Patient Inclusion in the Clinical Trial Process at Novartis Working to Make it Reality

Transcription

1 Patient Inclusion in the Clinical Trial Process at Novartis Working to Make it Reality Therese Johnsen, Clinical Trial Intelligence Manager 8 June 2015, London

2 Transparent, Patient Focused Drug Development Industry, Health Authorities and Patients all moving toward closer collaboration Patient Experience Data References 1. National Health Council Hoos et all; Partnering with Patients in the Development and Life Cycle of Medicine Therapeutic Innovation & Regulatory Science

3 PE in Clinical Trials: Project objectives and deliverables Leverage current Patient Engagement capabilities Define optimal Patient Engagement throughout the Clinical Trial Process Partner with Patient Relations and CPOs to support patients in our trials Mapped patient engagement activities currently being utilized in Novartis clinical trials to the Clinical Trial Process PEP Talks Series: experts in PE address Novartis Cross-functional process was developed to help Clinical Trial Teams and CPOs engage with patients and patient organizations Developing an education plan for patients to clarify why and how clinical research is conducted Finalizing implementation plan Initiating phased roll-out to clinical trial teams and countries. Establishing a foundation to support the inclusion of patients views in Novartis trials. *Per Good Clinical Practice (GCP), Novartis does not engage research participants whe are enrolled in Novarits trials, during the trial 3

4 Current Status of Patient Engagement in Novartis 60% of patient engagement activities implemented during patient recruitment Input for CDP Input to Protocol Design During Patient Recruitment After Study completion 4

5 Types of Patient Engagement Used at Novartis 60 Focus Group 50 Advisory Board Social media 40 Public rela;ons/communica;ons 30 Pa;ent protocol feedback Pa;ent informed consent feedback 20 Pa;ent prognos;c journey mapping 10 Pa;ent educa;on on clinical trials in general Pa;ent educa;on on specific clinical trial 0 Input for CDP Input to Protocol Design During Pa;ent Recruitment A?er Study comple;on Pa;ent input into recruitment tac;cs 5

6 Project outcome: A foundation for patient-centricity The team worked on solutions for embedding the patient perspective early on in our clinical trial process A common need was to foster greater collaborate internally at global sites and in the Regions and Countries Project participants discussed a broad range of benefits... Endpoints that resonate CLIINICAL TRIAL PROCESS (CTP) Ease patient burden: e.g., convenient visit schedules Reduced amendments Giving a Thank you to patients for contributing *Per Good Clinical Practice (GCP), Novartis does not engage research participants who are enrolled in Novarits trials, during the trial 6

7 Project Outcome: defining how we engage patients for clinical trials today and tomorrow CLINICAL TRIAL PROCESS (CTP) Patient engagement for program value Patient engagement for protocol design Patient engagement for recruitment and retention Patient engagement for sharing results Understand the value of study endpoints for patients Provide patient input into TPP Determine how products are actually used by patients Reduce amendments Support recruitment and retention Patient input into trial design Educate patients/participants about clinical research Increase recruitment and retention Recognize contribution of participants to the overall body of science: Send a Thank you Provide results Novartis Guidelines Patient Declaration Working with Patient Groups Grants, Donations, Sponsorships and Funding How-to Guide Processes to show PE at key timepoints along the CTP Process Map and RACI for Patient Engagement in Clinical Trials Assessment tool Patient Advocacy Toolkit List of questions, by PE activity, mapped to the CTP Online channels and social media Pharma Social Media Council erecruitment website *Per Good Clinical Practice (GCP), Novartis does not engage research participants who are enrolled in Novarits trials, during the trial Trial Results Transparency on trial results Guidelines for responding to requests for Clinical Data from Patient Advocacy Groups (PAGs) Thank you s to participants 7

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9 Partnership Bringing Patient Into Focus 9

10 Phase 2 Pilot Implementation Embedding the Patient Voice into Clinical Trials 10