Informations for Study Participants

If you participate in a trial that investigates a new diagnostic test, your medical therapy should not change at all. You can expect to be treated according to current medical standards no matter whether you participate in the study or not. If a new treatment is tested, you possibly receive a drug that may have unknown effects. Usually, study participants are randomly assigned to receive the new drug (“investigational product”) or the currently recommended treatment. It is unknown, which of both therapies is superior.

Usually, results for individual participants can not be provided during or after a clinical study. Only anonymised or pseudonymised data is stored preventing easy links between data sets and individual identity. Additionally, the meaning and impact of results is often unknown for new test methods. However, it is possible to access scientific publication that resulted from the study your participated in. We are happy to supply you with these articles from scientific journals.

Please contact the doctor or study nurse at our centre. We’ll do our best to answer all your questions. Furthermore, the Ethics Committee of the University of Lübeck can give advice and provide you with information on clinical trials. The German collaborative network of pharmaceutical companies for research and development VFA is offering information on its website www.vfa.de.

All clinical studies are approved by an independent Ethics Committee before participants are recruited. This ensures limited and safe storage of personal and health related data. All you data is transformed into anonymised or pseudonymised data sets to protect your privacy. All members of staff that are involved in the clinical trial are obliged to keep data confidential.

The doctor will counsel you at the beginning about the risks and benefits of the study. Often, a questionnaire about your personal and health-related data will be filled in. Diagnostic tests may follow (e.g. ECG, ultrasound, lung function testing). Also, biological samples can be collected (e.g. blood, urine, phlegm). In some studies, financial re-imbursement is granted for your participation.

The Research Center Borstel is focussed on lung diseases. The Center for Clinical Studies conducts trials on tuberculosis, COPD, asthma, allergy, lung cancer and other respiratory illnesses.

We are the interface between physicians that care for patients and researchers that investigate biological materials or new drugs. We plan, organise and conduct clinical trials with patients and healthy volunteers. Our job is to counsel patients and other study participants about the trial and to document all acquired data for statistical analysis.

The development of new drugs is regulated strictly. Governmental institutions (BfArM, EMA) and an independent Ethics Committee control that clinical trials are performed according to current standards. Most trials conducted at the Center for Clinical Study Borstel have been assessed by the Ethics Committee of the University of Lübeck.

No. Your participation is voluntarily at any time. Even if you agreed to participate in a study before, you can still withdraw your consent at any time without having to justify your change of mind. We were grateful though, if you let us know about your discontinuation, as we would like to book your appointment slot otherwise.

Any assessment of patients or patient material and any treatment of humans for scientific purposes can be called a clinical trial. New compounds need to run through several phases of clinical testing as part of the licensing procedure from phase I (first application in humans) to phase IV (observational study after the drug has been marketed).

New drugs and diagnostic tests need to achieve two aims: First, they need to be safe and must not harm humans that use the test or drug. Secondly, they need to be as good or even better than current methods or therapies that are already available. Clinical studies help us to learn more about the safety and benefits of new compounds, new tests, etc.

You should be able to attend the study center if you would like to participate. Also, you need to be able to understand the purpose and structure of the study without knowing all details by heart.

Pre-defined criteria determine your study participation. Inclusion criteria need to be met (e.g. you need to suffer from a certain disease, you should be 18 years or older, etc.) but exclusion criteria must not be met (e.g. you should not be alcohol dependent, pregnant, breast feeding, etc.). There are no criteria that are generally applicable to all trials, because they vary from study to study. You will be counselled about inclusion and exclusion criteria in case of your participation.

Most clinical trials require several visits at the study center. There are at least tree different types of study visits.

• Screening Visit
  The first appointment at at the study center enables the doctor to assess wether you are suitable for participation. He or she will check several inclusion criteria and exclusion criteria that are clearly defined for each study. Before you are are enrolled in a clinical study, the doctors will explain the planned trial and will provide you with a written information sheet (“Patient Information”). You will learn about the required visits, about risks and benefits and about diagnostic procedures and treatments that are part of the study. You then need to sign the “Informed Consent Form” before your data and measurements can be used for scientific purposes. I many cases, a questionnaire will be used to capture your personal and health-related data. Sometimes, assessments and tests can follow (e.g. ECG, ultrasound, lung function testing) or biological samples are obtained (e.g. blood, urine, phlegm). In therapeutic studies that evaluate new treatment options, you are likely to receive the new drug (“Investigational Product”) that should be taken according to the doctor’s instructions.
• Further visits
  Further appointments for study visits are booked in intervals of several weeks or months. The aim of theses consultations is to capture and document any health related changes. Ususally, you are asked to attend the study center for the appointments because further assessments, tests or sample collections are planned. In treatment studies, you may receive a new package of the investigational drug, while you have to hand in the old box.
• End of trial visit
  Most studies have pre-defined endpoints, for example if the new drug is not working as well as expected, or after one year of study participation. At this endpoint, an “End of Trial” visit is commonly performed, which again may include a physical examination, diagnostic test or other assessments. Some studies require a follow up by telephone after some years, if long term effects of drugs are in the focus of interest.