The term ‘medical breakthrough’, and the reporting of such events in the media, is often a double-edged sword. While I absolutely support the reporting of advances in medicine, we all know that each time the evening news proclaims a medical breakthrough, many people will have their hopes raised in vain.
In my last article, I described how the process of developing a new drug for Alzheimer’s disease, XanamemTM,  has taken more than 10 years to get from an ‘interesting observation’ to  being trialled in patients.
The process broken down into Phases
Many of you will remember thalidomide, a popular treatment in the 1960’s for morning sickness in pregnant women, was found to be the cause of limb deformities in their babies. An investigation found that thalidomide had not been adequately tested before it was approved for patient use. Important lessons were learned, regulations were developed, and now drugs have to go through several stages of testing, including three phases of testing in humans (known as Phase 1, Phase 2 and Phase 3) to ensure the drugs are safe and provide the necessary benefit to the patient. Each phase requires testing of the  drug in increasing numbers of patients – from around 50 patients in Phase 1  to several hundred or several thousand patients in Phase 3 trials.
The process of testing a new drug clearly  takes time. For example, XanamemTM is currently being tested in XanADu, a Phase 2 clinical trial. This  trial aims to test the drug in 174 patients at 20 sites across  the UK, the US and Australia. Once complete,  the  trial will have taken 2 years to complete. The duration of A Phase 3 trial is longer  because of the higher number of patients to be enrolled and the likely extended treatment period on the trial. The clinical trial process  does take a significant amount of time, but the process ensures that  drugs approved  to treat patients are safe and effective.
A major hurdle to the success of any clinical trial is being able to recruit adequate  patients. This  is not just specific to Alzheimer’s disease research – it’s a problem  across all the clinical research industry as a whole.
There are many reasons for this, including: strict criteria that patients must meet to be eligible to be involved in a trial; treating doctors or clinicians being unaware of  all the available trials  and/ornot having time to discuss trials with their patients; and a general lack of awareness by some patients of the existence of clinical trials. A high proportion of patients find out about clinical trials through their own research on the internet or via the media, and whilst this is positive, if we want to speed up the development of new drugs, which is particularly urgent in  Alzheimer’s disease, we need to find more effective ways to  find the right patients and recruit them into clinical trials.
Benefits in participating in clinical trials
There are  enormous benefits to be gained from participating in clinical trials, not least of which is the boost many people get from taking an active role in their own healthcare, and equally, the patient benefits from having regular and detailed medical care during the trial.  In turn, patients providing feedback to the researchers about their experiences can help refine and improve the quality of the research and the drug under investigation.
Clinical research is a delicate balance between giving patients access to treatments based on the latest scientific discoveries and ensuring that a repeat of thalidomide doesn’t occur through inadequate care and oversight with new drug research. That balance is currently well maintained through the global Regulations that govern clinical research; improving participation rates in clinical research will further help to retain  that balance, as clinical trial design and methodology is further refined with each clinical trial that is conducted.
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Author: Dr Bill Ketelbey
Dr Ketelbey has more than 30 years’ experience in the healthcare, biotech and pharmaceutical industries, including senior medical and management roles in the Asia Pacific Region with global pharmaceutical company Pfizer. Dr Ketelbey has a solid track record of product development over his years in the industry leading to the successful registration, launch and commercialisation of numerous market leading medicines in a broad range of therapeutic areas, including in Alzheimer’s Disease. Dr Ketelbey led the local clinical development, and was involved in the commercialisation, of Aricept™ (donepezil), the market-leading Alzheimer’s disease therapy Dr Ketelbey is a medical graduate from the University of the Witwatersrand, South Africa and a Fellow of the Faculty of Pharmaceutical Physicians from the Royal College of Physicians in the United Kingdom. He also has an MBA from Macquarie Graduate School of Management, Australia, and is a Graduate of the Australian Institute of Company Directors. Dr. Ketelbey is also a director of the Westmead Institute of Medical Research.
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