35th Anniversary Special Edition

Page 1

A commonly accepted definition of Hero is a person who is admired for courage, fortitude, strength and nobility! As the Center For Information & Study On Clinical Research Participation [CISCRP] wrote in their brochures, “It is said that the greatest gift is one which is given anonymously, given when you did not know whether you would receive any direct personal benefit in return...This is the gift you gave by taking part in clinical research.� While the degree to which you may have personally benefited from enrolling in a clinical study here at PRI is unique unto you, as illustrated (on page 2) in this Bulletin, you can take great pride in knowing that your involvement has helped to advance the field of medicine! Literally, so many lives have been improved because of you, and millions of others like you, chose to participate in a research study. We appreciate, admire and thank you--as a Medical Hero! Continued on Page 3


35 Years of Research! By Janet L. Minter Clinical Document Specialist For over 35 years PRI has been instrumental in the Food and Drug Administration (FDA) approval of a significant number of medications. The list below illustrates the wide range of medications we have studied here at PRI and the conditions/illnesses which have been successfully treated with these medications. Without your help, these effective/FDA-approved medications would not be available to help people. On behalf of all of us here at PRI, as well as the millions of patients that have benefited from these medications, we thank you, our study participants, your families and your caregivers. Your contribution makes a difference! Drug

Indication

Drug

Indication

Abilify® (aripiprazole)

Depression

Motrin® (ibuprofen)

Pain

Acomplia (rimonabant)

Weight Loss

Namenda® (memantine)

Alzheimer's Disease

Ambien® (zolpidem)

Sleep Disorders

Nimotop® (nimodipine)

Alzheimer's Disease

Ansaid® (flurbiprofen)

Anti-inflammatory/Arthritis

Parlodel® (bromocriptine)

Parkinson's Disease

Aricept® (donepezil)

Alzheimer's Disease

Paxil® (paroxetine)

Depression

Ativan® (lorazepan)

Anxiety

Pristique® (desvenlafaxine)

Depression

Axert® (almotriptan)

Migraine Headaches

ProSom® (estazolam)

Sleep Disorders

Betoptic® (betaxolol)

Glaucoma

Provigil® (modafinil)

Sleep Disorders

BuSpar® (buspirone)

Anxiety

Prozac® (fluoxetine)

Depression

Capoten® (captopril)

Hypertension

Relpax® (eletriptan)

Migraine Headaches

Cardizem-SR® (diltiazem)

Hypertension

Remeron® (mirtazapine)

Depression

Celexa® (citalopram)

Depression

Reminyl® (galantamine)

Alzheimer's Disease

Chantix® (varenicline)

Smoking Cessation

RevEyes® (dapiprazole)

Eye Disorders

Clinoril® (sulindac)

Anti-inflammatory/Arthritis

Seromycin® (cycloserine)

Tuberculosis

Contrave® (bupropion SR/

Weight Loss

Seroquel® (quetiapine)

Depression/Anxiety/Schizophrenia

Coreg® (carvedilol)

Hypertension

Serzone® (nefazadone)

Depression

Cymbalta® (duloxetine)

Depression

Sinequan® (doxepin)

Depression/Anxiety

DDA VP® (vasopressin)

Night Time Urinary Frequency

Sonata® (zaleplon)

Sleep Disorders

Desyrel® (trazodone)

Depression/Anxiety

Stadol® (butorphanol)

Pain

Diapid® (lypressin)

Urinary Disorders

Strattera® (atomoxetine)

ADHD

Effexor® (venlafaxine)

Depression

Surmontil® (trimipramine)

Depression

Effexor-XR® (venlafaxine)

Depression

Symbyax® (fluoxetine and olanzapine)

Depression

naltrexone SR)

Rave Reviews! At the completion of each patient’s participation in a PRI study, we send out Study Completion Questionnaire postcards. These questionnaires are designed to be returned to us as anonymous ratings of the care patients received from our physicians and nurses, as well as the likelihood of a patient referring someone to PRI. For those patients wishing to communicate additional remarks to us, pertaining to their experience(s) at PRI, there is a space on the postcard for optional comments. As indicated below, for 2009, our patient satisfaction scores were exceptional! To view some of the patient comments, please visit the Te s t i m o n i a l s s e c t i o n o f o u r w e b s i t e a t www.priresearch.com.

