What is your experience with clinical trials

Clinical Trials: Should You Take Part?

The first approvals of a vaccine against Covid-19 have now been made in the USA, Great Britain, Europe and a few other countries. In Germany, the vaccination process started at the end of December 2020. Before drugs are approved, their efficacy and safety must be demonstrated in clinical studies.

What are clinical trials?

In clinical studies it should be examined according to scientific criteria whether a new treatment method or a new drug is superior to the previous standard of treatment or the administration of a dummy preparation, a so-called placebo.

In any case, the use of new drugs or new medical treatment and examination procedures on humans is preceded by far-reaching animal and cell experiments. If these tests are successful, the new method will be tested in human clinical studies. Their participants are often referred to as test subjects or test persons. For this reason, the development of a vaccine against corona takes a certain amount of time to ensure the effectiveness and safety of the substance. However, in the case of a vaccine against SARS-CoV-2, the development took place very quickly and also at an early stage in coordination with the approval authorities. While the clinical phases usually take several years to complete, in the case of Corona, the development of a vaccine at the first company takes just under a year.

The way in which a clinical study is carried out (the so-called study design) determines the quality of the results.

Studies that have the highest informative value

  • placebo-controlled (comparison between active ingredient and dummy drug),
  • double-blind (neither doctor nor test person know which participant receives placebo or active substance) and
  • randomized (allocation of the forms of therapy to be compared according to the random principle)

be performed.

What happens to the data from clinical trials?

After the phase III studies have been carried out, the results obtained will be used by the respective drug manufacturer to apply for approval for the drug. Because before a drug can be prescribed by a doctor or is available in the pharmacy, it must be officially approved. For this purpose, the results from the clinical trials are checked by the approval authorities.

Licensing authorities are

  • the Federal Institute for Drugs and Medical Devices (BfArM)
  • the Paul Ehrlich Institute for Vaccines and Biomedical Medicines (PEI) and
  • in Europe the European Medicines Agency (EMA European Medicines Agency)

As with any other treatment, the doctor creates documents that contain information about the disease, the treatment measures and the results of the examination. In contrast to usual, a study requires that part of the data be passed on. However, this transfer is encrypted and only a few

Institutions such as those commissioning clinical studies, the competent supervisory authority and the competent federal authority that approved the study are allowed to view this data. Before participating in the study, the test subjects must agree to their data being passed on in the aforementioned framework. The data will continue to be used even if someone terminates the study prematurely.

The current data protection regulations apply to the storage of the data. As a rule, they are kept for at least ten years. All persons involved in the study - like treating doctors and nurses - are subject to confidentiality and are not allowed to pass on their data to uninvolved third parties.

What are the advantages and disadvantages of participating in clinical studies?

Participating patients have the option of receiving a treatment method that has not yet been generally accessible. In addition, special quality-assured medical supervision and intensive care are available through participation. In addition, depending on the study, participants often receive a financial allowance based on the time required.

In addition to the advantages mentioned, new treatment methods can also have previously unknown dangers:

  • New methods may be less effective than previous methods or even harmful.
  • Patients assigned to the control group are given a traditional drug or a dummy drug.
  • In addition, the close medical supervision can represent a high burden on an individual basis and be associated with restrictions. This includes, for example, specific dates or documentation requirements. It may be necessary to observe behavior or to coordinate other medical treatments with the study doctors.

Under no circumstances should you take part in several studies at the same time, as this makes the health risk unpredictable. Although it is also prohibited by law, there are always people who take such a high health risk for financial reasons.

How is the quality of the studies assured?

There are strict legal regulations for conducting clinical studies in order to limit the existing risk for study participants. The legal bases for conducting a clinical trial in Germany include: regulated in the Medicines Act.

The attending physician is obliged to inform each participant in detail about the possible benefits and all risks. Test subjects also receive important information about the study in writing. You must also meet precisely defined requirements in order to be included in a study. These can be, for example, a certain age or stage of illness or treatments that have already been carried out.

Before deciding whether to participate, you should always consult the attending physician. The test person's consent to participate must be given in writing in advance. However, it can be revoked at any time without giving reasons and without any disadvantages. For the study participants, a

Insurance must be taken out that financially covers the risk of possible damage to health. If you are interested in participating in a clinical study, you should check carefully beforehand whether such coverage exists. If not, there is no way you should agree.

A study may only be carried out if the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) have approved them for studies with blood products, vaccines and antibody preparations.
In addition, an ethics committee carefully weighs the benefits and risks of participating in the study according to ethical, medical and legal criteria. She only gives her consent to conduct the study if she has no concerns.

In Germany there is the WHO-recognized German Clinical Trials Register (DRKS) at the German Institute for Medical Documentation and Information (DIMDI). The registry currently documents more than 7,000 clinical studies.

The register thus helps, among other things, to find participants for studies or to avoid double studies.
Most importantly, it provides information that is easily accessible to the general public and academia.

Checklist: What to Consider Before Participating in a Clinical Trial

Under no circumstances should you consent to participation in a clinical study without clarifying the following points:

  • What is the specific goal of the clinical study?
  • How is the course of the study planned?
  • Who is funding the study?
  • Do you incur any costs for participating in the study?
  • Is there an allowance for expenses?
  • Is a Subject insurance been completed?
  • How long does it take to participate?
  • Which Obligations are associated with participation in the study?
  • Will longer follow-up be required after the study is completed?
  • What are the benefits and risks of participating in the study compared to previous therapy methods?
  • What experiences are already available for the new therapy method?
  • With which Side effects is to be expected?
  • Who is responsible for student support?
  • Who can in emergency or be contacted if you have any questions?
  • Which data are collected, processed and stored?
  • What restrictions must be expected at the beginning or during the clinical study (e.g. no pregnancy, no alcohol)?
  • What happens if the study is terminated early?
  • If necessary: ​​how can the treatment be continued after the end of the study?

This content was created by the consumer centers in Rhineland-Palatinate and Hesse for the network of consumer centers in Germany.