You play a key role
Patients like you play an important role in advancing the understanding of Lyme disease and other tick-borne illnesses and the discovery of new or improved treatments by participating in a clinical trial. There are many reasons why people volunteer to take part in a clinical trial. All who volunteer contribute valuable information that will help researchers find better treatments and diagnostic tests that may improve lives.
Help improve lives of others
“I volunteered because the information researchers learn from me today will help others with Lyme disease in the future.”Sara
Access to study treatment
“I participated in a clinical trial to gain access to a new treatment for Lyme disease.”George
Contribute to future treatments
“Both healthy volunteers and patients with Lyme disease who participate in clinical research help make medical advances for the future.”Dr. Sellati GLA Chief Scientific Officer
Understanding Clinical Research
What is clinical research?
Clinical research is the study of health and illness in people. Clinical trials are part of a lengthy, careful process done by researchers to determine whether a new treatment is safe and effective. When you volunteer to participate in a clinical trial, you help doctors and researchers learn more about Lyme disease and/or other tick-borne illnesses. Your participation in a clinical trial may help improve your health and the health of others who are living with Lyme and other tick-borne illnesses, now and in the future.
There are many terms that are used to describe clinical research, including:
- Clinical trial
- Clinical study
- Clinical research study
What is the difference between a clinical trial and a clinical study?
Clinical research involves people. Clinical trials are sometimes referred to as a clinical study or clinical research study or simply a study; the terms are often used interchangeably, but there are differences between a clinical trial and a clinical study.
- Clinical trial is the way a medical, surgical or behavioral intervention to prevent, detect or treat a disease is evaluated. This phrase is specific to the testing of a new intervention.
The three types of clinical trials are:
Test treatments or drug combinations to alleviate or reduce symptoms of Lyme disease or other tick-borne illnesses.
Focus on finding better ways to accurately diagnose Lyme disease or other tick-borne illnesses, particularly in the early (acute) stage.
Tests approaches to prevent onset of Lyme disease or other tick-borne illnesses from developing or returning. Prevention trials may study medicines, vaccines, lifestyle changes, and other interventions.
A clinical trial may explore:
- New treatments or new combinations of treatments
- New ways to use existing treatments
- New medical devices
- New ways to modify behaviors to improve health
- New ways to improve the quality of life for people with acute or chronic illnesses
In a clinical study, also known as an observational study, researchers collect data based on what is seen in groups of participants e.g. researchers “observe” study participants. Participants may receive treatments or procedures as part of their routine medical care, but study participants are not assigned to specific treatment or procedure by the Principal Investigator (as in a clinical trial).
Refers to the practice of looking for better ways to identify a disorder or condition.
Quality of life trials
Explore ways to improve comfort and the quality of life for individuals living with Lyme disease.
Aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up.
A clinical study may explore:
- The impact of the disease on quality of life
The overall purpose of clinical research is to find new, improved and safe methods of treating, preventing, screening for, and diagnosing a disease. Clinical research is vital to the development of new Lyme disease treatments and diagnostics as well as helping doctors and researchers gain a better understanding of the biology and impact of the disease.
FOR EASE OF UNDERSTANDING, WE REFER TO CLINICAL TRIALS AND OBSERVATIONAL STUDIES SIMPLY AS A “CLINICAL TRIAL”.
Phases of clinical trials
Clinical trial phases
Before a new treatment is approved for use in the U.S. it must go through a lengthy clinical trial process that includes multiple phases.
A Phase I clinical trial is usually the first time the treatment under investigation is delivered to human beings. The new treatment is delivered to a small group of healthy volunteers, usually 20 – 80 participants. The goal of a Phase I clinical trial is to establish the highest dose of the treatment under investigation that can be safely given without serious side effects. In addition to safety, Phase I clinical trials yield important information on effectiveness of a chosen delivery method (e.g., by mouth, injection, etc.).
In some disease states, patients will be given the treatment under investigation instead of healthy volunteers.
The treatment under investigation is given to a larger group (100-300) of patient volunteers (individuals with the disease the treatment is intended to treat) to determine its efficacy (ability to work in the intended disease). Phase II clinical trials continue to evaluate safety and identify the more common side effects of the new treatment.
