What is Clinical Research?
Clinical research is the study of Potential Medical Treatment Options for diseases impacting people of our country and world. Such studies are carried out with willing volunteers who participate in research (like you).
It is the way we learn how to:
Better Prevent an illness
Better Diagnose an illness
Better Treat an illness
A Clinical Trial is a type of Clinical Research Study. A clinical trial is designed to answer specific questions about NEW treatments or NEW ways of using existing (known) treatments or how to prevent known diseases such as virus infection that historically have proven to result in Millions of deaths and disabilities.
Why are Clinical Trial done?
Clinical trials are done to determine whether a NEW drug or treatment is safe and effective. Will it prevent a certain disease or will improve the result of treatment of certain disease. Clinical trials are part of a long, careful process which may take many years to complete.
Where do the ideas for trials come from?
All clinical trials begin by the need to answer a question. That question could be:
Can there be a better treatment option for a certain disease?
Can there be a more effective way of preventing a disease?
Can we have a treatment with less side effects?
Can we prolong life with a new treatment?
Can we prevent disability due to diseases?
The answer to all of the above questions starts in a Laboratory during the development of that treatment medication.
Then the treatment is used in laboratory animals humanely.
If the new medication shows promise, then the medication is evaluated in a Clinical Trial involving human volunteers.
Initially the study is done under very intense monitoring of healthy volunteers. If proved to be safe the study is expanded to a larger population of may be 100-500 approximately. If it continues to show promise the treatment is expanded to may thousands.
Who develops the Plan for Clinical Trial?
When you take part in a clinical research study, you and the Paradigm Research TEAM must follow a set plan called the “Study Protocol.”
It’s important to understand that a Clinical Trial by its nature is intended to answer a question. You might or might not benefit directly by participating in a Clinical Trial, but you can be sure to have made a significant contribution to the result of the study which may impact the lives of many people in the world. It is important to talk about this topic with your doctor or your Paradigm Researcher Center Team.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as a dedicated Research facility such as your Paradigm Clinical Research Center, Hospitals, Universities.
What are the different types of clinical trials?
• Treatment trials test new treatments, new combinations of drugs, or new approaches to a variety of diseases
• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include vaccines or other medications
• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health conditions.
• Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
Why should I consider participating in a clinical trial?
It is important to evaluate medications in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
Some people participate in clinical trials because they have exhausted standard (approved) treatment options – which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.
Other people participate in trials because they want to contribute to the advancement of medical knowledge and make available medications to future generations. Such people may be benefiting from Medications that were evaluated by Volunteers in prior trials. Such people understand that any medication on the market has passed through a rigorous Research Trial before being made available.
Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed in the Clinical Trial.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and 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 clinical 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 appropriate participants according to the Protocol for the Research Trial. The criteria help ensure that researchers will be able to answer the questions they are asking. This is the basis of all clinical research and trials.
What is Informed Consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What happens during a clinical trial?
The clinical trial team includes doctors and Research Coordinators. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed according to the protocol for the Trial
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff based on the schedule of contacts.
What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
• Play an active role in your own health care.
• If the new treatment works, you may be one of the first people to benefit.
• Help others by contributing to medical knowledge.
• Access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
• The trial sponsor may pay for some of your medical care or tests.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol or a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will never be disclosed.
Does a participant continue to work with a primary health care provider while in a Clinical Trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with your Paradigm Research Team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Can I leave a clinical trial after I have begun?
All participants in clinical trials are volunteers. You can choose to quit a clinical trial at any time, but talk to your Paradigm Research Team first. Your doctor can tell you how quitting the trial might affect your health and if there are other treatment options.
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions.
A protocol describes the Inclusion / Exclusion criteria that determines who may participate in the trial. It also describes the schedule of tests, procedures, medications, and dosages and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by your Paradigm Research Team to monitor your health and to determine the safety and effectiveness of the study treatment.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions:
• In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
• In Phase III trials, the study drug or treatment is given to large groups of people (1,000-20,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.
Most of the time, when you take part in a clinical trial, you will only be in that one phase of the study. Treatments move through the phases, but patients do not.
What is an Institutional Review Board?
An Institutional Review Board (often abbreviated as “IRB”) is a committee or panel comprised of medical and non-medical members who study and properly consider all clinical protocols involving human subjects. The involvement of human subjects in research is not permitted until an appropriate IRB has reviewed and approved the research protocol and informed consent.
When reviewing a proposed clinical research trial, the IRB assesses such things as the risks to the subjects & the anticipated benefits to the subjects and others. It also considers the importance of the knowledge that may reasonably be obtained from the study.
Where can I get more information on clinical trials?
There is an extensive FAQ on clinical trials on the web site: ClinicalTrials.gov website.
Or you can reach us to see what studies are ongoing at your Paradigm Research Center.
How do I sign up for a clinical trial?
You can call your Paradigm Clinical Research Center to enquire about the clinical trials that are currently ongoing or trials that will start in the near future.
There is a pre-screening process to ensure each participant meets the inclusion criteria for that trial.
Once you meet the inclusion criteria you will be asked to come to the Paradigm Clinical Research Center to go through a process called informed consent. The goal of informed consent is to make sure you understand the clinical trial’s plan. A member of the Paradigm Research Team will review the informed consent form in detail with you. This form explains the clinical trial’s purpose, plan, risks and benefits.
This is a great time to ask questions. If you decide to join the clinical trial, you will be asked to sign the informed consent form. The research team member will also sign the form, and you will receive a copy.
What should you consider before participating in a trial?
You should know as much as possible about the clinical trial and feel comfortable asking the members of Paradigm Research Team questions about the trial.
The following questions might be helpful for you to discuss with your Paradigm Research Team. Some of the answers to these questions are found in the informed consent document once your have agreed to participate in the Research Trial
• What is the main purpose of this study?
• Why do researchers believe the treatment being tested may be effective? Has it been tested before?
• Does the study involve a placebo or a medication that is already on the market?
• How long will the study last?
• What will I be asked to do as a participant?
• What kinds of tests are involved?
• Will I receive any compensation for being in the study?
• Will I be able to see my own doctor for my general health care issues?
• Will I receive any follow-up care after the study has ended?
As a research participant you have the right:
• To be told that you are participating in a Clinical Trial.
• To be told the purpose of the Clinical Trial.
• To be told what will happen during the study, what you are being asked to do, and how long it will last.
• To be told about possible risks, side effects and discomforts and some that are not known at the time of participation
• To understand how your personal information will be kept private.
• To withdraw from the study at any time.
• To an informed consent discussion. This means the research Team should explain the whole study to you, and then without any pressure, allow you time to make the right choice for yourself.
• To receive a copy of your consent form.
How does clinical trial affect me?
Only through clinical research can we gain insights or answers about the safety and effectiveness of NEW treatments and procedures. Participating in a clinical study contributes to medical knowledge. The result of that newly acquired knowledge will be New Treatment Medications, Safer Medications and means of avoiding epidemics that historically have resulted in more deaths than wars.
Groundbreaking advances in health care were possible ONLY because of participation of volunteers in clinical research.
Clinical research requires complex and rigorous testing. As research opens new doors to finding ways to Diagnose, Prevent, Treat disease and disability. Clinical trial participation is essential to help us find the answers. If no one volunteered in a clinical trial from this point forward there will be NO NEW Medications available and NO new Advances will be made.
Center watch https://www.centerwatch.com/health-resources/
Clinical Trials.gov https://clinicaltrials.gov/ct2/about-studies/learn#Participating
If you have any questions please contact your local Paradigm Clinical Research Center in Redding, San Diego or Wheat Ridge, Colorado.