Clinical Trial Accrual Challenges: Is Social Media Here to Help? (A. Denicoff)

1. Clinical Trial Accrual Challenges -
Is Social Media Here to Help?
Andrea Denicoff, MS, RN
Head, NCTN Clinical Trials Operations
Cancer Therapy Evaluation Program, Division of Cancer Treatment & Diagnosis
June 7, 2018

2. 2
Objectives
 Provide a brief overview of NCI’s National Clinical Trials Network
(NCTN)
 Review major clinical trial (CT) accrual challenges experienced by:
 institutions and sites (sites),
 investigators, research teams and health care providers (HCPs); and
 patients, family and friends (patients).
 Describe pilot efforts in using social media to highlight NCTN trials and
disease portfolio of trials.
 Pose questions for our discussion about where might social media
play a role to enhance awareness about cancer CTs.

3. 3
NCI’s National Clinical
Trials Network (NCTN)
Brief Overview

4. 4
NCI National Clinical Trials Network (NCTN) Structure
Alliance
ECOG-
ACRIN
NRGSWOG
COG
(pediatric)
NCTN
Centralized
Functions
Canadian
Network
Group
NCORP
LEGEND:
Central Functions:
• CIRB
• CTSU
• IROC
• Common Data
System & Hosting
• Network Accrual
Team
30 LAPS
Statistics/Data Ctrs
Tumor Banks
Operations Centers
Member Sites
Selected Major NCTN Trials
•Precision Medicine Trials: Screening & Assignment to Multiple
Interventions Requiring a National Patient Catchment Area
ADULT MATCH & PEDIATRIC MATCH (Target Therapies Across Histologies)
DART (Dual Immunotherapy in Rare Cancers)
LUNG MAP, ALCHEMIST (Target Therapies in Advanced & Early Stage Lung Ca)
•Multimodality & Non-Drug Trials
Role of Weight Loss in Treatment of Early Breast Ca
Dose-Escalated RT +/- ADT in Intermediate Prostate Ca
•Combination Therapy Trials
Cediranib & Olaparib in Recurrent Ovarian Ca
Chemo + Immunotx in Resected Stage III Colon Ca
and Deficient DNA Mismatch Repair
Brentuximab Vedotin or Crizotinib with
Chemotx for Newly Diagnosed ALCL

5. NCTN LAPS sites NCORP sites NCTN US Member Sites
Sites with at Least 1 Enrollment to NCTN studies - Mar 1, 2014 to Feb 28, 2018
(First 4 Years of the NCTN Program)

6. 6
Screened
on Study
Accrual
20,271
Patients
Intervention
& Cohort
Accrual
65,257
Patients
Overlap
10,342
Patients
NCTN Program Accrual
3/1/14 to 2/28/2018
Total Enrollments (Screened on Study & Intervention) = 85,528
Total # Unique Patients = 75,186 (~ 19,000/year)

7. 7
Brain/CNS
3%
Breast
26%
GI
7%
GU
14%Gyne
8%
Head and Neck
4%
Leukemia
5%
Lung/ Thoracic
12%
Lymphoma
2%
Melanoma
5%
Misc. (Adult)
9%
Myeloma
3%
NET
1%
Sarcoma
1%
Intervention
&
Cohort
Accrual on
ADULT
NCTN Studies
by Major
Disease Area
3/1/2014
through
2/28/2018

8. 8
Clinical Trial Accrual
Challenges
Review Major Barriers
Denicoff, McCaskill-Stevens, et al, NCI-ASCO CT Accrual Symposium:
Summary and Recommendations,
Journal of Oncology Practice (JOP) 2013, 9:6, 267-276.

9. 9
CT Accrual Challenges: Institutions & Sites
 Leadership - Prioritization of CTs is a key to success
 Resources - Institution/site leadership need to prioritize clinical
research program as a key part of their site, including supporting the
infrastructure and staffing to make it successful.
 Culture - Site investigators must be leaders with a committed clinical
research team that works collaborative to create a “culture” of research
at their site.
 Community Engagement - Institutions must be engaged within their
large communities and conduct outreach to patients/local community
and referring health care providers to increase awareness of clinical
trials and ensure diversity of trial participation.

10. 10
CT Accrual Challenges: Investigators, Teams and HCPs
 Commitment to clinical research, time, efficient trial identification, and
communication are keys to accrual success.
 Availability of trials to meet patient population needs & remain aware
of them at point of care.
 Use of CT matching tools, screening logs, and continuous reviews of trials
needing opening and closing are important factors facilitating patient
enrollment.
 Interest in trials for their patients, lack of perceived equipoise of CT
question and/or concern of toxicity of trial regimen.
 Communication about and discussing CT options with patients takes
time and requires effective skills.

