Antibiotic resistance and the challenges of conducting new antibiotic clinical trials

Nowadays, antibiotics are over-used leading to bacteria who become resistant to drugs. In order to avoid an antibiotic resistance, there are ways to contribute against resistance.

Antibiotics are essential medicines for preventing and treating infections caused by bacteria in both humans and animals. Antibiotics not only save lives when dangerous infections develop but they also allow doctors to perform complex surgery and organ transplants where infection is a major risk. In addition, they have played a major role in improving the care of newborn babies and people with cancer whose immune systems are too weak to fight off infections by themselves¹.

However, bacteria have developed many ways of adapting to survive the effects of antibiotics. They become ‘resistant’, and infections that were once easy to control become far more difficult ­– or even impossible – to treat². Antibiotic resistance is growing at an alarming pace around the world, especially in bacteria that cause common infections such as urinary tract infections and pneumonia³. The World Health Organization (WHO) believes that antibiotic resistance is now one of the biggest threats to health worldwide.²
There are several reasons for this worrying situation⁴. Antibiotics have been over-used and misused for decades. In some countries they are available for people to buy without a prescription and are often wrongly used to treat infections such as winter coughs and colds, which are caused by viruses, not bacteria⁵. The more people are exposed to antibiotics unnecessarily, the faster the bacteria evolve to become resistant to them. The situation has been made worse by the widespread use of antibiotics in farming, leading to resistant bacteria transferring from animals to humans and antibiotics getting into the environment.⁴
Tacking the global threat of antibiotic resistance has become a major focus for many governments and other organizations interested in human health. Ways to restrict the use of antibiotics have been proposed, and the urgent need to increase the number of effective antibiotics in the race against resistant ‘super-bugs’ has been highlighted.⁶ The development of new antibiotics has helped to fight resistant bacteria in the past, but very few new options have become available in recent years and less than 50 potential new antibiotics are currently being tested – a very small number considering that most drugs undergoing testing are not successful.⁸
There are several reasons why sufficient efforts have not been focused on finding new antibiotics to treat resistant bacteria. Some of these are economic, but many relate to difficulties in conducting clinical trials of potential new antibiotics and getting them approved.

Why has this happened?

What can be done?

What are the main challenges in developing new antibiotics?

Trials of new antibiotics in suitable patients are expensive to run and are thought to account for more than 80% of the cost of antibiotic development.⁶Drug companies are not permitted to conduct trials comparing new antibiotics with placebo (‘dummy’) medications but instead need to prove that a new antibiotic is more effective than an existing one.⁶Since the differences between the new and old antibiotic may be fairly small, large numbers of patients need to be enrolled in clinical trials to detect such differences.⁶

Hundreds of hospitals can be involved in testing a new antibiotic, presenting many practical and legal problems.⁹ In addition to these difficulties, almost every country in the world outside of the European Union requires new antibiotics to be registered with them individually before doctors in that country can prescribe them.⁶ This means that, if a new antibiotic is to be made available worldwide, applications for approval must be presented separately to up to 170 different medical authorities – a slow and expensive process. ⁶

To make it easier and less costly to develop new antibiotics, it has been proposed that research teams club together to form clinical trial networks.^6,9 If all studies were conducted in a similar way, it may be possible to share results between studies, meaning fewer people would need to take part. In addition, simpler ways of getting antibiotics approved worldwide would help to encourage the development of new antibiotics.¹ Progress has already been made towards this goal in the USA, Japan and Europe.⁶
Alongside efforts to speed up the availability of effective new antibiotics, it is essential that the public, healthcare professionals, politicians and the drug and farming industries work together to raise awareness of the impact of antibiotic resistance on human health. Greater understanding of this should lead to:⁶
Each of us at our own level can contribute to efforts against antibiotic resistance. As a patient, actions you can take include the following:
The world has at last woken up to the dangers ahead if we don’t all work together to stop the spread of antibiotic resistance and develop effective new drugs. The WHO and the United Nations have both made tackling antibiotic resistance a high priority. By using antibiotics more wisely – and joining forces to develop new antibiotics – governments, healthcare professionals and the public can turn this global crisis into a much more manageable situation.

What can we do now?

• Improved hygiene and infection control practices in homes, hospitals and other medical settings
• Appropriate restrictions on use of antibiotics in medicine and farming
• Improved global monitoring and surveys of drug resistance and antibiotic use
• New, rapid tests to identify exactly what is causing an infection to avoid giving an antibiotic which might not work
• Greater funding of antibiotic research, including clinical trials

What can I do, as a patient?

• Ensure you discuss with your doctor whether antibiotics are the right treatment for you in a given situation
• Discuss alternative options to antibiotics with your doctor, if you believe this would be suitable
• Be mindful of the amount of times you are taking antibiotics as a treatment. If you are wondering whether it is too frequent – ask your doctor
• Ensure you follow correct hygiene measures to limit the spread of infection. This applies in particular when you are in any medical environment such as the hospital or the doctor’s office, but also at home or at your workplace. Wash your hands frequently and stay home if you are ill to avoid spreading contagious germs
• For more resources & information, consider checking the World Health Organization (WHO) or your national medical system (for example the NHS in the UK), and talk to your healthcare professionals