Q. Phase III clinical trials are becoming more expensive, how can adaptive designs reduce their financial burden?

A. Yes confirmatory (Phase III) clinical trials are extremely expensive and may last several years. Adaptive designs can be used in all therapeutic areas and can be used to;

• Introduce flexibility
• Reduce study costs
• Reduce duration of the development process.

Q. What aspects of the study can be adapted?

A.  Study adaptations could include one or more of the following;

• Sample size reassessment
• Dropping or adding treatment arms
• Changing endpoints
• Combining phase II and phase III objectives within a single trial
• Testing for both superiority and non-inferiority.”

Q. What are Enrichment Designs and how can they benefit a study

A. Enrichment designs aim to identify differential treatment effects in patient subgroups and adapt the focus of the trial to subpopulations that benefit most.

Q. Can adaptive designs be used to refine drug dosing?

A. Yes, adaptive designs have a huge potential for dose-finding problems where model-based designs employing more than two or three doses are far superior to standard parallel trials in identifying the correct dose to carry forward to the confirmatory stage. Designing better phase II studies is expected to dramatically reduce the failure rate in phase III studies and hence reduce compound development costs.

Q. Can you share an example of a study with an adaptive design?

A. The George Institute has developed expertise in designing, simulating and conducting flexible study designs. Recently, we have been instrumental in obtaining regulatory acceptance for a seamless phase II/III trial in dermatology with regimen selection, early stopping for futility and sample size re-estimation. The trial has now been analysed and the sponsor is preparing the FDA submission.

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In January, our Malaysia team moved to new offices in KL and in March George Clinical China and George Clinical Hong Kong moved into two new office spaces to meet the demands of our growing teams.

“This is an exciting time for George Clinical, our regional hubs are growing and we are expanding our entities into new countries to meet the needs of our study sponsors whether they be large pharmaceutical companies or our internal research groups from the George Institute” stated Dr Marisa Petersen, Managing Director for George Clinical.

In addition George Clinical has expanded its capabilities in Japan, Taiwan and Korea through carefully structured partnerships which ensure all staff working on George Clinical studies are trained in, follow and are monitored for compliance with George Clinical SOPs.

Dr Petersen explains that “this arrangement allows us to leverage from the strong experience, relationships and networks of our partners while maintaining consistency in project execution and quick response times ensuring a well implemented study, completed on time and within budget”.

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George Clinical has been managing clinical trials in chronic disease since 2005 and is currently undertaking several large global studies to assess the impact of different treatments on cardiovascular and kidney disease outcomes in diabetic patients. The numerous large-scale, high impact clinical trials that conducted by George Clinical have informed healthcare policy across the world.

Having confidence that proven treatments will work in ‘the real world’ is a high priority for healthcare organisations, especially in low and middle-income countries where there is a large burden of chronic disease.

One current example of our work in chronic disease, is a new study in chronic obstructive pulmonary disease (COPD),  one of the world’s leading causes of death. Caused primarily by cigarette smoking, the disease is also growing in prevalence due to indoor and outdoor air pollution in developing countries.

For patients with COPD, breathlessness and sometimes acute exacerbations that require hospital admission are not unusual. Treatments are available, but are expensive. They include short and long-acting bronchodilators and, in more severe cases, inhaled corticosteroids (ICS).

George Clinical is managing the TASC (Theophylline and Steroids in COPD) Study, a study of low-dose corticosteroids and theophylline in the treatment of Chronic Obstructive Pulmonary Disease, to compare affordable treatments, and with the aim of reducing exacerbations in patients with COPD.

Academically-led and NHMRC funded, the TASC Study was developed to demonstrate that low-dose theophylline given together with low dose corticosteroids, both given orally, can reduce the rate of exacerbations in COPD.

Involving 2,400 patients in India and China, the TASC Study will run for five years and if successful, will lead to an affordable, accessible and easily administered treatment for COPD.

George Clinical provides clinical trial management for global and regional studies sponsored by pharmaceutical companies as well as for The George Institute for Global Health.

George Clinical operates in Australia, China, India and Asia.  It provides both a quality framework for clinical trial management across the Asia Pacific region, as well as offering scientific expertise to its clients by leveraging input from some of the best research leaders in the world through The George Institute.

