What Exactly Is a Clinical Study?
A clinical study is a kind of research that uses human volunteers (also known as participants) to further medical knowledge. Clinical trials (also known as interventional studies) and observational studies are the two basic forms of clinical investigations. Interventional and observational research are both included on ClinicalTrials.gov.
Participants in a clinical trial get particular treatments based on the study strategy or protocol developed by the investigators. Medical items, such as medications or equipment, procedures, or changes in participant behavior, such as food, are examples of interventions. Clinical trials may evaluate a novel medical technique to an existing standard, to a placebo with no active components, or to no intervention. Some clinical studies compare therapies that are currently on the market. When a new product or strategy is being investigated, it is not always clear whether it will be beneficial, detrimental, or no different from existing options (including no intervention). The investigators attempt to evaluate the intervention’s safety and effectiveness by assessing specific outcomes in the participants. For example, researchers may provide a medicine or therapy to patients with high blood pressure to determine whether their blood pressure drops.
Clinical trials used in medication research are sometimes classified according to phase. The Food and Drug Administration (FDA) defines these stages.
Some persons who are not qualified to participate in clinical trials may be able to get experimental medications or equipment via extended access. The FDA has further information about enhanced access.
In an observational study, researchers evaluate health outcomes in groups of individuals in accordance with a research strategy or methodology. Participants may receive treatments (including medical items such as medications or devices) or procedures as part of their usual medical care, but the investigator does not assign participants to particular interventions (as in a clinical study). Investigators may, for example, examine a group of elderly persons to learn more about the impact of various lifestyles on heart health.
To The Top Who Performs Clinical Studies?
- Every clinical trial is headed by a lead investigator, who is often a physician. A research team for clinical studies may comprise physicians, nurses, social workers, and other health care experts.
- Pharmaceutical corporations, university medical facilities, volunteer groups, and other organizations, as well as federal entities such as the National Institutes of Health, the United States Department of Defense, and the United States Department of Veterans Affairs, may sponsor or support clinical research. Clinical research may also be sponsored by doctors, other health care professionals, and other persons.
To The Top Where Are Clinical Studies Performed?
- Clinical trials may be conducted in a variety of settings, including hospitals, universities, physicians’ offices, and community clinics. The location is determined by who is performing the research.
To The Top How Long Do Clinical Trials Last?
- The duration of a clinical research varies according to the subject being examined. Before enrolling, participants are informed how long the study would continue.
To The Top Reasons For Clinical Studies
Clinical investigations, in general, are intended to contribute to medical knowledge about the treatment, diagnosis, and prevention of illnesses or disorders. The following are some frequent motivations for performing clinical studies:
- Evaluating one or more methods for treating an illness, ailment, or condition (for example, medications, medical devices, surgical techniques, or radiation therapy).
- Finding strategies to avoid the onset or recurrence of an illness or condition. Medicines, vaccinations, and lifestyle modifications are examples of such methods.
- Evaluating one or more treatments for detecting or diagnosing a certain illness or condition
- Investigating strategies for detecting a disease or risk factors for that condition
- Investigating and assessing methods to enhance the comfort and quality of life of persons with chronic illnesses via supportive care
- TO TOP
Participating in Clinical Research
A clinical study is carried out in accordance with a research procedure. The methodology is intended to address particular research questions while also protecting participants’ health. It includes the following details:
- The purpose for carrying out the research
- Who is eligible to participate in the study (the eligibility criteria)?
- The required number of participants
- The sequence of tests, treatments, or medications, as well as their doses
- The duration of the research
- What data will be collected about the participants?
Who Can Take Part in a Clinical Trial?
Who may engage in clinical investigations is defined by rules. These rules are known as eligibility criteria, and they are outlined in the procedure. Some research studies seek volunteers who have the diseases or disorders being examined, while others want healthy individuals. Some studies are confined to a specified set of people who are requested to participate by researchers.
Eligibility. Inclusion criteria are the variables that enable someone to join in a clinical trial, whereas exclusion criteria are the ones that exclude someone from participation. They are determined by factors such as age, gender, illness kind and stage, past treatment history, and other medical problems.
