Spa+Clinic Team Wait times for new lifesaving and pain drugs could be slashed by up to four years under an Australian initiative to fast-track the clinical trial approval process to bring new medicines to market.
The development could revolutionise global treatment for everything from cancer, heart disease, diabetes and asthma to non-life threatening chronic pain conditions such as Complex Regional Pain Syndrome (CRPS), back and joint pain.
Currently, clinical trials can be delayed for up to eight years because drug companies do not have easy access to suitable patients.
Australian company Neoclinical has created Australia’s largest voluntary “matching database” between patients and the 40,000 clinical trials that occur worldwide at any one time.
The registration service allows patients who want to be part of a clinical trial to find one that might be suitable for them.
In Australia 20% of all adults, or 1.5 million people, suffer from some kind of chronic pain, costing the Australian economy more than $34 billion every year. For 90%t of sufferers there is no long term effective treatment.
Globally, cancer costs US$ 1.16 trillion and is one of the leading causes of morbidity and mortality worldwide, with approximately 14 million new cases a year. That figure is expected to rise by 70% over the next two decades.
“Every great medical advance in modern history has involved a clinical trial to prove a drug’s benefits before regulators allow patients access to it,” says Megan Guy, managing director of Neoclinical and RN Specialist of Oncology.
“However, patients are largely unaware these trials exist, and pharmaceutical companies don’t know how to access willing participants. Keeping these two groups apart can delay the approval of life-saving drugs by years.
“Neoclinical’s matching database allows patients to voluntarily register for clinical studies in areas that may suitable for them.
“This has the potential to fast-track breakthrough drugs that could treat anything from cancer, heart disease, diabetes and asthma to non-life threatening chronic pain conditions.”
More than 60 clinical trials are currently underway in Australia for all kinds of pain from back and joint pain to cancer-related pain, but they need more than 56,000 patients worldwide before they can be completed.
In the case of cancer alone, more than 134,000 Australians are diagnosed with the disease ever year, including 72,000 males and 62,000 females. Of these, 48,000 die (27,000 males and 21,000 females).
After laboratory research and development, followed by clinical trials in mice, new drugs typically follow there phases in human clinical trials before regulatory approval:
Phase I: First time in humans to confirm safety, how is it absorbed, metabolised and excreted.
Phase 2: Proof of concept to determine if it has the expected effect on patients.
Phase 3: Large scale efficacy trials which are often world wide to compare it compare to current treatments.
Accelerating the approval process for human clinical trials provides an incentive for medical companies to invest in research and development.
It is estimated that pharmaceutical companies spend $1 billion to bring a new drug to market. Once a drug is patented, that company only has seven years rights over it, before other companies can copy it.
As a result, many new life-saving or pain-relieving drugs do not proceed past the development stage because clinical trials take too long.
Axsome Therapeutics is currently conducting a Phase 3 clinical trial that focuses on finding relief for pain for a condition known as Complex Regional Pain Syndrome or CRPS.
“There are so many people in Australia in constant pain and clinical trials are an essential part of the process to develop better ways to find relief. We estimate it can take years to conduct clinical trials on humans,” Axsome Therapeutics’ George Zafaris said.
Patients can discover if they might be suitable for clinical trials at NEOCLINICAL.COM
