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About participating in clinical research

Clinical studies with research subjects/test subjects are important for progress in medical research and helping people to have better health. At the same time, risks for participants must be minimised. The researcher is responsible for those people involved, both for their well-being and for the information that is collected, which is regulated by laws and ethical guidelines.

What is a research subject?

A research subject is a person who participates in a clinical research study. A research subject may also be known as a test subject, but the definition of a research subject has a wider meaning since clinical research is not always organised in clinical trials or experiments, but may also be observational studies or surveys.

Research subjects are usually divided into two groups:

  1. A patient is a person who has a diagnosis and is suffering from a disease
  2. A healthy research subject is a person who is not suffering from any disease

Healthy research subjects may be included in studies where we want to examine whether there are differences between healthy people and people diagnosed with a certain disease. Research subjects are also used to try out new pharmaceuticals, and may in addition undergo minor surgery or psychological trials. In some studies, research subjects answer questions about their living habits.

Being a research subject is a voluntary choice, and you can choose to stop participating in a research study at any time without giving any reasons.

There is a strong legislation in Sweden to protect research subjects.

Why do clinical research?

Clinical research is carried out to obtain new treatments that are as effective and safe as possible within the healthcare sector. It has enabled us to develop new drugs, different methods of treatment and medical-technical products that we now take for granted. Clinical research is also a prerequisite for the authorities to approve a new drug or a new medical-technical product, and for doctors to start using a new method of treatment.

What is a clinical trial and how is it done?

Researchers use clinical trials in clinical studies to examine the effects of a drug or evaluate a surgical method, psychological treatment, radiation therapy, physiotherapy, nutrition or medical-technical equipment. Research may also be about how the body works, human behaviour and habits, and so on.

Aspects examined include how the body reacts to a drug, how a drug is affected by other medications that may be used at the same time, what effects it has or does not have, how safe it is, if it functions differently in younger and older people, and how effective it is compared to previous treatments. Regarding other treatments than drugs, such as psychotherapy or cognitive behavioural therapy, researchers want to answer the same type of questions.

There are clinical trials directed solely at healthy people or studies for people with specific diagnoses, and sometimes people are needed from both groups.

All clinical trials are carried out in accordance with strict rules and are carried out in compliance with a trials plan, reviewed and approved by the relevant authorities

How is a clinical trial done?

The trial is carried out according to strict rules, which are similar throughout large parts of the world. We often compare a new treatment with an older, well-known treatment. It may also be compared with a placebo (sugar pills) in the case of diseases for which there is no treatment yet.

To be sure of really measuring the effects of the new treatment, and not the effect of the doctor's or the patient's expectations, many studies are double-blind. This means that neither the doctor nor the patient knows which treatment the individual patient is undergoing.

Before a clinical study can start it must be approved by the Swedish Ethical Review Authority, which has to approve biomedical research involving people. Among other things, the Board assesses whether the usefulness of the research is in reasonable proportion to the possible risks, how information for the patients should be formulated and how follow-up of patients is managed. If it is a study of a new drug, approval is also required from the Swedish Medical Products Agency. Principals, boards and authorities also have the right to make inspections at any time to ensure that the studies are scientific, ethical and legally correct.

Trials are carefully planned and carried out according to a predetermined protocol (trial plan), which must be reviewed and approved by theSwedish Ethical Review Authority as well as the the Medical Products Agency if it's a drug study. Only after approval may the clinical trials start. Clinical trials doctors (called "doctors") are obliged to carry out every trial in accordance with the prescribed guidelines.

Many doctors/researchers across the country often work together in the same trials. Many studies are international, i.e. clinical trials are in progress in several countries at the same time.

When starting to develop a new treatment, trials are carried out on a few, often healthy and voluntary, research subjects during a short period of time. The more we learn about the treatment method's effects and side-effects, the greater the trials become, and often include several hundred, sometimes up to several thousand patients, who are treated for as long as the disease requires. Trials may be from a few weeks, in the case of vaccines, for example, up to a year or more, in the case of diabetes, COPD or other chronic diseases.

Before you decide if you want to participate in a clinical study, you will be given both oral and written information on the trial, and you will have the opportunity to ask questions.

Path to approved drug

It takes about twelve years and costs hundreds of millions SEK to test, develop and approve a new drug.

The most promising substances are selected first and tested in a research laboratory. All drugs must undergo animal studies before they can be given to research subjects. Clinical trials are subsequently carried out on voluntary research subjects in four phases.

