Standardized Clinical Trials Endpoints to Help Health Authorities Tackle Respiratory Diseases.
We all know that smoking and some allergies are bad for our lungs, but now science is standardizing the way that we measure respiratory health, helping to judge the effectiveness of drug treatments better than ever, according to a new report by healthcare experts GBI Research.
The new report* shows that asthma and chronic obstructive pulmonary disorder (COPD), common conditions causing breathing difficulties, are now being studied using a set of common clinical endpoints, which help to standardize test results and draw conclusions regarding the effectiveness of new drugs.
COPD is cited as the fourth most common cause of death in the US by the National Institute of Health, representing a collection of progressive lung diseases including emphysema and chronic bronchitis, often caused by smoking, and is proving a heavy economic burden for state healthcare. Therefore, is has been imperative for health authorities to further improve on their endpoint measurements in order to compare the available treatment options for these disorders.
Clinical trial endpoints are used to measure the outcomes of medical testing, assessing the effects of new treatments. Endpoints in respiratory disease clinical trials should be accurate, precise, easily measurable and reliable, and range from techniques such as daily symptoms scoring, use of rescue medication and the quality of life score, to more specific vital signs such as measuring pulmonary function, respiratory rate and pulse.
The endpoints used in respiratory clinical trials are often chosen depending on the developmental stage of the molecule being studied, as agencies require Phase III trials to study direct clinical endpoints in order to grant drug approvals.
Physicians confirm diagnoses of asthma using pulmonary function tests (PFT), and classify the condition based on Peak Expiratory Flow (PEF) rate, frequency of symptoms and Forced Expiratory Volume (FEV). It is therefore not surprising that FEV was used in 29.9% of completed Phase III clinical trials for asthma products as a primary endpoint during 2000-2010, while another 29.3% of these trials used multiple PFT as a secondary endpoint.
Similarly, 49.2% of phase III COPD clinical trials during 2000-010 used FEV as a primary endpoint, while 20.3% used multiple PFTs as endpoints. PFTs were employed as a primary endpoint in 64 completed clinical trials for asthma and COPD.
Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles
This report presents the use of endpoints or outcome measures in respiratory disease's clinical trials for asthma, cystic fibrosis, chronic obstructive pulmonary disorder and pulmonary arterial hypertension. Detailed analysis about the clinical and surrogate endpoint used in various phases and stages of clinical trials are presented. This report presents detailed overview about the endpoint used in major marketed drugs and most promising molecules under development. It also contains company profiles of major companies involved with marketing of major marketed drugs under respiratory drug franchise.
This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.
Abstract
Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles
Summary
GBI Research in its report "Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles" presents the use of endpoints or outcomes measures in respiratory disease's clinical trials. In this report, endpoint used in asthma, cystic fibrosis, chronic obstructive pulmonary disorder and pulmonary arterial hypertension are presented. In this report detailed analysis about the clinical and surrogate endpoint used in various phases and stages of clinical trials are presented. This report presents detailed overview about the endpoint used in major marketed drugs and most promising molecules under development. The report contains company profiles of major companies involved with marketing of major marketed drugs under respiratory drug franchise.
Scope
The report starts with an executive summary, providing insights about the prominent endpoint used in respiratory clinical trials.
This report deals with different types of endpoint used in respiratory clinical trials. It contains brief account of advantages, disadvantages and regulatory aspects of each type of endpoint.
This report provides in-depth analysis of clinical trial endpoints used in asthma, COPD, cystic fibrosis and PAH clinical trials.
This report covers complete account of primary and secondary endpoints used in Phase III and Phase II clinical trials in above mentioned respiratory diseases.
In this report characterization and segmentation of trials based on their status, along with specific use of endpoints is also provided.
This report provides profiling of major marketed drugs based on their safety, efficacy and clinical study details.
The report contains company profiling of major companies associated with marketing of major respiratory drugs covering asthma, COPD, cystic fibrosis and PAH.
This report also includes endpoint analysis of terminated trials for asthma, COPD, cystic fibrosis and PAH. Analysis of terminated trials can be used in designing more robust trials and avoid any issues, which can result in termination of trial.
Reasons to buy
Understand the pattern of use of primary and secondary endpoints, according to specific indication's and clinical Phase of trial. This will help in designing clinical trials so as to and protect one's product from confronting any of the safety issues.
To analyze the major primary and secondary endpoint used in disease specific clinical trials.
Reinforce R&D strategies by identifying new endpoints to be used in disease and clinical phase specific clinical trials. This can increase positive outcome from a trial and aid in bringing molecules with increased efficiency and better safety profiles.
Develop key strategic initiatives by understanding the key focus of major companies developing drugs in respiratory franchise.
