Advancement of the Medical, Clinical and Pharmaceutical industry relies on a number of factors. They vary from having the right and appropriately qualified personnel, through registering relevant clinical trials and being compliant to Good Clinical Practice (GCP) regulations, to fulfilling ethical obligations when it comes to trial volunteers and so on. The list is just endless. However, many people omit one and very crucial factor which plays major role for the successful unfolding of the sectors mentioned above. This particular factor is related to the information gathered from a performed trial and the dissemination of the same information. Publications and presentations are part of the traditional methods for delivering data to the public eye. Unfortunately, they may leave gaps in the knowledge of people due to uncertainties and unexplained specifics. What is more, they are far more open to deviations and can be easily distorted. Data manipulation is a fact and the most worrying aspect of it is that average people who want to find out more about one study or another can be easily deluded. This is so because the final results of studies are either not being published or lack this bias-free character in case they are being published.
In our previous article„Clinical Trials Registry” we discussed why registering clinical studies before the official start date can contribute to the successful performance of the trial. Now, after it has been completed, there are other procedures which also help define the clinical project as highly efficient. Precisely, here we are referring to the adequate clinical trials result submission.
Who is responsible for the results submission?
The responsible party for the submission of clinical trials results can be:
- The sponsor of the research or
- The principal investigator (PI)
How are the result submitted?
Results information is presentedin a standard, tabular format. It must not include any forms of conclusions or discussions.
What should the results information reveal?
This information representsa summary information and, therefore, excludes any concrete data about patients. Instead, the submitted results information should be comprised of:
- A tabular summary about the progress of trial participants in each and every phase – number of human subjects involved at the beginning, number of human subjects involved who completed the whole process, and number of human subjects who withdrew.
- A tabular summary of the demographic information (age and gender) as well as study-specific measures (blood pressure) about every study participant.
- A tabular summary of outcome measure values – These planned measurements are underlined in the study protocol which is initially used to indicate the effects of a treatment on patients.
- A tabular summary of all expected and unexpected serious adverse events and a tabular summary of expected and unexpected adverse events of other kinds.
There is one final question which sums up the real significance of clinical trials results submission and that is the question of “Why is this needed?” Submitting a summary of the outcomes is equally valuable for IRBs, researchers, study participants, general audience as well as readers of medical journals. The submission provides well-structured information about the study results, presented in a standardized format. It also minimizes reporting manipulations and reduces publication bias. Last but not least, publishing study results updates people’s knowledge and encourages the realization of all ethical obligations which researchers, sponsors and other members of staff have towards participants.
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