A newly developed medication has a long journey to go before it can be acknowledged by the medical society. It starts as a rough idea and ends up in a pharmacy near your home. New medication is researched in a lab, tested on animals and then given on human in clinical trials. The trials are often sponsored by government agencies, pharmaceutical companies, disease foundations, voluntary groups, medical institutions, a group of physicians or even an individual.
There are some reasons why people want to take part in a clinical trial. They may want to play an active role in the effort of helping themselves and other people with the same condition, make a contribution to medical research and gain exclusive access to a new treatment. Not everyone is allowed to participate, each clinical trial has a guideline that describes people who can participate and who can’t. It is important for researchers to put a firm restriction in place to allow them gain an accurate result. There are several types of clinical trials:
• Treatment trials: They test the effectiveness and safety of new experimental treatments.
• Prevention trials: They examine ways to prevent a type illness on healthy people or relapse on people who previously have the same illness.
• Diagnostic trials: They seek more reliable ways to diagnose a specific disease.
• Screening trials: They seek to detect certain health disorders or diseases.
• Quality-of-life trials: They seek for better ways to improve the quality-of-life on people with illness.
All clinical trials undergo different phases, based on the number of participants:
• Phase I: An experimental treatment or drug is tested on a small group of participants (less than 100). The goal of this phase is to identify side effects, to determine an effective dosage and to evaluate safety factors.
• Phase II: An experimental treatment or drug is tested on a larger group of participants (100 to 300). The goal of this phase is to further evaluate safety factors and to assess effectiveness.
• Phase III: An experimental treatment or drug is tested on a large group of participants (1000 to 3000). The goal is to gain more insight on the effectiveness and possible side effects. At this stage, researchers also compare the new treatment or drug with previous ones that have passed the trials. The collected information can also be used to further assess safety factors.
• Phase IV: This phase involves studies that delineate additional information such as optimal use, benefits and risks. Although the medication is not yet approved, it is already considered as scientifically safe for targeted uses. It continues to evaluate the long-term effectiveness and safety of the drug. In fact, it may allow researchers to improve the medication, for example, researchers can test new methods for administering the drug.
Risks and benefits
Clinical trials offer some benefits to participants, some of them are:
• You have an access to a new drug or treatment before it is available to the public.
• You get to play an active role in improving health care for your specific condition.
• You get high quality and intensive medical care during a trial.
• You get a personal satisfaction as you are making an important contribution to an important medical research that can eventually help millions of people.
Unfortunately, things may not work so well:
• You may receive a placebo or sham treatment instead and don’t get a real benefit of the medication. A trial should include a placebo or sham treatment to allow researchers accurately measure the effectiveness level. If you get a placebo, there is a risk that your condition will get worse.
• A new medication or treatment may have a harmful side effect.
• Trial protocols can be time-consuming and more involved than you’re willing to endure.
• A possibility that the trial is a fraud. Although you’re paid after each session, there could be clinical research misconduct. Researchers can falsify data during the proposal, processing, design, recording, supervision, reviews, analysis, and reporting steps.
Before joining a clinical trial, you should make sure that you have the option of leaving the trial.
Among students, clinical trials are often considered as fast and easy way to earn money. In fact some particularly reckless participants can bring up close to $30,000 each year by taking part in a few clinical trials. The participant is asked to sign a consent form and to pass inclusion criteria. In the clinical research center, he is required to undergo some preliminary tests such as exercise tests, breathing tests, electrocardiogram and vital signs examinations. Those tests can be repeated during and after the clinical trials.
The participants must make a number of visits in a month. The pay for each visit depends on the type of trial the participants are enrolled in, the stage of the drug or treatment development, and the projected risks. A participant may get between $50 and $500 in a session. The trial can last for weeks, months or even years. To ensure data accuracy, participants are expected to comply with the guidelines.
How to find clinical trials?
You can visit www.clinicaltrials.gov to find a clinical trial performed by trusted organizations. The database can be searched by sponsor, drug intervention type, location and disease type. If you want to participate in a clinical trial you should learn more about it and feel comfortable asking the staffs. For example, ask about what care you should expect during the trial and what consequences you should face.