Premium Essay

Global Clinical Trials

In: Other Topics

Submitted By shiva27
Words 3908
Pages 16
September 28, 2007 Notification No.0928010 Attention to: Commissioner of Prefectural Health Supervising Department

From Director of Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare

Basic principles on Global Clinical Trials* Up to the present according to “Ethnic Factors in the Acceptability of Foreign Clinical Data” based on ICH-E5 guideline (Notification. No. 762, Director of Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health and Welfare, dated August 11, 1998), utilizing foreign clinical trial data in a new drug application what is called “Bridging” has been accepted in Japan, and post-marketing data in USA and EU have been taken into consideration in a review for regulatory approval where necessary. On the other hand, in the report entitled “Institutional reform for promoting science and technology and passing on the benefits of the scientific and technological advance” (Council for Science and Technology Policy, dated December 2006), it is mentioned to encourage global clinical trials in terms of efficient and rapid developments of new drugs. Moreover, in the final report of the special committee for “Effective & Safe Drugs Quick to Patients” (dated July, 2007), it is pointed out to promote global clinical trials in order to resolve “Drug lag (Circumstances where drug approved in EU and US are not approved in Japan and can not be provided to nations)” and to clear points to consider for conducting global clinical trials from the perspective of a review for regulatory approval. Taking into account the situation, current understanding regarding global clinical trials based on experiences in PMDA consultations is outlined as the attachment, entitled “Basic principles on global clinical trials”. We ask to inform manufacturers and sellers placed under your

Similar Documents

Premium Essay

Novo Nordisk and Clinical Trials in Emerging Economies

...Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision? 1. Ethical aspect. Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines: • Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials. • Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the benefits it brings...

Words: 1295 - Pages: 6

Premium Essay

Alirocumab Monotherapy

...Sanofi and Regenoron’s ODYSSEY Program is a collection of clinical trials. The ODYSSEY Phase 3 program, which is comprised of 14 global clinical trials and includes more than 25, 500 patients, represents the largest collection of clinical trials ever conducted for an investigational LDL cholesterol lowering drug. Based on the trials designed to evaluate the efficacy and safety of biweekly Alirocumab in patients with primary or secondary hypercholsteremia, Alirocumab treatment demonstrated not only consistent lowering LDL-C effects, but also tolerability and safety comparable to oral statins. Namely, in their 78 week randomized control trial (RCT) that involved 2341 patients with LDL levels of 70 mg per deciliter or higher, Robinson et al., (2015) claim that Alirocumab is highly effective at lowering LDL cholesterol levels when combined with a statin. Not only did Alirocumab yield significant bad cholesterol...

Words: 427 - Pages: 2

Premium Essay

Clinical Trials

...------------------------------------------------- Clinical trial From Wikipedia, the free encyclopedia | This article may be too long to read and navigate comfortably. Please consider splitting content into sub-articles and using this article for a summary of the key points of the subject.(October 2010) | Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries. Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services...

Words: 11900 - Pages: 48

Free Essay

So Cute

...The Global Pharmaceutical Industry Case Study Sarah Holland (Manchester Business School) and Bernardo Bátiz-Lazo (London South Bank University) Scenario Planning. A Worked Example in this Industry Context!. Step 1. Key trends • the pharmaceutical industry facing a rapidly changing environment, which offers both opportunities (such as harmonisation of regulatory requirements) but also threats (more discriminating purchasers) • the need for global presence to achieve adequate return on escalating marketing capabilities and R & D costs: • a strong focus on healthcare cost containment, such that new treatments must be justified on cost-benefit grounds, adding to development costs; • to command price premiums, new products must offer unique benefits, yet information leakage means that most products are imitated rapidly; • IT developments provide greater access to detailed healthcare information for both providers and patients, also pushing forward cost-effective treatments: • Educated consumers demanding advances in therapy; • There are opportunities to change organisational models but no-one has yet found a feasible alternative; • Continued industry consolidation. Step2 Identify and list forces likely to have an high impact on the industries future development. a) Increasing concentration of buyers b) Increasing power of distributors (parallel trade) c) Generic substitutes d) Scientific advances leading to new...

