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1 Medicals c i e n t i f i c study design risks medical-ethics review board 2

2 Table of contents M e d i c a l - s c i e n t i f i c study Preface 2 Introduction 4 Medical-scientific study 5 Why participate? 6 Risks and side-effects 7 Scientific drug study 8 Design of a studyk 9 Medical-ethics review board 10 You are asked 11 Your rights and obligations 13 Insurance 16 Researchers 17 Do you know enough? 18 Glossary 19 1

3 Preface Man does not live for himself alone. In all of the areas of life, that can been seen most clearly within the healthcare sector. In our country, we cover the costs of healthcare together, so that everyone in the Netherlands who has been afflicted by illness or accident can profit from state-of-the-art care. The system in our country is based on solidarity. In order to maintain the high level of care and, whenever possible, to improve it, scientific research in the field of healthcare is essential. Medical scientists are continually searching for new treatment methods. Scientific research on human beings is an absolute necessity. Here, too, an appeal is made for solidarity. If we feel able to do so, it is our task and responsibility to help medical science move forward and, where possible, make an active contribution. It goes without saying that, here, we must not lose sight of the interests of the individual. Nobody must ever become involved in medical research against his will and without his knowledge. The reverse is the case; researchers may appeal to a certain feeling of solidarity, but ultimately a person may only take part voluntarily. Research must be valuable; it must increase our knowledge. However, a comparative assessment must be made between the importance of the study and what is asked of the patient. It is the responsibility of a hospital to oversee this. For that reason, there is legislation and there are medical ethics review boards. These boards review every medical-scientific study beforehand that will be carried out on humans. They see if the study is valuable for the progress of medical knowledge and if the study has been carefully designed, with respect for those persons from whom cooperation is requested. 2

4 People who take part in a medical-scientific study can, therefore, be assured that they are not hurtling themselves into an adventure. Every study is assessed beforehand for its scientific value and ethnical admissibility. I hope that this information brochure will enable everyone, freely and responsibly, to make a decision if he/she is asked to take part in scientific research and, thus, to contribute to the quality of medical care -- a task that concerns us all. A.C. van Loenen, hospital pharmacologist, clinical pharmacologist Chairman, medical-ethics review board VU Medical Center The Dutch word onderzoek has several meanings, which can cause some confusion. [note from translator: there are different words in English for the different meanings] If you go the hospital for an onderzoek it is always a diagnostic examination. This means that you will be examined in various ways in order to discover the cause of your symptoms. Such an examination, therefore, only involves you and your complaints. A scientific study is also called onderzoek in Dutch, but this has a much broader objective and sometimes has no bearing at all on your specific complaints. Consent is always requested beforehand for participation in this type of study. Participation is always voluntary. This brochure is about this type of onderzoek. 3

5 Introduction You have been asked to take part in a medical-scientific study. This brochure will help you in making your decision about whether or not to participate. Here, you will find general information about medicalscientific research and about what participation means for you. Your doctor will give you specific information about the study itself, both verbally and in writing. This brochure is intended to supplement that information, not to replace it. In this brochure, the following question will be dealt with: What is medical-scientific research and what does it entail? Are there risks for the test subjects? What rights do the test subjects have? How is the study carried out? At the back of this brochure, you will find an explanatory glossary and space for notes and any questions you may have. A questionnaire has also been included that may possibly be able to help you in deciding whether or not to participate. If, after reading this brochure, you still have questions, then it is best to ask your physician. This also applies to the specific information concerning the study for which your cooperation is requested. 4