100%

90% 99%

98%

98%

85%

Nurse Rating Trental® (pentoxfylline)

Pain

Exelon® (SDZ ENA 713)

Alzheimer's Disease

Triavil® (perphenazine/amitriptyline)

Anxiety/Depression

Frova® (frovatriptan)

Migraine Headaches

Vasodilan® (isoxsuprine)

Blood Flow Improvement

Gabitril® (tiagabine)

Anxiety

Vestra (reboxetine)

Depression

Halcion® (triazolam)

Sleep Disorders

Vyvanse® (lisdexamfetamine dimesylate)

ADHD

Haldol® (haloperidol)

Schizophrenia

Wellbutrin® (bupropion)

Depression

Imitrex® (sumatriptan)

Migraine Headaches

Wellbutrin-SR® (bupropion)

Depression

Ketasyn™ (AC-1202)

Alzheimer's Disease

Xanax® (alprazolam)

Anxiety

Lamictal® (lamotrigine)

Depression

Zantac® (ranitadine)

Ulcers

Lexapro® (escitalopram)

Depression

Zofran® (ondansetron)

Prevents Nausea and Vomiting

Lunesta® (eszopiclone)

Sleep Disorders

Zoloft® (sertraline)

Depression

Luvox® (fluvoxamine)

Depression

Zomig® (zolmitriptan)

Migraine Headaches

Lyrica® (pregabalin)

Anxiety/Fibromyalgia

Zyban® (bupropion)

Depression

Maxalt® (rizatriptan)

Migraine Headaches

Zyflo® (zileuton)

Asthma

Meridia® (sibutramine)

Weight Loss

Zyprexa® (olanzapine)

Schizophrenia/Bipolar

Mirapex® (pramipexole)

Parkinson's Disease

Page 2

By My-Linh Tong, R.N., M.S.N., N.P. Clinical Research Nurse

PRI would like to introduce you to a key member of our research team, Kim Guevarra, R.N., M.S.N., N.P. Kim has been a resident of Orange County since the age of seven. She spent most of her formative years in Irvine, graduating from University High School. She did not go too far to attend college at the University of California, Irvine, where she earned a Bachelor’s Degree in Applied Ecology with a minor in Epidemiology and Public Health. She decided to flap her wings after graduation and study abroad in Laguna, Philippines, her native country, for three months to learn about the language, culture and social justice issues. This experience helped her solidify her intuitive nature to understand people and their differences. She returned to focus her attention on nursing. She was a member of the first graduating class of an entry-level Master’s program for Nursing at California State University, Los Angeles. It was here that she earned her Master’s degree in Nursing and a certificate as a Family Nurse Practitioner. Since then, Kim has worked at Huntington Memorial Hospital in Pasadena and at Kaiser Permanente Hospital and Medical Center in Irvine, both times on the cardiac telemetry unit. She also had extensive experience with ADHD at CHOC (Children’s Hospital Of Orange County) and University of California, Irvine for the “CUIDAR/COPE for attention and learning” program, as a social skills therapist for non-pharmacological research in children with ADHD. She is passionate about helping people especially with anxiety, depression and ADHD. She is also very excited to work with the new advancements in research for the treatment of Alzheimer’s disease. Her passion and excitement shows, as many patients have commented on her compassionate ways!

75% Depression

Kimberly Guevarra, R.N., M.S.N., N.P.

95%

80%

Eldepryl® (selegiline)

This Issue’s Featured Team Member

By Janet L. Minter Clinical Document Specialist

Physician Rating

Likelihood of referring someone to PRI!

In her spare time, Kim enjoys doing fun activities like Turbo Kick-Boxing, going to the beach and traveling. She has traveled extensively throughout Europe and the Philippines. She also loves to spend time with family and friends. We are fortunate to have Kim as such an important member of the PRI Team!

