A Comprehensive and Practical Guide to Clinical Trials

Delva Shamley, Brenda Wright

• Publisher: Academic Press
• Year: 2017
• Print ISBN: 9780128047293
• eBook ISBN: 9780128047309
• Topic: Medicina
• Subtopic: Teoria, pratica e riferimenti medici

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related.It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members.This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end.- Describes the entire clinical trial management process from start to finish in a step-by-step guide- Provides best practice elements, including case studies, practical examples, activities, and checklists

Chapter 1

Introduction to Clinical Trials

Brenda Wright

Abstract

Conducting a Clinical Trial is a systematic process of gathering a multitude of information for analysis. This chapter describes the Clinical Research Trial processes from beginning to end with illustrations, and links them to key stakeholders and Good Clinical Practice. This chapter defines the study design and the outcomes to be met. What makes a good research question and how this informs the design is discussed.

Keywords

Clinical Research; Clinical Trials; research question; research methods; key stakeholders

Chapter Outline

What Is a Clinical Trial? 1

Why Do We Do Clinical Trials? 1

Clinical Team 3

Study Participant 3

Medicines Regulatory Authorities 3

IRB/IEC Ethics Committees 4

Sponsor 4

Contract Research Organizations 5

Managing the Trial 5

Further Reading 9

The purpose of this book is to illustrate and provide guidelines and information for planning and conducting a successful Clinical Trial from the Project Management perspective. Project Management is the application of planning, knowledge, skills, and technique to execute projects effectively and efficiently.

It will also describe the processes from beginning to end, and link these processes to key stakeholders and Good Clinical Practice (GCP), all of which are critical to the success of a trial (Table 1.1 and Fig. 1.1).

Table 1.1

What Is Good Clinical Practice?

GCP provides guidelines as defined by the ICH, an international body which defines standards that governments can transpose into regulations for clinical trials involving humans. These standards are referred to as ICH-GCP or ISO-GCP.

It is a standard for clinical trials, which includes the design, conduct, performance, monitoring, termination, auditing, recording, analysis, reporting, and documentation of clinical trials. These standards ensure that the trials are scientifically and ethically sound and that the clinical properties of the pharmaceutical product under investigation are properly documented and the data and reported results are credible and accurate. It also ensures that the rights, integrity, and confidentiality of trial participants are protected.

GCP guidelines therefore protect the human rights of participants in a clinical trial and provide assurance of the safety and efficacy of the newly developed compound. These guidelines also require detailed documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. It defines the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. Quality assurance and inspections ensure that these standards are met.

The aim of GCP is to provide Investigators and their study teams with the tools to protect human subjects and collect quality data.

Figure 1.1 Key stakeholders.

What Is a Clinical Trial?

A Clinical Trial is a prospective biomedical or behavioral research project that involves human volunteers (participants) and/or uses materials of human origin, for example, observed behavior, answers to questions, and/or obtaining tissue or specimen samples.

Why Do We Do Clinical Trials?

Clinical trials are designed to answer a specific research question. They are used to determine if a new biomedical or behavioral intervention is safe, efficacious, and effective.

Good Research Questions are:

• Clear. They are easy to understand and unambiguous.

• Specific. They are specific enough to understand what constitutes an answer.

• Answerable. It is clear what data we need, to answer the questions, and how the data will be collected.

• Interconnected. All the questions are related in some meaningful way, forming a coherent whole.

• Substantively relevant. They are nontrivial questions that are fundamentally worthy of the research effort and cost.

Some approaches are:

• To evaluate interventions (drugs, medical devices, etc.) for treating a disease, syndrome, or condition.

• To evaluate interventions that will identify or diagnose a particular disease or condition.

• To find methods to prevent the onset or recurrence of a disease or condition (medicine, vaccines, lifestyle changes, etc.).

• To investigate and identify methods to improve quality of life and comfort for patients with chronic illnesses.

These approaches have to follow GCP guidelines as defined by the International Council for Harmonization (ICH) and subsequently adapted in many countries (Table 1.1).

Clinical Team

The Sponsor or its contracted research organization (CRO) will appoint an Investigator Site consisting of the Principal Investigator and his/her Clinical Team who will conduct the clinical trial. In many countries the research team will be provided by a Clinical Trials Unit (CTU), which is based within the institution. On others, a CRO may provide all the research staff.

Study Participant

A voluntary, informed person who has read and signed the Informed Consent Document, agreeing to the procedures, etc. he/she will be involved in during a Clinical Trial.

Medicines Regulatory Authorities

In the case of trials involving an investigative medicinal product, regulatory requirements include approval by a medicines regulatory authority (MRA). The MRA is responsible for ensuring that all clinical trials of both nonregistered medicines, and new indications of registered medicines, comply with the necessary requirements for safety, quality, and efficacy. Applications for clinical trials and for registration of medicines and medical devices are reviewed by a MRA expert committee, which considers among other issues the scientific, medical, and ethical issues of the applications. Reports on the progress of the study are sent to the MRA on a regular basis. Proof of safety, quality, and efficacy must be submitted when applying to the Medicines Control Council (MCC) for approval and registration of a med...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• List of Contributors
• Foreword
• Chapter 1. Introduction to Clinical Trials
• Chapter 2. Clinical Trial Phases
• Chapter 3. Setting Up of Site, Site Assessment Visits, and Selection
• Chapter 4. Regulatory Requirements
• Chapter 5. Contracts and Agreements
• Chapter 6. Protocol, Informed Consent Documents, and Investigator Brochure
• Chapter 7. Planning
• Chapter 8. Recruitment and Retention
• Chapter 9. Training
• Chapter 10. Data Management
• Chapter 11. Investigational Medicinal Product (IMP) Management
• Chapter 12. Collecting, Processing, and Shipment of Blood and Urine Samples
• Chapter 13. Source Document
• Chapter 14. Screening, Treatment, and Safety Follow-up Visit
• Chapter 15. Quality Management
• Chapter 16. Monitoring, Close-Out Visits, and Archiving
• Chapter 17. Audits and Inspections
• Glossary
• Index