Clinical trials

Clinical trials industry is constantly evolving, and also new clinical studies are being launched at an ever-growing pace. Clinical trial services have widely regarded as the principal method for obtaining a reliable evaluation of treatment effect on patients. Conducting clinical trials is a growing trend in the medical industry for testing the safety level and effectiveness of a newly developed medical device or drug. They provide the reliable basis for evaluating the efficacy and safety of new treatments in clinical trials industry. The historical perspective, present status, and future strategy for clinical trials provide a contextual framework.

The Virtual World of Digital Clinical Trials

Is it becoming a reality?

Emerging technologies have the potential to fundamentally alter how patients engage with and participate in clinical trials Creating a digital strategy for drug development has become a critical focus area for pharmaceutical companies Virtual digital clinical trials minimise the burden on clinical sites typically retaining a central coordinating s...

ELIXIR FOR SOURCING AND RETAINING CANDIDATES

Visit the science and pharmacy colleges in the vicinity where the vacancies exist talk to the Placement Cell and then finalise a date which is convenient both for the final year students who are awaiting results and also for the Human Resource HR teams and the line managers concerned The HR Department and the line managers concerned should prepare...

Speed, Quality and Cost

Leveraging Australia to expedite clinical development

In recent years the pharmaceutical industry has seen tremendous changes in the way it is expected to deliver new drugs to market being under increasing pressure to expedite the development of new therapies to decrease clinical study duration and to drive new treatments through their clinical phases as quickly safely and costefficiently as possible...

Innovation in Clinical Trials

Clinical trial development has evolved significantly over the past few decades Digital technology is increasingly used to improve clinical trial efficiency Its use spans all phases of drug development and impacts areas such as recruitment and retention of patients wearables virtual clinical trials and health economics outcomes research Leveraging e...

ManagingClinical TrialAgreements

Clinical trial agreements are an essential GCP document and are integral to achieving clinical trial success They define the legal relationship between sponsors Clinical Research Organisations CRO and sites and establish the rules under which the clinical trial will be conducted There are several key criteria which determine whether A Clinical Tria...

Managing Clinical-Trial Agreements

Clinical Trial agreements are an essential GCP document and are integral to achieving clinical trial success They define the legal relationship between sponsors Clinical Research Organisations CRO and sites and establish the rules under which the clinical trial will be conducted There are several key criteria which determine whether a Clinical Tria...

Patient Recruitment in Asia

Reducing the clinical burden

Today there are many innovative new approaches to patient recruitment and the number continues to grow The driver behind these innovations is the challenge that many western countries face in recruiting patients for participation in clinical studies The concept of patient recruitment is quite simple It involves recruiting the right patients at t...

Low Rates of Stroke and Major Bleeding with Rivaroxaban Confirmed by Global Study

XANTUS pooled results study

Results of the pooled analysis of the global XANTUS realworld study programme were announced recently at the European Society of Cardiology ESC Congress in Barcelona Spain The study investigated the use of the nonvitamin K antagonist oral anticoagulant NOAC rivaroxaban for stroke prevention in patients with nonvalvular Atrial Fibrillation AF irregu...

Wearables in Clinical Trials

Where we are & where we are going

With the demand for wearables and sensors in clinical trials on the rise pharmaceutical companies are increasingly faced with the challenges of both rising costs and market saturation of similar drugs and that is where Clinical Research Organisations CROs come into play From both a technology perspective and a processes perspective CROs can levera...

Use of Real World Evidence

Increasing throughout Asia

True experiments such as randomised controlled trials RCTthe gold standard when it comes to the approval of pharmaceuticals are often criticised as being unrealistic The results of these trials do not always generalise well and may not be applicable in the real world The use of real world data and real world evidence to supplement RCTs may be one s...

Patient Recruitment

An industry challenge

Patient recruitment and retention is frequently the most laborintensive and difficult part of the clinical trial process and is often a barrier to the successful completion of a study Industry data indicates that patient recruitment can represent more than per cent of total study costs and sponsors bear a tremendous cost when ambitious recruitment...

