Clinical trials are research studies that are carried out with voluntary participants. Also to be investigated whether a new device is reliable or comparable with former used. Each clinical trial should answer certain questions to improve the prevention, (early) detection, diagnosis or treatment of disease.
Research projects are approved and funded by many different organizations or even individuals, such as of doctors, medical institutions, foundations, self-help groups and companies. But there are also government body given and financed studies commissioned.
Human studies are carried out according to strict scientific and ethical principles. For each clinical trial, a so-called test procedure (also called protocol or log) has to be created. It concluded exactly what is to be investigated and how the research project is carried out. Additionally in this report is explained why the study is necessary. Each participating investigator has to work according to the same protocol.
To ensure the safety of participants, various approvals are required. Although this may be slightly different depending on the institution, in most cases the review (and approval) by a government agency and local bodies prescribed. This verification ensures that the participants are treated following the ethical principles and that the probable benefit of assessments in a reasonable proportion to the potential risks.
In each protocol, it is defined who can participate in the study and who not. Specifications are referred as inclusion and exclusion criteria. Each study has different criteria. For example, decided on the basis of age and sex, medical history, and current health status, whether a subject or patient can participate in a study or not.
The fact that only individuals are included with similar characteristics will ensure that the obtained results are based on the study question and not due to other influences. By specifying inclusion criteria, the accuracy and relevance of the obtained findings are improved.
But it also ensures that participants who might have a negative impact or even are at risk are not included.
Information about eligiblity in our studies can be found in the detail discribtion of each project.
Every eligible subject or patient has to be informed about all relevant content and aspects of the study before they - if they want to participate - voluntarily sign a consent form. As part of this participants will be informed about the purpose of the research, the examinations and surveys carried out during the study, the course of the treatment and/or assessment and potential risks and any anticipated benefits.
Also to an explanatory meeting with the investigator or a member of staff / employee of the study team, the study is described in detail in a written patient information. Who then wants to participate in the study will be asked to sign a consent form.
f this written permission is given, that is not to say that you have to stay in the study.
Rather, one can resign at any time at baseline or at any time during the study or a follow-up. Even the education process is not yet completed.
As soon as new findings, benefits or risks and side effects of the used procedure (or other investigated treatment form) are known during the study period, the investigators need to educate all participants about it again. If you still want to continue to remain in the study, if you will be a participant, you will be asked to sign an updated consent form.
Our research projects are carried out in different places, mostly at PAHC or Derriford Hospital (Plymouth, UK). It is also possible that they are carried out in medical practices, clinics, hospitals and similar institutions.
In some clinical studies, the participants are included in only one or two highly specialized centers, in other cases, the study is carried out on more than two test centers simultaneously.
The study will be submitted to the ethics committee for approval. The study will be started only after receipt of the approval vote.
Before you can participate in a study, is first clarified in an interview whether you meet the inclusion criteria or not. All study participants are then examined in a so-called preliminary investigation very thoroughly. Then the actual study starts. The procedure differs from study to study both in length and in the nature of the investigations. After the end of a study, the participants are re-examined thoroughly.
Your participation in the study is voluntary. You are not required to attend. You can stop participating in the study without suffer disadvantages in terms of treatment or your relationship to your doctor at any time without notice for any reason. For your safety, it is advisable that you inform the investigator if you have the intention to withdraw from the study.
In case of withdrawal from the study already obtained on request data / sample, the material can be destroyed. You can decide the withdrawal from the study whether you agree with the analysis of the material or your study data or not.
Should you wish to change your decision at a later date, please contact the study director. If you want this, only the actual study treatment may be discontinued, information about your disease, however, continue to be levied.
Upon completion of a research project, the findings will be carefully evaluated by the investigators and other academic staff.
The results of a research project are often published in medical journals. The journals also have a specialist to proof the publication about ethical consideration, correct statistical analysis and if the conclusion is in accordance to the findings. This ensures that the analysis made, and the conclusion is understandable and relevant.
Particularly important study results of general interest are sometimes taken up and discussed even before their publication in the media, at scientific meetings and by patient organizations.
Among the potential benefits of participating include the following aspects:
Participants have access to promising new treatment approaches that are often not available outside of a research projects.
The approved form of assessment/ treatment is more effective or detailed than the standard ones under certain circumstances.
Participants will be evaluated regularly and carefully and controlled medically by a consisting of doctors and other members of the medical and nursing professions.
The study results may also benefit future patients.
Before deciding to participate you should get a competent answer to all outstanding issues. Below is a list of frequently asked questions about (possible) participants to the investigator or the employees of the study team.
The research project itself
What is the purpose of the study?
Why are the investigators believe that to be examined form might be effective/ different to the already available one?
Who is the sponsor of the study?
From whom the purpose of the test was reviewed and approved?
Are the investigators and other staff members of the study team adequately qualified to carry out the study at all, and have they the required experience for this purpose?
How are study results and safety of study participants monitored?
How long is the project?
To whom the results are forwarded?
Potential risks and benefits
Which short-term benefits can I expect in a study?
What kind of long-term benefits can be expected in a study?
What short-term risks, such as side effects may I notice in participating?
What are the possible long-term risks?
What other treatment options are there?
What is the relation between potential risks and benefits?
Participation
What treatments, assessments and other tests will be done? And how often?
Are these treatments and tests associated with pain? If so, how can this pain be prevented or reduced?
To what extent additional investigations must be carried compared to the usual medical care?
If I have to take medicines, can I take them as usual while participating in the study?
Who handles the medical care of the participants?
How long will the study take place?
Personal interests
How is my daily life influenced by the study?
What support are available for participants and their families?
Can I talk to people who already participate in the study?
Financial issues
Will I be charged as a participant out of pocket?
Who can I contact if I need more information about financial matters?
