This document discusses strategies for improving patient enrollment in clinical trials. It notes that only a small percentage of cancer patients participate in trials currently. The workshop aims to share ideas that have worked for enrollment as well as new tools and methods that could be explored. Suggestions include revising informed consent forms to use plain language and visual aids, educating patients and physicians, using new technologies and community outreach, and focusing on customized education and communication rather than one-size-fits-all approaches. The goal is to move beyond traditional methods that have not proven effective and to empower sites and sponsors to find patients rather than hope patients find them.

1. REGIONAL
EXPERTISE
IN A GLOBAL
MARKET
Time to Roll up our
Sleeves and Focus on
Solutions and Strategies
to Get Past Living in
Hope on Enrollment
Dan Diaz
Vice President,
Global Business Development
215-348-3543

3.  19 years in the CRO/SMO space has provided a perspective
on how companies attack enrollment solutions
 Observation from conferences and from meetings with
sponsors, sites and vendors has shown that the standards
are still the same
 SPRI founded in 1972 as a Clinical Site
 Leading to our site strategies for achieving enrollment
 Focused on being different in our approach
 Setting the course for identifying new tools and expertise
 10th anniversary as a Specialty CRO

4.  We are calling this a “WORKSHOP”
 Time to roll up our sleeves
 Share Ways that Work- for your projects
 Find out what “We haven’t done before”
 Explore some of these tools
 Informed Consent Revisions
 Patient and Physician Outreach
 Community Intervention/Patient Advocacy Utilization
 National Enrollment campaigns
 Point of Care information
 Patient Advocacy Campaigns
 Patient Education
 Discuss “Why it did not work”

5.  Where are we from?
 Community Centers in Hospitals
 Academic/ Private/ Group
 Sponsor/Biotech/Pharma
 What percent of your office physicians participate in
trials?
 Do you have a patient advocate for clinical studies?
 Does the Hospital have one?
 For the Pharma’s/CROs - do you support payment for
advocates/ clinical trial materials/ publications at the
site level for Oncology Trials?
 How do you work that into your budget?
 Do you expect the CRO to put that in their budget
upfront?
 If no, does your company do this for other indications?

6. Time to Roll up our Sleeves
Our goal is not to
debate but Share Ideas
• Get a pen
• Get your texting ready
• We are asking for your
feedback

7. 1. What 3 Ways does My group approach patients? physician
level, Nurse level, Institution level
2. What are the top 3 ways your institution educates your
patients/families on clinical trials?
3. List 3 “other methods” you haven’t tried but have interest in
learning
4. What 3 cancer types are “easy for your clinic to enroll?”
5. What 3 types are harder?
6. What percent are Supportive Care trials?
7. Question for the group- Do we share that information with
other cancer centers in the area?
8. Why is your site selected for XX indication?
9. What are the top reasons why you are not chosen?
10. What are you willing to do to change?

9.  8% of US Based Oncology trials enroll on time
 Only 1-3% of US patients with Cancer participate in clinical trials
 Drug development delays within the trials are leading to many
company’s financial strife
 Hesitation to try new things runs rampant
 Reluctance to build in strategies upfront is Sponsors dilemma
Have you ever heard the following?
 “It is always the CRO’s Fault”
 The sites aren’t meeting their enrollment projections”

10.  What is helping us overcome these situations?
 What has made us successful?

11.  Here’s a list of methods that CROs always talk and write about…
Beware- Living In Hope and Running Studies the way they always have
 Pod Calls,
 1 hour per week site management
 Study Coordinator Calls
 Send Candy
 Standard Feasibility to their Database of Sites
 “Feasibility sent to 100 sites…” Do they really know them?
 Do they have a Freezer? They don’t ask- “How often do you use XXX on your patients with YYY cancer
 IF XXX is not readily used- SOC in that center- would they enroll patients in that trial? Not usually
 If they are a $1 B CRO, and 35 % of their studies are Oncology, and only 20% of the subjects are
getting enrolled in the US, how’s their database?
 Potential Strategy- Don’t add more sites- add countries
 6-8 month start up in an academic site is longer than time in Georgia/Poland/Belarus
 Some countries you can be up and going in less than 3-4 months (even in oncology)

12. Retention
Recruitment
Awareness
CISCRP

14.  Patient diagnosed with Thyroid Cancer in 1999
– Just enrolled in his second clinical trial.
 Reason for Participation
 First trial- Doctor did not like prognosis after relapse and surgery
 To be cured or be cured enough to go on and be in a position to be cured later on
 How did he find out about Clinical Trials in Oncology
 He was NOT approached about studies in 1999 when he was first diagnosed
 Not until relapse -and more surgery in 2007 was he approached about trials by his Oncologist in Nebraska
 Found a trial in St. Louis and he flew back and forth for 6 years
 PEARL- the local site performed all labs, x-rays, procedures
 St. Louis Site performed all dosing (second study is still set up the traditional way)
 None of his travel costs or mileage were covered by the sponsor
 Since 2007 I was told that he was in a pharma study using Sutent
 I was upset that the sponsor did not reimburse his travel costs
 It was then found out that it was a study sponsored by NCI
 Why I was happy- they kept him on study (challenged assessment of PFS- board agreed)
Outcome- Longest Living Survivor