Demystifying Biomarker Discovery

Proteomics is an emerging field that is frequently used for clinical biomarker discovery For this article proteomics is defined as a mass spectrometrybased approach used to identify proteins The biomarker discovery process is distinct from biomarker validation or the development of a clinical test The development of a clinical biomarker incurs heav...

Retention of Subjects

The question of informed consent

These days pharmaceutical development is increasingly becoming an area where high tech solutions exist for every difficulty encountered Genomic analyses and biomarkers are required for enrolment in an ever increasing proportion of studies Contract Research Organisations CROs have electronic files of potential investigators and patients for many dis...

Mobile Phones Always There Always On

Why not use It to enhance patient compliance, trial effectiveness and reduce trial cost

Clinical trials and Medical research is experiencing the fastest transition that it ever experienced With continuous innovation in technology drug research initiatives are getting tremendous support in terms of getting more compliant and secure processes in place making the research more result oriented With a fact that the cost to develop a drug a...

Clinical Trials in China & Japan

Dynamic opportunities for sponsors and CROs

The historical approach to clinical drug development and one that served drug companies well for the past thirty years was to initiate testing in humans at clinical research units typically located in the UK and the US and to proceed further to Phase II testing and beyond to patients with clinical evidence of the disease with investigators mostly l...

Innovation for Growth

Where does the company stand today with respect to its motto To emerge as a leading integrated researchbased global pharmaceutical company When we began the process of discovery research in very few believed that we could do it We were clear at that time and even now that innovation was the only way for sustained growth and for that one had to ve...

Developing Benefit-Risk Management Programmes

Best practices

Understanding the interrelationships among all key stakeholders is the critical aspect in risk management planning in todays rapidly changing complex global healthcare environment These can include payers providers patients care givers patient advocacy groups regulators and other government agencies All these stakeholders should be considered when...

Optimising the Site Selection Process

Assessment of investigator motivation

According to some estimates up to per cent of Investigators participating in a trial may recruit no patients When considering this statistic it is important to remember that every sitealso those that have not recruited to targethas been through a process of selection Whilst this process may determine whether a site can provide suitable staff and f...

Accelerating Central Nervous System Trials

Neurophysiological approaches

The incidence of Central Nervous System CNS illness is on the upswing and exacts a heavy human and economic toll According to the World Health Organization more than million people worldwide suffer from depression and the number is expected to rise The occurrence of Alzheimers disease is slated to grow by more than per cent in developed countries...

Clinical Trials in Oncology

Some sense and simplicity

The burden of cancer as a global health problem is underscored by its increasing incidence With better understanding of the biologic processes underlying the causes and progression of cancer great strides have been taken in inducing incremental improvements in survival Indeed the face of oncology has changed in the last decade from a paradigm where...

China

Clinical Trial Strategies for Small Pharma

Offshoring clinical research is becoming more prevalent as the biopharmaceutical industry seeks to address the escalating time and cost for drug development Implementing such a strategy in China presents three key opportunities availability of patients favourable cost structure and the worlds fastest growing pharmaceutical market These opportunitie...

Managing a Major eCTD Filing

An Amgen case study

The electronic Common Technical Document eCTD format provides an opportunity for regulatory operations groups to gain significant efficiencies through the standardisation and automation of publishing processes In order to take advantage of this opportunity it is important to first identify what kinds of tools are needed Some of these tools are elem...

Clinical and Non-Clinical Investigations

Improving the quality of development candidates

The pharmaceutical industry continues to face challenges in improving its RD costeffectiveness Despite the steady increase in the RD expenditure in the US pharma industry over the past years from US billion to US billion the number of new products launched has decreased from in to in Price Waterhouse Coopers Pharma There is not a s

Site Management Organisations in Asian Clinical Trials

Providing Competitive Advantage

Site Management Organisations SMOs frequently act as both partners and competitors in the conduct of clinical trials for Contract Research Organisations CROs and claim to show advantages over them to pharmaceutical companies Most effective is the integration of study site management in the classical CRO clinical services as it eases the communicati...

