clinical trial: recruitment & retention

8/14/2019 Clinical Trial: Recruitment & Retention

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RECRUITMENT &

RETENTIONAsijit Sen

Email: [email protected]


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The validity of clinical research studies are dependent on, Recruitment of adequate numbers of a representative patient population

Retaining participants in the study

Making sure the protocol is followed as directed

Once investigators and clinical sites are established, patient recruitment andultimately determine whether clinical studies adhere to timelines.

Recruitment of investigators, research sites, and patients is a constant concercourse of any sponsored clinical trial.


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Phase I ClinicalTrial: 40%longer thanplanned

Phase IIClinical Trial:30% longerthan planned

Phase IIIClinical Trial:30% longerthan planned

2%

7%

8%

12%

14%

Patient Retention

Data and Validation

Site Retention

CTMS etc.

Site Recruitment

Vendor Fees

Patient Recruitment

Clinical Trial Cost Driver

Ref.: Trialfacts.com | Published November 25, 2010Bar Chart Ref: Cutting Edge Information


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75%69%

59%

48%

Randomized:Screened Completed:Randomiz

Conversion Ratios Are Worsening

1999 - 2002 2003 - 2006


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At least 80% of pharmaceutical trials do not meet enrolmentdeadlines resulting in a loss of 1.3 million dollars/day for a candidate drug

Top reasons are,

Protracted budget negotiations

Slow regulatory & EC approval

Poor Patient Recruitment and Retention

Estimated 20% of investigators fail to enrol a singlepatient and 30% under-enrol in a given trial.

23%

27%

Regulatory & EC ASource Document VCollection of CaseResolution of Data Difficulty in Recrui

Chart Ref: McKinsey and Lehman Brothers interview of 49 executives and chief risk officers of pharmaceutical , biotech and medical device companies.

Ref: B. Spilker and J.A. Cramer, Patient Recruitment in Clinical Trials (Raven Press, New York, 1992).Ref: K.B. Drennan, Patient Recruitment: The Costly and Growing Bottleneck in Drug Development, Drug Discovery Today, 7 (3) 167170 (2002).


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For Sponsors:

Potentially skewed statistical results

Loss of position and/or revenue for product

Decline of confidence in investigators

For Sites:

Potential lost revenue for missing targets

Risk to future trial participation with sponsor Loss in patient confidence


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60

23

11

Reasons

Find Relief Ad

Earn Extra Money Be

Treatment by advanced science

Financial interest

Best quality of care & relief for their disease

Better medical treatment

Chart Ref: Cent


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Patient with target disease

Patient eligible to enter studies

Patient detected/ approached by theinvestigator

Patient willing to enter the study

Patients Remaining in the Study

Investigator, Advisors, Lite

Patients Groups

Investigator, Study Coord

Investigator, Study Coord

Patients, Investigator


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Clinical trial/Interventional

Pre-defined clinical group

Marketing-based

Seeking volunteers

Epidemiological

Preselect patients

Population-based methods (DMV lists, Random digit dialling)

Approach person/group


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Before starting a trial the following mustbe carefully considered, Protocol Design

Consider Primary Endpoints

Use Retrospective Cohort Reviews

If feasible and appropriate, simplify the study asmuch as possible

Region Selection Disease related differences such as

Incidence

Phenotypic and genetic variations

Environmental Settings (including climate)

Cultural (including religious) di

Stage of Industry Development

Types of Medical Care

Type of Legislation


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Study feasibility (understand the study population)

Is epidemiology data available? Type of disease how serious is it? What are their other option

Why would the site be motivated to enrol patients?

What are the barriers? (e.g. travel distances, number of clinic visits)

Site selection/assessment

Location of patient care where are treatment decisions made? (GP, tertiary care etc.)

Possibility of inter-disciplinary relationships? (if applicable)

Has the site done similar trials before? How is their recruitment history? Are facilities adequat

Human resources Are they adequate for the study? (e.g. Study Coordinators, Research Nurses


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Site specific strategies

Create tools to identify, approach, enroll and retain patients.

Anticipate problems.

Quickly recognise when recruitment is running behind schedule and pinpointing the problem

Make relevant patients/colleagues aware of the clinical trials being conducted at your site.


