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BUSINESS DEVELOPMENT IN CLINICAL RESEARCH. PATIENT RECRUITMENT & RETENTION MARKET RESEARCH IN CLINICAL RESEARCH PROJECT MANAGEMENT- CPM/ PERT ROLE OF CRO/ SMO IN CLINICAL RESEARCH OUT SOURCING CLINICAL RESEARCH BUSINESS DEVELOPMENT IN CLINICAL RESEARCH

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business development in clinical research
BUSINESS DEVELOPMENT IN CLINICAL RESEARCH
  • PATIENT RECRUITMENT & RETENTION
  • MARKET RESEARCH IN CLINICAL RESEARCH
  • PROJECT MANAGEMENT- CPM/ PERT
  • ROLE OF CRO/ SMO IN CLINICAL RESEARCH
  • OUT SOURCING CLINICAL RESEARCH
  • BUSINESS DEVELOPMENT IN CLINICAL RESEARCH
  • HIRING & RETAINING CLINICAL RESEARCH COORDINATORS (HR)
  • BASIC INFRSTRUCTURE: SPACE PLANNING/ SOPs & FINANCING
destination india
DESTINATION INDIA
  • Large & essentially treatment naïve patient pool
  • Low cost
  • Sufficiently good medical infrastructure & scientific pool
  • Availability of suitable subjects – a key component inspite of good funding, well designed, it may fail
trial process
TRIAL PROCESS
  • Phase I – a new drug or treatment for the first time in a small number of people (20-80), usually normal, healthy volunteers, (pharmacokinetic studies, bio-availability and bio-equivalence studies )
    • to evaluate its safety,
    • determine a safe dosage range, and
    • identify side-effects
  • Phase II –
    • drug or treatment is administered to a larger group of people (100-300) to further assess its safety and effectiveness
  • Phase III - drug or treatment is administered to large groups of people (1,000-3,000)
    • to further determine effectiveness,
    • monitor side-effects, compare it to commonly used treatments,
    • and collect information that will allow safe use of the drug or treatment
slide5

The Phase IV –

    • performed after the drug or treatment has been authorised for medical prescription and has been marketed.
    • continue testing the drug or treatment to collect information on the effect in various populations and any side-effects associated to long-term use.
    • Patients are randomly assigned to the group receiving the new treatment (treatment group) or to the standard group (control group) to ensure the trial's impartiality.
slide6

further characterise the drug.

  • For HIV drugs, which are approved on the basis of surrogate markers (for example, CD4 counts, changes in viral load), these studies are intended to document the drug's clinical benefit.
  • If the drug shows no clinical benefit, the sponsor is required to voluntarily withdraw the drug from the market.
  • also enable sponsors to evaluate the drug in populations that may not have been well represented in the Phase III trials
perspectives
PERSPECTIVES
  • Process of new drug delivery a time consuming & expensive process- 10-15 yrs/ $500-800m
  • Patient recruitment – 30% time consumed
  • Erstwhile – large hospitals where patient data available
  • Patient recruitment – key “bottle neck” in CTs
slide8

No. of patient required to undergo new drug trial gradually increasing

  • 5300 patients needed for each NDA
  • In US alone – 80,000 CTs undergoing (intense competition in US Europe
  • Attention towards Asia, Latin America and East Europe
cost of delay
COST OF DELAY
  • One study – “average cost of phase III CT - $4-20 m, minimum two P-III trials needed.
  • A moderate success drug – delay in P-III trial to cost $1.0 m per day
  • For a block buster drug - $ 4.0m
principles of patient recruitment
PRINCIPLES OF PATIENT RECRUITMENT
  • Reasons for joining CT –
    • to help advance knowledge of the disease in the interest of society/
    • lack of available therapy/
    • improved medical care
    • lack of health insurance,
    • advice from family physicians/
    • financial reasons
slide12

Barriers to participation-

    • Risk of side effects
    • Concern about getting placebo
    • Centre too far away
    • Unable to find a trial
    • Not eligible
    • Inconvenient hours
    • Not enough information
slide13

Nature of patients’ concerns

    • What if I change my mind and decide to drop
    • Will I get a placebo or real drug?
    • What is in it for me?
    • Will I be taken advantage of?
    • What is in it for my doctor?
slide14

