A clinical trial, or clinical study, is an investigation into the effects of a medicine. It can also be an evaluation of another type of treatment, such as a surgical method, radiation therapy, physiotherapy, special diets, medical devices, and more.

Clinical trials for medicines are conducted either at a dedicated research unit or within healthcare settings such as health centers or hospital clinics. The trial is often carried out on behalf of the company that developed the medicine, in collaboration with the responsible doctor and other staff. 

Clinical Studies are conducted to develop treatments that are as effective and safe as possible. They have led to the development of medicines, various treatment methods, and medical devices, among other things, which we now take for granted.

Among other things, it is investigated how the body processes the medicine, how the medicine is affected by other medications that might be used at the same time, what effects it has, if it works differently in younger and older individuals, and how effective it is compared to previous treatments. For treatments other than medicines, similar questions need to be answered.

Clinical studies are also essential for authorities to approve new medicines or medical devices, and for doctors to adopt new treatment methods. These trials collectively aim to answer the following questions about a treatment:

Does it work? How effective is it? Is it better than existing treatments? How safe is it? What is the best dose to use? What are the potential side effects?

A clinical study is conducted according to strict rules that are consistent worldwide. A new treatment is often compared with an older, well-known treatment. It can also be compared with a placebo, sometimes called a sugar pill, for example, in cases of diseases where no treatment currently exists.

To ensure that the effects of the new treatment are truly being measured, and not the effect of the research participant's expectations, many studies are conducted as double-blind trials. This means that neither the doctor, nurse, nor the research participant knows which treatment the individual is receiving.

After the study is completed, we always provide information about which treatment was given.

The trial is carefully planned and conducted according to a predetermined protocol, known as a trial plan, which has been reviewed and approved by both the Swedish Medical Products Agency and regional Ethical Review Boards. Many doctors across the country often collaborate on the same trial, and clinical trials are frequently international, taking place in several countries simultaneously. 

Healthy volunteers

In the early stages of developing a new treatment, trials are conducted on a small number of participants, often healthy volunteers, for a short period. The trial can last from a single day to several months, often requiring multiple visits to our clinic. During your first visit, you will receive verbal and written information from a nurse and a doctor.

Patients

As more is learned about a treatment's effects and side effects, the trial can expand, eventually involving hundreds, sometimes thousands, of patients, who are treated for as long as their condition requires. Trials can last from a few weeks, for example, for urinary tract infections, to a year or more, for conditions like high blood pressure or other chronic ailments. 

Health Check-up

In our early-phase studies, the first visit always involves a health check-up. This is an important part of the process to ensure all participants are healthy and suitable for the study. During the health check-up, participants undergo various medical examinations, which may include blood tests, ECG, blood pressure measurement, and other relevant tests.

We also ensure that all participants receive information about the study, and you will have the opportunity to ask questions and discuss any concerns with the study staff.

Compensation for participating in clinical studies may be offered, especially for healthy volunteers. However, in studies where you are a patient (patient studies), financial compensation is less common. 

What compensation do I receive?

The compensation for participating in a study is determined before the study begins and is reviewed by the Ethical Review Authority. The financial compensation depends on the scope of the study. It is a common misunderstanding that compensation is based on risk; instead, it is based on the time you need to dedicate to participate. Compensation is taxable, and if you are served food at the clinic, deductions will be made according to the Swedish Tax Agency's tables. It is often possible to receive travel reimbursement to and from the clinic (but not to and from the health check-up). Sometimes, you are also compensated for lost income. 

Your compensation will be paid on the last weekday of the month after you complete your study, but no earlier than 3 weeks after your last visit.

The medicines and treatment methods studied in clinical trials have always first been investigated in other contexts.

Before a medicine is given to humans at all, a series of animal tests are conducted to assess its safety and effects. Since humans differ from many animals, it cannot, of course, be guaranteed that they will react in exactly the same way as the test animals. For example, allergies are uncommon among animals. 

