What is a clinical study?
A clinical study is a research program designed to evaluate the safety and efficacy of a new drug or medical device in humans. Medicines undergo extensive and highly regulated testing before they can be used in medical practice.
This includes preclinical testing, which is happening in laboratories, followed by several phases of human clinical studies. Some clinical studies use healthy volunteers, whereas studies for oncology drugs only enroll patients with cancer.
People enter clinical studies for different reasons. For example, some people have a disease where there is currently no treatment available or the available treatments didn’t show the desired effect. Joining a study of an investigational drug might give them a renewed interest. Other people may decide to enroll in a study because their current therapy is not effective or tolerable enough and a study would provide another treatment option. The goal is that the investigated medicine has fewer side effects, is more effective or may offer other benefits. And finally, some people might volunteer because they wish to help improve medicines that will help others in the future.
Clinical research studies follow a specific set of standards and are closely regulated to ensure the safety of all participants. Safety precautions are put in place to protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is designed to make sure all study procedures are conducted correctly and safely.
You may benefit from participating in a clinical study in different ways:
- You get access to an innovative drug that would not otherwise be available
- You receive healthcare by physicians who are leading experts in their field of research
- You have the chance to make an important contribution to research
The purpose of a clinical study is to learn more about a medicine’s ability to work safely and effectively. Therefore there may be risks related to these drugs that will only become apparent in the course of the study. Your doctor will discuss all potential risks with you and will help you to weigh them against the possible benefits. It is important that you ask all questions that come to your mind so that you can make an informed decision.
Risks associated with participating in a clinical study include:
- The tested medication may have unknown side effects
- The tested medication may be less effective than anticipated
- People may respond differently to the same medication; even if some people respond well to the drug, it may be less effective or tolerable for you.
It is solely your decision whether or not you will take part in a clinical study. When you consider enrolling in a study, you will receive an “informed consent” document that explains the study in easy to understand language. It includes details about the study as well as your rights and responsibilities. The study staff will go through this with you and answer all your questions. It is your responsibility to make sure that you read and understand this document. You can also discuss it with your physician, family, friends, or any other person you trust. Once everything is clear to you and you decide to participate in the study, you will be asked to sign this document. You can change your mind and withdraw from the study at any time after signing the document and also after starting the treatment. You have the right to refuse some treatments or tests, however this could lead to your exclusion from the clinical study.
The informed consent document should enable you to understand:
- The purpose of the study
- The associated tests and procedures you will have to undergo
- The potential risks and benefits
- Your rights and responsibilities
- Your potential alternatives to participating in the study
- Who to contact (study doctor or center) for any questions you may have about the study.
No, you don’t have to pay for the drugs or the required tests and procedures. Generally study sponsors cover costs associated with any procedures that are required for this study. Participants are encouraged to talk to site staff for any additional questions regarding services provided.
No. Generally, studies do not provide compensation or stipends to participants. However, please discuss any questions regarding any unforeseen travel expenses with study personnel.
Some clinical studies compare a new drug to a placebo. A placebo is a harmless substance without any medical effect. It will look exactly like the studied medicine. However, in oncology research like the eXalt2 and eXalt3 studies, there are no placebos involved. Every participant receives an active drug; this could be the investigational drug or in some cases, the drug that is already approved for the disease, the so-called “standard of care”. The purpose of the study is to compare the effectiveness and safety of the new drug with the currently available standard of care treatment. The study staff will explain to you in detail the treatment design for the trial.
A clinical study requires teamwork of the participants, the healthcare professionals and the pharmaceutical company that developed the drug. In order to allow us to gain as much knowledge as possible about this new medicine, it is of utmost importance that you follow the instructions by the study staff. This includes instructions about how and when to take your medication and scheduling clinic visits for study related tests or procedures. It is also important that you inform the study personnel about any changes to your health or well-being, as these could be related to the study drug. This can include any small discomforts, for example a light rash or nausea, but can also involve symptoms which you think are unrelated to the study.
In general, if you are interested in participating in a clinical study, discuss this with your treating physician. They will help you to find out more about your opportunities. For more information on our eXalt2 and eXalt3 studies, click here.
The study staff will answer your questions at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, we want you to feel comfortable discussing them with a member of the study staff.
Yes. You can stop your participation in this study at any time for any reason. Discuss your options with your treating physician whenever you have questions about your participation. If you decide to leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.
You can visit any doctor during the study. Please let the study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit.
During your participation in the study, some of the data, such as information on your medical condition, will be collected and stored on paper and/or electronically in medical records. The data may be accessed and reviewed by regulatory authorities, ethics committees, the study sponsor (Xcovery), or contract service providers of the sponsor (who are obliged to keep your identity confidential) in order to examine whether the study has been properly conducted and the collected data are correct.
Generally, study drugs are only available to patients during the course of a clinical study. Every person’s treatment after participation is handled on a case-by-case basis. The decision on the best course of treatment should be discussed with your oncologist.
We, as the study sponsor, will make information about the outcome of the study results public upon its completion. If you have additional questions or need help to understand the information provided, please discuss this with your oncologist.