The new treatment is given to large groups of patient volunteers (individuals with the disease the treatment is intended to treat) to confirm its effectiveness compared to other FDA-approved treatments and to continue to monitor side effects.
Usually, hundreds to thousands of patient volunteers participate in Phase III clinical trials.
Once the drug successfully completes Phases I-III the trial results are submitted to the U.S. Food and Drug Administration (FDA) for approval. If the FDA agrees the results are positive, it will grant approval and the treatment will become commercially available.
Only after FDA approval can the medicine be prescribed by doctors for use by their patients.
After the new treatment is approved by the FDA, real-world studies continue for an extended time usually years.
The new treatment is studied in large, diverse groups of patients to monitor for long-term side effects.
What happens in a clinical study
How do researchers implement a clinical research idea?
Everything that happens in each phase of a clinical trial follows a plan detailed in a study plan, also referred to as a protocol, which describes the following:
- Purpose of the research
- Goals of the research such as the type of information to be learned from the clinical trial
- Eligibility requirements – defines the population of people that can participate in the clinical trial (for example: only men or only women, only those diagnosed with Lyme disease in past month, etc.).
- Details about tests, procedures, and/or treatments
- How long the clinical trial will last
- Potential benefits to participants
- Risks to participants and how the research team will minimize the risks
Who is in charge of a clinical research protocol?
The study plan (protocol) is reviewed and approved by an independent ethics committee, known as an Institutional Review Board (IRB), before the study can begin. The purpose of the Institutional Review Board (IRB) is to protect the rights and welfare of people that participate in a clinical trial. The ethics committee carefully reviews the clinical trial to ensure a balance between the potential benefits of the research with the risks to participants.
Throughout the entire clinical trial experience, there are many other people who provide oversight to safeguard study participants. A Principal Investigator – the person that conducts the clinical trial at a healthcare center. The sponsoring organization that develops the study plan and funds the research, the study doctor(s) and nurses who provide care to study participants.
US FOOD & DRUG ADMINISTRATION
The agency responsible for ensuring drugs, medical devices and equipment are safe and effective.
INSTITUTIONAL REVIEW BOARD (IRB)
An IRB is an independent ethics committee that oversees clinical trials. They review and approve the clinical trial before it is presented to potential study participants. An IRB’s primary role is to ensure the safety of study participants. The research team regularly updates the IRB on the progress of the clinical trial including information on safety.
A Sponsor is an individual, institution, company, government agency or other organization that is responsible for initiating, managing, and/or financing the clinical trial, but they do not conduct the clinical trial.
STUDY PLAN – OR PROTOCOL
provides a description of a clinical trial. It includes the purpose, objectives, design, methods, inclusion and exclusion criteria, and details the activities required of study participants.
CLINICAL RESEARCH TEAM
As a study participant, you will work closely with the research team that is led by a Principal Investigator (PI). The PI implements the study plan and may analyze the data and report the results of the clinical trial. Members of the research team regularly monitor the participants’ health and well-being to determine the safety and effectiveness of the research. A clinical trial may take place at a hospital, doctors’ office or clinical research center.
Participating in a clinical trial
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate, called inclusion criteria. The plan will also have factors that disqualify a person from taking part, called exclusion criteria. These standards include parameters such as age, gender, type and stage of disease, previous treatment history, and other medical conditions. Only those people that meet all of the inclusion criteria and none of the exclusion criteria can participate in a clinical trial.
The selection criteria ensure that researchers are studying the right people to help find answers to important medical questions.
If you are interested in volunteering, first find out if you are right for that clinical trial and if the clinical trial is right for you.
The safety and well-being of study participants are top priorities for the entire research team. If you choose to participate in a clinical trial, your health will be closely monitored, and your care will be adjusted if the research team thinks it’s in your best interest. If you decide at any point to end your study participation, you may do so in consultation with the PI and research team.
It’s important to learn all you can about a clinical trial before you participate. Understanding the purpose of the clinical trial and what you can expect will help you have a conversation with your treating doctor and family to decide if participating is right for you.
Informed consent is the process that helps you learn key facts about the clinical trial before deciding if you want to participant. The information will include details about the clinical trial, such as its purpose, risks and potential benefits, length of time you will be in the clinical trial, required procedures, and other important information. If you decide to participate in the clinical trial, you will be asked to sign the informed consent form.