15.  Progression finally led to ending study
 Question- Why wasn’t he informed about trials during initial diagnosis?
 His feeling was that “we” the industry only wanted to get patients who had no chance
of cure and were really in bad shape.
 What else did I learn? Informed Consent and Education Material
 Asked- between 1-10 what was his understanding of the IC
 Answer 4- he did not really understand what was expected, covered and his requirements
 2nd study- What was your understanding of the IC
 He called it a disclosure and said that it was much clearer and easier to understand
 He said he rated it between a “5-6” for his understanding
 I asked him “why he felt that way” and he said he was a “lay person” and did not have
the training
 Here’s the Rub- He has a Masters degree and is a Lawyer
 He had a hard time explaining what he was to do and had to overcome being scared to
participate- Friends and Family- at first thought he should NOT participate

16.  He said that some of the Patients that he talks to Say they felt pushed to get involved in
Placebo Controlled Studies (Pharma Sponsored?)
 He said that he did not want a Double-Blind study as he wanted to be Cured or to be good
enough to get to the next therapy that could cure him”
 Suggested that “we”- Doctors offices” inform and train patients to ask questions
 “Be Willing to offend the Doctor”
 Be willing to ask tough questions- why would/would not have me enroll in a trial?
 Why did you not tell me of clinical trials?
 What is the compensation for the clinical trials? Am I a Guinea Pig?
 Get Materials in the hands of the patients- before they are Diagnosed
 My Take as an industry, we need information on clinical trials, in every office, our
websites
He recommended magazines to be available
 He Knew “Cancer Today” and “CUREMagazine.com”-
 recommended- as CureMagazine was easy to understand
 Change CC.Gov It is too difficult to understand- He found the second study himself!

17. John’s Initial Goals
• See his oldest boy Graduate High School-
• He’s a Sophomore in College
New Goal
• See his Youngest graduate High School
• Be A Grandfather
• AFTER they graduate college
• “My goal is to be cured, or be good enough
to make it to when a cure is found and
available!”
• What goal to you have for “My Industry”
• Educate us before we get sick and need you

18. REGIONAL
EXPERTISE
IN A GLOBAL
MARKET
So Let’s Get Busy!
Strategies and
Solutions

19. Let’s set the baseline
• How many of you write your own Informed Consents?
• Who writes those for you?
• How many of you Accept and use the Sponsor/CROs?
• How many of you have used Color?
– Pictures
– Charts
– Imbedded objects?
– Patient Information Materials (in addition)
• Was it a Pharma/Bio sponsor or a Government Sponsored Trial?
• Do you believe that the real concern to not use these is the legal risk?

20. Pie charts of patients receiving a patient information form (top pie, n = 365) and their decision to
sign an informed consent form (second pie), their eligibility after signing (third pie), and their
final ability to start in a specific phase I trial (bottom pie).
van der Biessen D A et al. The Oncologist 2013;18:323-329
http://theoncologist.alphamed
press.org/content/18/3/323.f
ull

21. A study of clinical trial Informed Consent Forms (ICFs) found that
about 90% of ICFs are written at an 11th-grade level or higher. That
level is far too high because:
 In the United States alone, more than 90 million people have difficulty
reading
 1 out of 5 Americans reads at or below the 5th grade level
 The average American reads at an 8th-grade level or below
 Approximately 8 million US seniors have below-basic
literacy skills
 Literacy levels are even lower in many of the
countries where clinical trials are often conducted

22. Whilom, as olde stories tellen us,
Ther was a duc that highte theseus;
Of atthenes he was lord and governour,
And in his tyme swich a conquerour,
That gretter was ther noon under the sonne.
Ful many a riche contree hadde he wonne;
What with his wysdom and his chivalrie,
He conquered al the regne of femenye,
That whilom was ycleped scithia,
And weddede the queene ypolita,
And broghte hire hoom with hym in his
contree
With muchel glorie and greet solempnytee,
And eek hir yonge suster emelye.
Yes, this is from the real book 22

23. • Theseus was the governor of Athens
• He took over many countries
• When he conquered Scythia he married the
queen, Hippolyta
• He brought Hippolyta and her sister Emily
back to his country
• There was a great celebration
Now I understand 23

