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

– 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

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

• 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

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

• 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

1998-2001

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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

• 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

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

• 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

• 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

– 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 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

• 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

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)

2nd P- PRICE

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

3rd P- PLACE

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

company

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

• 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

• 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

• 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

1000 patients identified

Prescreening - 400

Fail to meet criteri

a - 250

Consent process -

100

250 randomised

Drop-out - 150EVALUABLE

PATIENTS - 100

STEPS IN RECRUITMENT PROCESS

• IDENTIFY• APPROACH- information sheet- risk & benefits• INFORMED CONSENT & SCREEN- history &

med exam & investigations• ASSESS• ENROLL - RECRUIT

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

– 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

• 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

• 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

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

analysis”