About 60% of all biomedical literature is not reproducible, yet pre-clinical basic research represents the basis to identify disease mechanisms, new drugs and diagnostics. One way forward is to introduce multi-center collaborative efforts such as pre-clinical trials and sharing data, samples and reagents.
Here we unite these efforts on a global scale and invite all biomedical researchers who are interested in elucidating mechanisms of diseases to contribute. All information will be shared and publications stemming from your input will be collaborative. Contact us for our MoU and procedures.
Together we can do it!
Three landmark studies (see below), all in the area of ischemic stroke, have shown the utility of re-analysing pre-existing studies to validate a previously claimed disease mechanism and/or therapeutic target. This included a systematic review, meta-analysis, risk of bias evaluation and repetition as a pre-clinical randomised confirmatory trial, a pRCT. The abbreviation is intended to sound similar to the gold-standard in clinical research, the randomised controlled trial (RCT). The “p” points out the fact that this is a pre-clinical trial.
Pre-clinical research has ideally two functions, i.e. to generate new hypotheses (exploratory trials) and to confirm these hypothesis and convert them into reproducible knowledge (confirmatory trials). Such pre-clinical evidence can then be the basis on which further development towards clinical trialling and therapeutic development is conducted.
The Three Rs (3Rs) in relation to biomedical science are guiding principles for a more ethical use of animals in testing. Whilst we fully support ‘Refinement’, i.e. the use of methods that alleviate or minimize potential pain, suffering or distress for the animals used, we are sceptical about ‘Replacement’, i.e. whether it will ever be possible to develop methods which avoid or replace the use of animals in medical research, we warn against ‘Reduction’. Every scientists likes to minimise the number of animals. However, this has often led to frequent statistical testing (p-value hunting) during an experimental series and publishing accidentally significantly positive results. As negative results are rarely published this has lead to a giant amount of literature of false positive, irreproducible results. Performing one excellent study, ideally as a multi-centre pRCT, will use in the end less animals than several meaningless studies.
For those interested in learning more about the three success stories, here they are: