Clinical Trials

Managing a Major eCTD Filing

An Amgen case study

This is a case study of how Amgen manages a major electronic Common Technical Document filing. It focusses on tools and processes developed and refined from 2005 to present. During this time, Amgen has filed three original Marketing Applications with an operational goal of submitting these simultaneously in four major regions (US, Canada, EU and Australia). Since operations groups exist in a fluid environment defined by evolving technology, it is important that these tools and processes adapt to meet the changing landscape of regulatory publishing.

Clinical Trials in Oncology

Some sense and simplicity

With the advancement of our understanding of pathobiology of many cancers, many biologically targeted agents have been developed. This requires a paradigm shift in clinical development, based on rational design and moving towards personalised medicine.

Accelerating Central Nervous System Trials

Neurophysiological approaches

Techniques such as electroencephalography and evoked potential are useful tools for translation of preclinical findings into Phase I studies. These methods can be used early on to show the presence or absence of central action and adverse effects of investigational compounds, speeding the search for biomarkers and leading to better GO / NO-GO decisions.

Optimising the Site Selection Process

Assessment of investigator motivation

Identifying sites which enroll in line with expectations represents a major challenge in clinical research. This article discusses strategies to address this challenge and explores "the golden site profile" concept.

Innovation for Growth

Glenn Saldanha who has steered the organization for the last nine years holds a Bachelor's Degree in Pharmacy from Mumbai University and is an MBA from Leonard Stern School of Business, New York University. Prior to Glenmark, Saldanha has worked with Eli Lily, USA and PricewaterhouseCoopers, USA.

Developing Benefit-Risk Management Programmes

Best practices

There are four distinct elements to consider in developing benefit-risk management programmes. They are: protocol design and review, active surveillance, provider and patient education and appropriate use programmes. The entire programme from design through implementation and maintenance will be overseen by programme management, quality management, continuous improvement and comprehensive communication.

Clinical Trials in China & Japan

Dynamic opportunities for sponsors and CROs

This article focusses on how to leverage the regional strengths of key Asia-Pacific countries such as China and Japan in clinical trials, while at the same time proactively ensuring consistency and quality.

Asian Clinical Trials

Managing patient reported outcomes

Selecting the appropriate method/type of Patient Reported Outcomes administration has strategic importance in the preparatory stage of clinical trials. In the results phase, PROs bring to the fore the patient's perception of treatment benefit and its impact on function and quality of life with distinct influences from the countries and regions where data have been collected.

Paediatric Drug Development

Taking a practical approach

Conducting clinical studies in children is often a difficult undertaking. However, with proper planning and using the right resources, one can run safe, timely and successful trials in this challenging population.

Optimising Development Costs

 

Trifunctional Antibody Format

Concept and first drug candidate

Trifunctional antibodies represent promising new cancer therapeutics based on a unique mode of action. The first drug candidate catumaxomab showed strong anti-tumour efficacy in a pivotal phase II / III trial in advanced cancer patients.

Offshoring

Cost-effective clinical research

In response to growing pressure to improve the efficiency of the drug development process, many pharmaceutical and biopharmaceutical companies are turning to emerging markets to reduce R&D costs and speed development times.

The Biomarkers Consortium

Advancing Biomarkers Research

The Biomarkers Consortium is an opportunity for public and private entities to join forces and pool resources in order to advance biomarkers research, an exciting and challenging mission. This novel experiment is an exciting and challenging endeavour that is presently undergoing evaluation and restructuring in some areas, to improve and optimise the identification, funding, and implementation of cross-sector biomarker projects.

Unleashing the Industry's True Potential

Closed loop clinical trial supply chain

Clinical trial supply chain will play a significant role in launch of new products in a globalised environment of clinical trials and clinical supplies manufacturing.

Clinical Supplies

Adapting to trial demand

In today's clinical trial environment, change is at the front lines acting as an obstacle to the success of a clinical supply plan. How many times has the clinical trial design changed after supplies are already packed and labelled? Preparing clinical supplies in this environment is challenging supply chains to create adaptive supplies that can easily respond to the changes in today's clinical trials.

Personalised Healthcare

Hitting the mark

The concept of Personalised Healthcare (PHC) is being driven by the idea of improved patient outcomes and also to contain soaring healthcare costs. It is only when the right patients receive the right treatment that the true value of PHC is realised. To achieve this, biomarkers that are quantifiable need to be identified to select the right patient populations. The challenges of implementing this new research strategy are complex and would require a multifaceted approach.