Foreign Biotech Trials In Asia

Emerging Trends

It has been suggested that the biotech sector in the Asia Pacific region is rapidly growing and could become a serious competitor to the US biotech industry However regulatory hurdles lack of intellectual property protection as well as cultural factors could slow down the sectors development In this rapidly globalising world drug companies wishi...

Clinical Trial Integration

Adopting an Innovative Approach

The number of solutions available to automate the clinical trials process is increasing at a fast pace with each solution providing a variety of targeted benefits to suit different requirements Often the same data point is imported into and processed by these different solutions affecting specific aspects of the clinical trials process in a similar...

Growth in Japanese Clinical Trials Market

The clinical trials environment in Japan has changed dramatically over the last eight years In particular changes in the Pharmaceutical Affairs Law PAL have allowed the acceptance of foreign clinical data and fuelled the growth of the clinical trial sector in the country There is an increased need for businesses involved in clinical trials to take...

Decision Making in Drug Development

Innovative designs

Early clinical drug development is targeted at gathering information about the toxicity and efficacy of a new drug compound Phase I trials determine the maximum tolerated dose of a drug while Phase II trials explore efficacy and lead to a critical decision of gonogo in terms of continuing a drugs clinical program Bayesian designs are particularly s...

Clinical Outsourcing in Japan

Ready to fulfill its Destiny?

Japan remains the second largest national market for pharmaceuticals at of the global marketas defined by IMS And yet there remain varying opinions about the status of Japans pharmaceutical industry Japans unique regulatory requirements are often cited as a particular cause of frustration by multinationals However the Japanese government has taken...

Ethics in Clinical Trials and Drug Development

Ready to fulfill its Destiny?

Ethical considerations have been part of the conduct of studies with humans for several decades However it is only since WW II and several abusive trial situations coming to attention that ethical considerations have become a prominent and critical part of the conduct of clinical trials both for safety and wellbeing of the subjects or volunteers en...

Metabolomics Strategy

Identifying tissue-specific drug effects

Clinicians commonly rely on a tiny fraction of the information contained in the metabolome measuring eg glucose and cholesterol to monitor diabetes and cardiovascular health respectively New analytical platforms for metabolomics and tools for informatics that afford extended and sensitive measurement of the metabolome are therefore expected to beco...

Adaptive Trial Design

Enhancing the quality of clinical trials

Investment in pharmaceutical research and development has more than doubled in the past decade however the increase in spending for biomedical research does not reflect an increased success rate of pharmaceutical development Reasons for this include a diminished margin for improvement escalates the level of difficulty in proving drug benefits eas...

The Biomarkers Consortium

Advancing Biomarkers Research

Biomarkers have the potential to streamline and even revolutionise investigations of pathobiology the conduct of clinical trials and regulatory decisionmaking for drugs and therapeutics This promise serves as the foundation and impetus for a novel publicprivate partnership initiated in October and known as The Biomarkers Consortium BC BC partner...

Japans Step Towards Global Studies

In September Japans Pharmaceuticals and Medical Devices Agency PMDA released a new guideline for the biopharmaceutical industry entitled Basic Concept for International Joint Clinical Trials The PMDA issued the guideline in response to growing concern about the druglag challenge facing Japan As of now new biopharmaceutical products typically ente...

Offshoring

Cost-effective clinical research

These are very challenging times for the researchbased pharmaceutical and biopharmaceutical industry While profits have remained relatively high for many of the toptier companies stock prices have tumbled precipitously Since market capitalisation for the major companies has dropped cumulatively about US trillion In other words over the last seven...

Trifunctional Antibody Format

Concept and first drug candidate

Triomab antibodies represent a new generation of antibodies that incorporate a novel mechanism for the treatment of cancer Trifunctional antibody chimaeras consist of light and heavy chains originating from parental mouse IgGa and rat IgGb monoclonal antibodies each with different antigen binding properties One binding site for the interaction...

