RECRUITMENT STRATEGIES: WAYS TO FACILITATE RESEARCH
PARTICIPANT ENROLLMENT AND
RETENTION
Rosleen Mansour, M.A.
Research Coordinator
Research Coordinator
Department of Psychiatry and Behavioral Sciences
September 25, 2012
RECRUITMENT ISSUES
(SOURCE: MARITHEA GOBERVILLE, PH.D) | Patient recruitment is the leading barrier in conducting studies
| 50% of sites enroll 1 or 0 patients
p
| 6% of clinical trials are completed on time
| “Time
Time to market
to market” is key concern for sponsor
is key concern for sponsor
| Can cost up to $1 million/day for delays in getting drug to market
tti d
t
k t
STEP 1: S
1: STUDY DESIGN/REVIEW/CONTRACT
Reviewing the protocol/contract:
| What is the target enrollment? N=???
N
Expected recruitment rate? Maximum N, minimum N?
y Multi‐site trials: Is enrollment competitive?
y Will the study be terminated once enrollment met?
y Ideal to have flexible target enrollment
y
| What are the recruitment milestones/timelines?
| Target population: review of inclusion/exclusion criteria
| What is the expected screening failure rate?
| What is the design of the study (e.g., Open Label vs. g
y g p
Placebo‐controlled), risks, potential benefits?
SAMPLE CONSIDERATIONS (CPHS)
| Cultural diversity is strongly encouraged
| Your clinical trial sample should be representative of Y
li i l t i l
l h ld b
t ti
f
the local population affected by the condition in terms of: y
y
y
Ethnicity/Race
Gender
Age
| Economically disadvantaged subjects: costs related p
p
p
to research should not preclude participation and financial remuneration, reward, or reimbursement for expenses must not be coercive to potential participants
| Exclusion of a particular group may only be justified in certain cases (see CPHS Recruitment guidelines)
STEP 2: 2: RECRUITMENT PLAN
1. What strategies have been successful in the past?
2. What resources do you need?
2. What resources do you need?
3. How will you recruit?
y
y
y
y
y
y
y
y
Databases
Approaching existing patients in clinic
Advertising (tv, radio, newspaper)
Sponsor referrals
Community outreach
External clinics/schools/facilities
Websites/internet
Advisory board/focus groups/surveys on patient sources and needs?
4. How will you ensure diversity? 5. When can you start to recruit??? What do you need to accomplish before you can recruit?
y
y
y
y
y
Contract/budget
IRB
Training
Site Initiation visit
Ordering of supplies
6 Subject renumeration compensation reimbursement?
6. Subject renumeration, compensation, reimbursement?
STEP 2: R
2: RECRUITMENT PLAN: C
: COMPENSATION?
1.
2.
3
3.
4.
5.
Must not be coercive and must be approved by IRB
Compensation must be equal to all p
q
participants
Reimbursement for expenses
Reimbursement for expenses
Compensation for time commitment
C
Compensation for inconvenience or ti f i
i
discomfort
STEP 3
3‐BUDGET
| How much is it going to cost for you to recruit and screen?
| What is the sponsor contributing to recruitment?