Continued from Page 1... Thanks to your involvement, coupled with some excellent preclinical work within the pharmaceutical industry and (as we like to believe!) a very dedicated, hard-working, team here at PRI, we can all look back at an amazing record of collaboration and accomplishment! Some very important advances have been made in treating illnesses like ADHD, anxiety, bipolar disorder, depression, insomnia, migraine headaches, nicotine addiction (i.e. smoking cessation), obesity and even persistent adult stuttering! While we have seen some important, although modest, improvements in the fight against Memory Loss in general and Alzheimer’s disease in particular, currently there are several extremely unique and potentially promising new medicines being evaluated around the world – as well as here at PRI! As noted in our 30th Anniversary PRI Bulletin, the science and promise of integrating genetics (or pharmacogenomics) into clinical research has been further increased and intensified over these past five years! Not surprisingly, we still see well over 95% of all study participants, correction: Medical Heroes, enrolling in studies here at PRI agreeing/consenting to allow a small amount of their (anonymized) blood sample to be used for

confidential genetic testing. This too further advances-the-field and the fight against many disorders and diseases! We are currently involved in a number of studies involving participants suffering from Alzheimer’s disease, depression, anxiety and even pre-Alzheimer’s disease (or “Prodromal Alzheimer’s”), where genetics and treatment responses are being correlated. This dynamic field of research has tremendous potential health and economic benefits enabling clinicians to more effectively identify responders and begin treatment(s) earlier, thereby reducing disease progression. Additionally, by excluding non-responders more readily, one can avoid side effects and/or the unnecessary economic burden in those who do not (or will not) benefit from a particular drug. Yes, each and every one of you can and should take pride in your designation as a Medical Hero! You have made a difference, a very real and important difference. We hope that you will encourage others to volunteer as well. We can assure you that your involvement, dating back to 1975, has always inspired and motivated everyone here at PRI! Moreover, we are not resting on what has been accomplished, not for a moment. We are well-positioned and highly-motivated to continue to improve the quality of life for as many people as possible, by helping to identify the safest and most effective medicines possible! It is what we have done for 35 years. We enthusiastically look forward to working with more Medical Heroes and together, there’s no limit on how much more we can accomplish!! Page 3


35 Years of Research! By Janet L. Minter Clinical Document Specialist For over 35 years PRI has been instrumental in the Food and Drug Administration (FDA) approval of a significant number of medications. The list below illustrates the wide range of medications we have studied here at PRI and the conditions/illnesses which have been successfully treated with these medications. Without your help, these effective/FDA-approved medications would not be available to help people. On behalf of all of us here at PRI, as well as the millions of patients that have benefited from these medications, we thank you, our study participants, your families and your caregivers. Your contribution makes a difference! Drug

Indication

Drug

Indication

Abilify® (aripiprazole)

Depression

Motrin® (ibuprofen)

Pain

Acomplia (rimonabant)

Weight Loss

Namenda® (memantine)

Alzheimer's Disease

Ambien® (zolpidem)

Sleep Disorders

Nimotop® (nimodipine)

Alzheimer's Disease

Ansaid® (flurbiprofen)

Anti-inflammatory/Arthritis

Parlodel® (bromocriptine)

Parkinson's Disease

Aricept® (donepezil)

Alzheimer's Disease

Paxil® (paroxetine)

Depression

Ativan® (lorazepan)

Anxiety

Pristique® (desvenlafaxine)

Depression

Axert® (almotriptan)

Migraine Headaches

ProSom® (estazolam)

Sleep Disorders

Betoptic® (betaxolol)

Glaucoma

Provigil® (modafinil)

Sleep Disorders

BuSpar® (buspirone)

Anxiety

Prozac® (fluoxetine)

Depression

Capoten® (captopril)

Hypertension

Relpax® (eletriptan)

Migraine Headaches

Cardizem-SR® (diltiazem)

Hypertension

Remeron® (mirtazapine)

Depression

Celexa® (citalopram)

Depression

Reminyl® (galantamine)

Alzheimer's Disease

Chantix® (varenicline)

Smoking Cessation

RevEyes® (dapiprazole)

Eye Disorders

Clinoril® (sulindac)

Anti-inflammatory/Arthritis

Seromycin® (cycloserine)