  • Phase 1 studies are made on a few healthy volunteer research subjects to see if the drug is tolerated by people and to get an idea of the appropriate dose. Fertile women are not usually included in this group.
  • Phase 2 studies are conducted on a small, homogeneous group of patients to find out whether the drug has a positive effect in the treatment of a disease or any adverse effects or other risks. The research subjects often have a very similar disease and may not take other drugs. This group includes both men and women.
  • Phase 3 studies are carried out on larger and slightly more varied patient populations. During this phase the trialled drug is compared with the current standard treatment for a longer period of time. If there is no other standard treatment, the drug is tested against a placebo. This group includes men, women, and sometimes special groups such as elderly people and children.
  • After Phase 3 the pharmaceutical company may apply for their drug to be approved. When the product is on the market, Phase 4 studies continue to ensure that no serious, unexpected adverse reactions appear.

Why should I be involved and will I be paid?

By participating in a clinical trial, you will be contributing to the development of new drugs and treatments which can help yourself and others, now and in the future.

When developing drugs or other treatments, it is necessary to study the effects and side-effects of the treatment for the disease it is hoped to cure. Rigorous requirements are set up for the symptoms or absence of symptoms of the disease being studied. For this reason, people with a disease or healthy volunteer research subjects must meet certain requirements for the study, in order for researchers to answer certain questions about the treatment.

Participation in a clinical trial is free and some trials are paid (in Sweden taxable). The amount paid depends on the time of participation and the degree of discomfort.

If you have a diagnosed disease, you participation in a study may contribute to finding a treatment which is more effective and better tolerated than the existing treatment. Sometimes an individual patient does not draw any benefit from the treatment, but still contributes to answering an important question and thus helps other patients with the same disease.

It is risky to participate and what protection do I have?

Participating in a research study may involve some discomfort in the form of blood tests and time-consuming checks/treatments. Adverse reactions may occur, but the safety and well-being of the research subject always have high priority.

The drugs being studied in clinical trials have always been examined in other contexts first. Before a drug may be given to people at all, it has undergone a series of experiments to test its safety and effects. Since human beings are different from many animals there is, of course, no guarantee that they will react in exactly the same way as animals. For example, it is unusual for animals to exhibit allergies.

The first trials on humans are carried out on a few healthy subjects over a short period of time. The effects are then studied on larger patient groups. At each new step, the medical company and the authorities make a thorough assessment of all the available results before proceeding. During all clinical trials, any side-effects are monitored according to a strictly defined and controlled system by both research doctors and the authorities.

All of these procedures mean that the risks involved in participating in a clinical trial are small. Since a clinical trial is investigating new drugs and treatments, however, it is not possible to know all side-effects in advance. At each new step, the medical company and the authorities make a thorough assessment of all the available results before proceeding.

The clinical trials doctor must inform all research subjects of possible side effects or other risks before the trial is started. The decision to take part in a clinical trial is not easy to make, so please feel free to write down any questions that you would like answered before your final decision, and don't forget that you can decide not to participate at any time.

What protection do I have if something should go wrong?

The doctor and the university hospital, university or company responsible for the research is required to ensure that every patient or healthy volunteer research subject is guaranteed adequate financial protection through an insurance policy or other satisfactory method, if any injury should occur in connection with the trial. Both public and private healthcare providers are obliged to sign a patient injury insurance premium.

Compensation can be paid from this insurance for physical and mental injuries (with certain exceptions) caused by the trial, care or treatment, faulty equipment or medical-technical product, incorrect diagnosis, infections, accidents, and drugs that were not administered correctly.

Injuries due to characteristics of the drug or shortcomings in the description of how it is to be used, however, are not compensated under the patient injury rules. Such injuries must instead be reported to
Pharmaceutical Insurance.

This is a voluntary insurance scheme which is paid for by companies that manufacture and import drugs sold in Sweden. This insurance compensates any injury caused by drugs, even if they have been given on proper medical grounds and in a correct manner. Compensation will be paid for any personal injury (with certain exceptions) which was very probably caused by the drug in question.

Lack of effect is not regarded as a drug injury and is thus not compensated. Every patient or healthy volunteer trial subject is guaranteed financial protection if injuries should occur in the context of the trial.

Who protects my interests?

The method of carrying out clinical research today is based on the Helsinki Declaration. The Declaration, adopted by the World Medical Association in 1964 and updated over the years, provides ethical guidelines for research on humans in the biomedical area.

It prescribes that it is the duty of doctors to constantly improve treatment and broaden our knowledge of diseases, but this must not take place at the expense of individuals' integrity or safety. Trials must be designed in such a way that the risk to participants is no greater than the benefits, and they must be so well-planned that it is really possible to answer the scientific question being asked.

In order to ensure that all of these requirements are met and that the participants' interests are protected, there are several parties involved: Participating research doctors and any companies involved share a joint obligation to justify exactly why a clinical trial should be made, and why they want to carry it out in a particular way. If a clinical trial is carried out without a company's participation, it is the responsibility of the research doctor in charge to justify the trial in the same way.

