Tag Archives: clinical trials

Open Trials

Open Trials is a project led by Bad Science author Ben Goldacre that aims to form a complete collection of every clinical trial conducted around the world. A clinical trial is when a new medicine is tested in humans for the first time. The results from these trials are used to decide how well the medicine works and how safe it is. Currently, not all clinical trial results are published, especially when the findings are negative. This can have dangerous consequences on patient safety as medicine regulators and doctors may not be fully aware of a medicine’s effects. Therefore Open Trials is an important project.

However, before medicines are tested in humans for the first time, they are required to undergo pre-clinical tests in various species of non-human animals. These tests are required to show that the medicines are safe and effective in animal models before they are allowed to be tested in humans. However, the usefulness of these animal studies has been questioned because of the inherent biological differences between species. The results from animal studies are often very different from the results in humans, meaning that ineffective or unsafe medicines are given to humans in clinical trials. Conversely, potentially good medicines are rejected before they get to be trialed in humans because of poor results in animals.

What if we had an Open Trials–like project for pre-clinical animal studies, so that every animal study was recorded and all the results were openly available for others to review?

Here are some of the potential advantages of such a project:
– Overcoming issues such as publication bias. This occurs because studies with positive findings are more likely to be published leading to an unrepresentative and often misleading view of research that has been conducted.
– All data is given to regulators, so they can make a fully informed decision about whether a new medicine is allowed to be tested in humans.
– Finding out how useful and predictive the animal models are for human diseases and treatments.
– Reducing animal use by preventing duplication of animal studies, particularly ones with negative findings. If a study finds that a drug doesn’t work in mice, the results are unlikely to be published. Therefore other researchers might test the same drug again, without realising that it has already been proven ineffective.
Overall, more open reporting of all data can only be a good thing for science. Open trials is fantastic step forward, but more can be done for other types of experiments. This openness would be particularly valuable with animal studies due to the considerable ethical costs of the research.