Feasibilty Assessments

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.


• 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.


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

Documents

Feasibilty Assessments