General information on clinical studies

From Drug Candidate to Approved Medication

Almost everyone has, at some point in their life, needed to take medication or, more generally, receive medical treatment.

What is less well known, however, is that effective and safe medications or treatment options are available for only about one-third of all diseases. There is therefore still an urgent need for new medications and therapies.

However, the path from a promising drug candidate to a safe and effective drug is a long one. This process takes an average of 13.5 years. And experience shows that out of 10,000 potential drug candidates, only a few ultimately make it to market.

But how are new drugs developed, and who guarantees their efficacy and safety?

Clinical Research

In the laboratories of universities and research-based pharmaceutical companies, new molecules are tested daily as potential candidates for drugs. However, because these investigations take place first in the laboratory and later in animals—not in patients—this phase of drug research is called “preclinical.” This essentially means “before the clinic.”

Once a candidate molecule has successfully completed all preclinical trials, further testing for efficacy and safety is conducted through studies involving volunteer subjects or patients. This stage of drug research is then referred to as “clinical” and is divided into three phases with different objectives. Studies in the clinical phases are called “clinical studies” or “clinical trials,” which are synonymous terms. Once an active ingredient has successfully completed all three clinical phases, it can be approved. However, even after approval, observational and safety studies continue to be conducted to monitor the new drug in routine clinical practice. These are then referred to as “Phase 4 studies.”

What does it mean to be a patient in a clinical trial?

The search for new drugs is very complex and very costly. And: it is not possible without the help of patients who volunteer to participate in clinical trials.

By voluntarily participating in a clinical trial, patients become an important part of drug research and the research teams. They thus take on an active role and responsibility in healthcare!

But what does it actually mean to be a “study participant”? What opportunities or risks do you face as a study participant compared to other patients? How time-consuming is participating in a study? Are there restrictions, and will the patient even incur costs as a result? After all, every patient wants the best possible treatment for their condition and doesn’t want to have to deal with additional difficulties or even disadvantages while already ill.

All these questions are entirely justified and can be answered in a single sentence: Patients who wish to participate in a clinical trial can rest assured that every effort will be made to ensure they are not put at risk, unnecessarily burdened, or in any way disadvantaged compared to other patients!

Before a clinical trial is permitted to proceed, it is verified that the safety, rights, well-being, and dignity of the study participants are guaranteed. This review is conducted by national and international, governmental and non-governmental organizations. In Germany, the Paul Ehrlich Institute in Langen (PEI) and the Federal Institute for Drugs and Medical Devices in Bonn (BfArM), as well as local ethics committees, are responsible for this. There, specific groups of people, following established guidelines, handle the approval and monitoring of trials. However, these groups do not consist solely of doctors and scientists. Lawyers and laypeople without a medical background are also represented there. This ensures that all patients’ needs in clinical trials are taken into account. As a result, trial patients receive very intensive counseling, examination, and monitoring—more than is even possible in routine care. Of course, this incurs additional costs. These costs, like all other costs arising from a trial, are paid by the trial’s “sponsor.” The sponsor may be a pharmaceutical company, but it can also be a patient network or a foundation such as German Cancer Aid. Important: the sponsor covers not only the costs incurred by the clinic or the physician, but also the costs incurred by the study participant. These may include, for example, additional travel expenses or lodging costs resulting from participation in the study.

Can I participate in a clinical trial as a patient?

The GPR Klinikum Rüsselsheim also aims to contribute to clinical research and help improve treatment options for patients in the future. To this end, the “Research and Innovation” department was established. One of the department’s main tasks is to coordinate the research activities currently underway at the hospital. For example, it advises and supports physicians who wish to offer clinical trials to their patients and ensures that these are conducted in accordance with national and international standards and guidelines.

 

How do patients at the GPR Clinic learn about a clinical trial?

All clinical trials conducted at the hospital are listed and described on the GPR Hospital website (Clinical Trials). This allows patients to quickly get an initial overview of the clinical trial landscape at the GPR Hospital. If you are interested, you can contact your treating physician or the “Research and Innovation” department directly. However, your doctor may also approach you as a patient about participating in a clinical trial.

“It is not grand words that bring about fundamental change in society: it is the many small deeds of individuals.”
Dr. Mildred Scheel, founder of “Deutsche Krebshilfe e.V.”