Are Geriatric Populations Underrepresented in Clinical Trials?

By

[Name of the Institute]

[Course Code]

CHAPTER 1: INTRODUCTION1

1.1. Outline of the Study1

1.2. Background of the Study1

1.3. Problem Statement2

1.4. Purpose Statement2

1.5. Significance of the Study3

1.6. Aims and Objectives3

1.7. Research Objectives4

1.8. Research Questions4

1.9. Research Hypotheses5

1.10. Definition of Terms5

Clinical Trials5

Geriatrics5

CHAPTER 2: LITERATURE REVIEW7

2.1. Geriatric Medicine7

2.2. Geriatric Clinical Trials7

2.3. Barriers in Involvement of Aged Patients in Clinical Assessments8

2.4. Recommended Practice Change in Elderly Adults for RCT9

CHAPTER 3: METHODOLOGY10

3.1. Research Method10

3.2. Research Design and Instrumentation10

3.3. Search Strategy11

3.4. Inclusion Criteria11

3.5. Exclusion Criteria11

3.6. Choice of Conditions to Study and Sample Size12

3.7. Procedure for Answering the Research Questions12

3.8. Limitations13

REFERENCES14

APPENDICES16

CHAPTER 1: INTRODUCTION

1.1. Outline of the Study

The study is about clinical trials issues in geriatric populations, which is distributed into three chapters. The first chapter includes the brief introduction of the study with its purpose, significance, research objectives to be met and research questions. The second chapter includes a literature review with respect to the geriatric clinical trials, reasons of exclusion and inclusion in the research. Furthermore, literature also covers the major possible strategies for competent management of issues related to underrepresented geriatric clinical trials and finally it is ended by recommending potential strategies in order to establish populations in better clinical trial designs for geriatric populations. The third chapter includes the methodology of conducted the study with all its specific information.

1.2. Background of the Study

In many advanced nations, the older patients are the fastest growing populations among the other proportions of age groups. The elderly patients group is sharing a medication profile in which variety of medicines are available for their usage since; they are experiencing a higher frequency of morbidities due to diseases, consumption of more drugs, excessive multiple medications and sensitivity issues toward unfavorable drugs reactions. For that reason, many pharmaceutical companies target their drug marketing towards the elderly groups. Curiously, most of the elderly patients are not included in the clinical trials of drugs. Therefore, there is to increase the participation of the elderly population in clinical drug trails thereby improving the safety and effectiveness of drugs, which are intended for this pharmacologically susceptible subpopulation. The drugs regulatory agencies and geriatrics societies must work together in order to explore new definitions, prepare new designs and invent new technologies for evaluating the inclusion of the elderly in clinical trials (Schmucker & Vesell, 1999).

1.3. Problem Statement

The older patients are considerably underrepresented in clinical trials (MacLennan, 1998). The American Geriatrics Society in its Annual Meeting in 2008 reported that the drug regulatory authorities should promote the inclusion of older patients in clinical trials of drugs (Cherubini, et.al, 2010). Thus, a research should be as following:

“The identification of causes for not including older patients in the clinical trials as well as removing of bias regarding to the participation of the elderly due to multiple co-morbidities should be addressed so that, geriatricians can receive help against age issues in clinical trials”.

1.4. Purpose Statement

The purpose of this research is to explore the inclusion criteria and the percentage of the elderly patients in clinical trials and ...