Clinical Trials: What, When, and for Whom?

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What is a Clinical Trial?

New tests and treatments aren’t offered to the public as soon as they are made. They need to be studied. Clinical trials are scientific studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device, is safe and effective in people. When found to be safe and effective, they can be approved by the regulatory agencies (such as the US Food and Drug Administration – FDA), and they may become tomorrow’s standard of care.

Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment, for certain illnesses or groups of people.

Clinical trials test:

Clinical trials phases:

Clinical trials need to be approved by regulatory agencies (such as the FDA) before testing new treatments on humans. The trials are one of the final stages of a long and careful research and development process, and they advance through four phases. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects. Clinical trials of drugs are usually described based on their phase:

  1. A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage and how it should be used or delivered.
  2. A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to understand whether the drug works in people who have a certain condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
  3. A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, or using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the phase III trial results are positive, it will approve the experimental drug or device.
  4. A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations. The reason for phase IV trials is that sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

Scientific standards:

The purpose of clinical trials is to answer scientific questions. Therefore, these studies follow strict, scientific standards which protect patients and help produce reliable clinical trial results. Every clinical trial has a protocol or study plan that describes what will be done during the clinical trial, how the clinical trial will be conducted, and why each part of the clinical trial is necessary. Some clinical trials include a placebo control group, which means that some of the patients participating in the trial will not receive the actual treatment, in order to exclude the possibility of a placebo effect.

The protocol or study plan also includes guidelines called eligibility criteria for who can and cannot participate in the clinical trial. Common eligibility criteria may include:

Criteria such as these help reduce the medical differences among people taking part in the clinical trial so that researchers can be more certain that the results are due to the treatment being tested and not to another reason. In addition, these criteria are meant to make sure that people with certain health problems that might risk them while using the tested treatment, will be excluded from the trial.

When should I consider a clinical trial?

It’s important to note that clinical trials are still trials and therefore are not for everyone. However, in certain conditions clinical trials might be a solution to consider, weighing on its benefits and risks. Some of the benefits include:

Clinical trials have risks too:

It’s important to consult your physician or a clinical trials expert before making a decision.

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