I want to learn about clinical trials
Clinical trials are a type of research. They involve people and test health-related “interventions” to see how they work.
Clinical trials often answer questions like:
- Is the intervention safe?
- Does the intervention improve or cure disease?
- Does the intervention help people feel better?
In clinical trials, researchers are investigating the effects and side effects of a new or known treatment.
It can be new medicine, medical equipment and software programs, diagnostics and new treatment methods such as surgery or radiation therapy.
Clinical trials are a cornerstone of health research and knowledge from clinical trials is central to medical advances.
- You can take part in testing the latest treatments.
- You can improve the treatment options for yourself and others.
- You can contribute to the development of new medicines and new forms of treatment.
- You can have frequent and thorough contact with healthcare professionals.
- You can get thorough knowledge about your own illness and how to best live with it.
- You can get knowledge about your health that you otherwise would not have gained.
- You can expect that participation is time consuming.
- You may experience side effects, both known and unknown.
- Your clinical trial doctor will inform you thoroughly about the clinical trial.
Clinical trials testing drugs are divided into four phases
Phase 1 – Is the medicine safe?
In phase 1, you examine how much of the medicine you can give before there are serious side effects. The experiments in phase 1 are often short with quite a few participants. The subjects are typically healthy volunteers. Only 1% of the total number of subjects are included in phase 1.
Phase 2 – Is the drug effective?
In phase 2, the relationship between dose and effect in people with disease is examined. Phase 2 typically involves between 50 and a few hundred participants. This type of trial usually lasts two to three months, but can last longer. 8% of the total number of subjects are included in phase 2.
Phase 3 – Does the drug work better than the treatment we know?
In phase 3, you look at the treatment effect and side effects in relation to the treatment you are already using. For example: Is the new treatment better, more effective or more gentle than the current one. Here you find out if the drug has the potential to be approved. Phase 3 trials typically involve between several hundred and several thousand participants. This type of experiment usually lasts several years. 81% of the total number of subjects are included in phase 3 trials.
Phase 4 – Are there side effects with long-term use, are there rare serious side effects?
Phase 4 trials are investigating side effects and effects in people who use the drug in their daily lives. There is a focus on rare side effects and on long-term effects and side effects. The studies in phase 4 run after the medicine has been approved. This type of experiment can have very different duration (months to years). 11% of the total number of subjects are included in phase 4 trials.
Scientific ethics medical committees
Before an experiment can begin, a scientific ethics medical committee assesses whether the experiment is ethically sound to carry out. They examine whether the trial participants rights have been respected, if the patient information is presented according to the current standards and whether the experiment will contribute new knowledge.
The Danish Medicines Agency
Before a trial may begin, the Danish Medicines Agency assesses whether the trial is medically justifiable to carry out. They look at both patient safety and whether the trial complies with current regulations.
The overall responsible for the clinical trial, including the presence of adequate, effective arrangements to set up, run and report a research project.
Responsible for the conduct of the research, in particular adherence to the protocol at the research site.
I am looking for a clinical trial
Trial Nation is working on creating an online overview of active clinical trials in Denmark. It is expected to launch in 2023. Read more about the project here.
Please see www.sundhed.dk for the current status.
In the meantime:
- Look at the webpages of relevant patient organisations
- Open www.clinicaltrialsregister.eu and follow the instructions.
- Ask your general practitioner or treating hospital doctor.
If you decide to participate in a clinical trial, you help researchers get new and valuable knowledge about your disease or condition. Some trials require patients with a specific disease or condition while others require participation of healthy individuals
Trials with patients are conducted when researchers believe that a new type of medicine, medical technology or diagnostic solution or a new intervention might be better than the one offered today. As a patient, you are not guaranteed to benefit from the trial, but it can have a positive effect on the treatment of your disease in the future.
If you are healthy and participate in a clinical trial, you contribute to achieving new knowledge in the health area for the benefit of everyone. This could be knowledge of the body’s functions, lifestyle or may be relevant with respect to disease prevention.
The trial participant, the clinical staff and the trial staff do not know which of the trial treatments the participant will receive.
The doctor’s determination of a disease based on tests, the patient’s symptoms and the doctor’s experience. Diagnosis means “through knowledge” in Greek.
An experiment often compares different treatments. This is called the arms of the experiment. A three-arm trial can compare two doses of a new drug with the best-known current treatment.
The procedure, the approach, the method.
A clinical trial protocol describes
- the objective of the study
- who is eligible to participate in the trial
- risks to the subjects
- details of tests
- procedures and treatments
- expected time frame
- what information will be collected during the trial.
You can see it as the experiment’s cookbook recipe.
Informed consent means a consent given on the basis of adequate information from a healthcare professional. As a patient or trial participant, you can revoke your consent at any time.
A clinical trial is clinical research that tests treatment, typically among a group of patients, and compares the effect and side effects with a group that does not receive the treatment. The tested treatment is also called the experimental treatment.
Trials conducted according to the same experimental protocol in several different countries with different trial leaders and with one coordinating trial leader.
Inactive treatment. The placebo treatment must look, taste, feel, smell just like the effective treatment. Placebo trials are only conducted if it is justifiable to refrain from treating trial participants.
The treatment to be studied and the treatment to be compared are randomly assigned to the trial participants, i.e there is no selection of which participant receives which treatment in the study.
