Why do we need clinical trials?
There is a great demand for new innovative therapies both in Germany and worldwide and clinical trials are obligatory to achieve that goal.
On one hand there is a constant monitoring and research on already existing medicine and therapies which are improving the safety for patients by gaining more knowledge and findings relevant for future use.
On the other hand clinical studies are used for scientific research and development of new treatments and medicine aiming for an optimal effect for patients concerning the safety, the reduction of side effects and an improvement of the medicinal therapy or drug compatibility.
What characterizes a good and reliable clinical trial?
Clinical trials have to stick to strict guidelines consisting of internationally accepted scientific and ethical rules which are constantly adapt to new upcoming states of knowledge.
These guidelines, whose aim it is to guarantee the safety of each participant, are summarized in the term GCP, meaning good clinical practice.
What are the different phases of a Clinical Trial in humans?
Clinical trials can be divided into 4 stages called “phases“. The earliest phases rather focus on whether the medicine works and what kind of side effects other than expected will occur whereas later phases compare the new treatment to an already existing treatment. In every phase from 1 to 3 the number of participants will be increased to get insights of how the tested therapy is suitable for a large population. Whereas about 10-15 participants take part in phase-0, there are already up to 10,000 participants involved in phase-3. These large numbers of participants makes clinical trials very expensive and only one out of 300,000 new drug compounds will become a new “medicine”.
Phase-0-trials are not obligatory and aim to find out if the medicine/drug works the same way as researchers expect it to do.
Phase-1-trials are especially focused on how the body copes with the given medicine in terms of compatibility, eventual side effects and how much of the drug is safe to give. Usually the given dose is as high as it is supposed to be after the medicine will be approved.
Phase 2 is then about finding the best dose to use as well as to analyse the effect of the drug/medicine within controlled experiments. Basically this phase’s aim is to check if the medicine works well and efficient enough to continue with phase 3, where a larger number of participants are enrolled into the trial.
As already mentioned above, phase-3-trials try to provide an evidence for a therapeutic effect. Usually large numbers of participants are involved in order to give an appropriate and reliable comparison to existing treatments for a large population. This phase is controlled by government and has to fulfil certain requirements as for example a positive risk-benefit balance. After passing all regulatory aspects the responsible authority will give permission to the pharma company to sell the new medicine.
Phase-4-trials are usually started after proving that the medicine works and a license has already been granted. Main reasons for this phase are to gain more and a broader knowledge about long term and rare side effects.
Do participants have any advantages?
Participants receive close monitoring, advice, care, and support by an extra trained medical team, which is usually not covered by health insurances. Moreover, participants get access to new and promising treatments, which both may help them and may also help the whole society by contributing to medical research.
Financially speaking, participants receive a representation allowance for example the refund of travel expenses.
However, it is important to say, that financial benefit should not be an argument for participating in clinical trials.
How does a clinical trial proceed?
Before taking part in a clinical trial, participants have to fulfil specific inclusion and exclusion criteria for the clinical trial participation which need to be checked by a medical examination. They have to undergo a detailed and explanatory meeting in which process, conditions, and potential risks are further explained in detailed by the investigator. The participant and the investigator sign a consensus form in order to document all relevant topics for the clinical trial.
Have these two steps been completed, the participant can be enrolled into the clinical trial and start according to the study protocol, e.g. taking the medicine to be tested.
After finishing the trial, participants are again checked in a final examination.
Are Participants allowed to cancel or interrupt clinical trials?
Clinical trials can be stopped at any time without giving a specific reason. Participants do not have to fulfil any obligations. However, it is recommended to talk about any thoughts with the treating doctor or scientist first.
What about the participants’ safety?
According to the declaration of Helsinki it is required that participants should not bet exposed to any needless risks and that every trial should be based on a free and optional participant’s choice. Consideration of risks and benefits (risk-benefit balance) is of great importance and should be discussed among other topics with the participants before starting a clinical trial. Risks should be kept as low as possible. Moreover, it is crucial to stick to a study protocol, which was developed and approved by an ethic committee before the trial is allowed to start. Only medical doctors with specific qualifications are allowed to conduct a clinical trial. In order to provide a double check, the clinical trial has to be permitted by government (Bundesinstitut für Arzneimittel- und Medizinprodukte/ German Federal Institute for Drugs and Medical Devices) first. During the trial, participants are constantly checked by doctors and receive a specific monitoring, which helps to stick to the given study protocol, the good clinical practice and to follow the international rules and current guidelines.
A specific clinical trial health insurance will cover any damages the participant might eventually suffer.
What happens to my personal data?
Personal data are kept secret according to the current data protection and privacy guidelines. They will be pseudonymized according to the Medical Products Act (Arzneimittelgesetzt) to deny unauthorised access and usage. All kind of data are protected by law and can only be revealed by a court under the given circumstances.
Do participants have to bear any costs?
In general all kind of clinical studies are free of charge. Representation allowances will cover any expenses the participant has to pay.
If you are interested in Clinical Studies, please continue reading on Our Studycenters. Or just contact one of our Studycenters (see contacts)