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Global Clinical Trials Playbook

Global Clinical Trials Playbook
  • Author : Menghis Bairu,Richard Chin
  • Publisher :Unknown
  • Release Date :2012
  • Total pages :310
  • ISBN : 9780124157873
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Summary : Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. * Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world * Provides real world international examples which illustrate the practical translation of principles * Includes forms, templates, and additional references for standardization in a number of global scenarios

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
  • Author : Menghis Bairu,Michael Weiner
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780124115309
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Summary : Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : James (Dachao) Fan,Li Huafang,Jing Yin
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070505
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Summary : China has the largest number of people with dementia and the incidence is projected to increase much faster than in the developed world. There is a great demand for new drugs that can prevent or treat the disease and great potential for conducting Alzheimer’s disease clinical trials. The majority of Alzheimer’s disease trials that have been conducted in China are local trials. In early years, there were deficiencies in trial design and implementation; however, with more attention from the government and concerted efforts among Alzheimer’s disease experts, the standards for conducting Alzheimer’s disease clinical trials have improved. There are currently 159 clinical trial institutions capable of conducting Alzheimer’s disease trials in China, offering good facilities, experienced investigators and easily accessible patient pools. Recently a few global pharmaceutical companies have expanded their Alzheimer’s disease trials into China. It is expected that with increasing exposure to global standards and improved training, China’s capacity and capability to conduct Alzheimer’s disease trials will be strengthened.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Jeffrey Cummings,Kate Zhong
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070406
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Summary : Globalization is increasingly common as a means of more rapidly recruiting patients, shortening clinical trials, abbreviating clinical development cycle times, and preparing for marketing in non-US markets. Globalization refers to the inclusion of trial sites in three or more international regions. Globalization is common and most drug development programs include both US and non-US sites. There has been limited evaluation of the transnational performance of clinical trial instrumentation used in drug development programs. The performance across nations, languages and cultures of the ADAS-Cog, Clinical Dementia Rating, Neuropsychiatric Inventory, quality of life measures, pharmacoeconomic measures, and activities of daily living tools has been inadequately researched. The creation of a library of well-tested and shared instruments would be of value in globalized trials. The approach to diagnosis of Alzheimer’s disease may vary across trial sites and create undesirable heterogeneity within clinical trials. Biological factors such as differences in liver metabolism enzymes, diet, education and head size may all create differences in treatment response in different ethnic settings. Sites across the globe may differ in terms of experience, and institutional review boards may also perform variably with regard to informed consent and human safety. These require vigilance by sponsors performing globalized trials. International efforts such as the Alzheimer’s Disease Neuroimaging Initiative provide data that will help reduce the variance and improve clinical trial quality. Improved understanding of the effects of globalization will enhance clinical trials and speed the development of new medications for patients with AD.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Seong Yoon Kim
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070543
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Summary : Prevalence of dementia in Korea is 9.1% of the elderly population, and those with dementia are thus estimated to be nearly 750,000. Dementia due to Alzheimer’s disease (AD) accounts for 45–75% of all dementia syndromes, whereas vascular dementia accounts for about 12–37%. Clinical research on AD has been greatly expanded in volume and quality in the last 10 years in Korea, partly due to public and governmental awareness of the increase of the elderly population. The national drug market for dementia in 2020 is estimated to be US$ 1,700 million. Past experiences in clinical research or drug trials for AD have taught us several lessons: 1) cognitive tests and function measurements need careful interpretation due to the unstable educational system in Korea between 1940 and 1970, and the rapid industrialization of modern Korean society; 2) in a governmental drive to encourage clinical research, several national collaborative research networks will work as a solid base for future clinical trials; 3) recent revision of clinical research-related regulations, and a change in the general public's views on drug trials, can be both an advantage and a disadvantage for drug trials at the same time.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yoko Fujimoto,Takeshi Iwatsubo
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070536