Optimising Development Costs

Executives have three levers available to them to manage clinical development operational costs such as Taking advantage of low cost countries in Asia and other areas around the world Outsourcing specific operational activities and Implementing lean clinical development practices

China\'s Clinical Trial Boom

A look at the linguistic and cultural challenges

Due to unprecedented economic growth and increased healthcare expenditures experts predict that by China will be the worlds fourth largest pharmaceutical market In addition to increased production and distribution by foreign pharmaceuticals China has become one of the regions primary locations for outsourcing clinical trials Growth in the clinical...

Paediatric Drug Development

Taking a practical approach

Its no secret that clinical research has steadily become more challenging and costly Patients are difficult to recruit regulations are more stringent and complex and patient expectations are very high However these realities of our field can be seen no more clearly than when attempting to develop medicines for children With the advent of legislatio...

Issues & Concerns in Conducting Clinical Trials in India

Indias strong value proposition has enticed multinational pharmaceutical companies to enter into or significantly expand existing operations in India in the fields of drug discovery contract manufacturing and clinical research In addition to huge internal market potential India presents an attractive destination for drug companies seeking to minimi...

Asian Clinical Trials

Managing patient reported outcomes

The process of bringing innovative medicines to market has become increasingly more difficult and complex in the last decade More rigorous regulatory requirements coupled with restrictive policies for drug reimbursement have slowed down the rate with which major pharmaceutical companies are able to reach patient populations with new molecules So...

Overcoming Regulatory Barriers

To Fast-Track Clinical Trials

The last decade has seen a significant increase in the number of global clinical trials being conducted in Asia In China and India the number of new global studies approved rose from less than in each country in to more than in India and to more than in China in This growth is due to a number of factors which have aligned to make Asia an attr...

Getting the Most from your Outsourcing Partner

Executing more cost effective and successful clinical trials

Multinational biopharmaceutical companies abandoned the practice of performing all of their Research Development RD functions in house years ago but the drivers behind the decision to outsource are changing While the need to reduce fixed costs remains a primary reason for big pharmas dependence on outsourcing partners a recent study found that imp...

NEWS

Lotus Pharmaceuticals Issues New Patent For Controlled-Release Diabetes Drug

Lotus Pharmaceuticals Inc has announced that its wholly owned subsidiary En Ze Jia Shi Pharmaceuticals has been issued a patent for controlledrelease of oral gliclazide which is commonly used to control mild to moderate adultonset Type diabetes The patent that covers the composition and preparation methods for the drug through has been issued...

Developing Opportunities

The area of global clinical trials has seen some exciting changes in the recent years Not only have project management best practices greatly influenced the development and management of global clinical trials within GCP guidelines and FDA regulations but these practices have also enabled project managersleaders and clinical trial specialists to fa...

Outsourcing CRO Services to China

The staffing challenge

The business benefits of outsourcing Contract Research Organisation CRO services to China are compelling in todays pharmaceutical marketplace and global economy Labour rates in China are much lower than in the West and additionally China offers a large pool of highly educated research talent that can be readily tapped to staff projects carried ou...

Getting the Most from your Outsourcing Partner

Executing more cost effective and successful clinical trials

Multinational biopharmaceutical companies abandoned the practice of performing all of their Research Development RD functions in house years ago but the drivers behind the decision to outsource are changing While the need to reduce fixed costs remains a primary reason for big pharmas dependence on outsourcing partners a recent study found that imp...

Human Antibody Discovery

VelocImmune - A novel platform

Antibody therapeutics are one of the fastestgrowing drug classes and take advantage of the endogenous immune system for the creation of novel therapeutics Antibodies are superior drug candidates because they are a natural constituent of the human immune response and possess many important favourable pharmacologic qualities such as halflife tolerabi...

Global Clinical Development

Reducing Japan’s drug lag

The venues of clinical development are increasingly moving from USA and Europe to Asia Pacific where the increase in simultaneous multinational trials has been very conspicuous In Korea for example the number of such trials has more than doubled between and to In such trials participating sites compete with each other in terms of their speed to...

Proteomic Biomarkers

Transforming drug development

The success of many investigational drugs is dependent on matching treatments with the appropriate target populations Variability in response to therapy both with regards to efficacy and to adverse events is leading the pharmaceutical industry down the path of personalised medicine Further pushing the process along are government and private insura...

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