CTFA_Blog-Photo1_10-21-24_VF
| |

Do We Need Clinical Trials?

Have you ever wondered how new medicines make it to your local pharmacy? Or how doctors know which treatments work best? The answer is clinical trials. But with all the advances in science and technology, you might be asking: do we still need clinical trials? The short answer is yes, and here’s why. 

What Are Clinical Trials? 

Clinical trials are carefully designed tests for new medical treatments. They help researchers determine if a new medicine or therapy is safe and effective. Think of clinical trials as a bridge between a promising idea and actually using it to help people.  

What’s the Point of a Clinical Trial? 

Clinical trials aim to answer some key questions about a new treatment: 

  1. Does it work? 
  2. Does it work better (or the same as) existing treatments?
  3. Is it safe?
  4. Are there any side effects? 

To answer these questions, researchers follow a strict plan; however, the specifics of how each trial works depends on the treatment being tested, the phase of research, and other factors, but typically, clinical trial participants are divided into groups. One group receives the new treatment, while another might receive the current standard treatment or a placebo (an inactive substance that looks like the real treatment). Researchers then closely monitor participants in each group to understand the treatment’s effects. 

Why Can’t We Skip Clinical Trials? 

We now have powerful computers, sophisticated lab tests, and the ability to study new treatments in animals. So, why aren’t these methods enough? While these preclinical studies provide valuable information before starting trials, they can’t fully predict how a treatment will behave in humans. Our bodies can react very differently than animals or cells in a test tube. Only human testing can reveal a treatment’s real-world effectiveness, its impact on daily life, and any long-term side effects. 

How Do Clinical Trials Keep People Safe? 

CTFA_Blog-Photo2_10-21-24_VF

Doing anything new can be overwhelming at first, including joining a clinical trial. But there are many ways researchers work to keep participants safe: 

  • Careful planning: Before a trial starts, researchers do many other tests to make it as safe as possible  
  • Close watching: During the trial, doctors keep a close eye on everyone’s health 
  • Clear information: Participants learn all about the trial before they join, including any risks
  • The right to stop: People can leave a trial at any time if they want to 

Why Your Involvement Matters 

Diverse participants are important for clinical research — both healthy volunteers and those with specific health conditions, depending on the trial. This diversity helps ensure that new treatments are effective for everyone. By joining a trial, you contribute to potentially lifesaving discoveries. Even if a treatment does not work, the information gained helps researchers move closer to finding better solutions. 

Clinical trials can also provide early access to promising new treatments for individuals facing limited treatment options. This can be a valuable opportunity to receive cutting-edge care. 

How Can You Get Involved? 

We need clinical trials, and clinical trials need participants! How can you do your part? Getting more information is a great place to start. Our Resource Library includes a variety of topics related to research, and you can search based on conditions or topics you are most interested in.  

If you’re considering participating in a trial, talk to your doctor. They might know about trials that could be right for you. You can also search for trials using online tools, like ClinicalTrials.Gov.  

Even if participation isn’t right for you, you can still do your part by spreading the word. Tell your friends and family about the importance of clinical trials. You never know who could benefit from this information.  

Similar Posts

They Gave Me 3 Years to Live. 30 Years Later, Here Are My Tips for Participating in Clinical Trials.
| |

They Gave Me 3 Years to Live. 30 Years Later, Here Are My Tips for Participating in Clinical Trials.