24.  Lower the reading level to a 6th grade level
 Reduce/replace legal and medical jargon-
 Develop Patient Resource Guides-if IC is already approved
 Use plain language
 Include phonetic pronunciation (pro-nun-see-A-shun) guides
 Pra-STATE not Prostrate - Patients “feel better” when they pronounce it correctly
 Add pictures, icons and other visual elements
 Take home “booklets” of the Informed Consent
 Use more white space
 Provide patients with clear, easy-to-follow schedules and calendar
 Work with Medical Writing groups- education agencies who perform this.
This isn’t normal standards for CROs

27. When you go to the site- look for Waiting Room information on
participation in clinical trials
Provide hand out information and call center information on
cancer within indications and advise them to go to “Pro-Clinical
Study” websites and organizations
Patient Resource Guides
Branded Materials- take-home kits
Provide material to local non-profit chapters
Provide them with a list of sites and information on clinical trials

28.  Broadcast media, including television, radio and newspaper
 Direct mail to targeted demographics
 Recruitment website
 Search engine optimization for disease-state searches
 Social media posts
 Healthcare professional office materials, including easels, brochures, posters and
study overview and eligibility requirement handouts
“If you can make something easier, more convenient, more straightforward and easier
to understand, patients will improve their level of compliance,”
John Yates, MD, executive director of clinical research at Merck Research Laboratories.
Shelton D. Patients in clinical trials don’t always follow the program.
American Medical News.
http://www.southjersey.com/articles/?articleID=2171. Accessed March

29.  Web-Based
 Web keys for quick
web access-even for kids
 Websites that guide the
patient/family member
to the right resources
 Outbound recruitment
 Telephone scripts
 Newspaper ads
 Radio scripts
 Informed Consent
 Patient guide
to informed consent
 In-Office recruitment
 Nurse inclusion/exclusion criteria
 Educational wall charts
 Patient brochures
 Patient Resources
 Appointment reminders
 Post cards; magnets
 Health-literate
trial education
 Patient Information (study specific)
Sponsors Should Take the lead on this
Mid size/larger have the Medical Education teams.
CROs don’t usually put this in the budget as it “makes
their costs higher than the competition and
THEY aren’t asked for these types of solutions

30. For what percent of your studies do the
sponsors provide these types of materials?
Patient web-keys for quick access
to the global website
And Study InformationInteractive educational
website
Recruitment
materials in a box

33. How many times have you had MD
to MD training or Discussions from
CRO or Sponsor?

34. Whether for Study or Condition- Do
you find these Helpful?

36. Technology tools
 Use new Survey technology and search electronic databases for
patient information
 Survey technology saves time and money and provides better data in
faster time
 Site Portals –being used for increased communication
 Use the Web for patient recruitment including
Texting, web, adverts on Pinterest, Non-profit orgs
 Open up for Skype and video calls
 Community Tools- Shared experience and success

37. Pinterest, patient/patient, community outreach,
Facebook, Website

39. 39
122- Number of mobile-cellular subscriptions per 100 Developed World
inhabitants (ITU 2011)

40. 40
UK-based study –Texting
• www.linkedin.com/pub/joann-miller/2/22/844
95%
18%
0% 20% 40% 60% 80% 100%
Text
Phone
“No Show” rate for people who received SMS
reminders was over 20% lower than those who
received phone reminder
How many of you use this method?
Study subjects had a strong preference to receive visit reminders
by text over phone.

41.  Geographical Location
 Patient Population
 Staff Credentials
 Facilities
 PAST HISTORY
 Recruitment
 Responsiveness

42.  Create meaningful questions
 Survey & CDA – automate!
 Tracking – automate!
 SEV – when needed
 Selection recommendations

43.  Do not live in hope -Enrollment Just Doesn’t Happen
 If you are doing things the same way and they haven’t worked do
something different
 Redo the IC- Can your Family understand the IC? Test it!
 Use CROs and 3rd Parties to develop these Tools it will develop a strong
call-to-action message
 Engage the investigator through a new, unique way of discussing the
disease and clinical trial opportunities
 Use new Technologies as it helps patients with adherence and compliance
 Empower investigators to educate patients
their own way (customizable)
 Track how the patients have found out about your studies.
 If they found you- great- but you should be finding them

44. Thank you to my contributors
Dan Chupka
Infinata, Inc.
dchupka@infinata.com
781-762-9158
www.biopharmclinical.com
Brian S. Schaechter
973-727-3768
bschaechter@artcrafthealthed.com
www.artcrafthealthed.com
ddiaz@spriclinicaltrials.com
www.spriclinicaltrials.com
Susan MH Lewenz
Litéra AxxiTRIALS
+1(336)375-29x142
SLewenz@Litera.com
Medikidz USA
716-597-9073