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Summary : Considering the difficulty of clinical development for Alzheimer’s Disease (AD), understanding each country’s specific situation is an important first step in reducing the operational burden on clinical trials while maintaining the quality of the study. In this chapter, the long history of clinical development for AD in Japan is introduced. There has been a lot of experience in Japan of AD clinical development from the time of developing donepezil to the current global development of AD disease-modifying drugs. However, this experience has not always been a success story and has often been the cause of much frustration, such as the failure of Phase III studies, high regulatory requirements, development and implementation of neuropsychological tests, influence of ethnic factors, etc. However, all of these points provide us with a good source from which we can learn about the challenges of the clinical trials and discuss how to strengthen the quality and efficiency. It’s important to take advantage of this experience for future success in the clinical development of AD, especially in emerging markets.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Menghis Bairu,Sidney A. Spector,Richard Chin
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070390
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Summary : A rapid increase in the globalization of clinical trials is being driven by a need for lower cost, greater speed, and higher quality. Increasing costs—approximately 20% per year—account for much of this effort. Trials in developing countries—done with rigorous controls and safeguards—can lower the cost of drugs, distribute modern science and medicine, and enhance the health of patients around the world. Lesser developed countries offer a large pool of willing, treatment-naïve patients. Globalization of clinical trials introduces potential issues: for example, ethical concerns, harmonization, logistical challenges. Researchers must take into account potential ethnic, genetic, and other differences which can make extrapolation from one geographical region to another problematic. Differences between populations and geographies are divided into intrinsic and extrinsic differences. Historically, these differences have not resulted in changes to the risk–benefit ratio of outsourcing clinical trials.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070499
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Summary : There is considerable interest, both nationally and internationally, in conducting dementia research in India. Motivated by a rapid increase in the aging population and a desire for indigenous, self-sufficient healthcare and medical research, dementia research in India is on course for rapid growth in the coming years. Several challenges will have to be overcome along the way. A solid and general clinical research culture and a supportive healthcare system, both tailored to the specific needs of the dementia field and its vulnerable patient population, will have to be established through careful guidance of government regulators and collaborations with academic, industry and public stakeholders both in and outside India.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070529
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Summary : Turkey straddles the continents of Europe and Asia, and this unique geographical location steers its economy. On the world economic scale, as an exceptional emerging economy, Turkey is the 16th largest economy in the world and the sixth largest economy as compared with the European Union countries, according to gross domestic product. The Turkish pharmaceutical sector is ranked 16th in terms of market value, and it is 36th in terms of the clinical research conducted and the volume of pharmaceutical exports. Investments by foreign companies have increased since 1984 and 19 foreign capital firms have entered the Turkish pharmaceuticals market since 1990. Today, there are approximately 300 entities operating in Turkey. Turkey has a long tradition of providing clinical trial legislation, regulation and guidelines; the country has taken major steps towards harmonizing its legislation with those of the European Union in the field of clinical research. Currently Turkish regulations are completely in line with EC Directives. Clinical trials performed in the field of Alzheimer’s disease in Turkey since 1997, including their rationale, design, summary, and outcomes, are discussed in this chapter.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Hans J. Möbius
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070420
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Summary : Regulatory approval of the first rational AD therapeutic tacrine occurred in 1993, followed by the approval of three other, AChEIs, and the NMDA antagonist memantine in 2002 (EMA) and 2003 (FDA) respectively. Since then, despite an enormous research and development effort, the past 10 years have seen a series of failures to translate pathophysiological understanding of dementia into new medicines. This includes a move away from neurotransmission to a focus on underlying pathological processes. The major reason for these failures was probably the continued absence of a unified disease theory of AD and too narrow a focus on the potential aetiologies of this complex disorder. To foster progress and not repeat mistakes of the past it is time to critically analyze the past approach. This chapter serves as a reminder of potential shortcomings in the field across the complete spectrum flow from animal testing through regulatory approval to daily practice.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Lynne Hughes
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070512
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Summary : This chapter provides an overview of the increasingly important role of emerging markets in Alzheimer’s disease trials, particularly Eastern Europe, where there is a robust population of accurately diagnosed subjects for trial participation, and recruitment rates are on a par with those in Western Europe and the USA. Some of the challenges and opportunities involved in global trials are discussed, such as the potential for high recruitment, availability and compliance with biomarker assessments, reimbursement of background medications, and the overall efficiency of the sites’ and countries’ performance.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Tiia Ngandu,Francesca Mangialasche,Miia Kivipelto