The first human studies are conducted on a small number of healthy volunteers for a short period. After that, the effects are studied in larger patient groups. At each new step, both companies and authorities conduct a thorough assessment of all available results before proceeding. Throughout all clinical trials, any potential side effects are monitored by both companies and authorities according to a strictly defined and controlled system. 

All of this combined means that the risk of participating in a clinical trial is minimal.

Both companies and responsible doctors are obliged to ensure that every patient or healthy volunteer participant is guaranteed adequate financial protection through insurance or other satisfactory means, should injuries occur in connection with the trial. 

Both public and private healthcare providers are therefore obliged to take out patient injury insurance. From this insurance, compensation can be provided for physical and psychological injuries (with certain exceptions), caused by examination, care or treatment, equipment or medical device malfunction, incorrect diagnosis, infections, accidents, and improperly handled medicines.

However, injuries due to the properties of the medicine or deficiencies in the description of how it should be used are not compensated in accordance with the rules of the Patient Injury Act. Instead, such injuries should be claimed from the insurance company where the pharmaceutical company has product liability insurance; this is stated in your consent form. In many cases, the pharmaceutical company has taken out this insurance through Svenska Läkemedelsförsäkringen (lff.se).

The way clinical research is conducted today is based on the Declaration of Helsinki. The Declaration, adopted by the World Medical Association in 1964 and updated over the years, provides ethical guidelines for research involving human subjects in the biomedical field.

It states that it is the physician's duty to constantly improve treatment methods and expand our knowledge of diseases, but that this must not come at the expense of individual integrity or safety. Trials must be designed so that the risk to the participant is no greater than the benefit, and they must be well-planned to genuinely answer the scientific question posed.

To ensure that all these requirements are met and that participants' interests are protected, several parties are involved:

• Participating physicians and any companies involved have a shared responsibility to clearly explain why a clinical trial should be conducted and why it should be done in a specific way. If a clinical trial is carried out without a company's involvement, it is the responsible physician's duty to provide the same justification.

• The physician has a duty to assess whether the trial is medically sound and feasible. Once the company (if involved) and the physician agree on the trial's design, it must be approved by both the Swedish Medical Products Agency and a regional ethical review board (for all trials), which includes both medical professionals and laypersons. 

• The Swedish Medical Products Agency reviews that the drug trial is correctly planned, that information about the drug is well-supported, and that all regulatory requirements for safety, etc., are met.

• The Swedish Medical Products Agency also conducts inspections, reviewing clinical drug trials to ensure that all parties carry them out correctly. 

• The regional ethical review board reviews all types of clinical trials and assesses whether the balance between potential risk and potential benefit for the individual is acceptable, and whether the information intended for participants is accurate and understandable.

As a participant in a clinical study, you have both rights and responsibilities.

A fundamental right is to receive an accurate description of the study and how much time it is expected to take. You always have the right to contact the study staff at any time. Participation in the study is entirely voluntary. You have the right to withdraw at any time, and you do not need to explain why you wish to discontinue. 

However, if you choose to withdraw your participation, it is important that you inform the researcher. Before withdrawing, it is advisable to discuss your decision with a responsible doctor or nurse, as the study staff typically wish to conduct a final examination and retrieve any unused medication and materials.

To draw accurate conclusions about the treatment, it is important that all patients participating in the clinical trial follow the instructions and attend all scheduled visits. Therefore, it is important that you notify the study team if you are unable to attend an appointment. It is also important to inform them about any other treatments you may be receiving. Similarly, it is important for the doctor/nurse to know if you have been unable to follow the instructions given during the study.

Before and during some of the study, samples will be taken from you. All samples will be handled in accordance with the Biobank Act and will only be used for what you provide consent for.

Before consent is given for your sample to be collected and stored in a biobank, you will be informed, among other things, about the purpose of the sample collection. 

You have the right to limit or withdraw your consent for the storage or use of your samples at any time, which means that the samples must be destroyed or de-identified if destruction is not possible.