•• Clinical Research Teams: Clinical Research Teams: Pros /Cons of Internal StaffPros /Cons of Internal Staff

Jaderson S Lima

Medical Director

sanofi-aventis Brazil

•• Clinical Research Teams: Clinical Research Teams:

Internal staff: are there Pros /Cons? Internal staff: are there Pros /Cons?

……but there are management critical points.but there are management critical points.

Management staff:1. Investigator(s)2. Coinvestigator(s)3. EC/IRB members4. Professional consultants5. Regulatory Agency reviewers6. Trial coordinators7. Trial monitors8. Monitoring committees; data review committees; other9. Project leaders / champions10. Project managers11. Supervisors of data processors and data entry operators12. Statistical reviewers13. Executives at the sponsoring institutions14. Contract organization staff and executives15. Data analysis committees16. Independent auditors of diagnoses, laboratory data, trial conduct, other17. Independent review committee of trial results and interpretation

SpilkerSpilker, B. , B. –– Guide to Clinical trials: Guide to Clinical trials: LippinkottLippinkott--Raven; Raven; PhillPhill. PE. 1996. PE. 1996

…when one deals with multiple trials!

Survey conducted inSurvey conducted in7,500 sites7,500 sites

Marc Marc SottySotty, Senior Clinical Director (, Senior Clinical Director (CRUsCRUs))

“…“…dedicated group of collaborators,dedicated group of collaborators,……working in the country within theworking in the country within themedical department, but reporting to international clinical devmedical department, but reporting to international clinical development.elopment.””

→→→→→→→→ following the same proceduresfollowing the same procedures

→→→→→→→→ receiving the same trainingreceiving the same training

→→→→→→→→ communication on a daily basis with corporate project teamcommunication on a daily basis with corporate project team

→→→→→→→→ rapid turnaround answers to investigatorsrapid turnaround answers to investigators’’ questionsquestions

→→→→→→→→ CRUsCRUs liaise at the country level : internal staff understands localliaise at the country level : internal staff understands localbusiness culturebusiness culture

→→→→→→→→ Committed team with company values, standardized informationCommitted team with company values, standardized information

CenterWatch, May 2006

CenterWatch, May 2006

CenterWatch, May 2006

Relationship with investigators Relationship with investigators plus plus knowledge of knowledge of CRAsCRAs a critical pointa critical point

→→ Low turnover rate at top rated companiesLow turnover rate at top rated companies

→→ being supported by the local medical directorsbeing supported by the local medical directors

→→ simplifying number of training in processes, SOPs, IP, simplifying number of training in processes, SOPs, IP, monitoring monitoring

tools, safetytools, safety

→→ studystudy--specific and product / disease specific training or specific and product / disease specific training or outsourced outsourced

staff working with different sponsors / studies at the same timestaff working with different sponsors / studies at the same time??

→→ CRUsCRUs subsidiaries lowsubsidiaries low--cost countries may better fit the offcost countries may better fit the off--shoring shoring

workload management approach.workload management approach.

“ Keep the knowledge internally, minimizing the sub-contracting of most of our trials. As a consequence, it allows our collaborators in each country to build privileged relationship with the investigative sites involved in our trials”.

Olmstead, F. Appl.Clin.Trials; August 2: 2004.

→→Standard execution of protocol and procedures among and between Standard execution of protocol and procedures among and between the the

various clinical sites.various clinical sites.

→→ comparison of product quality (versus outsourcing).comparison of product quality (versus outsourcing).

→→ operational efficiency and cost ( versus outsourcing).operational efficiency and cost ( versus outsourcing).

→→ unwillingness to disclose confidential data with compound of a unwillingness to disclose confidential data with compound of a high high

degree of confidentiality.degree of confidentiality.

Life is beautiful but Life is beautiful but ……reality?reality?

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Life is beautiful but Life is beautiful but ……reality?reality?

Declining Research Productivity of PhRMA

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→→Survey in 30 major Survey in 30 major pharmapharma companies in 1999 = companies in 1999 = ““17% reported that 17% reported that sistematicalysistematicaly gathered and reviewed CRO and investigative site gathered and reviewed CRO and investigative site perfomanceperfomance metricsmetrics……

……in 2004 = 93% of companies reported doing soin 2004 = 93% of companies reported doing so”” 11..

→→→→→→→→ ““A quarter of pharmaceutical R&D spend is outsourcedA quarter of pharmaceutical R&D spend is outsourced”” 2.

1.Getz, K.A. App. Clin. Trials; Jun 1, 2005.2.Mattingly, S. (2003) at www.GCPj.com

→→ All trials inAll trials in--house = NOT FEASIBLEhouse = NOT FEASIBLE

→→ Hybrid systemsHybrid systems

→→ Avoid a bit of quandaryAvoid a bit of quandary

→→ FDA being skeptical and adversarial regarding studies submitteFDA being skeptical and adversarial regarding studies submitted by d by

Pharmaceutical industry regardless of how they are conductPharmaceutical industry regardless of how they are conducteded

→→ Further FDA Further FDA ““reformsreforms”” of drug approval process imposing timeof drug approval process imposing time--

consuming burdens on the pharmaceutical industry consuming burdens on the pharmaceutical industry

Olmstead, F. Appl.Clin.Trials; August 2: 2004.

FurthermoreFurthermore……

→→→→→→→→ Fixed internal staff is not flexible enough to: Fixed internal staff is not flexible enough to:

. Quick rescuing studies ( low worldwide recruitment);. Quick rescuing studies ( low worldwide recruitment);

. Adopting new priority projects on a short timeline. Adopting new priority projects on a short timeline

. Decision. Decision--taken process on resources allocation;taken process on resources allocation;

. Recruitment process in a competitive market;. Recruitment process in a competitive market;

. Re. Re--engeneeringengeneering the goals of researchthe goals of research

. Dealing with extra workload. Dealing with extra workload

and in Braziland in Brazil……

→→Difficulties in recruiting qualified personnel (competitive Difficulties in recruiting qualified personnel (competitive mktmkt); );

→→ Lack of training and highly skilled professional = room for Lack of training and highly skilled professional = room for

improvement .improvement .

→→TimeTime--consuming training of new comers.consuming training of new comers.

and in Braziland in Brazil……

→→→→→→→→ LabourLabour laws limits does not allow much flexibility for temporary laws limits does not allow much flexibility for temporary

contracts.contracts.

→→→→→→→→ Within Within SanofiSanofi--aventis,aventis, the Brazilian affiliate is one with the the Brazilian affiliate is one with the lowest number of temporary contracted out stafflowest number of temporary contracted out staff

→→ Need of developing new Need of developing new centrescentres X lack of internal staff = X lack of internal staff =

strategic outsourcing in Brazil and opportunity for goostrategic outsourcing in Brazil and opportunity for good partnership d partnership

((CROsCROs, , SMOsSMOs, etc)., etc).

…and the future:

. Clear trend for a decreased number of highly networked R&D global pharma companies.

.A diversity of small, but highly specialized pharmaceuticalcompanies.

.Highly specialized outsourcing patners to better cope with thefuture needs of drug discovery and development.

CONCLUSIONCONCLUSION

. MEDWATCH SURVEY: TOP RATED COMPANIES DO PROFIT ON THE WELL TRA. MEDWATCH SURVEY: TOP RATED COMPANIES DO PROFIT ON THE WELL TRAINED, INED, COMMITTED AND MOTIVATED INTERNAL STAFFCOMMITTED AND MOTIVATED INTERNAL STAFF

. INTERNAL STAFF PROVIDES A COST EFFECTIVE TOOL TO DEAL WITH MUL. INTERNAL STAFF PROVIDES A COST EFFECTIVE TOOL TO DEAL WITH MULTIPLE TRIALS TIPLE TRIALS AND PROJECTS WORLDWIDE (OFFAND PROJECTS WORLDWIDE (OFF--SHORING)SHORING)

. MULTINATIONAL, MULTICENTER TRIALS ARE COMPLEX ENOUGH FOR THE . MULTINATIONAL, MULTICENTER TRIALS ARE COMPLEX ENOUGH FOR THE INTERNAL INTERNAL STAFF ONLY TO COPE WITHSTAFF ONLY TO COPE WITH

. IN BRAZIL THERE IS MUCH CONERN REGARDING TEMPORARY EXTERNAL CO. IN BRAZIL THERE IS MUCH CONERN REGARDING TEMPORARY EXTERNAL CONTRACTS BUT NTRACTS BUT THERE IS ALSO A BIG ROOM FOR OUTSOURCINGTHERE IS ALSO A BIG ROOM FOR OUTSOURCING

. . FUTURE TRENDS IN RESEARCH WILL PUSH FOR MUCH CREATIVITY

AND STRENGHTENING PARTNERSHIP BETWEEN ALL PLAYERS

IN THE REALM OF CLINICAL RESEARCH

THANK YOU !