Tuberculosis

Contrave® (bupropion SR/

Weight Loss

Seroquel® (quetiapine)

Depression/Anxiety/Schizophrenia

Coreg® (carvedilol)

Hypertension

Serzone® (nefazadone)

Depression

Cymbalta® (duloxetine)

Depression

Sinequan® (doxepin)

Depression/Anxiety

DDA VP® (vasopressin)

Night Time Urinary Frequency

Sonata® (zaleplon)

Sleep Disorders

Desyrel® (trazodone)

Depression/Anxiety

Stadol® (butorphanol)

Pain

Diapid® (lypressin)

Urinary Disorders

Strattera® (atomoxetine)

ADHD

Effexor® (venlafaxine)

Depression

Surmontil® (trimipramine)

Depression

Effexor-XR® (venlafaxine)

Depression

Symbyax® (fluoxetine and olanzapine)

Depression

naltrexone SR)

Rave Reviews! At the completion of each patient’s participation in a PRI study, we send out Study Completion Questionnaire postcards. These questionnaires are designed to be returned to us as anonymous ratings of the care patients received from our physicians and nurses, as well as the likelihood of a patient referring someone to PRI. For those patients wishing to communicate additional remarks to us, pertaining to their experience(s) at PRI, there is a space on the postcard for optional comments. As indicated below, for 2009, our patient satisfaction scores were exceptional! To view some of the patient comments, please visit the Te s t i m o n i a l s s e c t i o n o f o u r w e b s i t e a t www.priresearch.com.

100%

90% 99%

98%

98%

85%

Nurse Rating Trental® (pentoxfylline)

Pain

Exelon® (SDZ ENA 713)

Alzheimer's Disease

Triavil® (perphenazine/amitriptyline)

Anxiety/Depression

Frova® (frovatriptan)

Migraine Headaches

Vasodilan® (isoxsuprine)

Blood Flow Improvement

Gabitril® (tiagabine)

Anxiety

Vestra (reboxetine)

Depression

Halcion® (triazolam)

Sleep Disorders

Vyvanse® (lisdexamfetamine dimesylate)

ADHD

Haldol® (haloperidol)

Schizophrenia

Wellbutrin® (bupropion)

Depression

Imitrex® (sumatriptan)

Migraine Headaches

Wellbutrin-SR® (bupropion)

Depression

Ketasyn™ (AC-1202)

Alzheimer's Disease

Xanax® (alprazolam)

Anxiety

Lamictal® (lamotrigine)

Depression

Zantac® (ranitadine)

Ulcers

Lexapro® (escitalopram)

Depression

Zofran® (ondansetron)

Prevents Nausea and Vomiting

Lunesta® (eszopiclone)

Sleep Disorders

Zoloft® (sertraline)

Depression

Luvox® (fluvoxamine)

Depression

Zomig® (zolmitriptan)

Migraine Headaches

Lyrica® (pregabalin)

Anxiety/Fibromyalgia

Zyban® (bupropion)

Depression

Maxalt® (rizatriptan)

Migraine Headaches

Zyflo® (zileuton)

Asthma

Meridia® (sibutramine)

Weight Loss

Zyprexa® (olanzapine)

Schizophrenia/Bipolar

Mirapex® (pramipexole)

Parkinson's Disease

Page 2

By My-Linh Tong, R.N., M.S.N., N.P. Clinical Research Nurse

PRI would like to introduce you to a key member of our research team, Kim Guevarra, R.N., M.S.N., N.P. Kim has been a resident of Orange County since the age of seven. She spent most of her formative years in Irvine, graduating from University High School. She did not go too far to attend college at the University of California, Irvine, where she earned a Bachelor’s Degree in Applied Ecology with a minor in Epidemiology and Public Health. She decided to flap her wings after graduation and study abroad in Laguna, Philippines, her native country, for three months to learn about the language, culture and social justice issues. This experience helped her solidify her intuitive nature to understand people and their differences. She returned to focus her attention on nursing. She was a member of the first graduating class of an entry-level Master’s program for Nursing at California State University, Los Angeles. It was here that she earned her Master’s degree in Nursing and a certificate as a Family Nurse Practitioner. Since then, Kim has worked at Huntington Memorial Hospital in Pasadena and at Kaiser Permanente Hospital and Medical Center in Irvine, both times on the cardiac telemetry unit. She also had extensive experience with ADHD at CHOC (Children’s Hospital Of Orange County) and University of California, Irvine for the “CUIDAR/COPE for attention and learning” program, as a social skills therapist for non-pharmacological research in children with ADHD. She is passionate about helping people especially with anxiety, depression and ADHD. She is also very excited to work with the new advancements in research for the treatment of Alzheimer’s disease. Her passion and excitement shows, as many patients have commented on her compassionate ways!

