Clinical trials are invaluable. They provide high-quality data for making important healthcare decisions. Thanks to clinical trials, the quality of human life has vastly improved.
What are clinical trials?
Clinical trials are conducted by researchers to find out if a new therapy, drug, diet or medical device (e.g. a pacemaker) is safe and effective. Often, a clinical trial is used to determine if a new therapeutic treatment method has less harmful side effects than a standard treatment. Other clinical trials are performed to investigate ways of detecting the disease early, even before the occurrence of symptoms. Some trials test various methods for preventing health problems. A clinical trial may also concern techniques for improving the lives of people suffering from life-threatening diseases or chronic health problems.
Translations of documents related to clinical trials conducted in the European Union must comply with the Clinical Trials Directive (e.g. Directive 2001/20/EC, 2005/28/EC). It is also necessary to comply with the standards for naming diseases. Translations of medicinal products and raw materials are regulated by the European Pharmacopoeia.
The phases of clinical trials
Clinical trials consist of four phases in which the procedure is tested, the correct dosage of the drug is determined, and side effects are investigated. If, after the first three phases, researchers consider the drug to be safe and effective, then the effects of the clinical trial are approved and monitoring is continued.
Drug clinical trials are usually described based on their phase. Phase I, II, III and IV studies are usually required to determine if the medicine can be approved.
- In Phase 1, the experimental treatment is tested on a small group of often healthy people (20 to 80 years old) to assess its safety and side effects and to find the right dose of the drug.
- In Phase 2, more people (from 100 to 300) participate. While safety is the main concern in Phase I, efficacy is what counts in Phase II. This phase aims to obtain preliminary data on whether the drug works in people who have a specific disease or condition. Moreover, research on safety is continued, including short-term side effects. This phase may last for several years.
- In Phase 3, more information is gathered on safety and efficacy. Different populations and different doses are tested, and the drug is used in combination with other drugs. The number of study participants usually ranges from several hundred to about 3,000 people. If the test results are positive, then the experimental drug or device is approved.
- In Phase 4, testing of drugs or devices takes place after approval of their use. The efficacy and safety of a given drug or device are monitored in large, diverse populations. Sometimes the side effects of the drug may not be clear until more people take it over a long period of time.
Are clinical trials safe?
Researchers are required to follow strict rules to make sure all the participants are safe. Each clinical trial also follows a thorough research plan or protocol which describes what the researchers will do. The potential risks associated with participating in clinical trials include the following:
- A new treatment can cause serious side effects or be uncomfortable.
- The new treatment may not work or may not be better than the standard treatment.
- The patient may be part of the control group, which means that he or she is receiving standard treatment or a placebo without treatment.
- A clinical examination may be tiresome for the patient. For example, medical appointments can take a long time. The patient may be forced to visit the medical centre several times or to remain in the hospital.
As with any study or treatment, side effects may occur, therefore it is important to consider the risks when participating in tests.
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Why is it worth taking part in a clinical trial?
There are many reasons why people decide to participate in a clinical trial. Some patients join because the treatments they have tried so far have not been effective. Others sign up because there are no other treatments available for them. By participating in a clinical trial, they can learn about new treatments before they become widely available. Many people say that participating in a clinical trial is a way to play a more active role in their own healthcare. Others say they want to help scientists learn more about certain health problems. Regardless of your motivation, when you decide to participate in a clinical trial, you are involved in scientific discoveries.
What is the next step after finding a clinical trial?
Once you’ve found a trial you want to join, contact the attending physician or coordinator who is responsible for the entire process. These contact details can usually be found in the trial description. The first step is a control visit to see if you qualify for the study.
After obtaining all the above information, you can make an informed decision whether you want to participate in a clinical trial or not. You can leave the trial at any time and for any reason without having to provide any explanation. Thorough knowledge of clinical trials will allow you to make an informed and responsible decision.
Medical translation services – values and benefits
Medical translations from Polish involve the translation of documents related to health care, the pharmaceutical industry, and biotechnology sciences. These translations must comply with HIPAA and other legal standards. Medical translation services enable clear communication with every patient, regardless of the language they use. They are provided through a network of professional medical translators who also deliver certified translations.
As the clinical trial procedure is complex and time-consuming, translations prove to be very helpful in this process. Specialised documentation of drugs, research and procedures are very important, therefore accurate translation in this area is essential.
Feel free to try our medical translation services. One of our specialties are clinical trials translations – all translations are created by top-class specialists. If more information is required, please call or send us an email!