Would you take part in an experimental medical treatment?

Clinical study - should I participate?

What are clinical trials?

Clinical studies are carried out to test how effective, tolerable and safe a new treatment is. Or to compare different treatment or examination options. Because it is often unclear which of the available methods is the best. And there are still no effective drugs for many diseases.

Before that, a research group is investigating a new method in the laboratory and with animals. It is only used on people when it has proven to be safe there. An ethics committee must approve each study in advance. It includes people from many areas, such as medicine, ethics, law, theology and often patient representatives. These independent institutions check whether the strict legal requirements for the protection of the participants are being adhered to.

Clinical studies are important: this is the only way doctors can find out what really helps and what side effects occur. Often, a tested treatment also proves to be ineffective or unsafe. Any well-conducted study helps improve care for sick people. Therefore your participation can be very valuable. There is also "health services research". She observes the use of medical measures under everyday conditions. Other requirements and quality criteria apply for this. This information sheet relates only to clinical studies.

Why are there different types of studies?

In order to examine the effectiveness of a drug or a treatment method, comparative studies are necessary. One also speaks of controlled studies.

For this purpose, suitable patients, selected according to strict guidelines, are randomly divided into two groups, in technical terminology: randomized.

Some receive the new drug, others a dummy drug or a drug that has already been tested. After a certain observation period, a comparison is made of which treatment results and side effects occurred in both groups.

These randomized controlled trials give reliable results when done correctly. But they are complex. For this reason, experimental and non-comparative studies are first checked to determine whether the requirements for a randomized study are met at all.

Advantages and disadvantages of participation

Before you decide to participate in the study, weigh up the possible advantages and disadvantages:

Advantages:

  • You have access to new treatments.

  • You will be carefully monitored, examined and intensively supervised by doctors during the study.

  • They help develop effective and safe therapies.

Disadvantage:

  • The new treatment may be less effective than the usual, or it may not work at all.

  • Some side effects are unpredictable.

  • You may be given the dummy drug.

  • You have to keep regular appointments.

What you should know

  • Your doctor has a duty to inform you verbally and in writing about the benefits and risks. Your written consent is a prerequisite for participation.

  • You must be insured against possible damage to health. You can see the insurance conditions.

  • Your participation is voluntary. You can cancel at any time without giving a reason. There are no disadvantages for you.

Publish results!

Clinical trials are very expensive. They are often carried out by the manufacturers, for example the pharmaceutical industry. Again and again it happens that "undesirable" results are suppressed. For example, when the tested drug from a manufacturer is not as effective as expected. Studies show that about half of all studies carried out are not published because of unpleasant results. Among other things, this can lead to the effectiveness of certain drugs being misjudged.

This means that research withholds knowledge from doctors and sick people: They cannot make good treatment decisions if they do not know important data on effectiveness and damage. If studies are already registered in a public study register before they start, it is easier to check their publication later.

In Germany there is such a freely accessible, central study register: www.drks.de. An international study register is: www.clinicaltrials.gov.

What you can do yourself

You can help promote the publication of studies and their quality. With your participation you are making an important contribution to research. You can also ask for something for this. Participate in a study only under four conditions:

  • The study is registered in a publicly accessible, central study register.

  • Get written confirmation that the results will be published.

  • The study protocol, which describes how the study is carried out, is publicly available.

  • The study question is answered on the basis of the existing knowledge. This means that the study is based on a systematic search and evaluation of the existing literature.

What else can you ask?

Even if your doctor has provided you with detailed information, some questions may still be unanswered:

  • What is the research goal of the study?

  • What is known about the new drug?

  • Who is funding the study?

  • What do I have to consider while participating?

  • How much time do I have to plan for examinations and other appointments?

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June 2018, published by the German Medical Association and the National Association of Statutory Health Insurance Physicians