y
E.g., Advertising firm? National campaign, materials? | Recruitment costs:
Costs for advertising, flyers, website design
y Costs for staff time (community networking, developing recruitment materials, posting information, contacting l
f
colleagues, contact participants,)
y
| Screening costs :
Screening costs :
Telephone screening
y Screening failures
Screening failures
y
PLANNING‐BUDGET PERSONNEL TIME
Time estimates
Screen
Timeline in Study
Item
Patient Qualification/Screening
Recruitment
Administrative Time (reg binder, filing, billing)
Phone screening
Visit Prep/Scheduling
Informed Consent
Inclusion/exclusion
Patient History
Physical Exam
Vital Signs
Menarcheal status (female)
Urine Pregnancy Test
Personnel Needed *
SC
SC
SC
SC
SC
SC
MD
MD
MD
MD
SC
Pre‐visit
Dose Titration
MAINTENANCE
Visit 0
Visit 1
Visit 2
Visit 12
Visit 13/Final
Screen Visit
Baseline
Week2
Week42
Week48
60
30
30
30
20
15
5
15
60
60
60
60
15
5
15
15
5
15
5
15
5
15
Total/participant
60
60
30
Serum Pregnancy Test
SC/Nurse/CRU
10
Clinical Laboratory Tests
12-lead ECG
Reading of ECG
assessment1
assessment2
assessment3
assessment4
assessment5
assessment6
assessment7
t7
assessment8
assessment9
Adverse event collection
Prior/con meds
IP dispensed
IP instruc/compliance/accountability
SC/Nurse/CRU
SC
MD
SC
SC
SC
SC
SC
SC
SC
SC
MD
MD
SC
SC/MD
SC
45
20
10
25
180
90
30
15
15
15
10
45
20
10
30
15
20
30
15
20
15
15
15
15
10
15
15
15
10
10
15
15
10
10
15
15
10
10
15
15
20
20
45
30
20
20
45
30
20
20
45
30
20
20
45
30
15
20
45
30
45
20
20
20
20
45
20
13.83
1 83
1.83
1.33
8.67
5.92
0 83
0.83
0.67
3.00
4.33
0 58
0.58
0.33
1.42
3.83
0 33
0.33
0.33
0.92
7.92
1 00
1.00
0.92
4.33
83.08
8 75
8.75
6.50
30.67
$ 130 $ 45 $ 25 $ 15 $ 65 $ 485 Post Visit Processing
Regulatory/Electronic
R
l t /El t i llogging
i
Scoring of measures
Completion/collection/review of study forms
Data entry
Processing Lab samples
PI review of CRFs
Team administrative (meetings, trainings)/mo
Total Study Coordinator (SC)Time (hr)
Total Physician (MD) Time
Total PI Time (hrs)
Total Participant Time (hrs)
Particpant reimbursement
SC
SC
SC
SC
PI
Team
2.50
PLANNING‐BUDGET
SPONSOR BUDGET WORKSHEET - Costs Billable To RESEARCH Study
Principal Investigator:
Study Title:
Sponsor:
Start Date:
A. ***STARTUP COSTS (non-refundable):
Investigator Meeting
Base
-
30% IDC
-
TTL Inv.
-
IRB Fee: Awards >$50,000.00 = $2000
Protocol submission
Consent development
Administrative Fee: (budget, contract, recruitment,
regulatory set-up)
CRU start up
Other:
Long Distance
SUB-TOTAL STARTUP COSTS
C. PER PATIENT COSTS:
$ 3,000.00
$ 3,000.00
Standard of Care
(SOC) or Research Pre-screening
Research (R)
Visit 0
Screen Visit
$
Visit 1
Baseline
900.00
3,900.00
900.00
3,900.00
Visit 2
Week2
Visit 3
Week4
Visit 4
Week6
Visit 5
Week9
Visit 7
Week18
Visit 8
Week24
Visit 13/Final
Week48
Telephone screen
Research (R)
Informed consent
Research (R)
$
100.00
Physical exam/med hx
Assessment 1
Assessment 2
Clinical Laboratory
Tests
ECG readings
Research (R)
Research ((R))
Research (R)
$
$
$
150.00
100.00
100.00
$
50.00
$
50.00
$
50.00
$
50.00
$
50.00
$
50.00
$
50.00
$
50.00
Research (R)
Research (R)
$
$
100.00
100.00
$
$
100.00
100.00
$
$
100.00
100.00
$
$
100.00
100.00
$
$
100.00
100.00
$
$
100.00
100.00
$
$
100.00
100.00
$
$
100.00
100.00
$
$
100.00
100.00
Prizes, treats, supplies
Patient Stipend
Patient Parking
SUB-TOTAL PER PATIENT COSTS
Research (R)
Research (R)
Research (R)
$
$
$
5.00
50.00
20.00
$725.00
Total
$ 30.00
$ 30.00
$250.00
$250.00
$250.00
$250.00
$250.00
$250.00
$250.00
$250.00
Number
N
b PATIENT
Telephone Screened
50.00N Phone screen
NUMBER OF
PATIENTS Screened
20.00N SCREEN
NUMBER OF
PATIENTS Enrolled
10.00N ENROLL
SUB-TOTAL PATIENT
COSTS
D. ***OTHER INVOICE ITEMS:
UPON OCCURRENCE
Recruitment costs
Unscheduled Safety Visits
Unscheduled SRS
FDA Audit Fee
IRB Fee - Continuing Review
Amendment
Querie Resolution
SAE
Total of Other Invoice Items
$
36,000.00
TO BE INCLUDED IN CONTRACT
Base
30% IDC
TTL Invoice
$ 9,200.00
$ 2,760.00
$ 11,960.00
*Total Amount to Be
Received From Sponsor
*
(does not include "Other invoice items")
Other invoice items will be invoiced as they occur
*Note: Total amount to be received is based on an estimated recruitment numbers of subjects.
