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Those therapies or drugs that prove highly promising in basic and preclinical research must be tested in a clinical study to understand how well they can be tolerated and how effective they are in humans with a spinal cord injury.
Clinical studies span a period of at least eight years and cost millions. What’s more, you also need a large number of comparable patients, which can make it even more difficult to perform clinical studies.
Besides funding clinical studies, Wings for Life aims to shorten the time between the discovery of a potential treatment and its availability for the patients. For this reason, we’ve created a special program called “Accelerated Translational Program” (ATP). The ATP will provide funds and experts to make good and safe therapies quicker available.
So far, Wings for Life has been able to fund 16 clinical pilot studies in this evolving area of research.
Phases of a clinical trial
All clinical trials have specific enrollment criteria, as well as exclusion criteria, because not all patients qualify for a new treatment.
Phase I: Safety trial
Using a relatively small number of healthy volunteers researchers try to examine, if a drug displays similar results in humans as in preclinical animal models. The goal is to exclude potentially harmful side effects. The phase I trial also aims at identifying a first dosage of the drug and at analysing pharmacokinetics (e.g. uptake and elimination of the substance) within humans. Under certain circumstances patients can be included into this phase (phase I/II).
Phase II: Efficacy trial
The drug is applied to patients for the first time. A Verum group of patients receives the active ingredient containing dosage form and is compared to a placebo group receiving a control substance or the standard medication. The phase II trial aims at assessing the efficacy and tolerance of the new substance and at optimising the dosage.
Phase III: Long term trial
After successfully passing phase II the new medication is tested on a large number of patients mostly within several clinical centres. Phase III trials aim at unravelling long-term effects.
After successfully ending phases I – III a comprehensive report for approval is compiled to summarize and to compare all data. Based on this report the responsible medical administration decides on the approval of the drug.
Phase IV: Sentry trial
After approval further data are collected out of everyday clinical practice. This phase IV trial aims at identifying additional information concerning tolerance and efficacy of the drug, as well as effects in the context of other medications or comorbidities.
ICCP Guidelines for experimental therapies
What you should know if you are considering participation in a clinical study. Information booklet for people with spinal cord injuries, their families and friends: Download ICCP Guidelines.