What are Clinical Trials?

By The Preston Robert Tisch Brain Tumor Center

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I'm sure many of us have come across the term "clinical trials" at some point while discussing potential medical treatments. In this article, we're here to provide a clear and concise explanation of what clinical trials are. 

Simply put, clinical trials are rigorous research studies designed to evaluate the safety and effectiveness of medical treatments, drugs, or interventions in human participants. Let’s dive more into the topic and discover why they hold such a crucial place in modern medical advancements. 

The Importance of Clinical Trials 

  • Advancing Medical Science: Clinical trials are the backbone of medical progress. They pave the way for new treatments, medications, and therapies. These trials enable scientists and researchers to find innovative solutions for a variety of medical conditions.

 

  • Ensuring Safety: Before any treatment reaches patients, it undergoes rigorous testing through clinical trials. This meticulous process ensures that therapies are both safe and effective, protecting the health and well-being of patients. 

 

  • Ethical Considerations: Clinical trials are conducted with the utmost ethical standards. Participants' rights are protected, and every trial is carefully reviewed by an ethics board. This commitment to ethics maintains trust in the medical community.

The Phases Of Clinical Trials 

Clinical trials are divided into distinct phases, each serving a specific purpose. Here is a general breakdown of what these four phases look like: 

  • Phase I: This phase involves 20-30 participants, has a 70% success rate, and can last up to several months. Researchers determine the safety of the new medication and treatment.  

 

  • Phase II: This phase involves 100-300 participants, has a 33% success rate, and can last up to two years. Researchers are studying its efficacy during this phase, providing valuable data for further evaluation.

 

  • Phase III: This phase involves 1,000-3,000 participants, has a 25-30% success rate, and can last up to one or four years. During this phase, they are studying the safety, efficacy, and dosing. 

 

  • Phase IV: This phase involves thousands of participants, has a 70-90% success rate, and lasts around one or more years. Here they are studying the long-term effects and cost effectiveness of the treatment.  

Pediatric Clinical Trials: Duke’s Brain Tumor Center

Why Study Children? 

Children have clear and distinct developmental and physiological differences from adults. The importance of conducting clinical trials specifically in children cannot be overstated. These trials are essential because they help researchers discover the most effective ways to treat medical conditions in pediatric patients. 

Unlike adults, children's bodies function differently, and therefore, it's crucial to develop medicines and treatments tailored specifically to their needs rather than simply modifying adult dosages and therapies. Pediatric clinical trials undergo rigorous ethical evaluations and adhere to stringent standards before they are permitted to enroll participants. This ensures the utmost safety and appropriateness of the treatments for young patients.

 Enrolling Your Child In Clinical Trials  

When considering participation in a clinical trial, it's essential to communicate with your medical team to identify studies that may be suitable for your child's specific brain tumor. Researchers have precise requirements when enrolling participants, following a predefined plan known as a protocol. 

Each study has its own eligibility criteria, which may include factors such as the child's age, sex, the type and grade of the brain tumor, previous treatment history, and the presence of other health conditions. Ensuring your child meets these criteria is critical for their participation in the study.

Understanding Informed Consent 

Before enrolling your child in a clinical trial, both you and your child must fully understand the potential risks and benefits of participation. Informed consent is the process through which you learn about these aspects, ask any questions you may have, and make an informed decision regarding your child's involvement.

In most cases, one or both parents/legal guardians will be asked to provide written permission for their child's participation. By signing the consent form, you are acknowledging that your medical team has provided you with comprehensive information regarding the treatment's risks and benefits, that you've had the opportunity to ask any necessary questions, and that you are making an informed choice in the best interest of your child's health and well-being.

Brain Cancer Center Near You 

When it comes to seeking the best possible care for both adult and pediatric brain cancer, the Preston Robert Tisch Brain Tumor Center stands out as a leader in its field. With a team of world-renowned experts in the field of neuro-oncology. These dedicated doctors bring a wealth of experience along with a deep commitment to advancing brain cancer research and treatment. 

At our clinic, you can have access to exclusive clinical trials that are not available anywhere else. These trials represent the forefront of brain cancer research, offering patients the opportunity to be at the forefront of medical advancements. If you or your loved one are facing this challenging diagnosis, we can help. Visit our brain tumor center in Durham, NC, and choose the Preston Robert Tisch Brain Tumor Center as your trusted partner in the fight against brain cancer.

Clinical Trials: Your Questions Answered 

How can I participate in clinical trials? 

To participate in a clinical trial, you can speak with your healthcare provider or visit clinicaltrials.gov to find trials suitable for your condition.

 

Are clinical trials safe? 

Clinical trials prioritize safety. Rigorous protocols and ethical standards are in place to protect participants.

 

Do I have to pay to participate in a clinical trial? 

In most cases, participating in a clinical trial is free. Additionally, some trials may offer compensation for your time and travel expenses.

 

How long does a clinical trial last? 

The duration of a clinical trial varies depending on its phase and purpose. It can range from several weeks to several years.

 

Can I leave a clinical trial if I change my mind? 

Yes, you have the right to withdraw from a clinical trial at any time, and your decision will be respected.

 

What happens after a clinical trial? 

After a trial concludes, researchers analyze the data, and if the treatment proves safe and effective, it may become available to the public.


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