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Merck Sharp & Dohme is the New Zealand subsidiary of Merck & Co., a leading international research-based pharmaceutical company, one of whose aims is to improving human health through the research and manufacturing of innovative products. Merck Sharp & Dohme has been part of the New Zealand health sector since 1962 and currently employs 105 people, most based in Newmarket, Auckland.
The New Zealand team is part of the larger international team discovering, developing, manufacturing and marketing a broad range of pharmaceutical products for use in the treatment of human beings to improve their health.
You have been invited to take part in a clinical trial. This may be your first time on a clinical trial or you may have been involved in one before, but either way the idea of participating in a trial may seem daunting. Below is a brief run-down on what clinical trials are, and what is involved if you agree to participate in a clinical trial.
1. What is a clinical trial?
A clinical trial is basically a scientific study that involves human participants. Clinical trials are often done by the pharmaceutical company in collaboration with independent investigators. The aim of clinical trials is to investigate whether a medicine is reliable, safe and effective for a particular disease or condition.
Clinical trials are used by authorities such as the Ministry of Health (MOH) in New Zealand, or the Food and Drug Administration (FDA) in the USA, to decide whether the medicine should be allowed on the market. After marketing approval, trials continue to work out in more detail who else may benefit from the medicine, and whether this medicine has any other applications.
Clinical trials also allow doctors to measure the extent of the medicine’s effect, so they can predict with some confidence how much benefit other patients with the same condition will get, and whether there are any potential side effects doctors need to warn patients to look out for.
2. What happens in clinical trials?
A clinical trial can be designed in a number of ways.
In randomised controlled clinical trials, large numbers of people are recruited to participate in the study. The people who have been recruited are divided by random allocation into two or more groups, so that the groups are similar in terms of age, sex, illness and other factors that could have an impact on the study results. One group is given the medicine being studied, the other group is given a placebo (a tablet which has no active medicine) or a standard treatment for the disease.
You may have read that many clinical trials are ‘double blind’ trials. This means that during the course of the trial none of the participants, clinical trial staff/study staff know who is taking the study medicine or the placebo/standard treatment. This way nobody knows who is taking what until the end of the trial, and so no one can affect the outcome of the trial in any way. The participants are given the study medicine or the placebo/standard treatment to take in the same way as their family doctor would request. At the end of the trial, the results from the people taking the study medicine are recorded and then compared with the results of the people taking the placebo/standard treatment, using statistical measures. This way researchers can get an accurate picture of what people can expect if they begin taking the medicine.
There is a method called “unblinding” which shows the researcher what trial medication the participant is taking should they need to know because of a side effect.
3. What are the stages in clinical trials?
There are various stages or phases involved in the journey of the development of a new medicine, from the laboratory until the local pharmacy where it is available to consumers.
Initial Testing: Following the initial development of the medicine, which can take several years, it is extensively tested in the laboratory and on animals to work out its actions, to determine what the side effects might be, and to make sure it is not harmful.
After the initial development and testing, clinical testing begins and this requires Ministry of Health approval and Ethics Committee review. Clinical trials are divided into three phases of study, each phase involving greater numbers of people.
Phase I: Here the focus is mostly on the safety of the medicine. Studies are normally conducted on healthy volunteers, usually numbering between 20 to 100 people. Researchers study the effective and tolerated dose and how the medicine is absorbed, broken down and eliminated by the body, as well as identifying any side effects at different doses. This phase generally lasts several months. Usually about two-thirds of medicines progress past phase 1.
Phase II: Here the focus is on the effectiveness of the study medicine in treating the intended disease. In this phase there is also some emphasis on side effects and risks in participants with existing health problems. Generally, a few hundred patients participate in phase II trials, which take longer than phase I trials. Only about one third of medicines successfully complete this phase.
Phase III: In this phase the focus is on safety, effectiveness and determining the right dose to treat the disease. Several hundred people with the disease in question may participate. By using such large numbers of people, less common side effects will emerge. Of the medicines that complete phase II, most of these successfully complete phase III.