6 Medical-scientific research Medical-scientific research is done in order to, among other things, find better treatments for diseases. The researchers investigate whether or not a new treatment satisfies the expectations and if it has side-effects. Such scientific research is only possible with the cooperation of test subjects. These could be patients, but could also be healthy volunteers. The cooperation of patients is essential as the research deals with studying the effects of a treatment. Other names for medical-scientific research are:: scientific research, clinical (scientific) studies, clinical research, clinical trial and medical experiment. In this brochure, we will continually use the term scientific research. Scientific research focuses on various objectives, for example: Methods for diagnosing an illness (diagnostics); Treatment of a disease; Acquisition of more insight into the functioning of the human body and pathological processes. Acquisition of more insight into the functioning of the human body and pathological processes. Scientific research can be focused on a new drug, a new surgical technique, but also on a different treatment or treatment method. Sometimes it is about a combination of treatment possibilities. However, it can also be concerned with research that has no immediate connection to the disease for which you came. Not all scientific research with patients originates with doctors. Scientific research is also done by other professional groups within the healthcare sector. You may also be asked to take part in this type of research. 5

7 Why participate? Scientific research makes it possible to implement newer and increasingly better treatment methods. Scientific research is also necessary to prove that a new drug works and is sufficiently safe before it is allowed to be put on the market and is available in the pharmacy. Without scientific research, medical science would no longer be able to develop further. A great deal of scientific research is only possible if patients provide their cooperation. You may have various reasons for participating in scientific study. A scientific study is done in order to test a new treatment that is probably better than the old one. Whether or not the treatment is, indeed, better must still be proven; that is what this study is for. The treatment has, for example, fewer side-effects than your usual therapy or the treatment is easier for you. There are, however, not always advantages if you take part in a scientific study. Sometimes, the patients themselves do not profit at all from the study they are participating in. The study is then intended to help future patients. That, too, can be a reason to participate. Whatever your reason for wanting to participate in scientific research, it is important that you know beforehand precisely what is involved. 6

8 Risks and side-effects One of the first questions that arises in patients who are asked to be test subjects is: am I at risk if I participate? The answer is: yes, that is possible. The treatments in a scientific study are new and not all of the risks and side-effects are known yet. That is, after all, precisely the objective of the study: the detection of all the effects of the treatment. For that reason, there is a certain risk for the test subject in nearly every scientific study. How large that risk is depends on the type of treatment, the patient and the condition of his illness. The researchers take all kinds of measures to make the possible risks as small as possible. Your doctor will tell you about the possible risks and side-effects of the study you have been asked to participate in. Before you decide to participate, you must weigh the possible advantages against the risks or disadvantages. 7

9 S c i e n t i f i c D r u g T r i a l Many patients are asked to cooperate in scientific drug trials. Before doctors can try out a new drug on test subjects, that drug has already been through a long trajectory in laboratories and research centers. If laboratory testing has shown that a new drug would work well, the researchers then test the drug to see if it works on animals and whether or not it has side-effects. It is not until animal testing has provided good results and appears safe that it is time for research on people. Therefore, before people cooperate in a scientific drug trial, a great deal of research has already been done. The trial with people is generally carried out in various phases. In the first phase, a small number of test subjects (generally healthy volunteers) are involved. In the following phases, patients are included, first in a small numbers, later in larger groups. The doctors who carry out the study in the hospital are required to ensure that there are as few risks as possible for the test subjects. There are, moreover, various authorities that assess the scientific drug trials beforehand. One of those is the medical-ethics review board (see page 10). The central government also has its own precautionary requirements. 8

10 Design of a study Often, during the trial, the researchers compare the new treatment with the existing treatment. In order to do this, the test subjects are divided into groups. In order to have groups that are as comparable as possible, and so that the study can be done as objectively as possible, the system of randomization is used. Randomization By using a system that resembles drawing lots, it is determined which patients will receive the new treatment and which the existing one. The test subjects are not able to influence the results of the lottery, and neither can the doctor. Which group the patient is put into is entirely a matter of chance. Often, a clinical trial is done double-blind: neither your doctor nor you then known which group you are in. (If, in the case of an emergency, it nonetheless becomes necessary, it is always possible to find out which group you are in). Placebo Sometimes, a researcher wants to know if the positive effect of a new treatment is only due to this specific treatment. Several factors could, namely, play a role here. In order to learn more about this, it is necessary to compare the new treatment with no treatment. This is done by giving the one group of patients the treatment and not the other. This is not so simple, because if you do get the drug and your fellow test subject does not, then you both know which group you are in. In order to be able to compare the new treatment with no treatment, researchers will then make use of a placebo 9