In 1994, I was a 37-year-old Army major stationed in Michigan with my wife, Cecelia, and our five-year-old daughter, Patrice. Little did I know that learning how to participate in clinical trials would save my life.   One morning before heading to work in January 1995, I went to the doctor’s office to get results from an MRI I had because of persistent back pain, which had been bothering me for six months. The doctor told me I had chronic myeloid leukemia (CML). He gave me three years to live. He then explained that the only potential cure was a bone marrow transplant. But, as an African American, my chances of finding a match were slim. There were — and still are — few people of color on the marrow donor registry. I took it upon myself to change that. I started organizing marrow drives, visiting churches, malls, colleges, and military bases nationwide.  In December 1995, I relocated to Atlanta, Georgia, and continued my efforts.  In April 1996, at a marrow drive in Columbus, Georgia, a local businessman with a different type of leukemia approached me. He shared his leukemia story, explaining how an experimental treatment at the MD Anderson Cancer Center in Houston had saved his life. He urged me to visit MD Anderson, so I did.   I flew to Houston and met a doctor who enrolled me in a few experimental treatments. But by 1998, after three years, they stopped working. I became extremely fatigued, waking up exhausted and in pain every day. Despite organizing and participating in numerous marrow drives, I had not found a matching donor. Time was running out.   As a last resort, I asked my doctor about any other drugs that could help. He mentioned a potential drug that was still in its pre-clinical trial stage. When it was approved for use in humans, I entered the Phase I clinical trial for STI571. I responded exceptionally well. Nine months into the trial, I ran a 26.2-mile marathon in Alaska! Five months later, I cycled 111 miles in Tucson, Arizona, raising funds for leukemia research.   Three years passed, and in May 2001, the FDA approved STI571 as Gleevec. Among the hundreds of thousands of lives Gleevec has saved, I am the longest-living survivor. In the decades since, I got to see my daughter grow up, attend Harvard University and Emory Medical School, and become a doctor. I’ve celebrated birthdays and wedding anniversaries and been there for every special moment, all because of a clinical trial.   The doctors gave me three years to live. It’s been nearly 30 years — and counting.   What Does This Have to Do With You?   Gleevec was the first tyrosine kinase inhibitor (TKI) cancer treatment. Now there are 80, seven approved in the last year. I am humbled and honored every day to not only be alive, but to have helped change the cancer treatment game. Being part of something bigger than myself — the clinical trial — felt so good that I decided to dedicate my life to clinical research education and patient advocacy. Because the more people know about clinical trials and how to find a clinical trial, the more lives will be saved today and in the future.   Maybe by telling you my story, you’ll be inspired to be part of something bigger than yourself, too.   How to Participate in Clinical Trials  Clinical research is different from what it once was. Back when I was in the Gleevec trial, I did everything by myself. I had to find a place to live in Houston where I stayed for three months, and then find my way back to Houston every 90 days for about three years. These days, there are patient advocates, support services, and more, all dedicated to making research participation as easy as possible.   Despite the differences, there are things that hold true. To participate in clinical trials, you need to know the benefits, do your homework, and start your research journey as soon as possible. In addition, you can enter a trial in a later phase and can withdraw from a trial without penalty.  Know the Benefits of Clinical Trials  Clinical research is essential! Every prescribed drug in your medicine cabinet has gone through a clinical trial. Clinical trials provide treatment at least equal to the current standard of care. When you’re a clinical trial patient, you not only access the newest care (often for free), but you also get the chance to contribute to the future of medicine.   This is especially true for patients of color. Many racial and ethnic minorities aren’t well-represented in clinical research, so it’s even more important for us to step up and participate. In fact, new regulations have been introduced in the industry that put requirements on patient diversity. Otherwise, tomorrow’s treatments won’t be as effective for everyone.   Do Your Homework   Your doctor may not offer clinical trials unless you ask. You need to do your own research so you can talk to your providers about trial options.  Luckily, there are an abundance of clinical trial resources out there, from advocacy groups to government websites.   You should research clinical trials even if you’re healthy or happy with your current treatment. First, many trials need healthy volunteers. Second, a clinical trial might not offer you a better outcome or prognosis, but it may help your quality of life or help educate you on your condition.   Start Now   Trials move slowly, but they go fast once they get going. I first heard about clinical research 18 months before the Gleevec trial. If I hadn’t known to ask the doctor in Houston, I would have missed out. Don’t wait. Begin your research, get on lists, and talk to your doctor now.   Turn 3 Years Into 30  My biggest takeaway on how to participate in clinical trials? Leave no stone unturned.   If you’re not trying clinical research, you haven’t tried every option. Perhaps a clinical trial won’t mean the difference between life and death for you, but it might make a difference in your quality of life. It might mean survival for someone else today, tomorrow, or in 30 years.   I invite you to be part of something bigger than yourself by exploring the resources on Clinical Trials For All to learn more about clinical trials or helping us spread awareness. 

I’m About to Start a Clinical Trial. Now What?
| |

I’m About to Start a Clinical Trial. Now What?