The doctor has an obligation to assess whether the trial is medically correct and feasible. When the company (if there is one involved) and the doctor are in agreement on the design of the trial, it must be approved by the Medical Products Agency and by a regional ethical trials board (for all trials) consisting of both doctors and lay people.

The Medical Products Agency checks that the drug trial is correctly planned, that the information on the drug is well-founded, that all regulatory requirements on safety etc. are met. The Medical Products Agency also carries out inspections in which clinical trials are examined to ensure that all parties are performing them correctly.

The regional ethical trials board examines all types of clinical trials and assesses firstly whether the relationship between the risk and the potential benefit for the individual is acceptable, and secondly if the information intended for the participants is correct and comprehensible.

What rights and obligations do I have?

According to the ethical trials law, a clinical research study may only be carried out if you, the research subject, have voluntarily agreed to the specific trial, and this must be documented. Your consent applies only if you have been given information on the research in advance.

You have the right to information on:

  • the overall plan for the research,
  • the aim of the research,
  • the methods that will be used,
  • the consequences and risks that the research may cause,
  • who is the research principal,
  • that participation in the research is voluntary, and
  • your right as a research subject to cancel your participation at any time.

You are thus entitled to cancel your participation at any time, and you do not need to explain why you do not want to continue. If you choose to cancel your participation, it will not affect your continued treatment.

Before you cancel, though, it is a good thing to discuss the decision with the doctor or nurse in charge, because trial staff generally want to make a final examination and you should return any drugs and materials not used.

For it to be possible to draw the right conclusions about the treatment, it is important that all patients participating in the clinical trial follow the instructions and are present on all the occasions. Think carefully before you agree to participate, because it is best if participants can be present during the whole trial period.

It is important that you contact us if you are prevented from attending any of the occasions. It is also important to tell us about any other treatment you are undergoing. The doctor/nurse needs to know if you have not been able to follow the instructions you were given during the trial.

What obligations do the people in charge of the trial have?

The company, university, hospital and research doctor in charge of a clinical research study have extensive obligations under the legislation in force.

Their responsibilities include:

  • the staff involved in the trial having the education that is needed and required by the authorities.
  • the doctors involved in the trial having the necessary skills and the resources in the form of time, staff, equipment and patients.
  • all the documentation on the treatment studied being submitted to the authority for evaluation.
  • participation doctors being given adequate training in the treatment studied and in research methodology.
  • new knowledge generated by the trial being communicated to participating doctors and the authority.
  • providing trial drugs during the trial and ensuring that they are correctly marked.
  • checking that the examination is carried out in a proper manner and that the data collected correspond with that in the patient journals.
  • any adverse reactions occurring during the trail being documented and reported to the authority. This responsibility is shared with the doctor in charge.
  • adequate insurance cover, if any injuries should arise despite all precautions.
  • the results after the completed trial being presented in a scientifically correct way.
  • all the data collected during the trial being archived in a reliable manner, so that the trial can be checked and reconstructed at a later date.

Confidentiality – how does that work?

When you participate in clinical research, you have the same protection of privacy as all other patients in Swedish healthcare. The data collected during the clinical trial is registered on special forms with a code but without your name or civic registration number. Only the doctor and his/her staff have access to your "pass key", with which it is possible to connect collected data to you.

In the case of clinical trials of drugs, a representative of the company that manufactures the drug (or the researcher in charge of the trial if no company is involved) also needs to be able to check the data in the patient form against the original information in the patient's journal.

Similar checks may also be made by representatives from the Medical Products Agency or foreign medical products authority. That is why all participants in clinical trials need to give these representatives permission to read their patient journals. Of course, these outside persons are obliged to follow the same rules of confidentiality as healthcare staff, which is regulated in the Secrecy Act.

In some trials encoded data (without names or civil registration numbers) are sent to countries outside the EU, and under the General Data Protection Regulation (GDPR) all participants need to give their permission for this.

If you do not wish to give consent to these conditions, you cannot participate in the trial.

What happens afterwards?

Prior to the trial of a drug, for example, the doctor should already have discussed continued treatment after the trial ends, if you have a diagnosed disease. One option is to continue the treatment you had before the trial. Alternatively, another treatment may be tried as a result of the trial.

Many studies are carried out as a double-blind. In these trials, the individual doctor does not know what treatment you have been given when you are finished with the trial, but only when all patients are finished. The doctor will then enter the treatment you were given in your journal, and you are also told. You will also be told of the effects, if this has not already been communicated. Prior to the trial, the doctor should already have discussed with you continued treatment after the end of the trial.