Motivation for patient to participate

    • Access to promising therapy
    • Access to greater medical expertise
    • Close individualised medical attention care
    • Emotional support
    • Some thing to do (break boredom)
    • Altruistic feeling
ethical issues
ETHICAL ISSUES
  • Confidentiality and personal Health Information
  • Advertising for CT patients- prior approval of IRB/ IEC
  • Undue influence
  • Vulnerable population- children/ mentally disabled/ elderly/ students/ employees of investigators (Legally acceptable representative)
methods of recruitment
METHODS OF RECRUITMENT
  • Essentials – scientific planning and budget during protocol design stage
  • Investigator database
  • Clinical referrals
    • Opt- out procedure
    • Opt-in procedure
  • Advertising
  • Mass media campaign- radio/ TV/ press release/ mass mailing/ bill boards/ public service announcements/ through call centres (24 hrs telesrvice)
criteria for advertisement
CRITERIA FOR ADVERTISEMENT
  • Neither misleading nor coercive
  • No claims for proven safety/ effective/ superiority over others
  • Use of terms “new treatment” “new therapy”, “new drug” not permitted without explanation
  • Not to promise “free medical treatment”
inclusion in advertisement
INCLUSION IN ADVERTISEMENT
  • Name of research facility
  • Purpose of research & eligibility criteria
  • Time commitment and remuneration, if any
  • Contact person for more information
  • Word “RESEARCH” should appear
  • Monetary compensation only as inducement
marketing essentials
MARKETING ESSENTIALS
  • Marketing research
  • Market segmentation
  • Target marketing – particular section of society
  • 4 Ps – product specification / place/ price (what it will cost to patients)/ promotional activities (campaigns/ appointing recruitment agencies)
  • Differentiation
  • Positioning
essential of recruitment materials
ESSENTIAL OF RECRUITMENT MATERIALS
  • Neither misleading nor coercive to patients
  • No claims to believe that the treatment is proven safe and effective/ equivalent or superior to other treatments
  • The terms “New treatment”/ “New medication”/ “New Drug” not to be used without explanation- avoid misleading terms “receive new treatments”/ receive new therapy”
  • Do not promise free medical treatment- when intent is only not to charge patients for taking part in the study
1 st p product specification
1st P- PRODUCT SPECIFICATION
  • Therapeutic indication of drug –
    • patients with limited options (cancer/ rare diseases);
    • patients not satisfied with current form of treatment & accept alternatives;
    • conditions in which patient is hesitant to share with doctors (sexual dysfunction/ urinary incontinence)
2 nd p price
2nd P- PRICE
  • What it will cost to the patient
  • Time
  • Inconvenience of travel
  • Leave from current job
  • Cost of any complications
3 rd p place
3rd P- PLACE
  • Facility of investigator –
  • CRO/ SMO/ Hospital/ Pharmaceutical company
4 th p promotion
4th P- PROMOTION
  • Advertisement
  • Community based - Medical Camps
  • Referrals
  • Call centres
  • Web based- clinicaltrial.gov has appx 87000 trials in 170 countries/ companies’ web sites/ online partnership with search engines/ customised web sites – posting prequalified questionnaire and prescreen subjects online
call centres
CALL CENTRES
  • First point of contact for patients
  • Obtain health information data through telephone screen
  • Rapidly processing and filtering data to spread the recruitment over several sites
  • Identify appropriate modality of advertisement working –
  • giving first appointment
  • Limitations – intensive trg to operators/ language specialist for multinational/ unable to handle large traffic/ data confidentiality
difficulties in patient recruitment
DIFFICULTIES IN PATIENT RECRUITMENT
  • No strategic thinking to include recruitment in early stages of development- during protocol design.
  • Very narrow definition of inclusion/ exclusion criteria
  • Inadequate budget
  • Unrealistic time line
  • Lack of basic knowledge in recruitment in Investigator
  • Lack of dedicated staff
  • Own data inadequate
  • Negative publicity from media
  • Staggering costs involved in delays in recruitment
recruitment metrics
RECRUITMENT METRICS
  • Measurement of recruitment process
  • Accountability- complete tracking of all points of contacts (from prescreening call- first visit- recruitment- enrollment- retention- linking with referrals
  • Recruitment funnel – pre screening numbers : final enrollment
  • -
recruitment funnel
RECRUITMENT FUNNEL

1000 patients identified

Fail to meet criteria - 250

Consent process - 100

Prescreening - 400

250 randomised

EVALUABLE PATIENTS - 100

Drop-out - 150

steps in recruitment process
STEPS IN RECRUITMENT PROCESS
  • IDENTIFY
  • APPROACH- information sheet- risk & benefits
  • INFORMED CONSENT & SCREEN- history & med exam & investigations
  • ASSESS
  • ENROLL - RECRUIT
approach to recruitment
APPROACH TO RECRUITMENT
  • Strategic planning- at protocol design stage/ monitoring of recruitment strategies
  • Budgeting- 10-15 % of total budget of study / appx $ 500 m spent per year by sponsors/ must in initial planning stage for correct appreciation of expenses
  • Monitoring & tracking
  • Metrics
  • Training –
    • by sponsor to investigator sites
    • By investigator to its staff
retention of study objects the patients
RETENTION OF STUDY OBJECTS – the patients
    • Harder than recruiting
    • Equals in Management – CRM for customer retention
    • Dropout rates- appx 25% ; very high rates make study invalid
  • Factors to be considered
  • Patient profile – correct selection – demography/ personal attributes/ education/ personality compatible with remaining compliant
  • Key influence – reasons for participating
  • Barriers to participation
  • Motivators for participation
reasons for dropout
REASONS FOR DROPOUT
  • Lack of efficacy
  • Adverse reaction
  • Tool long a study duration
  • Need for invasive procedures
  • Unfriendly staff at site
  • Time constraints
  • Lack of transportation
  • Protocol too complex and difficult to follow
retention techniques tools
RETENTION TECHNIQUES & TOOLS
  • How valued they feel?
  • How well are they treated at every touch point?
  • Personal attention & treatment from everyone
  • Queries to be answered
  • Well informed
  • Regimen aids
  • Well compensated for time & travel
  • Sense of commitment & sense of belonging
  • Newsletter/ appointment reminders/ follow up calls/ educational material/ appreciation items at intervals
recent advances
RECENT ADVANCES
  • Professional recruitment providers
  • Increased use of Market Research
  • Informatics
  • Centralised recruiting
  • Development of Metrics – “Leaky pipe analysis”