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A 2004 European survey found that 68% of the people interviewed would coclinical trial. Nearly two-thirds of those respondents were motivated to advanscience. Other most-cited reasons for participation included:

Help others with the condition (57%)

Obtain better treatment for my condition (48%)

Obtain faster access to treatment for my condition (34%)

Ref.: BBK Healthcare. The 2004 International Will & Why Survey. 2004. Internet Poll of >2,300 patients, June 2004.


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A survey of almost 6,000 people with cancer conducted in 2000 took a look aadults participate in cancer clinical trials. Some of the highlights included:

About 85% of people with cancer were either unaware or unsure that participationwas an option, though about 75% of these people said they would have been willingthey known it was possible.

Ref.: Misconceptions and Lack of Awareness Greatly Reduce Recruitment for Cancer Clinical Trialswww.harrisinteractive.com/news/newsletter/healthnews/HI_HealthCareNews2001Vol1_iss3.pdf


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Clinical trial treatment would be less effective than standard care

Unable to find a trial

Not enough information

Inconvenient timing

They might get a placebo

They would be treated like a guinea pig

Travel distance

Out-of-pocket expenses

Ref.: www.harrisinteractive.com/news/newsletter/healthnews/HI_HealthCareNews2001Vol1_iss3.pdfRef: Center Watch 2002


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Serve unmet medical needs

Save resources & energies wasted with protracted clinical development

Improve firms competitor positioning

Better utilise protected product patient life

Meet funding related milestones


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Attraction Challenges

Large patient populations with diseases of

both developed & developing worldNascent clinical development e

Fewer competitor trials Prolonged regulatory process

Seasonal variation in southern hemisphere Relatively poor commercialisat

Potential for cost savings Ethical dilemmas

High growth markets of tomorrowConcerns regarding intellectua

protection


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Investigators own patients

Chart review

Medical records

Referral letters/emails to selected hospitals/GP clinics

Brochures, flyers and posters in outpatient clinics

Review of local/commercial patient panels

Post cards to referral networks

Notices to advocacy groups


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Print advertorials

Broadcast community services announcements or community television

Patient education materials in advocacy newsletters

Social media


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Source: B2B Content Marketing: 2012 Benchmarks, Budgets and Trends


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Source: Patient Recruiters 2012


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Recruitment method Days active Overall responses Screened

Pharmacy Claims 14 days 252 252

Google-Ads 7 days 0 0

Facebook-Ads 8 days 45 7

Craigslist 20 days 39 25

GoHealthPanel.com 42 days 10 7

Other Social Media Ad 3 days 11 9

Email campaign 10 days 83 80

Mail campaign 5 days 8 8

TOTAL

Source: Patient Recruiters 2012


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The Volume of Social Media Sessions on Portable Devices is Skyrocketing

Source: Flurry Analytics., January 9, 2012


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Recruitment

Websites


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Sometimes it is not about fillingthe funnel...

...Sometimes it is aboutmanaging our losses at various

stages of the study

Randomized(N=?)

U

Inte


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Engaging staff: People friendly individuals that they can have a connection with

Putting the right staff in the right positions...

Information about their health, medical condition, and the progress of the stu

Feel that they have someone to contact if they have questions or concerns.

Results sent to family physician.

Feel appreciated and know that their time and contribution is valued:

Visit reminder cards & telephonic follow-up calls prior to next visit.

Transportation or caregiver support.

Thank you notes Newsletter

Birthday cards Follow-up after study


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Dialoguing Assistance: Intensify communication and intervention

Visit Reminders

Compliance Reminders:

Consider providing assistance using phone and texting reminders where complicaor drug dosing instructions are involved.

Educational Support: Where difficult or complex trial procedures exist, Investigators/Study Coordinators

offering short tutorials

Treat clinical trial participants well

Attention is good for morale


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Ensure feedback is provided sensitively and quickly

Ensure any payments are processed swiftly

Self-monitoring Tools: to track progress and activity completion

Transportation:

Identify patients who need transportation assistance to prevent appointment cance

Intercept potential drop

-

outs: By investigating at the first sign of possible study withdrawal or lack of interest, site

prevent retention problems.


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Review commitment of others

Adequate delegation

Workload

Practicality of protocol

Up skilling staff in trial recruitment is advisable

Ask your CRO for help with training support


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Lots of pat ients randomized for my stud ies, No quer ies , a l l v is i ts andprocedures done per protocol , and a tr ip to Bahamas after the study isf in ished. That s a l l I want, Santa!! !


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clinical trial: recruitment & retention

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