How Are Participants Safeguarded?
Researchers utilize informed consent to offer prospective and enrolled participants with information about a clinical trial. This information assists participants in deciding whether to join or continue participating in the research. The informed consent method is meant to safeguard participants by providing adequate information for a person to comprehend the study’s dangers, possible benefits, and alternatives. The procedure may include recruiting materials, spoken instructions, question-and-answer sessions, and exercises to assess participant comprehension, in addition to the informed consent forms. In general, before participating in a study, a participant must sign an informed consent statement to demonstrate that he or she was provided information about the risks, possible benefits, and alternatives and that he or she understands it. A contract is not formed by signing the paper and granting assent. Participants may leave a study at any moment, even if the research is still ongoing. For questions to ask a health care physician or researcher about participating in a clinical trial, see the Questions to Ask section of this page.
Review boards at institutions. An institutional review board (IRB) must examine, authorize, and monitor every federally financed or performed clinical trial, as well as any study of a medication, biological product, or medical device regulated by the FDA. An IRB is made up of physicians, researchers, and community people. Its job is to ensure that the research is ethical and that participants’ rights and welfare are maintained. This entails, among other things, ensuring that research risks are minimized and appropriate in comparison to any prospective rewards. The informed consent document is also reviewed by the IRB.
Some clinical research are additionally regulated by data monitoring committees (also known as data safety and monitoring boards) in addition to an IRB.
Various federal authorities, notably the Office of Human Subjects Research Protection and the Food and Drug Administration, have the ability to investigate whether clinical study sponsors are appropriately safeguarding research subjects.
Relationship to Conventional Health Care
Participants in clinical studies often continue to visit their regular health care providers while participating. While the majority of clinical trials give participants with medicinal items or procedures linked to the sickness or condition being examined, they do not provide comprehensive health care. A participant may ensure that the study protocol will not clash with any drugs or treatments that he or she is receiving by having his or her normal health care practitioner collaborate with the research team.
Participation in a clinical research advances medical knowledge. The findings of these studies have the potential to improve future patient care by giving information on the advantages and hazards of therapeutic, preventive, or diagnostic goods or procedures.
Clinical trials serve as the foundation for the development and commercialization of novel medicines, biologics, and medical devices. At the time of the trial, the safety and efficacy of the experimental strategy or application may not be completely understood. Some studies may provide participants the opportunity to get direct medical benefits, while others do not. Most studies include some risk of damage or injury to the participant, albeit this risk may not be larger than the risks associated with ordinary medical treatment or illness progression. (In the case of IRB-approved studies, the IRB has determined that the risks of participation have been reduced and are appropriate in comparison to the expected benefits.) Many studies need extra procedures, examinations, and evaluations depending on the research protocol. The informed consent document will detail these criteria. A prospective volunteer should also share these concerns with members of the study team as well as his or her primary care physician.
Questions to Ponder
Anyone interested in taking part in a clinical trial should learn as much as they can about the study and feel comfortable asking the research team questions regarding the study, the procedures involved, and any costs. During such a conversation, the following questions may be useful. Some of these questions are answered in the informed consent agreement. Many of the issues pertain to clinical trials, while some apply to observational research as well.
- What is being researched?
- Why do researchers feel the intervention under consideration will be effective? Why can it fail to work? Has it ever been tested?
- What kind of therapies may I get throughout the trial?
- How will the interventions I get be chosen (for example, by chance)?
- Who knows which intervention I’ll get throughout the trial? Will I find out? Will the members of the study team be aware?
- What are the potential risks, side effects, and advantages of this study in comparison to my current treatment?
- What will I be required to do?
- What tests and procedures are being performed?
- How often will I have to go to the hospital or clinic?
- Will you need to be hospitalized?
- How long will the research last?
- Who will foot the bill for my participation?
- Will I be compensated for any additional expenses?
- What kind of long-term follow-up treatment is included in this trial?
- Will I be able to continue getting the intervention if I benefit from it throughout the trial?
- Will the study’s findings be made available to me?
- Who will be in charge of my medical treatment while I’m in the trial?
- What are my alternatives if I get harmed while participating in the study?