Words: 1044 - Pages: 5

Premium Essay

Mba Essay

...A “Calibrated Approach”: Pharmaceutical FDI and the Evolution of Indian Patent Law Web version: August 2007 Authors: Katherine Connor Linton and Nicholas Corrado1 Abstract India has charted its own intellectual property (IP) path over the last 35 years, attempting to foster the growth of a domestic pharmaceutical industry and access to medicine while, more recently, also addressing the requirements of the international IP regime. Multinational companies (MNCs) have responded to India’s movement towards compliance with the W TO intellectual property agreement, TRIPS, by increasing the quantity and quality of foreign direct investment (FDI) in the areas of pharmaceutical research and development (R&D) and manufacturing. By contrast, MNCs have adopted a more cautious attitude toward the patenting and commercialization of new pharmaceutical products in India, waiting to see how Indian courts and patent offices interpret the new laws, and awaiting the enactment of longdebated data protection legislation. The ultimate success of the Indian “calibrated approach” to fostering the domestic industry and access to medicine while also addressing international IP requirements remains to be seen. 1 Katherine Connor Linton (katherine.linton@usitc.gov) is the International Trade Analyst for Intellectual Property and Nicholas Corrado was a law student intern in the Office of Industries of the U.S. International Trade Commission (USITC). The views expressed are those of Ms. Linton and...

Words: 6873 - Pages: 28

Premium Essay

Pharmaceutical

...Instructor’s Manual CASE TEACHING NOTES The Global Pharmaceutical Industry Sarah Holland (Manchester Business School) and Bernardo Bátiz-Lazo (London South Bank University) 1. Introduction The case describes how the prescription pharmaceutical industry has changed since its modern beginnings in the early 1950s. The various forces affecting the competitive environment of the industry are discussed in terms of origins, immediate past and immediate future (2004 onwards). As a result, the note provides insights into the evolution of barriers to enter and exit the industry for prescription pharmaceuticals, while aiming to help students to recognise how to set boundaries for an industry. This is a detailed industry note on the “ethical” pharmaceutical industry which provides an opportunity to analyse key success factors of major players. The note centres on a descriptive overview of the predominant issues in the three major Triad market areas: the US, Europe and Japan (although major issues in emerging markets are also mentioned). The note covers the overall industry environment with in-depth discussion of the driving forces in the industry such as globalisation (in particular global regulatory issues, changing world demographics and worldwide pricing disparities); development of new technology; the importance of time to market; and amalgamations. The case also examines issues around corporate social responsibility. 2. Position of the Case The pharmaceutical industry...

Words: 8602 - Pages: 35

Premium Essay

Cro Management

...Advanced Clinical Trials Portfolio By Indian CRO’s The field of biometrics studies and analysis can be described as a set of technologies and methods that are used to recognize humans, depending on a certain set of traits. Biometrics traits can be divided into two principal groups. First, the physiological traits that are associated with the body shape, where we can include face recognition, palm print, fingerprint, iris recognition, DNA, hand geometry and many more. Second, the behavioral traits that are related to an individual’s behavior, such as typing speed and style, walking gait, voice quality and many more. Clinical research organizations (CRO) in India today offer a complete range of data management services in bio-equivalence along with Phase I-IV clinical trials. The objective is to convert raw data into accurate, inconsistent and dependable trial output staying in compliance with regulatory services. The CRO’s have the ability to manage multi-centric studies for global and domestic needs in various therapeutic areas. The Biometric services provided by them are used by several biotechnology, device, and pharmaceutical and other medical research organization. Indian CRO’s (Clinical Research Organizations) that conduct various clinical trial have their own dedicated Biometrics teams capable of helping clients at multiple levels of the trails and medical studies. They assist the clients with their advanced technologies and skill to come up with study designs, analysis...

Words: 495 - Pages: 2

Premium Essay

Global Pharma Industry

...Pharmaceuticals and Life Sciences Global pharma looks to India: Prospects for growth Table of contents Introduction 03 Background 04 A fast growing economy An expanding pharmaceutical market Government-provided healthcare improving, but private healthcare dominates Domestic market overview 09 Background Consolidation underway, despite challenges Contract manufacturing Vaccines Over the counter market holds significant potential Reaching the untapped rural market Growing Research & Development 15 Overview Clinical trials Biotech and biosimilars on track for growth Other growth areas Bioinformatics 20 Stem cell research Medical devices Global Pharma’s evolving business models and options in India 23 Background Export-oriented business (Contract Research and Manufacturing Services) Licensing Franchising Joint ventures Wholly-owned subsidiaries Practical concerns 27 Infrastructure Tax environment Counterfeiting Intellectual property Conclusion 30 Related reading: Pharma 2020 31 References 32 Acronyms 38 Introduction The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate...