Final total is subject to change according to actual number of participants
STEP 4: 4: DEVELOP RECRUITMENT MATERIALS
| Flyers/Brochures/Tearsheets
Templates available from CTRC: http://www.uth.tmc.edu/ctrc/recruitment.html
y Example flyer
y
| Ads (radio, newspaper, tv): develop scripts
| Website content
| Collecting information electronically or through Collecting information electronically or through
the web:
Caution: confidentiality of participants must be Caution:
confidentiality of participants must be
protected
y All PHI must be kept on secure servers in zone 100
All PHI must be kept on secure servers in zone 100
y
STEP 4: 4: DEVELOP SCREENING MATERIALS
| Pre‐Screening participants
y
With CPHS approval of waiver of authorization, the study team may conduct preliminary screening through research registry or conducting telephone screens
| Screening form, including:
Inclusion/exclusion criteria
y Potential participant contact information
y
| Recruitment script that explains how the person’s name was obtained, introduces study design, bt i d i t d
t d d i
requirements, risks, benefits, study medication, location of the research
location of the research
| Caution: No participants can undergo study p
procedures (e.g., discontinuation of prohibited ( g,
p
medications until they are consented)
CLINICAL TRIAL WEBSITES
| Clinical trials.gov
Online database of federal and sponsored trials
y Registration of certain clinical trials is mandatory
y
| Research Match: y
tool that helps connect volunteers with researchers. tool
that helps connect volunteers with researchers.
The database will sent invitation notices to potentially eligible volunteers
| UT Health Clinical Trials page
y
Maintained by CTRC
y
ASSEMBLE SCREENING TOOLS
| Screening logs: documentation of participants screened, including dates, reason for exclusion, and if possible gender and age
| Waiting Lists
| Participant database: for future research
Participant database: for future research
STEP 5: IRB APPROVAL
All advertisements and recruitment methods/materials must be reviewed and approved by CPHS All
advertisements and recruitment methods/materials must be reviewed and approved by CPHS
prior to implementation to assure that the information does not promise or imply a certainty of benefit beyond what is contained in the protocol/informed consent.
Guidelines for Recruitment Flyers, Ads, Posters, & Brochures
http://www uth tmc edu/orsc/guidelines/recruitment html
http://www.uth.tmc.edu/orsc/guidelines/recruitment.html
Recruitment Information should include some of the following elements (those in bold are mandatory):
|
“Research” is specified.
|
The ages for eligibility.
|
I l i /E l i
Inclusion/Exclusion criteria (e.g., “Right‐handed Participants only”).
it i (
“Ri ht h d d P ti i
t
l ”)
|
The purpose of the research must be clearly stated.
|
The amount of time required to complete the study.
|
Any benefits (Note: a straightforward and truthful description of the benefits to the subject for participation in the study e g no charge for taking part in the study no‐cost health examination or providing treatment and
study, e.g., no charge for taking part in the study, no‐cost health examination, or providing treatment and counseling for the drug addictions.)
|
Any risks. (Note: If there are minimal risks other than mild boredom or mild fatigue, you may either include them or state that they will be discussed prior to the beginning of the study.)
|
The contact person’s name is identified.
|
The institution is identified.
|
Monetary compensation information is optional.
(Note: Although the consent document must specify the EXACT amount of any financial compensation, recruitment materials should state that monetary compensation will be provided. |
The location of the research
The location of the research.
|
Things that should be avoided:
Do not emphasize monetary compensation.
Do not state the amount of compensation.
Do not use catchy words such as “exciting”, “cutting‐edge”, etc.
Do not recruit children directly.
recruit children directly
Do not misstate information contained within the protocol
STEP 6: R
6: RECRUIT!
