Clinical Trial FAQs
An important personal decision
It is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
What is standard therapy?
Standard Therapy is the scientifically established consensus course of treatment for a particular disease. Because advances in medical science are constantly improving the choice of available drugs and the consensus on how to best treat and monitor cancer, Standard Therapy is constantly evolving. Many of today’s Standard Therapy treatments began as experimental research 10 years ago. This means that in many cases your oncologist will recommend a proven Standard Therapy treatment regimen as the best way to treat your disease, based on the latest medical evidence. In some cases, there is no consensus Standard Therapy that is effective. This means that more research must be done, to discover a treatment that works, or to scientifically prove which among existing treatment options is best.
What is clinical research?
Clinical research studies or clinical trials are research projects in which patients help doctors discover tomorrow’s Standard Therapy by finding better ways to prevent, diagnose, or treat cancer, through the use of novel therapies and treatments. Carefully conducted clinical trials are the fastest and safest way to find the best treatments. Results are measured scientifically based on how research patients perform better than patients who receive regular Standard Therapy. Your doctor may recommend that you participate in a clinical trial if he or she feels that you may respond better to a new treatment than to the available Standard Therapy for your disease. If a study drug proves to be effective, participating in a Clinical Trial can allow you to be among the first patients in the world to access a potentially life saving therapy.
What is a clinical trial?
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions which can help determine if a medication or a treatment regimen is safe and effective for treating a specific condition or disease. Clinical trials compare the effectiveness of the study medication or treatment against standard, accepted treatment or against a placebo, if no standard treatment exists.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
What are the different types of clinical trials?
Intervention trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy). Sampling trials allow patients to further the field of cancer research by donating a small blood or tissue sample. These samples are used by scientists in Hackensack Meridian Health’s laboratories to study the structure and behavior of cancer cells. Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or a new cancer occurring in people who have already had cancer. Screening trials test the best way to detect cancer, especially in its early stages. Quality of Life trials explore ways to improve comfort and quality of life for cancer patients and survivors. These studies might test new ways to minimize pain and other side-effects, or explore ways to help cancer survivors return to work, active lifestyle, or sexual function following the completion of treatment.
What are the phases of clinical trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of 4 phases:
Phase I trials:
These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
Phase II trials:
A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
Phase III trials:
These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. In cancer trials, a participant will usually be assigned to receive Standard Therapy treatment, or Standard Therapy plus a new drug.
Phase IV trials:
These studies further assess the long-term safety and efficacy of new treatments.
Are clinical drug trials safe?
Some Clinical Trial drugs have already received F.D.A. approval for other types of cancer or other diseases, and have proven themselves to be safe and effective in thousands of patients. All clinical trials must be approved by an Institutional Review Board which scrutinizes safety data from pre-clinical studies, and from other studies involving the same drug compound. Clinical trials often require frequent Electric Cardiograms and blood tests to closely monitor how your body reacts. If you experience side effects from the trial drug, your doctor can immediately discontinue it. Additional monitoring is performed by a Data Safety Monitoring Board.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate that help produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria.” Those that disallow someone from participating are called “exclusion criteria.” These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify homogenous patient cohorts with the same type of disease, allowing for meaningful evaluation of new therapies. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Will I receive a placebo?
Most of the Clinical Drug Trials at Hackensack Meridian Health involve combination therapy regimes where a new drug is added to Standard Therapy treatment, in an attempt to enhance the effectiveness of these drugs. Sometimes monotherapy with a new drug agent is used, but usually only after patients have tried Standard Therapy, or for early stage. In any event, your physician will explain what treatment you can expect to receive in a clinical trial, what Standard Therapy alternatives exist, and the decision whether you want to participate is always yours to make.
What happens during drug clinical trials?
The clinical trial process depends on the kind of trial being conducted. Studies always begin with an explanation of the trial and a decision making process known as informed consent. Once a patient consents to participate, they are carefully screened and tested to document their baseline condition and to ensure that they meet inclusion criteria. In a trial with more than one study cohort, subjects are assigned to a specific group. Each cohort group might differ in the dose level, drug combination, or treatment used. It is important to remember that no one cohort group is therapeutically superior than another. If there was valid scientific evidence to definitively support one approach, then we wouldn’t need to conduct the clinical. The whole purpose of a clinical trial is to answer these questions. Clinical trials often involve extra tests that are used to measure efficacy and safety. Although this may require more blood draws and scans, this extra information can help your doctor and nurse monitor your treatment more closely.In some studies it becomes quickly apparent that a new drug works very well or in other cases that it doesn’t provide any advantage over Standard Therapy. Patients are sometimes surprised when a clinical trial stops abruptly or when they are moved from one cohort to another. This usually means that the question which the study set out to clarify, has been answered and your doctor can incorporate this medical knowledge into your treatment. For example if a study was trying to determine if an 800 mg dose of Drug A is more effective than a 400 mg dose of Drug A, as soon as the question was answered, all patients would be shifted to the most effective optimal dose level.After the intervention phase of a trial, you will often be monitored in the follow-up phase. This may involve questionnaires and surveys intended to see if the intervention worked and to check for any side-effects.