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070369
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Summary : Today there are more than 36 million demented persons worldwide. With the aging of populations, the prevalence of dementia and Alzheimer’s disease (AD) is expected to more than triple in the coming 40 years. Besides high age and genetic factors, evidence from observational studies shows that many modifiable vascular and lifestyle-related risk factors at midlife affect the risk of the disease. Control of vascular and metabolic risk factors, healthy diet, and maintenance of AN active lifestyle (physical, mental, and social components) may thus be the key issues on the road to prevent or delay the onset of AD. As the pathologic processes leading to AD may take decades to develop, it is crucial to identify optimal time windows for preventive efforts. Targeting several risk factors simultaneously and long duration of the intervention may be needed for the optimal preventive effect. As many persons are affected, relatively small effects of an integrative intervention on common risk factors may have a huge public health impact. Usage of biomarkers may help in identifying different risk phenotypes and in monitoring effects of the interventions. International collaboration is necessary to initiate future large-scale dementia prevention studies that are needed to formulate evidence-based preventive measures in cognitive decline and dementia.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Lynne Hughes,Spencer Guthrie
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070451
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Summary : This chapter reviews significant recent clinical trials involving potential disease-modifying drugs, including active immunotherapy, passive immunotherapy, γ-secretase inhibitors and modulators, β-secretase inhibitors, and amyloid-beta (Aβ) anti-aggregants. The challenges and opportunities involved in global trials are then discussed, such as variability in diagnosis and patient selection; patient endpoints for both symptomatic therapies and disease-modifying drugs; rater training and global validation of rating scales; competition to recruit the pool of patients available for clinical trials; and emerging logistical concerns related to the use of biomarkers.

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
  • Author : Menghis Bairu,Michael Weiner
  • Publisher :Unknown
  • Release Date :2013-09-18
  • Total pages :407
  • ISBN : 0124114644
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Summary : Global Clinical Trials for Alzheimer's Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer's disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer's disease. Written by leading experts with hands-on experience in designing and running global Alzheimer's disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer's disease global clinical trials in emerging markets and developing countries

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Muriel O’ Byrne,Menghis Bairu
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070437
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Summary : Data from clinical trials in emerging markets are becoming a standard component of the regulatory package being provided to support pharmaceutical marketing authorizations including the FDA New Drug Application (NDA) and the EMA Marketing Authorization Application (MAA). In this chapter, the highlights of the requirements for Alzheimer’s disease interventions are summarized, including a review of trial enrichment strategies. The topic of acceptance of foreign clinical data is also reviewed.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Nadina C. Jose,Lorne Cheeseman,Stephanie Danandjaja
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070574
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Summary : The incidence of Alzheimer’s disease is increasing worldwide. The need to fortify global resources conducting clinical trials becomes of paramount importance for sponsors to ensure less delay in marketing their products. This chapter provides a concise and practical approach to building capacity and capability in emerging or developing markets. Lessons learned from countries like China and India, where the top 12 pharmaceutical and biotech companies have become deeply entrenched in the last 10 years, serve as important benchmarks which can be referenced as new emerging markets like Vietnam, Indonesia, and the Philippines establish themselves as available and capable areas for clinical trials. Referenced case studies describe actual events from which valuable practical pearls can be adapted in other settings. Sponsors need to recognize that investing early on in developing project teams that can support these trials creates a better landscape for success.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Menghis Bairu
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070376
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Summary : More than 35 million people worldwide are living with dementia, the vast majority Alzheimer’s disease (AD)-related. By 2050, Alzheimer’s disease cases will triple to 115 million—one new case every four seconds—placing untold stress on overburdened social service and healthcare delivery systems, a potentially catastrophic global epidemic. Sixty percent of Alzheimer’s disease victims now live in lesser developed countries. In 2050, these countries will account for 71% of the total Alzheimer’s disease caseload. In 2010, the annual cost of AD was estimated at US$604 billion and rising, i.e., roughly 1% of the world’s gross domestic product. Many Alzheimer’s disease victims are stigmatized, resulting in isolation, abandonment, and withdrawal. Diagnosis and treatment are often non-existent. Only 9 of the 193 World Health Organization member states have implemented national dementia plans, all in the developed world. However, there is some promising news. National models for mitigating the epidemic exist. Research and recommendations are available to assist developing countries in blunting the worst ravages of the epidemic.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Peter Schüler,Klaudius Siegfried,Michael Hüll
