Frequently Asked Questions and Answers
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1. What are clinical trials, and why are they important?
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Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in clinical trials have an opportunity to contribute to knowledge and progress against diseases. They also receive up-to-date care from experts.
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2. What are the types of clinical trials?
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There are several types of clinical trials
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1. Prevention trials test new approaches, such as medications, vitamins, or other supplements, that doctors believe may lower the risk of developing a certain type of disease. Most prevention trials are conducted with healthy people who have not had disease. Some trials are conducted with people who have had disease and want to prevent recurrence (return of cancer), or reduce the chance of developing a new type of disease.
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2. Screening trials study ways to detect disease earlier. They are often conducted to determine whether finding disease before it causes symptoms, decreases the chance of dying from the disease. These trials involve people who do not have any symptoms of disease.
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3. Diagnostic trials study tests or procedures that could be used to identify disease more accurately. Diagnostic trials usually include people who have signs or symptoms of disease.
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4. Treatment trials are conducted with people who have disease. They are designed to answer specific questions about, and evaluate the effectiveness of, a new treatment or a new way of using a standard treatment. These trials test many types of treatments, such as new drugs, vaccines, new approaches to surgery or radiation therapy, or new combinations of treatments.
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5. Quality-of-life (also called supportive care) trials explore ways to improve the comfort and quality of life of diseased patients and survivors. These trials may study ways to help people who are experiencing nausea, vomiting, sleep disorders, depression, or other effects from disease or its treatment.
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6. Genetics studies are sometimes part of another disease clinical trial. The genetics component of the trial may focus on how genetic makeup can affect detection, diagnosis, or response to particular disease treatment.
Population- and family-based genetic research studies differ from traditional disease clinical trials. In these studies, researchers look at tissue or blood samples, generally from families or large groups of people, to find genetic changes that are associated with disease. People who participate in genetics studies may or may not have disease, depending on the study. The goal of these studies is to help understand the role of genes in the development of disease.
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3. Who sponsors clinical trials?
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Government agencies, such as the ICMR and other part the Department of Health, government of India, sponsor and conduct clinical trials. In addition, organizations or individuals, such as physicians, medical institutions, foundations, volunteer groups, and pharmaceutical & biotech companies, also sponsor clinical trials.
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4. How are participants protected?
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Research with people is conducted according to strict scientific and ethical principles. Every clinical trial has a protocol, or action plan, which acts like a "recipe" for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. The same protocol is used by every doctor or research center taking part in the trial.
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All clinical trials that are federally funded or that evaluate a new drug or medical device subject to DCGI regulation must be reviewed and approved by an Institutional Review Board (IRB). Many institutions require that all clinical trials, regardless of funding, be reviewed and approved by a local IRB.
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The Institutional Review Board (IRB), which includes doctors, researchers, community leaders, and other members of the community, reviews the protocol to make sure the study is conducted fairly and participants are not likely to be harmed. The IRB also decides how often to review the trial once it has begun. Based on this information, the IRB decides whether the clinical trial should continue as initially planned and, if not, what changes should be made.
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An IRB can stop a clinical trial if the researcher is not following the protocol or if the trial appears to be causing unexpected harm to the participants. An IRB can also stop a clinical trial if there is clear evidence that the new intervention is effective, in order to make it widely available.
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5. What are eligibility criteria, and why are they important?
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Each study's protocol has guidelines for who can or cannot participate in the study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health status. Eligibility criteria for treatment studies often require that patients have a particular type and stage of disease.
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Enrolling participants with similar characteristics helps to ensure that the results of the trial will be due to what is under study and not other factors. In this way, eligibility criteria help researchers achieve accurate and meaningful results. These criteria also minimize the risk of a person's condition becoming worse by participating in the study.
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6. What is informed consent?
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Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate or not.
This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or nurse, people receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form.
However, signing the form does not mean people must stay in the study. People can leave the study either at any time- before the study starts or at any time during the study or the follow-up period.
The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.
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7. Where do clinical trials take place?
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Clinical trials take place in doctors' offices, cancer centers, other medical centers, community hospitals and clinics, and veterans' and military hospitals in cities and towns across India and in other countries. Clinical trials may include participants at one or two highly specialized centers, or they may involve hundreds of locations at the same time.
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8. How are clinical trials conducted?
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Clinical trials are usually conducted in a series of steps, called phases. Treatment clinical trials are always assigned a phase. However, screening, prevention, diagnostic, and quality-of-life studies do not necessarily always have a phase. Genetics clinical trials generally do not have a phase.
