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Preparing for Patient Recruitment Success
by Conducting Recruitment
Feasibility
John NeedhamPatient Recruitment Strategy
• Reluctance to plan earlier, believing somehow this study will be different from previous performance
• Under funding of recruitment and retention efforts• Poor understanding of the disease entity, patient
motivation and behavior when developing a protocol• Poorly conducted site and protocol feasibility
assessments.• Poor management of Investigator relationships.• Expecting a vendor to rescue the enrollment later
Sponsor Challenges around Patient Recruitment
Keys to Recruitment and Retention Success
Understand, educate and inform the patient
Appeal to patient’s needs
Motivate the patient to participate
Offer unprecedented care
Provide ongoing attention
Show explicit appreciation
Demonstrate the value of their contribution
Enrollment Feasibility: How will the protocol design affect recruitment?
As a team prepares for launch of a study, without measureable enrollment data and a specific enrollment budget:
• no assumptions can be made about the ability to successfully enroll the required volume of patients within the enrollment period
• nor should any assumptions be made about any site’s the ability to retain an adequate number of patients throughout the participation period.
Clinical Research Process: Participant Enrollment Feasibility
When it is used: • Industry best practice: at the Protocol Summary
• Ideally, conducted early enough so that should the results indicate the study, in its current form, will not reach the enrollment goals, there should be adequate time and convincing metrics to change any possible design parameter to maintain the integrity of the study design but also achieve patient enrollment and Site interest.
Clinical Research Process: Participant Enrollment Feasibility
• Thorough attitudinal research should be conducted in the therapeutic area of the study.
• Ideally, whoever does the research (Sponsor or CRO), will compile:
– metrics on the disease: incidence, prevalence– the current standard of treatment in USA– unwanted side effects of current treatments – attitudinal concerns of those afflicted – details that will allow Sponsor to correctly
identify the most efficient means of reaching and gaining the interest of potential participants
– ways to coach investigative sites in dealing with the patients’ motivation.
Clinical Research Process: Participant Enrollment Feasibility
The additional factors include:• geographic patient distribution, • relevant demographics and patient psychographics• patient attitudes toward clinical trials in general• patient attitudes toward the specific protocol • dis-incentives to participation• Patient and their GP’s level of interest in the new
drug; how large a problem is it going to be treating; • how unsatisfied are they with current treatments• willingness to participate throughout the trial
duration• potential competitive trial activity • local studies seeking similar patients
0.0%2.0%4.0%6.0%8.0%
10.0%12.0%14.0%16.0%18.0%20.0%
18-34 35-44 45-54 55-64 65-74 75+
Age
% with Diabetes
Males
Females
The Diabetes Dashboard0
20406080
100120140160180200
< $15,000 $15,000 -$24,999
$25,000 -$34,999
$35,000 -$49,999
$50,000 -$74,999
$75,000 ormore
Income Range
Ind
ex (
Avg
. =
100
)
0
20
40
60
80
100
120
140
160
180
200
White Black AmericanIndian/Aleut
Asian/PacificIslander
Hispanic
Ind
ex
Distribution of 9,194,284 COPD PatientsBy Gender and Age
Male; 44.0%
Fe-male56.0%
Source: Optum Clinformatics™ for Clinical Trials, Current Year
COPD Disease Area RankingAll Patients Including Uninsured: “Heat Map” – Highest Prevalence in Red
Source: Optum Clinformatics™ for Clinical Trials, Current Year
Highest Prevalence Is Tri Cities, KY - 11.3%72,934 Patients Out of 18+ Population of 643,554
19803 Wilmington DE
Quick Facts for 19803 Population: 20,993
Median Age: 48
Median Income: $92,100
Consumer Spend: $614 MM
Consumer Spend ($/HH): $71,434
Upper Crust
Wealthy Older w/o Kids
03 Movers & Shakers
Wealthy Older w/o Kids
08 Executive Suites
Upper Mid Middle Age w/o Kids
15 Pools & Patios
Upper Mid Older w/o Kids
14 New Empty Nests
Upper Mid Mature w/o Kids
10 Second City Elite
Upscale Older w/o Kids
Some anticipated challenges may include:
Macro Challenges:• The competitive landscape for sites and patients • Inadequate funding for effective recruitment; the
absence of a retention strategy • Who is a better choice as the PI: a specialist or a
GP?• Delayed trial start time or a start date near
holidays; Drug availability issues• Availability of sites where the desired patient
resides• Site fatigue: multiple studies within the same drug
class• Cultural challenges within an ethnicity toward
clinical research or placebo trials
Some anticipated challenges may include:
Micro Challenges:• PIs having difficulty finding subjects in previous
trials• Sub-optimal previous CRO’s site recommendations
and recruitment plans • Lack of internal support to take proactive measures
resulting in the rescue mode whereby teams pay more than they should
• Challenges with consenting patients and excessively long consent forms
• Enrolling a diverse population (gender, race, age)• Challenges to patient motivation (retention) in long
term studies; family support; inadequate compensation
Questions to be explored at the SITE level
• Ethical concerns about blinded, placebo controlled study in adults or children?
• Expected average enrollment rate per month for this condition?
• Anticipated challenges with the consent process with these patients for this study?
• Why would your patients consider a placebo controlled study?
• Why do you want to conduct this study?• Are you conducting any similar studies?
In your previous COPD studies, were you able to achieve your enrollment goals?
En sus estudios anteriores de EPOC, ¿pudieron alcanzar sus metas en cuanto a la inscripción?