So you’ve enrolled in a clinical trial. Congratulations! You’ve just taken an important step toward contributing to better health outcomes for people all over the world. And for many of you, this may also mean that you are receiving research as care for yourself. This is a big, exciting step and we’re here to help you know what to expect.  Understand Your Trial Phase There are clinical trials for each phase of pharmaceutical or medical device research. Here is a quick breakdown of what the different phases mean to help you understand more about the trial phase you are participating in.  Phase 0: These early exploratory clinical trials test less than 1% of the amount of the drug that will be used in later trial phases. This low-dose trial makes sure the medicine works as expected in the human body before conducting full-dose trials.  Phase I: Trials in this phase are all about safety. This type of trial often seeks healthy volunteers.  Phase II: Now we’re getting into treatment effectiveness trials. If you’re receiving research as a care option, you may be in a Phase II trial.  Phase III: Once a treatment is proved effective, longer-term trials that last several years and involve many more trial volunteers like you take place. This is another trial phase where you may be receiving research as a care option.  Post-market: Once new treatments are approved, ongoing studies may continue to observe the long-term effects of the drug.  Medical device trials: If you are volunteering for a medical device trial, the safety trial phase is called a pilot study, also known as a feasibility study. The effectiveness trial phase is called a pivotal trial. Then once the device is approved, post-market studies continue just as they do for pharmaceuticals.  Informed Consent As a clinical trial volunteer, a research representative will walk you through what is called the “informed consent” process. This is where study staff explain the possible risks and benefits of the trial and everything that is involved in your participation. You will have the opportunity to have any questions answered and confirm that you want to participate after receiving all the information. You can also choose to have a patient advocate support you through this process.  Trial Access The sponsor of your trial will discuss the logistics of trial access with you. Some trials require on-site, in-person visits to participate in the study, while others have some on-site visits and some check-ins that can be conducted from your home or from your existing medical practitioner’s office (called “hybrid trials”). In fact, some clinical trials can be conducted completely remotely with data collected from your home or doctor’s office (called “decentralized or virtual trials”). Your study’s sponsor will explain all the details for your particular trial so you know exactly what to expect.  If travel to the study site is required, your sponsor can answer questions about support with travel financing and logistics.  What Happens When the Trial Is Over? It can take years from the start of a clinical trial to when the study is completed and all data are reviewed and analyzed. Stay in touch with your sponsor contact about study results, realizing that the final results of any study may take quite a long time to be released.  In the meantime, work with your sponsor, patient advocate, and/or your trusted medical team to continue your clinical trial journey.  Want to learn even more about what it’s like to participate in a clinical trial? Be sure to check out our other blogs to discover firsthand stories from patients like you as well as more information about how and why to participate. 

Clinical Trial Myth Busters: Get the Facts About Research
| |

Clinical Trial Myth Busters: Get the Facts About Research

How much do you know about clinical trials? If the answer is very little, you aren’t alone. 41% of Americans know nothing about clinical research.   If you haven’t heard of clinical trials at all, they are how researchers test new medical treatments and drugs to make sure they are safe and work well. Trials are essential for any new medicine to become available.   If you have heard of trials before, it’s possible some of the things you’ve been told aren’t actually true. There are many clinical trial myths out there, but we’re here to help clear up the confusion.   Keep reading to learn the truth about five common research myths.   Myth: Only very sick people participate in clinical trials  Fact: Many people can take part, even healthy ones  Some people think that clinical trials are only for people with serious, life-threatening conditions and no other treatment options. It’s true that trials can provide vital hope by offering new treatments that aren’t available elsewhere. However, there are many types of research available, and you don’t need to have a severe condition to take part.   Each trial has specific rules about who can join. Researchers may need people at different stages of a condition, from early to advanced, and for both common and rare diseases. Healthy volunteers are also needed in some cases.   The bottom line: don’t rule yourself out of clinical research completely. Although not every trial will be the right fit, many could be.   Myth: Clinical trials treat participants like lab rats  Fact: Participants are respected and protected   One unfortunate myth is that clinical trials are dangerous and that people who participate are treated like test subjects or even “guinea pigs.” The truth is that participants’ rights and safety are well protected.   There are many different rules in place to ensure trials are safe. While risk levels can vary, researchers must explain these risks and work to reduce them. Steps to do this include regular checks throughout the study and ways to report any problems quickly.   Myth: You can only participate from a big city   Fact: Technology opens more ways to join trials   If you don’t live in a major city, you might think there aren’t any clinical trials near you. There is a bit of truth that many trials are often hosted at large hospitals or universities in big cities. However, advances in technology are changing this.  More trials than ever before involve local doctors or even allow you to participate from your home. These options are not available for all trials, but there are more opportunities to take part in research than you might expect, and you don’t always need to travel to a big city. And if you do need to travel, you can find studies that will cover the cost and help with planning.   Myth: Your doctor needs to refer you to a trial  Fact: You can find and join studies on your own  You may think that the only way to get into a clinical trial is through your health care provider. While talking to your doctor about research is a great place to start, it is not the only option. However, you may learn after talking to your doctor that they aren’t involved in or familiar with clinical trials. In this case, it’s important to know that it doesn’t need to be the end of your research journey.   Tools like Carebox, Antidote, or ClinicalTrials.gov allow you to search based on your health condition. You can also add filters to find trials that might be a good fit. Once you see one that could be an option, reach out to the contact for that trial to ask questions and learn more.   Depending on your condition, you may also be able to work with a patient advocate who will search for trials for you and help you throughout the process. You can find an advocate through non-profit organizations related to your illness or, in some cases, through your health care provider.   Even though you don’t need your doctor to refer you to a trial, you can still ask them about how participating might affect your current care.  Myth: Getting involved is too complicated   Fact: Resources can make the process easier   At first, it may seem like you need to be an expert to find and take part in a trial. However, the good news is that this isn’t the case. People from all backgrounds participate in research — and you can, too. There are many resources available to help make this process easier.  Our Resource Library is a great starting point. We’ve collected information from trusted sources about a wide variety of clinical research topics, and you can search based on what you want to learn.   Even if you are not interested in participating in a trial, there are still ways to get involved. Just by reading this blog and sharing what you’ve learned, you can help more people understand the truth behind clinical trials.  

