PCORnet Front Door/ GPC Research Opportunity Assessment Process. Thursday 1:00 2:30 PM

Transcription

1 PCORnet Front Door/ GPC Research Opportunity Assessment Process Thursday 1:00 2:30 PM

2 PCORnet FRONT DOOR POLICY April 15, 2016 PCORnet, The National Patient-Centered Clinical Research Network, will establish a Front Door administrative unit in the Coordinating Center. The Front Door unit will guide interested parties in accessing PCORnet resources. Potential research partners such as investigators, patient groups, healthcare organizations, clinicians or clinician groups, government and industry scientists, and funders, can seek information for engaging PCORnet and accessing PCORnet research resources through the PCORnet website. The types of resources that will be available, subject to adherence to applicable PCORnet policies and procedures, are: a) data network queries, b) requests for network collaborators (to connect with one or more appropriate investigators and networks to collaborate on study planning and implementation), and c) requests for conducting a PCORnet Study, which will involve obtaining PCORnet Study designation (as defined in the PCORnet Governance Policies). The PCORnet Research Committee will review all PCORnet research requests and will provide oversight of Front Door unit activities, whereas the Coordinating Center will be responsible for executing Front Door unit activities.

3 5.1 Requirements for PCORnet Studies PCORnet Governance Policy 2/5/2016 To qualify for PCORnet Study designation, a study must: 1. Be patient-centered 2. Include at least one PCORnet Network. 3. Use quality-checked data standardized to the PCORnet Common Data Model format for those variables that are available in the Common Data Model. 4. Use as many of the following PCORnet resources as possible, when appropriate for the study design: a. PCORnet Query Tool b. PCORnet Single IRB Agreement c. PCORnet Data Sharing Agreement d. PCORnet Master Services Agreement e. Coordinating Center project management resources f. Other resources to be defined by the PCORnet Council or its designee 5. Demonstrate how patients are engaged in the design, conduct, analysis, or dissemination of the research.

4

5 Front Door Requests Data Network Request Requests from investigators who want to work with PCORnet and its Distributed Research Network (DRN) to obtain aggregated results Request for Network Collaboration Requests to connect with one or more Partner Networks or appropriate investigators to collaborate on study planning and implementation. Request for PCORnet Study Designation Coming Soon

6 Current PCORnet Designated Studies RELIANCE - Roflumilast or Azithromycin to Prevent COPD Exacerbations INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED) Short- and Long-term Effects of Antibiotics on Childhood Growth COMBINE; AntiTNF Monotherapy versus Combination Therapy with Low Dose Methotrexate in Pediatric Crohn s Disease PCORnet Bariatric Study ADAPTABLE: Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness Study Protocol Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn s Disease (DINE-CD) Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial Monitoring and Peer Support to Improve Treatment Adherence and Outcomes in Patients with Overlap Chronic Obstructive Pulmonary Disease and Sleep Apnea via a Large PCORnet Collaboration (O2VERLAP) Variation in case management programs and their effectiveness in managing high-risk patients for Medicare ACOs Healthy Mind, Healthy You Resiliency Education to Reduce Depression Disparities The Impact of Patient Complexity on Health Care Performance Identifying and Predicting Patients with Preventable High Utilization Harnessing PCORnet to Study Comparative Effectiveness and Safety of Biologic Therapies

7 GPC Research Opportunity Assessment Process (ROA) Form available on GPC website

8 Goal: Sustainable Research Engagement Process How do we follow and respond to PCORnet research opportunities? How should we organize the GPC ROA process? How do we engage our local research community? How do we engage our local patient/community resources?

9