Develop and maintain community relationships
| Network with other providers, schools, and groups
| Establish give and take relationships with the community
Post Flyers in various locations
| Identify locations where you will find potential participants (ensure you receive approval to post)
y
y
y
y
y
Hospitals
Clinics
l
Facilities
Schools
Supermarkets, libraries, employment centers,
Mailouts
| Send letters and flyers to colleagues, support groups, past patients
Advertise
| Start with UT Media
| Radio, tv, newpaper
Radio tv newpaper
| websites
Presentations
| Start with your department, school, institution
| Support groups, organizations
Attend Community events
| Fundraisers
| Resource fairs
UT RESOURCES
UT R
| Office of sponsored projects
| CTRS
http://www.uth.tmc.edu/ctrc/recruitment.html
| CPHS
p //
/
/g
/
http://www.uth.tmc.edu/orsc/guidelines/recruitm
ent.html
| Media Relations http://www.uthouston.edu/advancement/publi
c‐affairs/media‐relations.htm
| Office of communications/graphic design (websites, flyers, logos)
| Office of Advancement/Communications/design
STEP 7: S
7: SCREEN!
Have staff available to take calls
| Train your staff
Train your staff
|
y
y
y
y
y
y
y
y
y
y
y
|
GCP training? Knowledge of protocol, inclusion/exclusion
Knowledge about condition and study population
Confidentiality issues
Communication style (a lot of information presented y (
p
understandably and in a non‐coercive manner)
Ability to establish rapport with potential participants
Ability to listen, be polite, yet keep calls as a screen and redirect y
p
y
p
participants to the screening interview
Cultural considerations
Safetyy
Ability to be sensitive in explaining if did not meet screening criteria
Ability to refer to services if needed
Continuously update the waiting list
STEP 8: ASSESS YOUR RECRUITMENT
STRATEGIES
| Obtain the source of the referral when screening
| Evaluate recruitment milestones
| Revise recruitment plan as needed (with Revise recruitment plan as needed (with
approval from CPHS)
| Obtain feedback from participants on reasons Obtain feedback from participants on reasons
they did/did not participate and the screening experience in general
experience in general
| Periodically re‐distribute flyers and re‐send l tt t
letters to colleagues
ll
RECRUITMENT CHALLENGES
| Study visit burden
y
inform participant of number of visits, length of visits and study length
| Inform participants of study requirements from the onset (e.g., prohibited concomitant medications, no new therapies)
| Assist participants with appts/planning visits
p
p
pp /p
g
Confirm and remind for upcoming visit (emails, cards, calendars)
y Provide doctor excuses for missed work/school
y Transportation (maps, costs to travel)
p
( p,
)
y
RECRUITMENT CHALLENGES
| Consenting challenges
y
y
y
y
y
Apprehension of participating in clinical trial and taking A
h i
f
ti i ti i li i l t i l d t ki
new medication
Fear of non‐FDA approved drug
Fear of adverse affects
Reluctance to risk receiving placebo
Fear of study procedures (e g blood draws or other
Fear of study procedures (e.g., blood draws or other procedures)
Having a well‐trained and understanding clinical staff and PI to help address these concerns
staff and PI to help address these concerns
¾ Providing participants with the safety nets they (
,p g ,
need to feel comfortable (contact numbers, pagers, emergency information)
| Current trends in community/condition
¾
RETENTION STRATEGIES
|
Visit Experience
y
y
y
|
Avoid and Address False Expectations
Avoid and Address False Expectations
y
y
y
|
Be continuously honest about study limitations
Be sympathetic to concerns about lack of response/remind patients contributing to science
PI should be available to address patient concerns/questions
PI should be available to address patient concerns/questions
Build and maintain relationships with participants
y
y
y
y
|
keep visits as smooth and brief as possible by preparing ahead for participants, not over‐scheduling, and ensuring wait times are minimized
Have waiting room materials (magazines, toys)
Reduce annoyances/barriers to participant (e.g., parking convenient, wait time)
Study personnel should be professional and pleasant
Use clinical skills and empathy to help participants with difficult procedures
Conduct specialized training with study staff if specialized population (e.g., children, aggression, etc)
Establish trust with your participants
Communication/Follow‐up
Communication/Follow
up
y
y
y
Call participants between visits to check in (especially if long interval between visits)
Confirm and remind of upcoming appointments
Obtain updad contact information for participants
RETENTION STRATEGIES
| Keeping eligible participants, eligible:
Re‐affirm/remind of exclusion/prohibited concomitant medications at each visit
y Anticipate problems/issues for each specific participant A ti i t
bl
/i
f
h
ifi
ti i
t
(e.g., cannot swallow compound, side effects, coordination of care))
y Counsel on strategies to improve IP compliance
y Remind of importance of visit windows
y
| Explain the preferred process for dropping out of the study (e.g., importance of being evaluated and returning study medication)
| If participant needs to be terminated from study provide follow‐up referrals (leave on a good note)