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RECRUITMENT &
RETENTION
Asijit Sen
Email: asi.jit.sen@gmail.com
 The validity of clinical research studies are dependent on,
» Recruitment of adequate numbers of a representative patien...
Phase I Clinical
Trial: 40%
longer than
planned
Phase II
Clinical Trial:
30% longer
than planned
Phase III
Clinical Trial:...
75%
69%
59%
48%
Randomized:Screened Completed:Randomized
Conversion Ratios Are Worsening
1999 - 2002 2003 - 2006
4
 At least 80% of pharmaceutical trials do not meet enrolment
deadlines resulting in a loss of 1.3 million dollars/day for...
 For Sponsors:
» Potentially skewed statistical results
» Loss of position and/or revenue for product
» Decline of confid...
60
23
11
6
Reasons
Find Relief Adv Science
Earn Extra Money Better Medical
 Treatment by advanced science
 Financial int...
Patient with target disease
Patient eligible to enter studies
Patient detected/ approached by the
investigator
Patient wil...
 Clinical trial/Interventional
 Pre-defined clinical group
 Marketing-based
 Seeking “volunteers”
 Epidemiological
 ...
 Before starting a trial the following must
be carefully considered,
» Protocol Design
» Consider Primary Endpoints
» Use...
» Study feasibility (understand the study population)
» Is epidemiology data available? Type of disease –how serious is it...
» Site specific strategies
» Create tools to identify, approach, enroll and retain patients.
» Anticipate problems.
» Quic...
 A 2004 European survey found that 68% of the people interviewed would consider joining a
clinical trial. Nearly two‐thir...
 A survey of almost 6,000 people with cancer conducted in 2000 took a look at why so few
adults participate in cancer cli...
 Clinical trial treatment would be less effective than standard care
 Unable to find a trial
 Not enough information
 ...
 Serve unmet medical needs
 Save resources & energies wasted with protracted clinical development
 Improve firm’s compe...
Attraction Challenges
Large patient populations with diseases of
both developed & developing world
Nascent clinical develo...
 Investigators own patients
 Chart review
 Medical records
 Referral letters/emails to selected hospitals/GP clinics
...
 Print advertorials
 Broadcast community services announcements or community television
 Patient education materials in...
Source: B2B Content Marketing: 2012 Benchmarks, Budgets and Trends 20
Source: Patient Recruiters 2012
21
Recruitment method Days active Overall responses Screened Qualified
Pharmacy Claims 14 days 252 252 150
Google‐Ads 7 days ...
 The Volume of Social Media Sessions on Portable Devices is Skyrocketing
Source: Flurry Analytics., January 9, 2012 23
Recruitment
Websites
24
Sometimes it is not about filling
the funnel...
...Sometimes it is about
managing our losses at various
stages of the stud...
 Engaging staff:
» “People friendly” individuals that they can have a connection with
» “Putting the right staff in the r...
 Dialoguing Assistance:
» Intensify communication and intervention
 Visit Reminders
 Compliance Reminders:
» Consider p...
 Ensure feedback is provided sensitively and quickly
 Ensure any payments are processed swiftly
 Self‐monitoring Tools:...
 Review commitment of others
 Adequate delegation
 Workload
 Practicality of protocol
 Up skilling staff in trial rec...
…Lots of patients randomized for my studies, No queries, all visits and
procedures done per protocol, and a trip to Bahama...
31
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Clinical Trial Recruitment & Retention

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Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.

Published in: Health & Medicine, Business

Clinical Trial Recruitment & Retention

  1. 1. RECRUITMENT & RETENTION Asijit Sen Email: asi.jit.sen@gmail.com
  2. 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. 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. 4. 75% 69% 59% 48% Randomized:Screened Completed:Randomized Conversion Ratios Are Worsening 1999 - 2002 2003 - 2006 4
  5. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 19.  Print advertorials  Broadcast community services announcements or community television  Patient education materials in advocacy newsletters  Social media 19
  20. 20. Source: B2B Content Marketing: 2012 Benchmarks, Budgets and Trends 20
  21. 21. Source: Patient Recruiters 2012 21
  22. 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. 23.  The Volume of Social Media Sessions on Portable Devices is Skyrocketing Source: Flurry Analytics., January 9, 2012 23
  24. 24. Recruitment Websites 24
  25. 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. 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. 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. 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. 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. 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. 31

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