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

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

3. 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. CISCR survey, IMS Health – Plan and Manage Clinical Trials 2014

4. 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