The end of the clinical trial does not mark the end of all communication between you and the research team. Once treatment is completed and the study is closed, patients should feel free to ask the trial staff what treatment they were getting. The study staff shares this information as soon as it is available and they are allowed to do so. They will also share the trial results when they become available.
If you request to see your data from the trial, researchers may have to wait until trial results are made public before sharing the information with you.
After a clinical trial is done, researchers carefully analyse all the data they collected. If findings are positive overall, or there is further analysis to do or more questions to answer, they may decide to move on to the next phase of testing. Alternatively, they may decide to stop testing because the drug was not safe or effective enough.
When a phase 3 trial is completed, the researchers examine the data and decide if the study results warrant submission to government agencies for marketing approval of the medication.
Most clinical trials run for the planned length of time. Sometimes, though, the Therapeutic Goods Administration (TGA) or the sponsor may end the trial early. The medication may be producing unexpected or more severe side effects – its harms outweighing its benefits. Another reason could be that not enough patients were recruited in the allotted time
In some cases, a trial might be stopped because results are more positive than expected. For example, if there is clear evidence early on that the new drug is effective, the trial may be halted so that the new treatment can be made widely available as soon as possible.
If your trial is stopped early for any reason, the research team notifies you immediately and advises you on the next steps. The trial doctors are still committed to providing you with ongoing care: with your consent, they will consult with your usual healthcare provider(s), fully inform them as to your health status and transfer you back into their care.
Results from clinical trials are often published in peer-reviewed scientific or medical journals. This means that before trial results are approved for publication, the findings are evaluated and supported by peers, who are researchers and experts in the same field as the trial researchers. Peer review ensures that the analysis and conclusions of the trial are sound. If the results are significant, they may also be discussed at scientific meetings before they are published.
You can ask the research team if your trial’s results have been or will be published.