Institutional PresentationInstitutional PresentationSergio Gloger M.D.Sergio Gloger M.D.

sergio.gloger@psicomedica.clwww.psicomedica.comwww.psicomedica.com

June 2005June 2005

PsicoMedica Research Group

June 2005June 2005

June 2005June 2005

Mission

To perform research activities based on GCP/ICH and fulfilling FDA/EMEA/local regulations standards

To provide clinical services for the general public trough specialized programs

To provide continuing education for professionals, patients and the public in general

June 2005June 2005

Research Activities

International Multicenter Clinical Trials 15 studies since 1999 (extension studies not

included)

Sponsors• Servier, Johnson & Johnson , Astra-Zeneca,

Wyeth, Merck (MSD), Pfizer, Novartis, Lilly, Sanofi-Aventis

CROs • Covance, Quintiles, PPD, ICON

Central Labs • Covance, MRL, Biomedical Systems, Quest

Diagnostics

June 2005June 2005

Research ActivitiesResearch Activities

DIAGNOSIS STUDIES

No

PATIENTSRandomized/Assigned to site

Major depressive Disorder* 7 147 / 132

Bipolar Disorder (Acute/mixed mania)

1 22 /20

Bipolar disorder (Acute mania)* 1 3 / 8

Post Traumatic Stress Disorder 1 8 /8

Panic Disorder 1 30 / 24

Borderline Personality Disorder 1 9 / 6

Alzheimer Disease 2 38 / 18

Schizophrenia 1 43 / 30

Total 15** 300***/ 246

Table 1. Protocols by diagnosis, 1999 to June 2005Table 1. Protocols by diagnosis, 1999 to June 2005

*Recruitment ended prematurely by the sponsor in one MDD and one BD study*Recruitment ended prematurely by the sponsor in one MDD and one BD study**Extension studies not included**Extension studies not included******Actual recruitment 22% over assigned number of patients to the siteActual recruitment 22% over assigned number of patients to the site DROP-OUT RATE: 18%DROP-OUT RATE: 18%

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Research ActivitiesResearch ActivitiesTable 2. Major Depressive Disorder Simultaneous Protocols Table 2. Major Depressive Disorder Simultaneous Protocols

2003-2004*2003-2004*

*Extension studies not included*Extension studies not included**Recruitment ended prematurely by the sponsor**Recruitment ended prematurely by the sponsor

Study Recruitment Period

(months)

Screened Patients

Screen Failures

No (%)

MDD1 14 47 3,4 patients p/month

6 (12.7)

MDD2 9 414,5 patients p/month

5 (12.1)

MDD3 ** 1,5 11 7,3 patients p/month

3 (27.2)

Total 15 996,6 patients p/month

14 %

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Academic Research Activities Academic Research Activities (current)

Identification of peripheral resistance to thyroid

hormone in a refractory to treatment mood

disorder population

The use of the Refetoff Protocol (progressive high

doses of T3) to revert refractory to treatment

mood disorder patients

Validation of a screening depression rating scale in Parkinson disease and other medical illnesses

June 2005June 2005

Professional Staff Professional Staff Staff Number

Psychiatrists adult child and adolescent

84

Neurologists adult child and adolescent

42

Nutriologist 1

Study Coordinators (registered nurses) 3

Nurse technician 1

Psychologists adult child and adolescent

92

Occupational Therapist 2

Phonoaudiologist 1

Administrative 3

June 2005June 2005

Headquarters 280 square meter facility Medical neighborhood Easy access and parking Facilities specially designed for clinical protocols Fax and photocopy machines available Broad-band internet access Comfortable waiting room Specific areas for monitor visits Eleven consultation offices Independent research and administrative areas Fully equipped laboratory procedures room Independent drug and CRF storage facility: temperature

and access controlled Access to a clinically integrated 16 bed in-patient clinic

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Recruitment Strategies

General and specific strategies according to study characteristics

Access to a high number of patients consulting in PsicoMedica (100 new patients and 750 visits per month by June 2005)

Patient visits expected to increase in the near future Easy access to own database (over 2500 files by june

2005) All medical staff involved in research allows in-house

referrals Medical staff working in other institutions allows

network referrals

June 2005June 2005

Recruitment Strategies

Staff involved in educational activities in diverse settings, such as universities, academic meetings, schools and the general public

Frequent media interviews for educational purposes increases consultation (no need to promote trials favors recruiting “non-biased” patients)

Waiting rooms check-list leaflets and other educational materials for identification of pathologies

Telephone screening interviews are offered for those who call to PsicoMedica and do not reserve an appointment

The above strategies allowed in the past 22% excess recruitment over contract

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Quality of work

Strict GCP/ICH based procedures (i.e. Informed Consent process)

PI available and involved in study procedures Full-time trained study coordinator (R.N.) Back-up study coordinators (R.N.) Experienced and work stable co-investigators

staff Same investigator/rater in charge of the patient

along the study Main rating scales administered solely by

physicians

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Quality of work

Structured patient records and other source documents properly stored

Routine registration of pre-screened subjects not complying with entry criteria

Rating scales used in routine clinical work Regulatory procedures and data handling are accurate and

fast processed IRB “Comité Etico Científico - Servicio de Salud

Metropolitano Oriente” does a good quality work with a fairly brief response time (average 3-4 weeks )

Site has been successfully audited by sponsors and CROs Quality Control Division in four separate studies

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Summary

PsicoMedica is an institution devoted primarily to medical research and clinical trials

Neuroscience has been our main research focus and we are actively looking forward to be involved in additional medical areas

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Summary

PsicoMedica has successfully carried- out 13 phase II and III, and two phase IV, international multicenter clinical trials, involving 300 patients in 8 different medical conditions

PsicoMedica has been successfully audited in four different studies

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Summary

PsicoMedica is in a privileged position for expanding its research activities do to its organizational structure, management strategies and qualified human resources

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Summary

Chile is a privileged place to carry-out clinical trials considering the following :

Access to an educated patient population willing to volunteer for medical trials

Very low rate geographical mobility Generally no need to advertise for

recruitment Well trained medical and nurse

professionals

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Summary Tradition in academic research Critical research activities

performed by physicians High standards in communication

and technological facilities Honesty and probity are attitudes

toward work deeply rooted in Chilean society

Economic and political stability