Build effective strategies by clinical phase wise endpoint analysis of clinical trials. This can help in reducing the drug's time to market.
Exploit strategies for designing of clinical trials by identifying the advantages and disadvantages involved with the use of specific endpoints.
Table of Contents
TOC
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 10
2 Introduction 13
3 Clinical Trials Endpoints in Respiratory Diseases - An Overview 14
3.1 Introduction 14
3.2 Types of Endpoints 14
3.2.1 Primary Endpoints 14
3.2.2 Secondary Endpoints 14
3.2.3 Surrogate Endpoints 15
4 Endpoints - Clinical Trials in Asthma - Marketed and Pipeline Products Assessment 16
4.1 Introduction 16
4.2 Primary Endpoints Used in Asthma Clinical Trials 20
4.2.1 Pulmonary Function Tests: 20
4.2.2 Vital Signs and Physical Activity 20
4.2.3 Biomarkers 20
4.2.4 Serious Adverse Events 20
4.3 Secondary Endpoints Used in Asthma Clinical Trials 21
4.3.1 Pharmacokinetics and Pharmacodynamics 21
4.3.2 Quality of Life Scores 21
4.3.3 Clinical Laboratory Tests - Biochemistry and Serum Hematology 21
Figure 1: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Total Number Of Clinical Trials, 2000-2010 16
Figure 2: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Phase of Clinical Trials, 2000-2010 17
Figure 3: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Status of Clinical Trials, 2000-2010 18
Figure 4: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Distribution of Clinical Trials, By Company (%), 2000-2010 19
Figure 5: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 31
Figure 6: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 33
Figure 7: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 35
Figure 8: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 37
Figure 9: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 39
Figure 10: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 40
Figure 11: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 41
Figure 12: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 43
Figure 13: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 45
Figure 14: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 47
Figure 15: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 49
Figure 16: Endpoints - Clinical Trials in Respiratory Disorders, Asthma, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 50
Figure 17: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Total Number of Clinical Trials, 2000-2010 76
Figure 18: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Phase of Clinical Trials, 2000-2010 77
Figure 19: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Status of Clinical Trials, 2000-2010 78
Figure 20: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Distribution of Clinical Trials, By Company (%), 2000-2010 79
Figure 21: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 90
Figure 22: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 92
Figure 23: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 94
Figure 24: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 96
Figure 25: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 98
Figure 26: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 99
Figure 27: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 100
Figure 28: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 102
Figure 29: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 104
Figure 30: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 105
Figure 31: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 107
Figure 32: Endpoints - Clinical Trials in Respiratory Disorders, COPD, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 108
Figure 33: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Total Number of Clinical Trials, 2000-2010 125
Figure 34: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Phase of Clinical Trials, 2000-2010 126
Figure 35: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Status of Clinical Trials, 2000-2010 127
Figure 36: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Distribution of Clinical Trials, By Company (%), 2000-2010 128
Figure 37: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 136
Figure 38: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2000-2010 137
Figure 39: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 138
Figure 40: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2000-2010 139
Figure 41: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 141
Figure 42: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2000-2010 142
Figure 43: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 143
Figure 44: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2000-2010 145
Figure 45: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 146
Figure 46: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2000-2010 148
Figure 47: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 149
Figure 48: Endpoints - Clinical Trials in Respiratory Disorders, Cystic Fibrosis, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2000-2010 150
Figure 49: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Total Number of Clinical Trials, 2002-2010 157
Figure 50: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Phase of Clinical Trials, 2002-2010 158
Figure 51: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Status of Clinical Trials, 2002-2010 159
Figure 52: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Distribution of Clinical Trials, By Company (%),2002-2010 160
Figure 53: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2002-2010 170
Figure 54: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Completed Phase III Clinical Trials, (%), 2002-2010 171
Figure 55: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2002-2010 172
Figure 56: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Active Phase III Clinical Trials, (%), 2002-2010 173
Figure 57: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Terminated Phase III Clinical Trials, (%), 2002-2010 175
Figure 58: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Terminated Phase III Clinical Trials, (%),2002-2010 176
Figure 59: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2002-2010 177
Figure 60: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Completed Phase II Clinical Trials, (%), 2002-2010 178
Figure 61: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension Global, Primary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2002-2010 180
Figure 62: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Active Phase II Clinical Trials, (%), 2002-2010 181
Figure 63: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Primary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2002-2010 183
Figure 64: Endpoints - Clinical Trials in Respiratory Disorders, Pulmonary Arterial Hypertension, Global, Secondary Endpoint Analysis of Terminated Phase II Clinical Trials, (%), 2002-2010 184
Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles published by GBI Research in June 25, 2012. This report consists of Pages: 194 and the price starts from US $ 3500.