If you cannot find a clinical trial that is suited for you, you can check again at a later time, where there may be new clinical trials which are suitable for you.
In 2022 a new and better way to find clinical trials in Denmark will be rolled out.
I have found a trial which I am interested in
Yes, if you as a participant fit all of the criteria for the clinical trial. Each clinical trial has its own criteria and you must fulfil all of them in order to enter the trial.
Inclusion criteria are requirements that you must meet in order to participate in that trial. For example:
Are you over 18 years old?
Do you have asthma?
There may also be physical requirements. For example:
Can you exhale more than 3 liters of air in one second?
Exclusion criteria are conditions that exclude you from being able to participate in the trial. For example:
Are you pregnant?
Are you a smoker?
Therefore, you must always have contact with the trial staff before you can count on participating in the trial.
About the study:
- What is the purpose of the study?
- Why is this particular approach and design the most effective?
- Who funds the study?
- Have there been any comments to the study?
- How long will the trial last?
- What time do I need to invest in order to participate in the trial, and what are the trial investigations that are additional to my regular treatment?
- Who will tell me about the results of the survey and how will I be informed?
About possible advantages and disadvantages:
- What are the possible short- and long-term benefits for me?
- What are the possible short- and long-term disadvantages for me?
- Is the balance between pros and cons of this study more attractive to me than the other treatment options?
It is ALWAYS voluntary to participate in a clinical trial. And you can withdraw from the clinical trial at any time. If you choose to stop as a participant, it does not affect your future treatment.
When participating in a clinical trial, you must have information about the experiment itself and about the pros and cons of participating in the specific study. You must have the information both orally and in writing. You are covered by the Patient Compensation, both when you participate in a clinical trial and if you choose not to take part.
For those who, permanently or temporarily, are unable to make an informed decision whether to consent to participate or not, the immediate family or guardian can give consent. For children under the age of 15, parents or guardians must give consent.
Personal data is an important part of clinical trials. Therefore, you must decide whether your health data may be processed and exchanged between those who perform the clinical trial before you can participate. In order to participate in the trial you must allow sharing your data collected in the trial.
Read more at www.dvmk.dk/forsoegsperson/dine-rettigheter-som-forsoegsperson
If you are being treated with experimental medication or procedures, it may prove to be better for you than the treatment you would otherwise have received. It may also turn out that it is not better.
For additional information, see Pros and Cons.
If you or your trial doctor assess that the trial medication or procedure is not beneficial to you, then treatment should be stopped immediately.
As a participant in a clinical trial, you will often have more contact with doctors and nurses. The increased attention to you as a patient is perceived as an advantage to some and as a disadvantage to others. Only you can decide whether you see this is good or bad for you.
As a rule of thumb, you will not be paid to participate in a clinical trial. This is because it should always be voluntary to participate in a clinical trial.
You will often get reimbursed for transportation costs.
The clinical trial typically takes place at a hospital, sometimes university hospital, or clinic. Here you will meet doctors and nurses who are employed at the hospital and who also work with clinical trials.
If you are part of a clinical trial, you will meet with a trial physician. The doctor is a specialist in the disease and the treatment to be investigated. The attending physician assumes responsibility for your treatment during the period in which you are participating in the trial.
I am in a clinical trial
You can share your participation in a clinical trial and information about it with anyone you wish.
You should have a copy of the patient information and informed consent from the clinical trial that describes the clinical trial in detail.
It is important to share information with your health care providers about any medication you may be on for the clinical trial. Consider bringing the Patient Information folder.
You should contact your trial doctor.
Please refer to your patient information.
Yes – absolutely. It is one of your central rights as a clinical trial participant.
If you decide to leave, please consider taking the time to explain your decision to the trial doctor.
I finished participation in a clinical trial
As a clinical trial participant, you should be informed of the results of the clinical trial once the entire trial is complete. You should speak to your trial doctor or trial team about how to obtain this information once the whole trial is completed. The whole trial may be completed a long time after your participation completed.
When you have completed your clinical trial participation, you will most often stop the treatment you received in the trial. When you are a patient, you will in many cases resume the treatment you received before the trial. There are however some clinical trials in which the treatment which is studied can continue after the trial is completed.
Podcast on Clinical trials
- Henriette Svarre Nielsen, Professor of Reproduction and womens diseases.
- Ulrik Lassen, Professor of Clinical Oncology and Personalised Medicine.
- Leif Vestergaard Pedersen, who is former director of the Danish Cancer Society, a member of the Danish Medicines Agency and i.a. former health director in the Central Jutland Region.
- Jakob Wedsted, postdoc at the Center for Advanced Studies in Biomedical Innovation Law
- Anne-Marie Axø Gerdes, Chairman of the Council on Ethics
- Steffen Thirstrup, advisor at NDA Advisory Services and former head of the drug approval in the Danish Medicines Agency
Ismail Gögenur, Professor at the Center for Surgical Science at Sjællands Universitetshospital
Nikolai Brun, then head of the medical evaluation and biostatistics unit at the Danish Medicines Agency – and then chairman of the big data task force at the European Medicines Agency, EMA
- Ida Sofie Jensen, CEO, Lif
- Allan Flyvbjerg, Center director of Steno Diabetes Center