• More about George Clinical
• Professor Christine Jenkins joins George Clinical as Head of Respiratory

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George Clinical China has appointed a new General Manager to lead its growing operation in China as it seeks to provide a stronger platform for delivering clinical trials across the Asian region.

A recognised healthcare professional, Philip Gregory has 25 years senior management experience in pharmaceutical, device and biotechnology industries.

Prior to taking up the role with George Clinical China he was the Regional Director Asia Pacific for Pharmaxis Ltd based in Shanghai, and earlier in his career, he worked in Japan, the USA and Europe.

He will now be based at the George Clinical China headquarters in Beijing.

A division of The George Institute for Global Health, George Clinical is a world-class provider of a full range of premium clinical trial development and management services. George Clinical has more than ten years experience in conducting world-class clinical trials and has played a role in some of the largest and most important global studies in this period.

According to George Clinical Managing Director Dr Marisa Petersen, the appointment of Mr Gregory signals the organisation’s focus on developing both regional and global business – China is key to both of these. George Clinical has a unique position in the outsourcing market, combining scientific expertise and trial leadership from some of the best research leaders in the world together with high quality, full service operations for the delivery of clinical trials across the Asia Pacific region.

In addition to Beijing, George Clinical also has offices in Bangalore and Hyderabad in India, Hong Kong, Malaysia and Australia.

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In 2002, 3.5 million people died of cancer in Asia. This is expected to increase to 8.1 million by 2020.

As the death rate and prevalence of cancer hits hard in Asia, specific concerns have been raised about the economic toll of the disease on patients and their families. Ongoing treatments are expensive and can impose a considerable financial burden. This is felt most strongly in socioeconomically disadvantaged groups particularly in low and middle-income countries where social safety nets, such as health insurance and access to health care, are less likely to be present.

In such settings, poverty is a real consequence of the costs associated with cancer treatment and its impact on people’s ability to work.

The ACTION study will examine the economic impact of cancer on households across the Association of South East Asian Nations (ASEAN) and assess the incidence of financial catastrophe and economic hardship associated with the illness. In addition it will examine the impact of cancer on quality of life of these patients, and the variations in the way in which patients within and across these countries are managed.

Researchers from The George Institute for Global Health and George Clinical are working with hospitals and decision makers across eight of the ASEAN (Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand, the Philippines and Vietnam) to assess the impact of different cancers on quality of life, economic hardship and household income.

The ACTION study, funded by Roche Asia Pacific, is a longitudinal study of 10,000 patients with a first time diagnosis of cancer in hospital. Patients will be followed throughout the first year after their cancer diagnosis, with results available in 2014. These results will inform the design of health systems programs, health insurance schemes and in identifying measures to ensure access to appropriate care for people living with cancer.

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Researchers from Australia, China, Japan, and the USA, led by Professor Vlado Perkovic, Executive Director of George Clinical in Sydney, and Dr Jicheng Lv from the Peking University First Hospital, have reported new findings that suggest intensive blood pressure lowering regimens, which use a combination of drugs to reduce blood pressure more intensively than usual, are effective at preventing more heart attacks, strokes and kidney failure than less intensive treatment.

Professor Perkovic said the systematic review included studies that involved 37,000 participants and compared intensive blood pressure treatment against standard blood pressure lowering regimens.

“Compared to standard blood pressure lowering strategies, more intensive strategies reduced the risk of major cardiovascular events by 11%; intensive blood pressure lowering strategies reduced the risk of heart attack by 13%; the risk of stroke by 24%; the risk of end-stage kidney disease by 11%; and the risk of protein in the urine (a sign of kidney damage) by 10%,” Professor Perkovic said.  

“Overall, intensive strategies reduced blood pressure by 7.5/4.5 mmHg more than the less intensive strategies. The benefits were similar at different blood pressure levels, including in trials that aimed for blood pressures below currently recommended targets (130 mmHg systolic or 80 mmHg diastolic)

“We calculated that for every thousand hypertensive patients at high risk of cardiovascular disease, more intensive blood pressure lowering regimens could prevent two of the 20 cardiovascular events predicted in these patients every year.” 

Professor Perkovic said that few large-scale randomized trials had been done to evaluate the effects of intensive blood pressure lowering amongst patients with uncomplicated hypertension.

“Further trials are required to more clearly define the risks and benefits of blood pressure targets below those currently recommended, given the benefits suggested by the currently available data,” he said.

Full details of the study and results were published in PLoS Medicine.