Different Types of Clinical Research and What They Mean for You 
| |

Different Types of Clinical Research and What They Mean for You 

Without clinical research, there would be no new treatments, no improvements in our understanding of how diseases work, and no new options for prevention. In short, clinical research is essential.  Not all research is the same. There are two broad types: observational and investigational. They each have different goals and work in different ways, but they both rely on people like you to participate and spread the word.   Read on for an overview of observational and investigational clinical research and learn how you can get involved.   Observational Research: Observing Health Patterns  Observational research gathers data and looks for patterns. If participants have a medical condition, they will continue their usual treatment plan during an observational study. Participants in this type of research do not receive new treatments. Instead, researchers observe and record various data, depending on the goal of the study, while the participants keep their general routine the same.   Participation may involve filling out a survey, meeting with a researcher for an interview, or providing a blood or tissue sample.   Types of Observational Studies  Who Can Participate?   Each observational study will have unique requirements based on what the researchers are interested in. In many cases, both healthy volunteers and people with a specific condition are needed.   Since observational research does not require you to take a new medication or change your routine, you can often participate in multiple observational studies at one time.   Why Does Observational Research Matter?  Observational clinical research provides essential information about how diseases work and what risk factors could be. Each new study gives more information, and it takes many studies over a long period of time to clarify possible links between behaviors and diseases.   What does this mean in the real world? For one, it can help people make more informed decisions about their lifestyles to have a better chance of staying healthy. Recommendations like increasing physical activity, maintaining a balanced diet, and avoiding smoking all have their roots in observational research.   Observational studies can also identify factors outside of an individual’s control that increase the chance of developing a certain disease. This gives doctors the information they need to screen for those conditions sooner, potentially improving and saving lives.   Investigating Research: New Treatments  Whereas observational research gathers information about health, investigational research (i.e., clinical trials) puts this information into practice and tests new ways to prevent, diagnose, manage, and cure diseases.   During a clinical trial, researchers monitor participants to ensure safety and track whether the new treatment works correctly. Depending on the trial, participants may go to a specific location (a trial site) to receive treatment, or a health care professional may monitor them while they undergo treatment at home.   Clinical Trial Phases  Clinical trials have four phases, and each serves a specific purpose.   Who Can Participate?   Like observational research, different trials look for various traits among participants. Along with looking for people with the health condition the treatment will target, clinical trials may have other requirements depending on the specific goals.   The phase of the trial also changes who can participate. Phase I trials often involve healthy volunteers, as this gives the opportunity to study safety before involving those whose disease may make them more likely to have negative effects.   Why Does Investigational Research Matter?  Any advancement in medicine that you can think of owes its creation to clinical trials, from the most common over-the-counter medications to innovative treatments for serious conditions. Investigational research is essential to determine what treatments are safe and effective. Clinical trials can also provide options for those who don’t have many other treatment choices, like those with rare diseases.   Ready to Get Involved?   Whether you’re interested in taking part in observational or investigational research, you have the power to make a real difference for the future of medicine. You can ask your doctor about studies or trials that may be right for you, or you can use an online tool like Carebox, Antidote, or ClinicalTrials.gov to start your search.   And if participating directly isn’t the right choice for you now, that’s okay too! You still can do your part by sharing information and staying informed. You never know who in your network could benefit from this knowledge.