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Drug Studies for Patients with HIV and/or Hepatitis in Berlin
There is a long way to go until a new drug is ready to be sold in pharmacies. It takes as long as ten years from the first development of a potential remedy to the final approval by the authorities. This is true for the HIV-drugs, the so called ART (antiretroviral drugs) and hepatitis drugs as well.
Numerous patients volunteered for the clinical studies and helped develop more efficient tablets with less side effects since the breakthrough of the HIV combination therapy (HAART) in the mid 1990ies. As a matter of fact, EPIMED has been involved in the testing of many of today’s indispensable and well-tolerated ART drugs and EPIMED Patients have often the opportunity to be treated with highly effective substances not yet available on the market.
What is a Clinical Study?
The steps of the development of a drug are divided in the pre-clinical (Laboratory, “in vitro”, animal experiments) and in clinical studies.
In the phase I(a) studies a substance will be applied for the first time in humans. These studies are conducted with healthy test persons without the relevant medical condition the drug is developed for to assess the tolerability, the metabolism and the toxicity of a substance. At EPIMED, we do not carry out this phase of trials, yet we do participate in phase I(b) studies. In these clinical trials a drug in development will be studied for the first time in patients bearing the relevant medical condition the drug is being developed for.
Phase II and III studies are research and therapy studies with patients. They are needed to investigate the efficacy, dose finding, development of the pharmaceutical formula, establishing of the side effect profile and the long time tolerability.
Phase IV studies are carried out after the final approval of a drug, e.g. an analysis concerning the long term side effects.
Who Conducts Clinical Studies?
The sponsors are mostly pharmaceutical companies but also national or independent research institutes. Studies are carried out in hospitals and, to a lesser extent, in private practices.
EPIMED is a joint venture of twelve specialists’ practices in the field of HIV and hepatitis and the Department of Internal Medicine /Infectious diseases of the Vivantes Auguste-Viktoria-Klinikum. We offer drug studies for patients with HIV and hepatitis since 1997.
To topWill I Become a Guinea-Pig if I Take Part in a Study?
We would not need clinical studies with humans, if only we knew all pros and cons, the efficacy and lack of efficacy of new substances readily at the beginning. Yet this does not make a study participant to a guinea-pig. The most important difference is the complete voluntariness of the participation and the opportunity to withdraw from the study at any point. For this reason studies are not allowed in correctional facilities and the concern of the patient safety of physical integrity is always paramount to the scientific advance and the marketing effort of the pharmaceutical companies.
The patient safety is regulated by German constitutional law and the Declaration of Helsinki of the World Medical Association, the German law on pharmaceutical products (Arzneimittelgesetz) as well as European and international regulations (ICH-GCP). The crucial point is a thorough informed consent with explanation of the advantages and potential risks of the study that will be signed by the patient and the trial physician, as well as insurance for the test persons with high coverage. Before a study can start it has to be approved by an ethics committee. In Berlin it is the ethics committee of the health authorities (Landesamt für Gesundheit und Soziales)
Which Advantages Do I Have if I participate in a Clinical Study?
First of all, there is the opportunity to be treated with a new substance that is potentially more effective then the currently available medicine from the pharmacy – for instance for faster and more effective reduction of the viral load. The side effects can be less severe, too or the pill burden is less with a new substance.
In clinical studies the drugs will be provided by the sponsor and there is no need to pay the prescription fee. After a study is completed there is often the possibility to continue in a so-called “roll-over” programme to be able to become the trial drugs until they are approved for the commercial release. Furthermore, in clinical trials you will be examined with the most up-to-date techniques and frequent laboratory analyses.
What Will Be Done in the Course of a Clinical Trial?
Your treating physician will check whether your data in the patient record and your actual laboratory results fit into the inclusions and exclusions criteria of the study protocol. The eligibility will be finally checked at the screening visit in the EPIMED central unit in Vivantes Auguste-Viktoria-Klinikum. Many studies have to be placebo controlled and double blind for the scientific scrutiny of the outcome. Therefore, you will be randomized to one of the treatment arms with either the active substance or placebo at the baseline visit. Such studies have a short duration to avoid any harm to the participants. Other studies may last up to several years. The sponsor offers adequate reimbursement for mere research studies with no treatment aspect that involve blood tests of the drug concentration (pharmacokinetics) and a longer stay in the study centre from 8 up to 48 hours. Other studies may include reimbursement of travel expenses.
What Makes EPIMED so Special in Comparison with other Trial Sites?
We put a strong emphasis on the cooperation between the treating physician and the trial physician, between the research and the everyday medical treatment as well as between the hospital and the specialists’ practices. This means that your treating physician receives the study results, the concomitant medication is directly addressed with the treating physician and you can be seen at the study visits either in the EPIMED central unit or in the office of your treating physician. At EPIMED you are taken care by a team of experienced and competent physicians, study coordinators and study assistants.
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