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Part of The George Institute for Global Health, George Clinical undertakes large-scale, high-impact clinical trials to provide evidence that influences health policy worldwide.

Dr Marisa Petersen, Managing Director of George Clinical, said the organisation was widening its clinical trials focus to include respiratory diseases, such as asthma and COPD (Chronic Obstructive Pulmonary Disease), in recognition of its major role as a contributor to chronic disease and disability across the world.

“We are adding respiratory expertise to our team of world renowned experts who combine cutting edge clinical knowledge with expertise in clinical trial design,” Dr Petersen said.

“Our focus on research into respiratory disease is complementary to some of the more established research areas The George is known for such as cardiovascular disease and neurology.”

Professor Berend said that more than 10 million people died of lung disease every year, representing 7% of all deaths worldwide.

“Particularly relevant to Australia is chronic obstructive pulmonary disease, or COPD, a deadly, chronic disease affecting approximately 2.1 million Australians,” he said.

“It is also the third most burdensome disease in Australians and the fourth most common cause of death.”

“It’s so important we raise the profile of lung health especially as we continue to see the devastating effects of COPD and its increase not only here but around the world.”

Professor Berend, who was Director of the Woolcock Institute of Medical Research at Royal Prince Alfred Hospital in Sydney, also joins Professor Christine Jenkins, who has recently been appointed Professorial Fellow and Head of Respiratory Trials at George Clinical.

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George Clinical has been located in India at the Hyderabad offices of The George Institute and will continue to maintain a presence there whilst expanding its operations into Bangalore, a city known for its entrepreneurs, technology and clinical trials.

A division of The George Institute for Global Health, George Clinical is a world-class Academic Research Organisation that offers a full range of premium clinical trial development and management services. George Clinical has more than ten years experience in conducting world-class clinical trials and has played a role in some of the largest and most important global studies in this period.

The Bangalore premises will house Project Management, Clinical Operations and Data Management teams and offers capacity for substantial growth in the future.

According to George Clinical Managing Director Dr Marisa Petersen, the new premises will allow for growth and provide broader access to clinical trial sites and to partners and customers. “Bangalore is a great location for George Clinical, as it is known for its excellent transport and technology infrastructure and is also home to many forward-thinking organisations, our current and future partners and customers”.

The post George Clinical expands in India appeared first on George Clinical.

Professor Christine Jenkins

Professor Christine Jenkins has been appointed Professorial Fellow and Head of Respiratory Trials at George Clinical. This role will complement her current role as Head of the Airways Group with the Woolcock Institute and her clinical work at Concord Hospital.  Christine’s area of research interest is the clinical management of airways disease.

Over the last decade, Christine has made an invaluable contribution to improving clinical guidelines in asthma and COPD. Her current research examines interventions in older people with asthma and COPD, focusing on patient education, pulmonary rehabilitation, persistently symptomatic asthma, and patient centred outcomes. She teaches and supervises graduate and post graduate students, and has supervised seven PhD students. She has a particular interest in the design and conduct of clinical trials in respiratory disease, working extensively with the pharmaceutical industry on the development of new therapies.

Christine also contributes strongly to promoting asthma and COPD awareness and understanding in the community and has been an active contributor to clinical guidelines in airways disease. Her contribution was acknowledged by the award of Member in the Order of Australia in 2003 for recognition of service to respiratory medicine as a physician, administrator and educator, especially in the field of asthma education.  Christine has also written two books on asthma, one for medical students and one for patients, their families and carers.

With this appointment, George Clinical is taking an important step towards developing an international respiratory trials capacity, acknowledging the predicted global burden of respiratory disease and its impact on quality of life, productivity and mortality in the next 10 – 20 years and beyond.

The post Professor Christine Jenkins joins George Clinical as Head of Respiratory appeared first on George Clinical.

Professor Stephen Macmahon

Stephen joins an elite group in recognition for his innovative application of scientific knowledge.

Throughout the years, Stephen has dedicated himself not only to improve healthcare through research and application, but also, to the innovative application of research in resource-poor countries and regions.

Earlier this year, Stephen was also elected into the Australian Academy of Science for his leadership in cardiovascular research which he carried out alongside many of our other talented researchers at The George Institute.

The new Fellows will be formally admitted to the Academy at a ceremony in late June this year. The election brings the number of Fellows to 1061.

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