75% Depression

Kimberly Guevarra, R.N., M.S.N., N.P.

95%

80%

Eldepryl® (selegiline)

This Issue’s Featured Team Member

By Janet L. Minter Clinical Document Specialist

Physician Rating

Likelihood of referring someone to PRI!

In her spare time, Kim enjoys doing fun activities like Turbo Kick-Boxing, going to the beach and traveling. She has traveled extensively throughout Europe and the Philippines. She also loves to spend time with family and friends. We are fortunate to have Kim as such an important member of the PRI Team!

Continued from Page 1... Thanks to your involvement, coupled with some excellent preclinical work within the pharmaceutical industry and (as we like to believe!) a very dedicated, hard-working, team here at PRI, we can all look back at an amazing record of collaboration and accomplishment! Some very important advances have been made in treating illnesses like ADHD, anxiety, bipolar disorder, depression, insomnia, migraine headaches, nicotine addiction (i.e. smoking cessation), obesity and even persistent adult stuttering! While we have seen some important, although modest, improvements in the fight against Memory Loss in general and Alzheimer’s disease in particular, currently there are several extremely unique and potentially promising new medicines being evaluated around the world – as well as here at PRI! As noted in our 30th Anniversary PRI Bulletin, the science and promise of integrating genetics (or pharmacogenomics) into clinical research has been further increased and intensified over these past five years! Not surprisingly, we still see well over 95% of all study participants, correction: Medical Heroes, enrolling in studies here at PRI agreeing/consenting to allow a small amount of their (anonymized) blood sample to be used for

confidential genetic testing. This too further advances-the-field and the fight against many disorders and diseases! We are currently involved in a number of studies involving participants suffering from Alzheimer’s disease, depression, anxiety and even pre-Alzheimer’s disease (or “Prodromal Alzheimer’s”), where genetics and treatment responses are being correlated. This dynamic field of research has tremendous potential health and economic benefits enabling clinicians to more effectively identify responders and begin treatment(s) earlier, thereby reducing disease progression. Additionally, by excluding non-responders more readily, one can avoid side effects and/or the unnecessary economic burden in those who do not (or will not) benefit from a particular drug. Yes, each and every one of you can and should take pride in your designation as a Medical Hero! You have made a difference, a very real and important difference. We hope that you will encourage others to volunteer as well. We can assure you that your involvement, dating back to 1975, has always inspired and motivated everyone here at PRI! Moreover, we are not resting on what has been accomplished, not for a moment. We are well-positioned and highly-motivated to continue to improve the quality of life for as many people as possible, by helping to identify the safest and most effective medicines possible! It is what we have done for 35 years. We enthusiastically look forward to working with more Medical Heroes and together, there’s no limit on how much more we can accomplish!! Page 3


A commonly accepted definition of Hero is a person who is admired for courage, fortitude, strength and nobility! As the Center For Information & Study On Clinical Research Participation [CISCRP] wrote in their brochures, “It is said that the greatest gift is one which is given anonymously, given when you did not know whether you would receive any direct personal benefit in return...This is the gift you gave by taking part in clinical research.� While the degree to which you may have personally benefited from enrolling in a clinical study here at PRI is unique unto you, as illustrated (on page 2) in this Bulletin, you can take great pride in knowing that your involvement has helped to advance the field of medicine! Literally, so many lives have been improved because of you, and millions of others like you, chose to participate in a research study. We appreciate, admire and thank you--as a Medical Hero! Continued on Page 3


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