11 treatment. A placebo looks exactly like the drug being tested, except that a placebo does not contain any active substances. Research with placebos is only permitted if there are no negative effects for your disease. The researchers and the medical-ethics review board pay close attention to this. M e d i c a l - e t h i c s review board The Human Medical Research Act (WMO) stipulates that research proposals may not be implemented until they have been approved by an authorized medical ethics review board. Many Dutch hospitals have such a board, as does the VU Medical Center. This board, is composed not only of physicians, but also a nurse, a hospital pharmacist, a general practitioner, a psychologist, a clinical epidemiologist, an expert in the field of medical ethics, a lawyer and person who assesses the study from the viewpoint of the patient. The board examines, among other things, whether or not: the study is worthwhile; there are not too many risks and/or disadvantages for the test subjects who are involved; there is sufficient written information available for the test subjects. 10

12 If the board feels that the study does not sufficiently take the interests of the patient into account or is too heavy a burden for the test subjects, it will not approve the study. This means that the researcher may not implement his study in the present form; he will first have to make adjustments. Doctors may, therefore, not simply carry out a study without assessment and approval beforehand. The study which you have been asked to participate in has been approved by the medical-ethics review board of the VU Medical Center. The medical ethics review board provides a general judgment about the admissibility of the scientific study. That does not mean that the board members are advising you to take part. They do not, after all, know your situation and, therefore, cannot decide this for you. You alone can determine if the possible advantages of the study compensate for the disadvantages. You are asked Your consulting physician or another staff member at the hospital will ask you if you would like to participate in a scientific study. He will discuss the study with you. Whatever he says will also be given to you in writing so that you can read it all again. If the doctor does not offer you the information in writing, you must request it. The information will also include the following: What is the objective of the study? Which treatment is being studied? What is the design of the study? What possible extra burden would there be for you from the study? What are the advantages and disadvantages for you? What will be expected of you during the study? 11

13 Moreover, the doctor will tell you what your rights and obligations are. The following chapter will discuss this more extensively. Before you decide whether or not to participate, you will be given time to think the matter over. Think about all the information and list all the advantages and disadvantages for yourself. Nearly every scientific study means, in practice, more tests and check-ups, more visits to the hospital and, therefore, more time and effort on your part. At any time, you may ask for extra information or explanation. You can find the information about who to ask in the written information about the study. You may also make an appointment with your doctor to discuss your questions. It also often helps to discuss the information with your partner, family, friends or family doctor. You may also ask for information and advice from a doctor who is not involved in the implementation of the study (an independent physician). The name of this doctor can be found in the written information on this study. If you are prepared to participate, you will be asked to sign a written permission form. This is called an informed consent form. Signing it is a kind of statement that you are, in principle, willing to participate; it means that the study has been explained properly to you and that you, subsequently, are voluntarily providing your cooperation to the study. It does not mean that you therefore also obligate yourself to complete the study. At any time, you may withdraw from the study. It is possible that the researcher will ask your permission to save blood or other body substances that are over after the necessary tests have been done. He will ask if this may be used again at a later time to do other tests. Sometimes, blood is necessary to test new laboratory methods or to determine normal levels in the blood. 12

14 This also applies for blood that was drawn from you to repeat certain tests in case something went wrong with the test the first time. Thus, you can avoid having to have blood drawn again in the case that a test failed. These blood samples are then provided solely with a code; thus, without your name and further personal data. In most cases, you will never hear about this again. If, by chance, something is found in the blood that is important for you, then we will attempt, via the code, to find out if you can still be reached. Such a coincidental finding is, however, not to be expected. Your rights and obligations As a test subject, you have rights. In order to protect test subjects, legal guidelines have been established. There are regulations concerning what a doctor may or may not do in a scientific study. The most important rights of the test subjects will now be discussed. T h e r i g h t t o d e t e r m i n e f o r o n e s e l f a b o u t p a r t i c i p a t i o n ( v o l u n t a r i n e s s ) You are never required to take part in a scientific study. It is always your free choice. If the doctor asks you if you want to be a test subject, you are certainly free to refuse. Nobody will blame you. If you decide not to participate, that will not have any negative consequences for your treatment; the doctor will not look down on you for it. 13

