Clinical Trials – Facts to Consider About New Treatment Options

Clinical trials are biomedical research studies aimed at determining the efficacy, safety levels, and possible side-effects of new medications and therapies. The majority of clinical trials involve testing new medications designed to treat many types of conditions, ranging from auto-immune and blood diseases to cancer. In the case of new medications, the trials are jointly run by pharmaceutical companies, which are responsible of designing the new drugs, and hospitals or health centers, which administer them to patients.

clinical trials

Clinical Trial Facts to Consider Before Enrolling

Most people who consider enrolling for clinical trials do it because existing commercially available drugs and treatments have not succeeded in curing their ailments. Others do it so that doctors and scientists can gather as much information as possible in order to treat diseases. Patients considering participating in clinical trials should analyze several factors, including the mechanisms by which the drugs act, the phase that the clinical trial is in, the inclusion criteria, the potential side effects, and the availability of alternative treatment options, before reaching a decision.

Types of Clinical Trials

According to the US National Institute of Health, there are five types of clinical trials, according to their purpose and treatment options.
  • Treatment Clinical Trials: new drugs, therapies or surgical procedures are tested on patients.
  • Prevention Clinical Trials: new medications, vaccines or vitamins are given to people in order to prevent diseases.
  • Diagnostic Clinicial Trials: involve testing new methods to diagnose diseases or conditions.
  • Screening Clinical Trials: new ways to detect conditions are tested.
  • Quality of Life Clinical Trials: new ways to improve the quality of life for individuals which chronic illnesses are tested.
On the other hand, some clinical trials may involve giving placebos, whether knowingly or unknowingly, to some of the participants. It is important for people considering enrolling in clinical trials to find out whether they could be receiving placebos or new medications.

Phases of Clinical Trials

New medications have to go through five phases of clinical trials before they can be approved by the FDA or corresponding health authority. In total, the development of a new drug can take up to 10 years and pharmaceutical companies usually spend millions of dollars in the process. For this reason, clinical trial protocols have to be carefully planned and followed so that as many external variables can be eliminated while testing the new medications. (Meinert, 1986)
The phases of clinical trials are as follows:
  • Pre-Clinical Studies:This stage involves testing the drugs on lab animals in order to get preliminary information about the new medication’s toxicity, efficacy, and pharmacokinetics, or, in other words, how the body processes and eventually eliminates the drug.
  • Phase 1 Clinical Trials: This is one of the most important stages of clinical trials since it involves the first time a new medication is tested on human beings. Phase 1 clinical trials usually accept between 20 and 100 participants and they are done to determine safe dosage ranges and side effects.
  • Phase 2 Clinical Trials: The new medication is given to a larger group of people (100 to 300) in order to further assess its effectiveness and safety.
  • Phase 3 Clinical Trials: The purpose of phase 3 clinical trials is to confirm a drug’s effectiveness, to monitor its side effects, and to compare it with existing treatment options. It usually involves between 1000 and 3000 participants.
  • Phase 4 Clinical Trials:Also known as post marketing surveillance trial, this stage involves the safety surveillance of a drug after it has been granted permission to be sold in the market. It determines possible interactions of the new medications with other drugs and detects long term side effects.

Benefits of Participating in Clinical Trials

When all treatment options have been explored, some patients can only resort to clinical trials in order to treat their condition. Participants will usually receive expert medical care and their progress will be closely monitored. On the other hand, pharmaceutical companies and hospitals usually agree to provide medications to patients even after they have been accepted by health regulation agencies.

Considering the amount of time and money that the companies spend developing new medications, this means that participants could avoid spending large sums of money on expensive drugs once they are widely available.

Risks of Participating in Clinical Trials

It is clear that people participating in phase 1 clinical trials are subjected to greater risks than those enrolled in later phases. Sometimes unpredictable side effects could appear while new medications are first given to human beings. Since pharmaceutical companies and hospitals need to be very thorough during clinical trials, sometimes they place restrictions on participants. Some are not allowed to eat certain foods or vitamins, travel overseas or have to go to hospital to be routinely monitored. People interested in participating in clinical trials should carefully read the informed consent form to find out about these possible inconveniences.

Benefits And Risks Should be Weighted Before Participating in Clinical Trials

Clinical trials are necessary for the development and release of new medications to the market. Before participating in one, people should analyze the potential benefits and risks involved, as compared to existing treatment options. In the end, participating in a clinical trial can save a patient’s life. On the other hand, depending on particular circumstances, clinical trials can also cause inconveniences or even undesirable side-effects. A very useful site containing information on clinical trials run all over the world is ClinicalTrials.gov, run by the US National Institutes of Health.


Disclaimer: The information contained in this article is for educational purposes only and should not be used for diagnosis or to guide treatment without the opinion of a health professional. Any reader who is concerned about his or her health should contact a doctor for advice.

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