Phase I trials are the first step in testing a new approach in people. In these studies, researchers evaluate what dose is safe, how a new agent should be given (by mouth, injected into a vein, or injected into the muscle), and how often. Researchers watch closely for any harmful side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations.
Phase II trials study the safety and effectiveness of an agent or intervention, and evaluate how it affects the human body
Phase III trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy. Participants are randomly assigned to the standard group or the new group, usually by computer. In most cases, studies move into phase III testing only after they have shown promise in phases II and I. Phase III trials often include large numbers of people across the country.
Phase IV trials are conducted to further evaluate, the long-term safety and effectiveness of a treatment. They usually take place after the treatment has been approved for standard use. Several hundred to several thousand people may take part in a phase IV study. These studies are less common than phase I, II, or III trials.
People who participate in a clinical trial work with a research team. Team members may include doctors, nurses, social workers, dietitians, and other health professionals. The health care team provides care, monitors participants' health, and offers specific instructions about the study. So that the trial results are as reliable as possible, it is important for participants to follow the research team's instructions. The instructions may include keeping logs or answering questionnaires. The research team may continue to contact participants after the trial ends.
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9. What are some of the benefits of taking part in a clinical trial?
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The benefits of participating in a clinical trial include the following:
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1. Participants have access to promising new approaches that are often not available outside the clinical trial setting.
2. The approach being studied may be more effective than the standard approach.
3. Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.
4. Participants may be the first to benefit from the new method under study.
5. Results from the study may help others in the future.
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10. What are some of the possible risks associated with taking part in a clinical trial?
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The possible risks of participating in a clinical trial include the following:
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1. New drugs or procedures under study are not always better than the standard care to which they are being compared.
2. New treatments may have side effects or risks that doctors do not expect or that are worse than those resulting from standard care.
3. Participants in randomized trials will not be able to choose the approach they receive.
4. Health insurance and managed care providers may not cover all patient care costs in a study.
5. Participants may be required to make more visits to the doctor than they would if they were not in the clinical trial.
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11. What are some questions people might ask their health care provider before entering a clinical trial?
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It is important for people to ask questions before deciding to enter a clinical trial. Questions people might want to ask their doctor or nurse include the following:
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The Study
1. What is the purpose of the study?
2. Why do the researchers think the approach being tested may be effective? Has it been tested before?
3. Who is sponsoring the study?
4. Who has reviewed and approved the study?
5. What are the medical credentials and experience of the researchers and other study personnel?
6. How are the study results and safety of participants being monitored?
7. How long will the study last?
8. How will the results be shared?
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Possible Risks and Benefits
1. What are the possible short-term benefits?
2. What are the possible long-term benefits?
3. What are the short-term risks, such as side effects?
4. What are the possible long-term risks?
5. What other treatment options are available?
6. How do the possible risks and benefits of the trial compare with those of other options?
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Participation
and Care
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1. What kinds of treatment, medical tests, or procedures will the participants have during the study? How often will they receive the treatments, tests, or procedures?
2. Will treatments, tests, or procedures be painful? If so, how can the pain be controlled?
3. How do the tests in the study compare with what people might receive outside the study?
4. Will participants be able to take their regular medications while in the clinical trial?
5. Where will the participants receive their medical care? Will they be in a hospital? If so, for how long?
6. Who will be in charge of the participants' care? Will they be able to see their own doctors?
7. How long will participants need to stay in the study? Will there be follow-up visits after the study?
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Personal Issues
1. How could being in the study affect the participants' daily lives?
2. What support is available for participants and their families?
3. Can potential participants talk with people already enrolled in the study?
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Cost Issues
1. Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate charges be?
2. What is health insurance likely to cover?
3. Who can help answer questions from the insurance company or health plan?
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12. What happens when a clinical trial is over?
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After a clinical trial is completed, the researchers look carefully at the data collected during the trial before making decisions about the meaning of the findings and further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase, or stop testing the agent or intervention because it was not safe or effective. When a phase III trial is completed, the researchers look at the data and decide whether the results have medical importance.
The results of clinical trials are often published in peer-reviews, scientific journals. Peer review is a process by which experts review the report before it is published to make sure the analysis and conclusions are sound. If the results are particularly important, they may be featured by the media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become standard practice. (Standard practice is a currently accepted and widely used approach.
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