15 T h e r i g h t t o r e c e i v e i n f o r m a t i o n a n d a s k q u e s t i o n s You will be given a great deal of information from your doctor, both verbally and in writing. You are entitled to information, not only beforehand but also during and after the study. The doctor is required to provide you with that information. Moreover, you are entitled to time to consider and consult before you make a decision. You may always ask questions yourself: before, during and after the study. You must not be afraid to be considered troublesome. It is important that you know what is going to happen. Your doctor will try to answer your questions. Do not hesitate to ask a question again if you are not certain that you have understood the answer. For the doctor, the information about the study is familiar and obvious. For you, it is new and unfamiliar and, perhaps, not completely clear after only one talk. T h e r i g h t t o s t o p p a r t i c i p a t i n g i n t h e s t u d y b e f o r e i t i s f i n i s h e d Even when you have given your permission, you may withdraw from the study, for example, if you feel, after awhile, that participation in the study is, after all, too difficult for you. Even if you have already started with the scientific study, you always have the right to stop at any time. In some studies, that is not immediately possible once you have started. In those cases, the medication that you have been given must, for example, be cut down. That means that the dose of the drug must be decreased gradually. It is also possible that a medical procedure has already been done. The doctor will then, in consultation with you, decide what the best way for further therapy for you is. 14

16 Confidentiality of your data During the scientific study, the researchers collect specific data on, for example, the manner in which your body reacts to the treatment. The data collected concerning you is confidential and processed under a code. Your data is, namely, given a number; your name is not used. It is, moreover, not important for the study. The researcher only has access to the data under a number. The medical data that is important for you for the study can be examined by the authority who commissioned the study. Even when the results of the study are published, your name will never be able to be traced. Obligations Alongside of your rights, you, as a test subject, also have obligations. Thus, for some examinations, you will have to have fasted or you must bring the remaining medication with you every time you come. If you do not keep the appointments and adhere to the obligations, the study cannot be well conducted and the outcomes will be unreliable. In that case, your doctor will terminate your participation in the scientific study and discuss a further treatment with you The obligations differ for every study. You will receive information about this from your doctor. 15

17 Insurance Researchers try to ensure that nothing goes wrong during the study. Moreover, the medical-ethics review board sees to it that measures have been taken to avoid, as much as possible, damage due to the study. However, it is always possible that unforeseen problems arise. It is good to know that the hospital or the organization that is having the study done has taken out a special risk insurance for the study. This will pay for any possible damages that are incurred as a result of the study. Just as with any other insurance, you must adhere to certain regulations. Only then can a claim be made for the payment of damages. An insurance company does not compensate if it has not been sufficiently proven that the damage is a result of participation in the study or if you have willfully not followed specific instructions. If you feel that you have suffered damages as a consequence of your participation in a scientific study, you may contact the insurer of the study who is named in the information letter. Complaints For complaints that are connected to the implementation of the study and that you cannot solved with the doctor/researcher, you may turn to the complaints scheme in the VU Medical Center. 16

18 Researchers Some people would like to know who has designed the study or who it is who wants the data. You may ask your doctor who, in your case, started the study. There are various possibilities: 1. The initiative can be taken by the pharmaceutical industry or manufacturers of medical equipment. In their companies, they have developed a new drug or instrument that is not yet on the market. Before it can be put on the market, it must first be well tested to see if its use is effective and sufficiently safe. The company then asks a number of doctors if they will investigate that. If the outcomes are positive, then the drug can be officially registered. Large pharmaceutical manufacturers often ask the cooperation of several hospitals at the same time. In this way, they are able to collect as much data as possible. This is called a multicenter trial or a multicenter study. 2. There are also special research centers or institutes that have scientific studies done, for example, the Dutch Cancer Society. Also, a department of the hospital can itself decide to carry out a study. 3. Many scientific studies are carried out in academic medical centers. There, the task is to increase knowledge concerning disease. The usability of new and also of current -- methods of research and treatment must be tested. 17

