Clinical research is medical research involving people. Clinical trials are research studies performed with people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
WHAT IS A CLINICAL TRIAL?
A clinical trial is an efficient and ethical manner for a patient to access a medicine prior to it being approved by regulatory authorities. Patients who choose to participate in clinical trials play a critical role in developing new medicines. Clinical trials incorporate regular safety monitoring, and create a venue to explain potential risks of the investigational therapy. Clinical trials also have the ability to establish clinical benefit for the investigational therapy, and this may lead to the investigational therapy becoming an approved drug capable of offering benefit to others.
Clinical trials have to be approved before they start and are carefully designed, reviewed and completed. It is an application of a scientific method designed to test hypotheses and monitor and assess outcomes.
WHY SHOULD I CONSIDER A CLINICAL TRIAL?
Most treatments and therapies for metastatic breast cancer have been developed over the past 20 years. That may seem like a long time but it really isn’t. There are still limited lines of treatment for metastatic breast cancer and for some types, there are only two or three. Sometimes a clinical trial can be a great first option, so you are trying the newest treatment or therapy for your disease type.
You should always weight the pros and cons on any treatment or intervention.
Clinical trials Increase knowledge about metastatic breast cancer. Clinical research helps increase knowledge in terms of how metastatic breast cancer needs to be approached and treated. The information gathered from clinical trials adds value to scientific knowledge. This is important to upgrade medical care and make it more accessible.
Clinical trials are hugely beneficial to the field of science. They test how well new interventions and approaches work in the participants which leads to new scientific discoveries. Each trial is an attempt to answer scientific questions. As a result, it contributes to the discovery of new medicine and treatment guidelines. The drug, vaccine or any other intervention could be more effective than the standard approach.
Clinical trials can also be risky for people who participate. New vaccines, drugs, supplements that are under study may not be necessarily be better than the standard procedure. Sometimes, the side effects of the drug administered to participants can become fatal. Randomized clinical trials are subject to risks as patients do not know what interventions they will receive. Healthcare insurance providers also do not cover costs for these trials. Therefore, participants have to make an informed choice before selecting a clinical trial.
Costs for clinical trials can be expensive and usually range in billions per drug. While planning the research, factors like protocol design, site selection and execution of the trial have to be considered. Usually, there is not a cost to the patient, however, there may be expenses such as travel and lodging if a trial is not located at your cancer center.
HOW DO I FIND CLINICAL TRIALS?
You have many options to consider for clinical trials
Consult your physician/oncologist
Provide your information to a clinical trial matching service to have your information curated for clinical trial options . Some services have an associated cost.
CenterWatch. https://www.cancer.net/research-and-advocacy/clinical-trials/finding-clinical-trial provides information on clinical trials.
EmergingMed Clinical Trial Navigator Service. https://app.emergingmed.com/emed/home online service identifies clinical trial options. Patients complete a questionnaire about their diagnosis, stage, and treatment history. Available clinical trials are matched based on the answers.
Search for clinical trials on your own (see search below). We recommend using www.ciitizen.com/METAvivorCTSearch or https://clinicaltrials.gov. It shows public and private clinical research trials in the US and abroad.
Search METAvivor - Clinical Trials
Tips: Make your search broad first by entering in the first search box advanced breast cancer, breast cancer metastasis, metastatic breast cancer, stage IV breast cancer. If you want a more specific search return, you can add types of MBC such as TNBC, Her2+ or positive, Her2- or negative, ER PR + …etc.)
WHAT IF A CLINICAL TRIAL SITE IS NOT OFFERED NEAR ME?
You may want to consider traveling to a clinical trial site. Sometimes the clinical trial can provide a stipend for travel or resources for lodging during your treatment.
WHAT IF I CANNOT PARTICIPATE IN THE CLINICAL TRIAL AND I AM OUT OF OPTIONS?
Two programs are available for you to explore if you are out of treatment options: Right to Try and Compassionate Use. Metavivor patient advocates worked very hard to pass the Federal Right To Try act in 2017 and 2018. In 2018, the Federal Right To Try Act was signed into law. It isn’t widely used because most patients are not aware of it.
WHAT IS RIGHT TO TRY?
Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA).
This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.
Patients should first consult with their physician and that their physicians consult with the sponsor of the investigational drug or biological product. The sponsor is in the best position to provide information about whether the drug or biological product meets the criteria to be considered an eligible investigational drug for use under the Right to Try Act.
WHAT IS COMPASSIONATE USE?
Sometimes clinical trial enrollment is not possible for those living with metastatic breast cancer. Patients may therefore seek access to investigational medicines outside of a clinical trial.
Sometimes called “expanded access”, compassionate use is a potential way for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. This is a potential solution when patients run out of treatment options but do not have access to a clinical trial.
Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
THERE ARE FOUR PHASES OF CLINICAL TRIALS:
Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
Discuss the possibility of a clinical trial with your doctor. ClinicalTrials.gov has information on clinical trials from 50 states and 209 countries. You can search on Metastatic or Advanced Breast Cancer and see all trials or you can be more specific about your subtype or the organs where your breast cancer has metastasized. We feel this search tool is the best because it gives you options for current trials and also allows you to review results of trials that are complete.
METAvivor - Clinical Trials