Words: 17333 - Pages: 70

Free Essay

Pharmaceutical Drugs and Drug Companies

...close look of the drug business you will realize that is it has all the characteristics of an oligopoly started above. Because of the fewer number of firms there is always the tendency of collision, secondly in a relatively un-concentrated market barriers to entry and may simply reflect high operating cost. The high cost of getting this product to the market include clinical trials, patent approval and FDA approval; industry-financed studies claimed $114 million 1987, later went up to $231 million, $403 million, and then $2.1 billion in 2006 for FDA approval, patent approval and clinical trials. Oligopolies in most cases tend to go multinational which is largely associated with todays’ drug companies. In terms of research and development, I will say it is the backbone of the pharmaceutical industry which makes it very important. I will want to focus on Pfizer one of the big names in this industry. Pfizer’s Global Research and Development is probably the group that the company takes the most pride in for obvious reasons. If we take a broader look at R&D we will see the role and importance of Contract Research Organizations (CROs). CROs account for about 20 percent of drug companies' traditional development business, according to Graham Hughes, a founder and scientific director...

Words: 536 - Pages: 3

Free Essay

Administrative Ethical Paper

...Administrative Ethical Paper Della A. Dalberg HCS/335 March 31, 2014 Ethical health care topics typically become controversial topics that are aimed to think towards a conscience goal. The goal is to help explain the importance of the entire topic, rather than just the cons or, the pros. Ethical health care topics that are controversial happened to help develop personal views that are typically limited by personal beliefs. Currently, an ethical health care dilemma has been breaching media pertaining to the use of HIV and AIDS for cancer. Scientist and researchers in the health care world have successfully manipulated a modified version of HIV. The modified version is injected into the blood-stream to attack cancer cell (The Inquisitr, December 10. 2012). Cures for cancer tend to cause many controversial debates on the ethical standings of what is morally correct (The Inquisitr, December 10. 2012). The modified HIV, will not infect the patient with typical HIV symptoms, however, the modified HIV will act according to the traits in order to become the strongest cell in the human body (The Inquisitr, December 10. 2012). At the Children’s Hospital of Philadelphia, doctors manipulated a seven year old female’s immune system to help direct the cancerous cells. According to The Inquisitr   (December 10. 2012), “They took a batch of her own T cells-a type of white blood cell-and genetically engineered them to kill the B cells-another type of white blood...

Words: 1273 - Pages: 6

Premium Essay

Critical Thinking

...also meets on a monthly basis to monitor the project portfolio and make decisions regarding new developments. According to John Smith, “The PMB is an important decision making body because it shapes the future of the company by determining its product pipeline”. The PMB members include the CEO of XYZ, the CEO of XYZ Pharma, the heads of the different business units, the heads of Development, Research, Global Marketing and Strategic Planning, the regional heads for the US, Europe and Japan and the functional managers for Regulation, Clinical, Licensing, Technical Research and Development, and Patents. The portfolio group, led by John Smith, had analysed the project portfolio carefully and had highlighted several potential threats that required action. According to John, “There will be an indepth discussion of which projects will be allocated additional resources, and at expense of which other projects this will be”. The Pharmaceutical Industry The lion share of the pharmaceutical market is captured by approximately hundred manufacturers, which account for more than 90% of global sales. Exhibit 1 contains the top twenty pharmaceutical companies ranked by sales. Since the mid-1980s, the...

Words: 5468 - Pages: 22

Premium Essay

Xyz Pharama

...meets on a monthly basis to monitor the project portfolio and make decisions regarding new developments. According to John Smith, “The PMB is an important decision making body because it shapes the future of the company by determining its product pipeline”. The PMB members include the CEO of XYZ, the CEO of XYZ Pharma, the heads of the different business units, the heads of Development, Research, Global Marketing and Strategic Planning, the regional heads for the US, Europe and Japan and the functional managers for Regulation, Clinical, Licensing, Technical Research and Development, and Patents. The portfolio group, led by John Smith, had analysed the project portfolio carefully and had highlighted several potential threats that required action. According to John, “There will be an indepth discussion of which projects will be allocated additional resources, and at expense of which other projects this will be”. The Pharmaceutical Industry The lion share of the pharmaceutical market is captured by approximately hundred manufacturers, which account for more than 90% of global sales. Exhibit 1 contains the top twenty pharmaceutical companies ranked by sales. Since...

