The document discusses the critical factors influencing recruitment and retention in clinical trials, emphasizing the need for adequate patient population involvement and adherence to protocols for successful study outcomes. It highlights significant delays and financial losses due to recruitment challenges, poor communication, and logistical barriers faced by trial participants. Additionally, the document suggests strategies for improving participant engagement and retention while providing insights into motivations for patient participation in trials.

1. RECRUITMENT &
RETENTION
Asijit Sen
Email: asi.jit.sen@gmail.com

2.  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 and retention then
ultimately determine whether clinical studies adhere to timelines.
 Recruitment of investigators, research sites, and patients is a constant concern during the
course of any sponsored clinical trial.
2

3. Phase I Clinical
Trial: 40%
longer than
planned
Phase II
Clinical Trial:
30% longer
than planned
Phase III
Clinical Trial:
30% longer
than planned
2%
7%
8%
12%
14%
25%
32%
Patient Retention
Data and Validation
Site Retention
CTMS etc.
Site Recruitment
Vendor Fees
Patient Recruitment
Clinical Trial Cost Drivers
Ref.: Trialfacts.com | Published November 25, 2010
Bar Chart Ref: Cutting Edge Information
3

4. 75%
69%
59%
48%
Randomized:Screened Completed:Randomized
Conversion Ratios Are Worsening
1999 - 2002 2003 - 2006
4

5.  At least 80% of pharmaceutical trials do not meet enrolment
deadlines resulting in a loss of 1.3 million dollars/day for a given
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 single
patient and 30% under‐enrol in a given trial.
18%
13%
19%23%
27%
Regulatory & EC Approval
Source Document Verification
Collection of Case Report Form Data
Resolution of Data Descripencies
Difficulty in Recruiting Patients
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) 167–170 (2002).
5

6.  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
6

7. 60
23
11
6
Reasons
Find Relief Adv Science
Earn Extra Money Better Medical
 Treatment by advanced science
 Financial interest
 Best quality of care & relief for their disease
 Better medical treatment
Chart Ref: Center Watch Survey 7

8. Patient with target disease
Patient eligible to enter studies
Patient detected/ approached by the
investigator
Patient willing to enter the study
Patients Remaining in the Study
Investigator, Advisors, Literature,
Patients Groups
Investigator, Study Coordinator
Investigator, Study Coordinator
Patients, Investigator
8

9.  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
9

10.  Before starting a trial the following must
be carefully considered,
» Protocol Design
» Consider Primary Endpoints
» Use Retrospective Cohort Reviews
» If feasible and appropriate, simplify the study as
much as possible
» Region Selection
» Disease related differences such as
» Incidence
» Phenotypic and genetic variations
» Environmental Settings (including climate)
» Cultural (including religious) differences
» Stage of Industry Development
» Types of Medical Care
» Type of Legislation
10

11. » Study feasibility (understand the study population)
» Is epidemiology data available? Type of disease –how serious is it? What are their other options?
» 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 adequate?
» Human resources –Are they adequate for the study? (e.g. Study Coordinators, Research Nurses, Co‐Investigators
11

12. » 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.
12

13.  A 2004 European survey found that 68% of the people interviewed would consider joining a
clinical trial. Nearly two‐thirds of those respondents were motivated “to advance medical
science.” 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.
13

14.  A survey of almost 6,000 people with cancer conducted in 2000 took a look at why so few
adults participate in cancer clinical trials. Some of the highlights included:
» About 85% of people with cancer were either unaware or unsure that participation in clinical trials
was an option, though about 75% of these people said they would have been willing to enrol had
they known it was possible.
Ref.: Misconceptions and Lack of Awareness Greatly Reduce Recruitment for Cancer Clinical Trials
www.harrisinteractive.com/news/newsletter/healthnews/HI_HealthCareNews2001Vol1_iss3.pdf
14

15.  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.pdf
Ref: Center Watch 2002
15

16.  Serve unmet medical needs
 Save resources & energies wasted with protracted clinical development
 Improve firm’s competitor positioning
» Better utilise protected product patient life
» Meet funding related milestones
16

17. Attraction Challenges
Large patient populations with diseases of
both developed & developing world
Nascent clinical development environment
Fewer competitor trials Prolonged regulatory process
Seasonal variation in southern hemisphere Relatively poor commercialisation potential
Potential for cost savings Ethical dilemmas
High growth markets of tomorrow
Concerns regarding intellectual property
protection
17

18.  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
18

19.  Print advertorials
 Broadcast community services announcements or community television
 Patient education materials in advocacy newsletters
 Social media
19

20. Source: B2B Content Marketing: 2012 Benchmarks, Budgets and Trends 20

21. Source: Patient Recruiters 2012
21

22. Recruitment method Days active Overall responses Screened Qualified
Pharmacy Claims 14 days 252 252 150
Google‐Ads 7 days 0 0 0
Facebook‐Ads 8 days 45 7 1
Craigslist 20 days 39 25 21
GoHealthPanel.com 42 days 10 7 3
Other Social Media Ad 3 days 11 9 2
Email campaign 10 days 83 80 3
Mail campaign 5 days 8 8 0
TOTAL 180
Source: Patient Recruiters 2012
22

23.  The Volume of Social Media Sessions on Portable Devices is Skyrocketing
Source: Flurry Analytics., January 9, 2012 23

24. Recruitment
Websites
24

25. Sometimes it is not about filling
the funnel...
...Sometimes it is about
managing our losses at various
stages of the study
Randomized
(N=?)
Completed
Study (N=?)
Unqualified, Not
Interested, Drop Out
25

26.  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 study.
 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
26

27.  Dialoguing Assistance:
» Intensify communication and intervention
 Visit Reminders
 Compliance Reminders:
» Consider providing assistance using phone and texting reminders where complicated trial devices
or drug dosing instructions are involved.
 Educational Support:
» Where difficult or complex trial procedures exist, Investigators/Study Coordinators might consider
offering short tutorials
 Treat clinical trial participants well
 Attention is good for morale
27

28.  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 cancellations
 Intercept potential drop‐outs:
» By investigating at the first sign of possible study withdrawal or lack of interest, site staff can help
prevent retention problems.
28

29.  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
29

30. …Lots of patients randomized for my studies, No queries, all visits and
procedures done per protocol, and a trip to Bahamas after the study is
finished. That’s all I want, Santa!!!
30

31. 31