Clinical trials are research studies that test whether a new potential therapy is safe and effective for patients. They evaluate new drugs, behaviors, or devices, and reveal whether these potential therapies work for particular illnesses or particular groups of patients. Clinical trials provide the best available data with which to make healthcare decisions, and are considered the gold standard in the development of new therapeutic options.
There are two main types of clinical trials: interventional studies and observational studies:
- Interventional studies. These are clinical trials testing whether a specific intervention (such as a drug, device, or behavioral change) affects health-related outcomes. Different groups of people are assigned at random to receive and not receive the intervention in a process called randomization. Typically the group that does not receive the intervention — also known as the control arm — receives either the current standard of care or a placebo (a fake version of the intervention), depending on the condition. It’s important to note that trials for life-threatening conditions such as cancer will not offer a placebo. Interventional trials are also typically blinded, meaning that the volunteer is not aware if they are in the control group or receiving the intervention, or double blinded, meaning that both the researcher and the volunteer are not aware.
- Observational studies. These studies, on the other hand, are ones in which participants are put in groups based on their characteristics, and an intervention is tested in each of these groups. The difference is that the groups are assigned based on volunteer characteristics, rather than at random. Both types of studies follow a protocol, a detailed plan for the study written by the trial sponsor and approved by the FDA.
A trial sponsor is an organization which initiates, funds, and conducts a clinical trial. This is often a pharmaceutical company, but it can also be a university or another type of research organization. When selecting a clinical trial, it’s important that potential volunteers are fully aware of and comfortable with who is sponsoring the trial.
Potential volunteers for trials can be anyone. While many people view clinical trials as a last resort only to be relied upon when all other options have been exhausted, this is not the case; research studies need a variety of participants to enroll. Some trials are looking for volunteers who have been recently diagnosed, while others may be only need those who have been living with a condition long-term. Certain studies may require patients who have had different treatment experiences in the past. Every trial is different, but with thousands of studies recruiting, there is likely a trial that is right for you.
What are the phases of clinical trials?
Clinical trials begin with an idea in a lab. Researchers thoroughly test potential treatments in the lab and in animals before ever beginning trials in humans. If these lab and animal tests are successful and the therapy looks promising, the researchers will begin to conduct research studies beginning at Phase 1 and moving through to Phase IV:
- Phase I clinical trials test whether drugs are safe to use in humans.
- Phase II clinical trials test the effectiveness of a drug or medical device. This stage can last from several months to a few years, and generally involves several hundred participants.
- Phase III clinical trials are typically the largest. They involve anywhere from several hundred to several thousand participants in a randomized, blind study. This testing phase can last several years as the FDA gathers thorough data about the drug’s effectiveness and potential side effects.
- Phase IV trials, also known as Post Marketing Surveillance Trials, take place after a drug or device has been approved. In this phase, pharmaceutical companies monitor a drug’s long-term effectiveness and impact, compare it to existing trials in the market, and determine the cost effectiveness of the new treatment.
It’s a big decision to take part in a clinical trial, and it’s important that patients and caregivers fully understand all of the benefits and risks before enrolling. We’ll discuss these in the next section.
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