Words: 5468 - Pages: 22

Premium Essay

Case Analysis of Global Pharmaceuticals

...The Global Pharmaceutical Industry Case Analysis This case by Sarah Holland and Bernardo Bátiz-Lazostudies studies the evolution of the ethical pharmaceutical industry and analyses the various forces affecting the discovery, development, production, distribution and marketing of prescription drugs. The authors further analyses the critical issues of corporate social responsibility in the industry and the strategies being followed by major pharmaceutical companies and the challenges and opportunities for the future. This case bases its research to find evidence to support or disprove findings of a report published in the Gardiner by analysts at the investment bank of Dresdner Kleinwort Wasserstein which claimed that the world's major drugs companies are operating a business model that is unsustainable and rapidly running out of steam. On the surface however, the pharmaceuticals business seems like the epitome of a modern, mature industry that has found a comfortable way to make profits by the billion. According to the case large pharmaceuticals companies are currently facing the most challenging times since a decade. Even though the industry has made tremendous contributions to human well-being, its roles and actions are still criticized by the media and under constant scrutiny by national governments in their efforts to reduce expenditure in healthcare. Stringent laws and regulations have come in action which has made product approval, pricing and promotions costlier...

Words: 6162 - Pages: 25

Premium Essay

The Balanced Scorecard

...Robert S. Kaplan (rkaplan@hbs.edu) is the Baker Foundation Professor at Harvard Business School. David P. Norton (dnorton@ thepalladiumgroup.com) is the founder and president of the Balanced Scorecard Collaborative, Palladium Group, in Lincoln, Massachusetts. Bjarne Rugelsjoen (bjarne@rugelsjoen.no) is a director at GoalFocus, a performance-coaching consultancy based in London. Managing Alliances with the Balanced Scorecard Fifty percent of corporate alliances fail. But you can increase your partnership’s odds of success by applying these techniques. by Robert S. Kaplan, David P. Norton, and Bjarne Rugelsjoen 114 Harvard Business Review January–February 2010 HBR.ORG C ILLUSTRATION: BRETT RYDER orporate alliances are a 50/50 bet—at least according to a recent study by McKinsey & Company, which found that only half of all joint ventures yield returns to each partner above the cost of capital. That’s worrying, given that partnerships and alliances are central to many companies’ business models. Originally used to outsource noncore parts of supply chains, alliances today are expected to generate a competitive advantage. So it is necessary to dramatically improve their odds of success. Why do alliances fail so often? The prime culprit is the way they are traditionally organized and managed. Most alliances are defined by service level agreements (SLAs) that identify what each side commits to delivering rather than what each hopes to gain from the partnership...

Words: 3927 - Pages: 16

Premium Essay

Apc Financials

...C Marginalized APC Inc. Top 10 BioPharma Companies: Key Annual Financial Metrics APC $ (mil) Net Sales Cost of Products Sold $19,152 $5,098 26.6% % Genentech $ (mil) $36,017 $9,797 27.2% % Amgen $ (mil) $14,642 $4,070 27.8% 72.2% 18.1% 8.3% % Novo Nordisk $ (mil) $9,566 $2,506 $7,060 $1,636 $890 26.2% 73.8% 17.1% 9.3% % Merck Serono $ (mil) $7,454 $2,020 $5,434 $1,327 $581 27.1% 72.9% 17.8% 7.8% % Baxter BioScience $ (mil) $5,573 $1,494 $4,079 $1,031 $568 27% 73.2% 18.5% 10.2% % Biogen Idec $ (mil) $4,247 $1,249 $2,998 $824 $446 29.4% 70.6% 19.4% 10.5% % Genzyme $ (mil) $3,562 $1,104 $2,458 $705 $349 31.0% 69.0% 19.8% 9.8% % CSL Ltd.* $ (mil) $3,211 $967 $2,244 $581 $350 30.1% 69.9% 18.1% 10.9% % Allergan $ (mil) $1,310 $385 $925 $258 $152 29.4% 28.2% 27.0% 70.6% 71.8% 73.0% 19.7% 18.5% 17.8% 11.6% 9.8% 9.0% % Top 10 Top 5 % % Gross Margin $14,054 73.4% $26,220 Marketing, Selling and Administrative $3,508 18.3% $6,447 Advertising and Product Promotions $2,209 11.5% $2,917 Total SG&A Research and Development Operating Margin Total Expenses $5,717 29.9% $3,464 18.1% $4,873 72.8% $10,572 17.9% 8.1% $2,650 $1,215 $9,364 26.0% $6,591 18.3% 28.5% $3,865 26.4% $2,606 $4,100 17.8% 28.0% $2,525 26.4% $1,856 $2,678 19.4% 28.0% $1,908 25.6% $1,312 $2,214 17.6% 29.7% $1,599 28.7% $1,003 $1,477 18.0% 26.5% $1,270 29.9% $756 $973 17.8% 22.9% $1,054 29.6% $616 $787 17.3% 22.1% $931 29.0% $706 $607 22.0% 18.9% $410 31.3% 28.3% 26.9% $288 $227 22.0% 18.8% 18...

Words: 761 - Pages: 4