Cancer Education and Research Institute (CERI)'s Cancer Education Programs
Cancer Education and Research Institute®(CERI)'s, formerly Cancer Research Simplified, mission is simple: Cancer Education for All™! Our Team of cancer experts provides you with the most reliable, most up-to-date, and simplified cancer information available. Our educational programs quickly became trusted and highly sought after worldwide.
CERI strongly stands behind the importance of cancer patient empowerment and is a worldwide leading source for simplified, multi-language cancer education. Knowledge is power and empowerment is the key for greater treatment success, early diagnosis, as well as cancer prevention.
For any questions or requests, please contact us.
CERI strongly stands behind the importance of cancer patient empowerment and is a worldwide leading source for simplified, multi-language cancer education. Knowledge is power and empowerment is the key for greater treatment success, early diagnosis, as well as cancer prevention.
For any questions or requests, please contact us.
Clinical Trials - Part I
By Claudia Bertuccio, Ph.D. |Cancer Education and Research Institute (CERI)
Scientific edits: Ayguen Sahin, M.Sc., Ph.D. |Cancer Education and Research Institute (CERI)
Editing team: Tugce Tunalilar, Elif Irtemçelik
Scientific edits: Ayguen Sahin, M.Sc., Ph.D. |Cancer Education and Research Institute (CERI)
Editing team: Tugce Tunalilar, Elif Irtemçelik
What is a clinical trial?
A clinical trial is a research study during which researchers and doctors search for new biomedical treatments, therapies or medical devices for a specific disease. The investigation of these new treatments is performed in humans and is designedwith rigorous precision andethical respect.
There are two types of clinical trials: observational or interventional.
Interventional trials consist of studies in which humans are assigned to receive specific interventions by an investigator and whose outcomes are measured. Intervention means a single treatment or therapy.
Observational trials consist of studies in which humans have previously received specific interventions. The investigator solely observes and measures the outcomes but does not assign specific treatments to the participants of the study.
There are two types of clinical trials: observational or interventional.
Interventional trials consist of studies in which humans are assigned to receive specific interventions by an investigator and whose outcomes are measured. Intervention means a single treatment or therapy.
Observational trials consist of studies in which humans have previously received specific interventions. The investigator solely observes and measures the outcomes but does not assign specific treatments to the participants of the study.
Why are clinical trials necessary?
|
Taking part in a clinical trial is very important because the information obtained from clinical research studies can help others and save lives in the futureby contributing to scientific knowledgeof specific diseases. In addition, participants have access to promising and more effective new interventions that are not publicly available yet.
Participants in clinical trials should consider that the new treatment may have side effects or risks that doctors do not expect andthis new treatment may not be better than the standard therapies. However, clinical trials are conducted by well-qualified doctors and scientists and they will closely work with the patient. If any side effects occur, the research team will perceive immediatelyand solve the problem. Clinical trials and their phases
Before new drug candidates justify a path into clinical trials, the efficacy, toxicity and pharmacokinetic properties of the new drugs are tested in animals and human tissue cells for assuring the safety and efficacy of the drug in humans. These preliminary studies are called ‘Preclinical Research’. If the drug candidate has positive effects, the company decides to continue with further development of the new drug.
The information obtained during preclinical studies has to be reported to the Food and Drug Administration (FDA) as Investigational New Drug Applications (INDs). If INDs are approved, companies are allowed to begin clinical trials in humans. Clinical trials are conducted in clinics and hospitals, where volunteers or/and patients receive constant medical attention. |
|
Clinical trials are categorized by four phases:
|
Phase 0 (also called human microdosing) is a new exploratory idea from FDA. The studies are conducted on a small group of healthy volunteers (10 to 15), which will receive less than 1% of the therapeutic dose of a new drug (a microdose) to ensure the absence of side effects. These studies will not take more than seven days. Phase 0 studies will give only preliminary pharmacokinetic results in humans without therapeutic or diagnostic plan. The main purpose of Phase 0 is to establish very early in the clinical trial process if a promising drug candidate will work in humans as was expected from preclinical studies, consequently, saving time, money and resources.
Phase 1 clinical trials most often recruit a small group of healthy volunteers (20 to 100) to determine the pharmacokinetic effects, the best and safest dose, the safe dosage range(tolerability), frequency the drug can be administered and to identify the side effects associated with increasing the dose. Phase 2 clinical trials are performed on larger groups of subjects (100 to 300) with a certain disease or a condition. In Phase 2, researchers evaluate safety, potential short-term side effects and risksassociated with the new drug. |
|
Phase 3 clinical trials include large group of people (hundreds or thousands) with particular medical condition from multiple recruiting centers. Phase 3 studies can take several years to complete and are the most expensive and time-consuming. The large group of subjects is assigned randomly to one of two group options (trial arms): control group or experimental group. In a control group all of the participants receive an existing treatment or a placebo. In the experimental group all of the subjects receive the new intervention. The goal of a Phase 3 clinical trial is to gather additional information about effectiveness, monitor side effects, safety and evaluate the benefit-risk relationship.Also, Phase 3 studies provide information about whether the new intervention is better than or has similar effects as the usual treatment.
The assignment of a participant to a control or an experimental group is done by a computer program, which avoids human choices. Neither the participants nor the research team can influence the group’s designation.
If the new drug provides satisfactory effect, the company submits a large file with the description of methods and results in humans to the FDA. If the FDA approves the drug or the intervention, the company initiates the public sale of the drug.
The assignment of a participant to a control or an experimental group is done by a computer program, which avoids human choices. Neither the participants nor the research team can influence the group’s designation.
If the new drug provides satisfactory effect, the company submits a large file with the description of methods and results in humans to the FDA. If the FDA approves the drug or the intervention, the company initiates the public sale of the drug.
Phase 4 or post-marketing studies are performed after a drug has been approved for general public use. In a much larger patient population and longer period of time, the company continues to learn more about the new product collecting information about any adverse side effects, uncommon toxicities, how the drug works in a wide population and any advantages over other competitive products.
References:
1. FDA Introduces New Phase 0 for Clinical Trials: Some Enthusiastic, Some Skeptical- Fromer, Margot J. Oncology Times: 10 August 2006 - Volume 28 - Issue 15.
2. Concise guide of clinical trials. Allan Hackshaw. April 2009, BMJ Books
3. Clinical trial explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals. David Kerr, Kirstine Knox, Diane Robertson, Derek Stewart, Renee Watson. April 2008, BMJ Books
1. FDA Introduces New Phase 0 for Clinical Trials: Some Enthusiastic, Some Skeptical- Fromer, Margot J. Oncology Times: 10 August 2006 - Volume 28 - Issue 15.
2. Concise guide of clinical trials. Allan Hackshaw. April 2009, BMJ Books
3. Clinical trial explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals. David Kerr, Kirstine Knox, Diane Robertson, Derek Stewart, Renee Watson. April 2008, BMJ Books
#clinicaltrials #whatisaclinicaltrial #whyareclinicaltrialsnecessary #clinicaltrialphases #interventionaltrials #observationaltrial #researchstudy
👉 Like our Facebook page for daily cancer info: Cancer Education and Research Institute
#canceredinstitute
#canceredinstitute
You might also like:
|
|
|
Disclaimer: We can not assume responsibility of misinterpretation of content.
Please donate to support our cause - help us continue with our trusted educational programs:
Cancer Education and Research Institute, fka Cancer Research Simplified, is a registered 501(c)(3) non-profit organization.
Your donations are tax deductible to the extent permitted by law.
Your donations are tax deductible to the extent permitted by law.
