for Cycle 3 2015 1:15 Pragmatic PFA Award 1:15 – Consider for Approval: Proposed Slate for Cycle 3 2015 1:40 Broad PFA Awards 1:40 Wrap up and Adjournment
Board Vote • Approve the minutes of the June 21, 2016 Board Call for a Motion to: meeting • Second the Motion Call for the Motion • If further discussion, may propose an Amendment to the Motion or an Alternative to Be Seconded: Motion • Vote to Approve the Final Motion Voice Vote: • Ask for votes in favor, opposed, and abstentions
Award Slates from Targeted PFAs Christine Goertz, DC, PhD Chair, Selection Committee Evelyn P. Whitlock, MD, MPH Chief Science Officer
Cycle 3 2015 Targeted PFAs • Treatment-Resistant Depression • Clinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain • New Oral Anticoagulants (NOACs) in the Extended Treatment of Venous Thromboembolic Disease • Treatment of Multiple Sclerosis
Pathway to a Funding Announcement LIST 1 Staff use Tier 1 and Tier 2 review criteria to determine topic eligibility, producing List 1 Science Oversight Committee (SOC) reviews and LIST 2 endorses topics for topic briefs, producing List 2 SOC reviews topic briefs and approves them for LIST 3 Advisory Panel review, producing List 3 Advisory Panel (AP) reviews topic briefs using Tier 3 LIST 4 review criteria, producing List 4 LIST SOC reviews AP results and staff recommendations; 5 endorses topics for further refinement, producing List 5 Staff and SOC use Tier 4 review criteria to assess LIST LIST questions; SOC assigns questions to targeted or 6 7 Pragmatic Clinical Studies PFA, producing Lists 6 and 7 Board reviews and approves SOC reviews and approves questions for Approved Approved questions for targeted PFA Pragmatic Clinical Studies PFA
Treatment-Resistant Depression
Objective of the PFA • To address important knowledge gaps regarding the management of treatment-resistant depression • Priority Research Question: • For patients with treatment-resistant depression who have failed two adequate trials of antidepressant medications, what is the comparative effectiveness of augmentation strategies versus switching to other treatments? • Funds Available: up to $30M
Slate Overview Process Overview • 10 Letters of Intent (LOIs) submitted • 7 LOIs invited to submit a full application (70%) • 7 applications were received (100% of invited LOIs) • We are proposing to fund 3 applications* out of 7 received applications (43%) *Recommended by the Selection Committee
Treatment-Resistant Depression 3 Recommended Projects* Project Titles Electroconvulsive Therapy vs. Ketamine for Severe Resistant Depression Switching vs. Augmentation in Treatment-Resistant Depression Optimizing Outcomes in Treatment-Resistant Depression in Older Adults *All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.
Project 1: Electroconvulsive Therapy vs. Ketamine for Severe Resistant Depression • Research Question: • What is the comparative effectiveness of electroconvulsive therapy (ECT) vs. ketamine treatment for outpatient treatment-resistant depression (TRD) patients? • Population: • Patients aged 18-70 years old with TRD referred for ECT treatment across 4 sites • Intervention: Ketamine infusion treatment • Comparator(s): ECT • Outcomes of Interest: • Primary: Treatment response rate • Secondary: Depression severity (clinician-rated), changes in self-reported memory impairment and quality of life, psychiatric symptom scores; cognitive and memory assessment • Study Design: Randomized clinical trial, non-inferiority design • Sample Size: 400 patients (4 sites) • Length of Follow-up: 6 months
Project 1: Electroconvulsive Therapy vs. Ketamine for Severe Resistant Depression (cont.) • Engagement: • Multiple stakeholders were engaged during the planning process (patients, patient advocacy organizations, and third-party payers). These stakeholders will actively participate during study conduct and dissemination • Potential Impact: • Evidence from this study supporting the effectiveness of ketamine treatment for treatment-resistant depression could lead to rapid adoption for patients who currently have few treatment options other than electroconvulsive therapy
Project 2: Augmentation vs. Switching Strategies • Research Question: What is the comparative effectiveness, safety, and tolerability of two augmentation strategies with a switching strategy for patients with treatment-resistant depression? • Population: Adults ages 18-80 years old who meet criteria for treatment- resistant depression at specialty clinics across 10 study sites • Intervention: Augmentation or switching in one of 3 treatments arms • Comparators: • Arm 1: Augmentation with aripiprazole, an atypical antipsychotic • Arm 2: Augmentation with repetitive transcranial magnetic stimulation (rTMS) • Arm 3: Switch to venlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI) • Outcomes of Interest: • Primary: Depression severity (clinician-rated) • Secondary: Quality of life; family and social relationships; work productivity, functioning • Study Design: Randomized controlled trial • Sample Size: 639 patients • Length of Follow-up: 12 months
Project 2: Augmentation vs. Switching Strategies (cont.) • Engagement: • Multiple stakeholders were engaged during the planning process (National Institute of Mental Health (NIMH), U.S. Food and Drug Administration (FDA), hospital administration, pharmaceutical industry, non-researcher clinicians). Advisory board includes patient partners and family members of patients and will be involved in all aspects of study conduct • Potential Impact: • Results would provide needed guidance in managing treatment-resistant depression, as no other studies of this size have been done on augmenting and switching strategies for patients who have not responded to two or more antidepressant treatments
Project 3: Optimizing Outcomes in Treatment-Resistant Depression in Older Adults • Research Question: What are the comparative benefits and risks of antidepressant switching strategies (adding and switching) in older adults with treatment-resistant depression (TRD)? • Population: Adults age 60+ years old with TRD at primary care and specialty clinics across 5 sites • Intervention: Add or switch to one of three Step 1 drug pharmacotherapy treatment groups; those who do not improve in Step 1 will continue to Step 2 • Comparator(s): • Step 1 (N = 1500), 3 arms: adding aripiprazole; adding bupropion; switch to bupropion • Step 2 (N = 800), 2 arms: adding lithium; switch to nortriptyline • Outcomes of Interest: • Primary: Psychological well-being and remission (depression severity) • Secondary: Physical function; social participation; safety (adverse events including falls/fall-related injuries), aging-related variables • Study Design: Randomized controlled trial • Sample Size: 1,500 patients • Length of Follow-up: 12 months
Project 3: Optimizing Outcomes in Treatment-Resistant Depression in Older Adults (cont.) • Engagement: • Stakeholders will be engaged through the stakeholder advisory board. Patients and health care providers will be engaged through qualitative semi-structured interviews to inform the advisory board and study team • Potential Impact: • There is a lack of evidence-based treatment strategies for managing treatment- resistant depression in older adulthood. The current study will provide evidence to address a major public health problem for the country's growing population of older adults
Treatment-Resistant Depression 3 3 Recommended Projects* Projects PFA Allotted Proposed Total Budget* Treatment-Resistant Depression $30M $39.9M *All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.
Board Vote • Approve funding for the recommended slate of Call for a Motion to: awards from the Cycle 3 2015 Treatment- Resistant Depression PFA • Second the Motion Call for the Motion • If further discussion, may propose an to Be Seconded: Amendment to the Motion or an Alternative Motion • Vote to Approve the Final Motion Roll Call Vote: • Ask for votes in favor, opposed, and abstentions
Clinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain
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