Preface

Chapter 6 **Multimodality Imaging to Detect Vulnerable Plaque in Coronary Arteries and Its Clinical Application 91**

Chapter 8 **Ethical Aspects of Vulnerable Group of Patients in**

Pablo Alejandro Millones Gómez

Sabe Sabesan and John Zalcberg

Aurora Occa and Susan E. Morgan

**Inventory (CTCI) 199**

**A Pilot Study 109** Katarzyna Rygiel

**Clinical Trials 125**

**Research 139**

**Section 4 Clinical Trials 123**

**VI** Contents

Pannipa Suwannasom, Yohei Sotomi, Yosuke Miyazaki, Erhan Tenekecioglu, Yoshinobu Onuma and Patrick W. Serruys

Chapter 7 **"Calendarium Vitae" for Hospice Patients and their Caregivers:**

Ekaterina Ivanova, Ilko Getov and Hristina Lebanova

Chapter 10 **Access to Clinical Trials Closer to Home Using Tele-health 157**

**Medical Research and Clinical Trials: A Systematic Review 177**

**Recruitment and Consent: The Clinical Trial Communication**

Soroya Julian McFarlane, Janice Krieger and JoNell E. Potter

Susan E. Morgan, Amber Finn, Jessica Raley, Wei Peng, Aurora Occa,

Chapter 9 **Nature of Vulnerability in Biomedical and Psychosocial**

Chapter 11 **Training Programs for Improving Communication about**

Chapter 12 **Assessing Communication Practice during Clinical Trial**

The book Clinical Trials in Vulnerable Populations has 12 chapters divided in four sections:


More than 30 authors came from different countries of the world, from Serbia to Turkey. The editor of this book is Professor Milica Prostran MD, Ph.D. Professor Prostran is a phar‐ macologist as well as a clinical pharmacologist with a subspecialty in clinical pharmacology - pharmacotherapy. This editorial task was due to her vast experience with publishing in respected international journals. She has published more than 200 *in extenso* papers in inter‐ national journals indexed in CC/SCI, and over 50 chapters in international and national books. Professor Prostran serves as a member (and referee) of the Editorial Board of several highly respected international journals - *Frontiers in Ageing Neuroscience*, where she is an As‐ sociate Editor, *Frontiers in Pharmacology*, *Current Medicinal Chemistry*, as well as several na‐ tional scientific and professional journals.

"Vulnerable subject - a subject who is at risk (from trialist rather than from disease). Exam‐ ples include patients with very serious diseases and with high expectations of the benefits of a new product, subjects who have a working relationship with investigators (medical stu‐ dents, nurses, employees of pharmaceutical companies, etc." (Day, 2007).

Some authors make a distinction between a vulnerable population and a special research population.

A vulnerable population includes children and minors, pregnant women, fetuses and human *in vitro* fertilization. Also, cognitive impaired persons and prisoners are included in this group.

On the other hand, a special population includes students, residents, employees, terminally ill patients and minorities (Prostran et al., 2012, Prostran et al., 2016).

The potential reader is shown the modern approach to clinical trials in vulnerable popula‐ tions, from different points of view (Medič et al., 2016). The chapters deal at length and clari‐ ty with their topics. Finally, I believe that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of them must consider this very important field of medicine: clinical trial in vulnerable patients. Also, I believe that the answers to their questions may be found in this book and may make their practice at least more bearable.

Last but not least, I want to express my gratitude to Ms. Diana Olloni from InTechOpen, for her constant help during the editing of this book.

### **Professor Milica Prostran MD, Ph.D.**

**Minority Patients**

**Section 1**

Chair of Pharmacology Clinical Pharmacology and Toxicology University of Belgrade, Serbia

#### **References**


**Section 1**

**Minority Patients**

Last but not least, I want to express my gratitude to Ms. Diana Olloni from InTechOpen, for

[1] Day S. Dictionary of clinical trials, 2007.2nd edition, John Wiley & Sons, Ltd, Chi‐

[2] Prostran M, et al. Bioethics in clinical trials: vulnerable subjects. In: Bioethics and pharmacology: ethics in preclinical and clinical drug development, eds. Z Todor‐

[3] Prostran M, et al. Pharmacotherapy of pain in the older population: the place of

[4] Medić B, et al. Evaluation of novel biomarkers of acute kidney injury: the possi‐ bilities and limitations. Current Medicinal Chemistry, 2016, 23, 1981-1997.

ović, Milica Prostran and Karel Turza, 2012, 87-100.

opioids. Frontiers in Aging Neuroscience, 2016, 8, 144.

**Professor Milica Prostran MD, Ph.D.**

Clinical Pharmacology and Toxicology

Chair of Pharmacology

University of Belgrade, Serbia

her constant help during the editing of this book.

**References**

VIII Preface

chester.

**Chapter 1**

**Provisional chapter**

**Scientific and Ethical Considerations for Increasing**

Since its inception, a major weakness in clinical trial research has been an inability to recruit diverse populations into clinical trials. These under-represented populations are mostly comprised of the poor, the elderly, children, women, and racial/ethnic minorities (African Americans and Hispanics). This fundamental weakness is further exacerbated by the fact that these same groups are often disproportionately affected by the diseases being studied in clinical trials. There are various patient specific, provider specific, and policy related causes for the existence of these disparities. Regardless of the cause, the lack of participation of these groups in clinical trials raises important questions about the quality and ethics of clinical research. The goal of this document is to discuss the evidence and reasons behind disparities in clinical trial participation. We also provide a discourse on potential mechanisms to address disparities in clinical trial accrual including the ethical considerations of financial incentives, the impact of a more stringent policy and review process for product approval from the Food and Drug Administration (FDA) including a diversity mandate with an associated population black box warning.

**Keywords:** African American, hispanic, clinical trials, underrepresented, health disparities,

Since its inception, a major weakness in clinical trial research has been an inability to recruit diverse populations into clinical trials. These under-represented populations are mostly comprised of the poor, the elderly, children, women, and racial/ethnic minorities (African Americans and Hispanics). This fundamental weakness is further exacerbated by the fact that these same groups are often disproportionately affected by the diseases being studied in clinical trials. There are various patient specific, provider specific, and policy related causes for the existence

**Scientific and Ethical Considerations for Increasing** 

DOI: 10.5772/intechopen.70181

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution,

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,

distribution, and reproduction in any medium, provided the original work is properly cited.

and reproduction in any medium, provided the original work is properly cited.

**Minority Participation in Clinical Trials**

**Minority Participation in Clinical Trials**

Additional information is available at the end of the chapter

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.70181

food and drug administration (FDA)

Julius M. Wilder

**Abstract**

**1. Introduction**

Julius M. Wilder

**Provisional chapter**