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070413
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Summary : To date (2013), we have witnessed over 100 years of research on Alzheimer’s disease (AD). In the past century, this gave new and deep insights into its pathophysiology. However, no new treatment with an innovative mode of action has found its way to the patients since the first targeted therapies with cholinergic drugs like Tacrin. So far A-beta and related targets have shown negative results in pivotal Phase III studies, after showing promising trends in Phase II. Thus the question arises as to whether A-beta is the wrong target for disease-modifying treatments, or whether other substantial changes to clinical development plans need to be made, e.g. including patients at risk of developing AD instead of those already experiencing symptoms. Alternative targets and study design options like enrichment strategies, however, do not evolve as an easy alternative solution.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Ricardo F. Allegri,Pablo Bagnati,Sonia Brucki,Ricardo Nitrini
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070482
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Summary : Dementia is seriously disabling for those who have it and is often devastating for their caregivers and families. There are 7.7 million new cases of dementia each year, implying that there is a new case of dementia somewhere in the world every four seconds. The growth of dementia in the next 20 years will be much more acute in those countries with low and medium salaries. The World Health Organization wrote a report about dementia, calling on all governments to define dementia as a public health priority. Dementia clinical studies are becoming more and more complex with the number of enrolled patients increasing. Historically, the majority of patients recruited into clinical trials for medicine development have been from Western Europe and the US. However, clinical trials are increasingly recruiting patients from more countries, including developing countries. South America has larger urban populations than other emerging regions and could provide treatment-naïve patients for clinical trials.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : H. Michael Arrighi
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070468
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Summary : Alzheimer’s disease (AD) confers an additional risk of death. The magnitude of this impact is related to the person’s underlying mortality and current AD stage. When planning clinical trials, estimating the number of deaths prior to study initiation, and periodically during the study as participants are enrolled, assists in providing an informative context, particularly if there are few life events. Additionally, deaths have the potential to introduce a bias, thus, equal follow-up needs to ensure for participants assigned to either active or placebo, particularly if the period of observation for safety events extends beyond the end of the study. During AD clinical trials, patients discontinue for reasons other than death and at substantially high rates, which has the potential to introduce significant bias. Planning and incorporating strategies to improve retention and identify successful techniques should be an integral part of the study process.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Sidney A. Spector
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070567
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Summary : Decades ago, pharmacogenetic research established that one’s genetic profile might predict efficacy and safety of medicines. Polymorphic expression of isoenzymes of the cytochrome P-450 enzyme system explains a significant amount of the variability of inter-individual responses to medicines. In Alzheimer’s disease, the highly variable clinical response to cholinesterase inhibitors metabolized by the liver is explained on this basis. More recently, translation of basic pharmacogenomic research through the drug development process has led to the approval of ”personalized“ medicines, for example, in the field of oncology, cardiology and psychiatry, based on an individual’s underlying genotypic variance of phenotypically expressed pathogenic targets and pathways. Translational pharmacogenomic research in Alzheimer’s disease has emerged as a viable alternative to the study of large populations with similar phenotypic expression of symptoms through stratification of sub-groups based on ApoE carrier status in clinical trials. When initiating a global research protocol, it is incumbent upon sponsors to actively engage stakeholders in developing and underdeveloped countries, including local government authorities, regulatory bodies, ethics review boards, community representatives and participants, to address all aspects of the clinical trial, especially informed consent, which may be more challenging in countries where local customs and practices dictate the need for innovative approaches. Implementation of pharmacogenomics in the clinical trial requires further attention to ethical detail related to what kind of informed consent is needed for use of stored DNA samples for future, unforeseen related or unrelated research, whether and to whom to disclose current and future study results, and ways by which the benefits of current and future discoveries are shared by stakeholders in developed and underdeveloped or developing countries.