Scientific presentation of REMA in 17ma Conferencia International Multidiscip...
Carman Research
1.
2. Experienced Physicians
John S. Carman, M.D.
Medical Director and Founder of Carman Research
Clinical research for over 38 years
Clinical trial investigator for over 300 clinical trials
Board certified in psychiatry
Well published with previous NIMH and
academic experience (University of Alabama)
Nathan Andrew Shapira, M.D., Ph.D.
Clinical research for over 12 years
Board certified in psychiatry; Ph.D. in neuropathology
Well published with previous industry (Solvay
Pharmaceuticals and Tikvah Therapeutics) and
academic experience (University of Florida)
3. Dedicated and Stable Team
Edwinia Paden-Johnson
Medical Records Coordinator
With Carman Research for 26 years
Casey Chacona
Senior Research Coordinator
With Carman Research for 10 years
Becky Empric and Robin Swinks
Research Coordinators
With Carman Research for 7 and 3 years, respectively
Marc McLaughlin and Lori Johnson
Office Administration and Recruitment
With Carman Research for 3 years
4. Broad Experience
Therapeutic Area Number of Studies (by 2009)
Major Depressive Disorder 139 (including 4 TRD)
Schizophrenia/Schizoaffective Disorder 44
Generalized Anxiety Disorder 37
Bipolar Disorder 27 (Mania); 15 (Dep); 4 (Proph)
Alzheimer’s Disorder 11
Panic Disorder 6
Insomnia 5
Social Anxiety Disorder 3
Obsessive-Compulsive Disorder 3
Adult Attention Deficit Disorder 3
Chronic Pain and Fibromyalgia 3
Obesity 1
5. Clinical Trial Phase Experience
Phase of Development Number (by 2009)
Phase Ib/IIa 10
Phase II 112
Phase III 140
Phase IV 39
6. Excellent Enrollment
Indication Screened Randomized
Major Depressive Disorder 35 30
Major Depressive Disorder 19 15
Major Depressive Disorder 22 16
Major Depressive Disorder 36 25
Major Depressive Disorder (ext) 15 10
Major Depressive Disorder 56 36
Generalized Anxiety Disorder 12 11
Generalized Anxiety Disorder 22 21
Generalized Anxiety Disorder 13 12
Generalized Anxiety Disorder 26 22
Bipolar Disorder, Depression 14 12
Overall for 2008-2009 (18 months) 270 210 (78%)
8. Quality Data
Physicians integrally involved in every visit and
administer rating scales
Very low rate of rater switching during study
Electronic data capture entered efficiently
Low placebo response rates:
24% for Major Depressive Disorder (5 studies)
30% for Generalized Anxiety Disorder (3 studies)
For studies over the past 4 years, with greater
than 10 per arm and code breaks available
High compliance:
In a recent phase II GAD trial with pharmacokinetic
Levels, our subjects demonstrated the highest
Percent confirmed compliance with study
medication.
9. Proven Results
In its 28 years of existence in Northwest Atlanta,
Carman Research has conducted clinical studies
for more than 60 sponsoring pharmaceutical
companies. Carman Research has been involved in
pivotal studies leading to approval and/or expansion
of indications for 23 psychoactive compounds now
on the market, for over 30 different formulations
or indications:
Abilify Geodon Saphris
Aricept Invega Seroquel (IR and XR)
Celexa Lexapro Wellbutrin (IR,SR and XL)
Depakote Namenda Xanax XR
Desyrel (IR and Paxil (IR and CR) Zoloft
Contramid) Pristiq Zyprexa
Effexor (IR and XR) Prozac
Emsam Remeron
Exelon Risperdal