10%
20%
16%
54%
a. No, we did not have enough potential participants in our databaseb. Yes but we went outside the practice to other clinicsc. Yes with only patients from my practiced. Yes but we had to go outside our practice to colleagues' re-ferralse. Yes but we needed to use advertisements etc.
11%
56%
22%
11%
a. No, no tuvimos suficientes participantes potenciales en nuestra base de datosb. Sí, pero nos salimos del consultorio y consultamos otras clínicas para buscar referencias c. Sí, solamente con pacientes de mi consultoriod. Sí, pero con la ayuda de proveedores de reclutamiento e. Sí, pero necesitamos utilizar publicidades, etc., que creamos
Questions to be explored at the SITE level
• In previous studies, what barriers have impacted patients from completing the study?
• In previous studies, did you achieve your enrollment goals from your database alone?
• Would you prefer a recruitment stipend for each patient so that you can create your own recruitment strategy and materials?
• What additional help would you like to receive from Sponsor/CRO?
• How much time should the Sponsor spend at the Investigator Meeting on Recruitment Strategy?
These questions should be explored at the PATIENT level
• Is your condition adequately under control or are you experiencing unpleasant side effects from your meds?
• Are your side effects unpleasant enough to interest you other medical therapies
• Have you ever thought about a new or different medication which may perform better?
• How would you feel about joining a research study during which you will be required to stop using your current medications; some patients will receive the study drug and some given a placebo (sugar pill)
• With other medications already approved for your condition, why would you consider participating in a placebo controlled study
The following questions should be explored at the PATIENT level
• Do you feel that you have received enough information from your Doctor, clinic, support group or the internet to help you manage your condition?
• Who provides you with the best (reliable, trustworthy) advice about dealing with your condition
• How far/long would you be willing to travel to be in a research study for your condition
• Would you consider joining a clinical study if the doctor conducting the study was not your own doctor
The following questions should be explored at the PATIENT level
• Would you consider joining a clinical study if one-third of the participants will receive a placebo not the medication?
• What further information would help you decide whether you would like to take part in a clinical study
• What might be a challenge for you when considering participation in a study with X appointments scheduled over XX weeks?
• What is the most important reason for considering a clinical study for your condition?
Public Perceptions
52%
41%
32%30%
22% 22%20% 20%
13%
20% 20%
46%
32%
39%
21%
8%11%
15%
Preferred Actual
Base: All Respondents
Preferred and actual sources for information about clinical research
What are your top 3 reasons for considering a clinical trial?
I can not afford the prescriptions and this is a
way for me to get treatment
5%
It's too late for me, but I'd participate to help others
19%
Other (please be specific)7%
I don’t like the side effects of my current
drug7%
My current drug is not working well enough
15%
My doctor thought it would be a good idea
6%
I know someone who was in a trial and it
helped4%
COPD prevents me from participating in certain
physical activities37%
What are your top 3 concerns about enrolling in a clinical trial?
Number of required study visits
8%
Duration or how long the study will last
6%
If this drug will do me any good
15%
Driving distance to the study clinic
17%
Other (please be specific)
2%
Scheduling study appointments in my
already busy schedule3%
Possibility of receiving a placebo
18%
Possible side effects of the study medication
18%
Getting to an appointment
7%
Having to sit too long in the waiting room before
being seen5%
Taking the medication correctly
1%
Whose recommendation about a clinical trial would you respect the most?
Pulmonologist61%
Family doctor (GP)16%
One of my friends1%
A previous trial participant
9%
Pharmacist1%
The internet5% Other (please be specific)
7%Chart Title
If you decided not to participate in a medication study, what would be your top 3 reasons?
Distance from study site was too far
27%
Possibility of receiving a placebo
18%
Not enough information about or afraid of side effects19%
Office hours did not work with our schedule3%
Too many visits were required for the study
8%
Did not want to get a placebo
18%
Too difficult to travel to an appointment
9%
Can not comply with the study requirements6%
Too difficult for me to take medications1%
Other (please be specific)2%Chart Title
Percentage who have used social media to learn about clinical research studies?
Overall North America
Europe South America
Asia Pacific
18-34 Year Olds
41%37% 36%
77%
68%73%
Base: All Respondents
Sources for Information
SURVEY RESULTS
DESTINATION
Drive 2,500 ‘likes’ on Facebook.Spend less than $0.35/like.150 participants complete survey.
NOTE: Target audience for MyCOPDTeam will be the patient. age 45+, male & female, in Australia and North America.
• IMPACT, LLC• OBIS• ePharmaSolutions• Innovis• Optum Insight• MMG• Acurian• Clariness • CoActive Health Solutions• Patient Recruitment Strategy, LLC
Vendors who offer the service:
How it is priced
• Normally these research projects are priced as a flat fee for a protocol/study deliverable.
• Fees will escalate as the number of countries (languages) to be surveyed increase;
• fees will vary for the disease state as oncology which, due to the small number of patients, will be more expensive than diabetes.
• Fees also escalate if the site surveys are focused on specialists (fewer in number) or GPs.
• An average report is <$20,000 but the range of fees can be $10,000 to $50,000 depending on the extent of the data needed and time frame it is needed in.
Summary
• The true cost of clinical research is not the cost of an evaluable patient. It is the cost of not getting our product on the market as quickly as possible
• Initiate efforts early… not when things go wrong
Related Webinars by Patient Recruitment Strategy, LLC
• Enrollment Fundamentals• Planning to Recruit• Recruitment Training at a PI Meeting• Fundamentals of Patient Retention• Point of Care tools for Sites