BUSINESS DEVELOPMENT IN CLINICAL RESEARCH - PowerPoint PPT Presentation

• 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

• 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

PATIENT RECRUITEMENT AND RETENTION

• 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

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.

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

• 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

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

• 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

• 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

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

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?

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

• 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)

• 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)

• 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”

• 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 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

• 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

• 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)

• What it will cost to the patient
• Time
• Inconvenience of travel
• Leave from current job
• Cost of any complications

• Facility of investigator –
• CRO/ SMO/ Hospital/ Pharmaceutical company

• 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

• 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

• 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

• 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
• -

1000 patients identified

Fail to meet criteria - 250

Consent process - 100

Prescreening - 400

250 randomised

EVALUABLE PATIENTS - 100

Drop-out - 150

• IDENTIFY
• APPROACH- information sheet- risk & benefits
• INFORMED CONSENT & SCREEN- history & med exam & investigations
• ASSESS
• ENROLL - RECRUIT

• 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

• 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

• 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

• 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

• Professional recruitment providers
• Increased use of Market Research
• Informatics
• Centralised recruiting
• Development of Metrics – “Leaky pipe analysis”