Proteomic Biomarkers

Transforming drug development

The success of many investigational drugs is dependent on matching treatments with the appropriate target populations. Such "personalised medicine" is now possible with recent advances in proteomics for the discovery and validation of biomarkers of disease and drug efficacy.

Global Clinical Development

Reducing Japan's drug lag

Japan's Ministry of Health, Labour and Welfare is adjusting its policies to accommodate the current trend of global clinical development to promote public health of the Japanese, especially in terms of quicker delivery of new drugs to patients.

Human Antibody Discovery

VelocImmune - A novel platform

The direct replacement of the unrearranged genomic DNA encoding in the variable regions of the mouse heavy and kappa light chain with the equivalent human genomic sequences creates a more efficient platform for the discovery of antibody therapeutics.

Outsourcing CRO Services to China

The staffing challenge

The ability to utilise Asia-based CRO capabilities can make it easier and more cost-effective for pharmaceutical and biotech companies to develop and market new products for the burgeoning pharmaceutical market in Asia.

Retention of Subjects

The question of informed consent

Although the factors that lead to the loss of subjects in clinical trials are poorly understood, lost to follow-up” is still too frequently recorded as an outcome. This article explores the issues involved in the planning and conduct of clinical trials, and suggests a number of practical and relatively simple steps that may be taken to enhance the retention of clinical trial subjects.

Demystifying Biomarker Discovery

The discovery of a disease biomarker using mass spectrometry involves careful planning and strategy. The article describes how a rheumatoid arthritis biomarker was identified and explains various steps in biomarker discovery.

Japan's Step Towards Global Studies

A new guideline on trial data provides opportunities for Japanese biopharmaceutical companies and global contract research organisations to work together to speed up drug development in Japan.

Adaptive Trial Design

Enhancing the quality of clinical trials

Adaptive / flexible trial design has begun to catch-up with the clinical trial services providers due to its umpteen benefits that go a long way in delivering better drugs in a much shorter time. This article looks at different types of adaptive designs available, their characteristics, infrastructure, and the associated legal aspects.

Metabolomics Strategy

Identifying tissue-specific drug effects

The maturation of metabolomics technologies is expected to have profound effect on pharmaceutical R&D. Over the past few years, technologies have matured to the stage where comprehensive and quantitative investigation of global metabolome has been made possible.

Clinical Outsourcing in Japan

Ready to fulfill its Destiny?

With the increasing popularity of global and regional trials in Japan, most global pharma companies are looking to develop as many compounds in Japan as possible. Yet, with limits to headcount increases, companies face limited options to achieve their business goals.

Clinical Trial Integration

Adopting an Innovative Approach

A clinical trial interchange platform can solve complex data integration challenges and also provide enterprise reporting, searching and aggregation capabilities.

Site Management Organisations in Asian Clinical Trials

Providing Competitive Advantage

In a changing market for clinical trials where fast recruitment of large patient numbers is of the essence, Site Management Organisation (SMOs) operating as independent CRO divisions offer significant advantages in the Asian market.

Clinical and Non-Clinical Investigations

Improving the quality of development candidates

Improving the quality of the exploratory development candidates selected to go into confirmatory clinical development should further reduce the risk of late stage failures.

Ethics in Clinical Trials and Drug Development

Ethical considerations have a multiplicity of roles during the conduct of clinical trials-from matters related to the design of a study, to the conduct and even to the reporting of results.

Decision Making in Drug Development

Innovative designs

Bayesian designs are particularly suited for early drug development as they combine historical information with current trial data to make decisions on toxicity, efficacy or futility.

Foreign Biotech Trials in Asia

Emerging trends

Asian countries seem to be welcoming foreign clinical trials, which create job opportunities for researchers, scientists and medical professionals and also bring new therapies to the country.

China

Clinical trial strategies for small pharma

Utilising a company that is based in China and understands both ICH GCP and China SFDA GCP requirements is very important for ensuring clinical trial integrity and success.

Developing Opportunities

Adoption of best project management and drug development practices have driven significant changes within clinical trials in Asia and Eastern Europe. Eric Morfin discusses the many opportunities now available in these new and growing areas.

New Demand, New Horizons

The Asia Pacific region has seen spectacular growth in large-scale clinical trials in recent years. Iylen Benedict highlights the reasons for the shift and outlines some of the challenges and synergies involved.

Advertorial

Added-Value Clinical Trials

A Bangalore-based company specialising in clinical trials is taking advantage of the recent change in intellectual property laws.

Growth in Japanese Clinical Trial Markets

Added-Value Clinical Trials

Regulatory changes and the acceptance of foreign clinical data have fuelled growth of the clinical trial sector in Japan.