4. How do researchers know the medicine won’t have unwanted effects?
As mentioned above, part of the purpose of clinical trials is not only to assess benefits but also to see if any unwanted side effects emerge, and how severe or common they are, as well as the benefits. Any side effects that occur in the group taking the study medicine are compared to the side effects seen in the placebo group or the standard treatment group. Most of the side effects in the placebo group are due to unrelated illnesses such as stomach upsets and colds. Only by having the two groups can the researchers determine whether an unwanted effect is due to the medicine or an unrelated illness.
5. What happens with the results?
The final results of the clinical trials are reported in the medical press, without individuals being identified. They are available for doctors, so that they can make scientifically-based assessments of the benefits and risks for each patient. A copy of the results can be obtained from your doctor, however, this may be some time after you have completed the trial. The data may be used to obtain permission from the Ministry of Health to market the product in New Zealand.
6. Who is involved in clinical trials?
You have been invited to participate in a clinical trial because you have a disease that is the focus of the study. The doctor who is managing your study is known as the investigator. S/he is responsible for the overall management of the study. Each investigator is supported by a team of co-investigators, sub-investigators and study co-ordinators who are responsible for your medical care while on the trial and will always put your safety and interests first. Each person will have defined responsibilities in the running of the trial. You will be given the name of the person you need to contact for appointments or advice.
7. How are clinical trials managed?
All parties (investigators, study co-ordinators and pharmaceutical company employees) involved with the development and testing of the study medicine must follow the study protocol. This sets out in detail the process and design of the study, the treatment(s) to be used and the measurements that will be required. In New Zealand all trial protocols must be approved by the local ethics committee which may be contacted if you have any concerns. If you would like advice as to your rights as a participant in a clinical trial you may approach a Health & Disability Consumer Advocate by contacting:
0800 20 55 55 (Upper North Island)
0800 42 36 38 (Mid/lower North Island);
0800 37 77 66 (South Island).
8. What do I have to do if I participate?
As a participant in a clinical trial, you too have responsibilities.
Before agreeing to participate in the trial you should read the participant information sheet and understand what participation in the trial will involve. You should ask the Investigator any questions necessary to understand the study. Participation in clinical trials is voluntary. If you decide not to participate, this will not affect your ongoing healthcare. If you do decide to participate, you may withdraw at any time without having to give a reason and this will not affect your future care.
By signing the Consent Form you are agreeing to participate in the study.
It is also important that you take the medicine as prescribed by the study staff. This involves taking your medicine at the requested times and attending regular check-ups at the clinic. During check-ups, you will be asked to bring your tablets with you to ensure you are taking the right number with the specified treatment. Failure to follow the trial instructions may cause an adverse event for which you may not be fully compensated by the company.
Because the trial is sponsored by a pharmaceutical company your participation will not be covered by ARCIC (ACC). Compensation will be provided by Merck Sharp & Dohme (NZ) Ltd. The Investigator will provide you with further details.
An ID card is issued to each participant in a study trial. The ID card provides information on the study number, the Investigator and Study Co-ordinator contact details and the participant’s medication.
9. Are there any risks?
There is always some risk associated with taking any medicine and there will also be an additional risk in taking any new medicines. If a side effect does occur during a clinical trial and it is decided that it is due to the study medicine, you may choose to withdraw from the study or your doctor may withdraw you from the study. Sometimes the trial is stopped.
10. Are there any other checks on clinical trials?
During a clinical trial all data are checked by a monitor. The monitor is employed by the pharmaceutical company to manage the study and to check that all evaluation data are correct and entered without errors. This is to ensure all ethical and good clinical practice guidelines are being followed by the doctors and medical team.
All clinical trials may be subject to an audit which is undertaken either by the pharmaceutical company or by local or international regulatory authorities.
Points to remember:
It is important to keep your appointments
Please bring your unused medicine back to your doctor/study nurse
Please contact your doctor or study nurse if you have any concerns
Please carry your participation ID card with you at all times
Merck Sharp & Dohme (New Zealand) Ltd
Level 2, 109 Carlton Gore Road
PO Box 99-851, Newmarket
Auckland
11-05-GEN-03-NZ-4249-O
TAPS NA8593
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