Contents
- What Is a Clinical Study?
- Clinical Trials
- Observational Studies
- Who Conducts Clinical Studies?
- Where Are Clinical Studies Conducted?
- How Long Do Clinical Studies Last?
- Reasons for Conducting Clinical Studies
- Participating in Clinical Studies
- Who Can Participate in a Clinical Study?
- How Are Participants Protected?
- Relationship to Usual Health Care
- Considerations for Participation
- Questions to Ask
What Is a Clinical Study?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.ClinicalTrials.gov includes both interventional and observational studies.
Clinical Trials
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators.These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet.Clinical trials may compare a new medical approach to a standard one that is already available, to aplacebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other.When a new product or approach is being studied,it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention).The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
Clinical trials used in drug development are sometimes described by phase. Thesephases are defined by the Food and Drug Administration (FDA).
Some people who are not eligible to participate in a clinical trial may be able to getexperimental drugs or devices outside of a clinical trial through expanded access. Seemore information on expanded access from the FDA.
Observational Studies
In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol.Participants may receive interventions (which can include medical products such as drugs or devices)or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator(as in a clinical trial).For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.
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Who Conducts Clinical Studies?
Every clinical study is led by a principal investigator, who is often a medical doctor.Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups,and other organizations, in addition to Federal agencies such as the National Institutes of Health,the U.S. Department of Defense, and the U.S. Department of Veterans Affairs.Doctors, other health care providers, and other individuals can also sponsor clinical research.
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Where Are Clinical Studies Conducted?
Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics.The location depends on who is conducting the study.
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How Long Do Clinical Studies Last?
The length of a clinical study varies, depending on what is being studied.Participants are told how long the study will last before they enroll.
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Reasons for Conducting Clinical Studies
In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions.Some common reasons for conducting clinical studies include:
- Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition
- Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
- Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
- Examining methods for identifying a condition or the risk factors for that condition
- Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness
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Participating in Clinical Studies
A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:
- The reason for conducting the study
- Who may participate in the study (the eligibility criteria)
- The number of participants needed
- The schedule of tests, procedures, or drugs and their dosages
- The length of the study
- What information will be gathered about the participants
Who Can Participate in a Clinical Study?
Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll.
Eligibility. The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
How Are Participants Protected?
Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. See the Questions to Ask section on this page for questions to ask a health care provider or researcher about participating in a clinical study.
Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored bydata monitoring committees (also called data safety and monitoring boards).
Various Federal agencies, including the Office of Human Subjects Research Protection and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
Relationship to Usual Health Care
Typically, participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. By having his or her usual health care provider work with the research team, a participant can make sure that the study protocol will not conflict with other medications or treatments that he or she receives.
Considerations for Participation
Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.
Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. (For trials approved by IRBs, the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.) Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These requirements will be described in the informed consent document. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.
Questions to Ask
Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions may be helpful during such a discussion. Answers to some of these questions are provided in theinformed consent document.Many of the questions are specific to clinical trials, but some also apply to observational studies.
- What is being studied?
- Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
- What are the possible interventions that I might receive during the trial?
- How will it be determined which interventions I receive (for example, by chance)?
- Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
- How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
- What will I have to do?
- What tests and procedures are involved?
- How often will I have to visit the hospital or clinic?
- Will hospitalization be required?
- How long will the study last?
- Who will pay for my participation?
- Will I be reimbursed for other expenses?
- What type of long-term follow-up care is part of this trial?
- If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
- Will results of the study be provided to me?
- Who will oversee my medical care while I am participating in the trial?
- What are my options if I am injured during the study?
This page last reviewed in March 2019
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FAQs
Learn About Clinical Studies - ClinicalTrials.gov? ›
Search a database of Federally and privately supported studies available through clinicaltrials.gov. Learn about each trial's purpose, who can participate, locations, and who to contact for more information. Clinicaltrials.gov.
How can I learn more about clinical trials? ›Search a database of Federally and privately supported studies available through clinicaltrials.gov. Learn about each trial's purpose, who can participate, locations, and who to contact for more information. Clinicaltrials.gov.
How often does ClinicalTrials.gov need to be updated? ›Required Updates to an Active ClinicalTrials.gov Record
In general, the Responsible Party must review and update, as necessary, an active study record at least annually. Failure to do so will result in the record being identified as having a problem that needs to be addressed.
FDAAA requires the reporting of results for all primary and secondary outcome measures/endpoints for applicable clinical trials. Tertiary and exploratory outcomes are not captured as part of FDAAA. The primary outcome of our trial has been completed, but secondary outcome data is still being collected.
Which clinical trials pay the most? ›- Altasciences Research Study #N-31000-EN-1. Location: Cypress, CA. Compensation: Up to $6,650. ...
- Altasciences Research Study #N-31700-EN-1. Location: Cypress, CA. Compensation: Up to $12,800. ...
- Labcorp Madison Study #8486-900. Location: Madison, WI. Compensation: up to $18,802.
While ZipRecruiter is seeing annual salaries as high as $171,500 and as low as $28,500, the majority of Clinical Trials salaries currently range between $62,500 (25th percentile) to $125,500 (75th percentile) with top earners (90th percentile) making $159,000 annually across the United States.
Can you make a career out of clinical trials? ›Clinical research is a competitive but growing field and provides rewarding career opportunities if you have qualifications or experience within life sciences. A career in clinical research involves playing a role in helping your employer conduct studies to ensure new treatments are safe and effective for patients.
Do 80% of clinical trials fail to meet enrollment timelines? ›Difficulty enrolling patients in a clinical trial can result in costly delays or even termination of the trial. In fact, nearly 80 percent of all trials fail to meet their original enrollment deadline1 and 55 percent of trials are terminated for failure to achieve full enrollment.
How many clinical trials fail per year? ›Why does 90% of clinical drug development fail? Only 1 out of 10 drug candidates successfully passes clinical trial testing and regulatory approval.
How many clinical trials are needed for FDA approval? ›Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials, to be sure that the findings from the first trial are not the result of chance or bias.
Is ClinicalTrials.gov peer-reviewed? ›
PCORI adopted a process for peer review and public release of the results of the comparative clinical effectiveness research studies that it funds. This process includes registering and submitting summary results information to ClinicalTrials.gov for relevant clinical trials and observational studies.
What is the golden standard for clinical trials? ›What Is a Randomized Controlled Trial? Of all the many ways research can be conducted, the gold standard level of proof where treatments and therapies are concerned is the Randomized Controlled Trial (RCT).
What is a major limitation of results from clinical trials? ›Participating in a trial may also influence the results. Limitation also includes the specificity of the questions answered; the narrow perspective of many trials leaves aside important information related to the consequences of the intervention on quality of life, satisfaction or costs.
What is the highest salary for a clinical trial manager? ›| Annual Salary | Monthly Pay | |
|---|---|---|
| Top Earners | $179,500 | $14,958 |
| 75th Percentile | $152,500 | $12,708 |
| Average | $128,124 | $10,677 |
| 25th Percentile | $96,000 | $8,000 |
For any failed trial, there can be many potential culprits for the failure. Sometimes these failures are unavoidable, but most of the time they arise due to poor planning or a misunderstanding of key biological and/or drug development principles.
Are clinical trials worth the money? ›Possible benefits
Well-designed and well-performed clinical trials provide benefits to you while allowing you to help others by contributing to knowledge about new treatments or procedures. You gain access to new research treatments before they are widely available.
Some clinical trial sponsors will pay for participants' travel costs. