Education Before Participation: What are the different types of clinical trials?

[ciscrp_official]

Treatment trials - test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials - look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic trials - are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials - test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) - explore ways to improve comfort and the quality of life for individuals with a chronic illness.

What kinds of trials have you participated in? Are there ones you prefer more than others?

[hbodu1]

Question - Are you based in the US or in another country? I think in the US there are different categories of clinical trials.

[ciscrp_official Partner in reply to hbodu1]

Hi hbodu1 , that's a great point our CISCRP offices are based in the U.S. in Boston. But I can imagine that is correct.

[hbodu1 in reply to ciscrp_official]

Thank you for your response. Do you find that you can delineate trials based on the types that you listed based on the basic information listed, either on your matching service or on ClinicalTrials,gov? How does that list compare to the trial types listed there (Phase I-IV, open label, etc.)? I just wonder if people get more confused when they look at the differing categories.

[misswoosie in reply to hbodu1]

Within each of the types of trials listed above there can be trials that are phase I-IV and open label studies. So you might have a phase I prevention study or a phase III treatment study.

It's worth knowing that phase I studies that involve a treatment are "healthy volunteer" studies, therefore by their nature are only looking at the safety of the treatment.

Phase II studies are carried out in a population of people who may benefit from the treatment and will be investigating safety primarily, but also effectiveness. They usually involve a larger number of investigations eg blood tests, at more frequent intervals throughout the study.

Phase III and IV studies are carried out when there is sufficient safety data available on the treatment from the phase I and II studies.

IMPORTANTLY- if at any point there are any serious safety concerns about a treatment in a clinical trial, the trial will be stopped , ie participants will be taken off the treatment, however , usually follow up will continue as per the protocol or an amended protocol which reflects the safety concerns.

Every clinical trial has what is known as a "safety committee" made up of appropriate experts . They meet at specific intervals throughout the study and review all adverse (unwanted) events recorded by clinical trial staff. Basically an adverse event is anything at all that a trial participant suffers whilst in the study whether related to the treatment or not. So anything from a common cold or sprained ankle to something that's related to the disease or condition which is being investigated by the trial.

Along the way, whilst moving from one phase to another various parts of the trial protocol may change quite considerably as information about the treatment is collected. For example, the maximum age of participants may change, people with specific medical problems or those taking specific medication may be excluded. Additionally, the dosage of the treatment may change and the type and timing of investigations may change.

I think it's important to point out that people who are included in clinical trials often have better outcomes than people who aren't, even if they're receiving placebo or the treatment is proved to be ineffective. The reason for this is that whilst participating in a clinical trial, you're being very closely monitored by the study staff and are provided with a direct contact for both the doctor who is the investigator and usually for a clinical research nurse/ officer.

[iface]

Hi lperze

Thanks for posting this information. Is there a resource that lists all the different Treatment trials, and Prevention trials that are enrolling participants?

[ciscrp_official Partner in reply to iface]

Hi iface ! I'm glad you found this helpful. If you're searching for a clinical trial I would recommend using CISCRP's service called Search Clinical Trials. You simply have to fill out a quick online form and we can help you find trials: ciscrp.org/services/search-...