Misconceptions

We recognize that — for many people — the decision to participate in a clinical trial is a daunting one, so we thought we would take this opportunity to debunk a few common clinical trial myths.

• Myth #1 – Clinical trial participants are “human guinea pigs”

  Medicines must pass extensive clinical research to ensure their safety and efficacy. Each trial follows a carefully designed protocol. This protocol describes the objective, the design of the trial, the methods used, the analysis of the data and the organization of the clinical trial and includes information on the safety mechanisms to protect the participants. A protocol also makes it possible to conduct the trial in a consistent way across all participating centres and to monitor the quality of the trial. This means that the protocol contributes to the quality, keeps the risk to the participants as low as possible and allows specific research questions to be answered in a scientifically reliable way.

  Investigational medicines (i.e. new drugs) are tested in the laboratory prior to clinical trials, with strict eligibility criteria to prevent harm or the testing of unpromising investigational drugs. Before a trial is approved, it is always assessed whether the benefits of the trial outweigh the potential risks. However, there is a residual risk of unpredictable side effects. In the extremely rare event of health damage, compensation is provided by statutory insurance schemes.

  Participants are given detailed information before giving their informed consent and can withdraw their consent at any time. Regulations and oversight ensure that clinical trials comply with scientific and ethical guidelines, with protocols reviewed and approved by an ethics committee and a competent authority before the trial begins.

• Myth #2 - If you sign up for a clinical trial, you lose control of your personal health information.

  Sharing clinical data informs treatment decisions and advances research, but protecting privacy is equally important. Clinical trial participants provide personal health information to the study doctor and team. However, this personal data is strongly protected. All personal participant information is separately stored from the trial data, and only a few people have access to the personal information.

  Your clinical trial data is also stored in encrypted form (pseudonymised). This means that no information is used that can directly identify you (e.g., name, contact details, date of birth, etc.), but only a number and letter code. The data is also analysed in this encrypted form.

• Myth #3 - You must be terminally ill to take part in a clinical trial.

  While some clinical trials focus on terminally ill people, clinical trials can be offered to people at any stage of a disease. Many studies also look for healthy volunteers. It is important for researchers to study both healthy people and people with a particular disease to learn more about the disease and treatment options.

  This means that clinical trials are offered not only to people who are terminally ill, but also to healthy people, those who just received a specific diagnosis and those who have exhausted some or all of the available treatment options available to them.

• Myth #4 – Clinical trials are dangerous

  Clinical trials are intended to test new medications, medical interventions, or devices, so there is always an associated risk. However, the safety of the participants is always paramount. Before a clinical trial is conducted, the safety of a new treatment must be proven through extensive preclinical testing in the laboratory.

  Clinical trials must be approved by independent Ethics Committees and competent authorities (e.g., BfArM, EMA, FDA, TGA), and written approvals are a prerequisite to starting a clinical trial. During clinical trials, participants are well protected by safety precautions.

  In the extremely rare event of health damage, compensation is provided by statutory insurance policies.

• Myth #5 – You cannot withdraw of a clinical trial

  Participation in a clinical trial is voluntary, which is also explicitly explained in the informed consent to be signed.

  Any participant can decide to withdraw from a clinical trial at any time without giving a reason or receiving a penalty.

• Myth #6 - If I withdraw from the clinical trial, it will affect my future treatment and doctor-patient relationship

  If you choose to discontinue your participation in a clinical trial, it will not affect your future treatment or impact your doctor-patient relationship.