Clinical Trials
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...