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CT Accrual Challenges: Patients, Families & Communities
 Doctor Recommendation – Lack of CTs discussed or offered
 Awareness of CTs as an option
 Misperceptions of CTs, lack of interest in research and perceived side
effects too great
 Financial Concerns - Lack of insurance coverage and high costs of
cancer care
 Social Issues - Impacts on family, work and social roles, travel and
transportation to CT site

12. Prospective Trial Accrual Tracking at a
Community Cancer Center*
New Cases = 1,012 (100%)
Available open trials?
58% w/out a trial
MD offer a trial to
patient ?
16% not offered
Trial eligibility?
20 % not eligible
Patient decision-making
4.2% overall enrollment
(42 of 1012 patients)
*Go RS et al. (2006), Cancer

13. 13
NCI CT Accrual and Screening Log Data: 2009-2012
Patients Prospectively Screened for NCI Trials
(n=4,483)
Ineligible
n=1,886 (42%)
Eligible
n=2,597 (58%)
Study
suspended
(n=16)
Urgent
treatment
(n=241)
Provider
declined
(n=570)
Patient
declined
(n=944)
1,771 eligible who did not enroll Enrolled
(n=826)
826 eligible who
enrolled
32% 53%
St. Germain, Denicoff, et al, Use of the National Cancer Institute Community Cancer Centers Program Screening
and Accrual Log to Address Cancer Clinical Trial Accrual, JOP 2014 10:2.

14. 14
Reasons* Healthcare Provider Declined to offer CTs
302
167
31 29 28
15 15 11 5 5 5 1
0
50
100
150
200
250
300
350
Top 2 reasons:
1. Preferred to
treat patient
with SOC
2. Concern for
patient co-
morbidities
and/or frailty
* More than 1
reason could be
selected

15. 15
Reasons* Patients Declined CT Participation
Top 3 reasons:
1. No desire to
participate
2. Prefer SOC
3. Concern for
side effects
* More than 1
reason could be
selected
408
368
82
42 37 30 28 26 25 24 16
3 2
0
50
100
150
200
250
300
350
400
450

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Accrual Challenge Puzzle
Where Does Social Media Fit for Patients?
Doctor
Recommendation
Lack of Trial
Awareness
Insurance &
Care Costs
Trial
Education
Access & Sites
with Trials
Social Issues
(transportation,
childcare, work)
Social Media?

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Accrual Challenge Puzzle
Where Does Social Media Fit for Providers and Sites?
Trials Available to
Recommend
Concern About
Patient Frailty /
Co-Morbidities
Preference
for Standard
of Care
Research
Resources
Knowledge of
Available Trials
Communication
Skills and Time
Social Media?

18. 18
Social Media Use
by CTEP and the NCTN

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CTEP Twitter Account: @NCICTEP_ClinRes
Account Target Audience:
 Clinical cancer grantees, sites, researchers, and research staff
involved in CTEP-supported trials including the NCTN and ETCTN
(Experimental Therapeutics Clinical Trials Network) trials.
Account Goals:
 Provide another way for our audience to learn about CTEP initiatives,
trials, and trial requirements

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CTEP Twitter Account: @NCICTEP_ClinRes

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New Trial Portfolios by Disease
NCTN trials: https://ctep.cancer.gov/initiativesPrograms/nctn_trials_by_disease.htm
ETCTN trials: https://ctep.cancer.gov/initiativesPrograms/docs/ETCTN_trials_by_diseaseFiles.pdf

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New NCTN Trial Portfolios by Disease: AYA Trials

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New NCTN Trial Portfolios by Disease: Breast Cancer

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Overarching Questions
 What is the goal of using social media?
 Social media can serve as a supplement to communications efforts
 Who is the target audience?
 Patients? Investigators? Sites?
 What does success look like & how to measure it?
 Rare to see a measurable increase in accrual attributable to a single effort

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NCTN Group Presentations at this Social Media Workshop
June 7th, Day 1 NCTN Presenters
 NRG Oncology: Thomas George, MD, University of Florida Health Cancer Center,
 Alliance for Clinical Trials in Oncology: Jamilah Owens, Alliance Communications
Manager
June 8th, Day 2 Presenters
 ECOG-ACRIN Cancer Research Group: Ruth C. Carlos, MD, FACR, University of
Michigan Comprehensive Cancer Center and Diane M. Dragaud, MA, Director of
Communications, ECOG-ACRIN
 Children's Oncology Group: Daniel T. Woods, Operations Manager, Children's
Oncology Group, COG Foundation
 SWOG Cancer Research Network: Wendy Lawton, Communications and Public
Relations Manager, SWOG

26. www.cancer.gov www.cancer.gov/espanol