19 Do you know enough? Questions that you can ask yourself before agreeing to participate in a scientific study: Have you also received written information about the scientific study? Is the following clear... who has set up the scientific study: what one wants to achieve with the scientific study you have been asked to participate in? what advantages this could have for you? what disadvantages there could be if you participate, such as (the chance of) possible side-effects. whether or not it going to be determined by drawing lots which treatment you will receive? which treatment you will receive or what will happen if you do not participate in the study? what the practical consequences are if you do participate (for example, admittance to the hospital, the necessity to come to the out-patient clinic more often, more frequent blood tests, extra procedures)? who is the physician in charge and how can he be reached? who is the independent physician you can turn to with questions about the study? what you can do if you have concerns in connection with the study? that participation is entirely voluntary? that you may terminate your participation at any time before the trial has ended? that non-participation or terminating your participation in the scientific study will have no adverse consequences for the doctorpatient relationship or for your further treatment? how insurance coverage has been regulated? 18

20 Glossary Clinical trial Literally, this means: clinical testing. See medical scientific study. Double-blind A research design in which neither the doctor nor the patient knows which treatment the test subject has been assigned. Ethics (medical) A system of moral norms and values, in particular in the area of health care. Pharmaceutical industry Drug industry Informed consent Literally, this means: informed permission. The permission that someone gives when he agrees to become a test subject in a clinical trial, after he or she has been given sufficient information about it. Clinical scientific study See medical scientific study Drawing lots See randomization Medical ethics review board The committee which assesses human scientific research in hospitals Medical experiment Legal term for medical scientific research, which is used in legal regulations. 19

21 Medical scientific study Systematic research of the effects of a new treatment or new treatment method according to a scientifically designed plan. Here, patients are often used as test subjects. Multicenter trial A scientific study that is carried out simultaneously in several hospitals, and sometimes even in several countries. Independent physician The physician who is not involved in the implementation of the study to whom the patient can turn for information and advice concerning the study. Researcher The person who carries out the scientific study. This is generally a physician, often the patient s consulting physician. Research protocol Detailed and planned description of a scientific study. Placebo A placebo looks exactly like the drug being tested. However, a placebo contains no active ingredients. Test subject This is a term that is used in scientific research for the healthy or sick volunteer who participates in the clinical trial. Randomization Drawing lots; chance determines which treatment a test subject will receive. 20

22 Second opinion Here, another doctor is asked for his/her opinion concerning the disease or treatment. Standard treatment The usual treatment that, at that time, is given to patients with a specific disease. This treatment is only called standard treatment during medical scientific studies. Study See medical scientific study VU Medical Center The name of the Academic Hospital of the Free University and the Faculty of Medicine of the Free University. WMO The Medical Scientific Research Act using human beings 21

23 22 Notes and questions

24 Information For general information concerning disease and/or treatment, you are welcome to come to the patient information desk of the VU Medical Center. You may come here with general questions about clinical pictures and syndromes and for information about patient organizations. The patient information desk can be found in the outpatient clinic, to the right of the main entrance. The desk is open on weekdays from 9.00am noon and can be reached by phone from 9.00am pm; number: (020) or per 23

25 Colophon Publication VU Medical Center Postbox MB Amsterdam Telephone (020) We would like to thank the research group of the Academic Hospital Maastricht for use of the brochure Participation in medical-scientific clinical trials. Design audiovisual center VU/VU Medical Center Printing document production center VU Medical Center January _E 24

26 VU medisch centrum postbus MB Amsterdam telefoon

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