Clinical Trials Challenges Marco Mohwinckel GIANT Healthcare Conference Clinical Innovation Session Nov 21st, 2018

Large and growing demand for patients enrollment in clinical research Source: Lily Clinical Trial Portal on www.clinicaltrials.gov data

Ineffective / inefficient / costly clinical trial recruitment efforts by pharma / CROs / sites 48% of trials miss enrolment targets 80% of trials face delays due to recruitment and retention challenges <5% of patients who meet criteria end up enrolling into trials Enrollment rates in trials dropped 20% since 2000 Est. 11% - 30% of trials fail to recruit Industry data shows an average funnel conversion rate of 7%. However, conversions rates are lower with the continued increase of eligibility criteria (industry trend) and especially in rare diseases, oncology, and competitive therapeutic areas. Source: Lily Clinical Trial Portal on various sources incl. www.clinicaltrials.gov, CISCR survey, IMS Health – Plan and Manage Clinical Trials 2014

Main Barriers and Solutions to Patient Recruitment Finding and identifying eligible patients Insufficient time, resources and staff for recruiting Length and complexity of consent form Protocol requirements other than recruiting criteria From a patient perspective  transportation to trial visit and out-of-pocket expenses Increased education of patients, physicians, research staff regarding various aspects of research Technology (e.g., greater use of EMR, new searching & matching tools, etc.) Obtaining patient and community input in research design Improvements in planning and budgeting Increased flexibility & streamlining of various aspects of recruitment, e.g., screening, visits, consent process etc. Solutions Source: CTTI Recruitment Project – Systematic Literature Review & Stakeholder Survey on Barriers & Solutions to trial recruitment; published on Applied Clinical Trials, Sep 2015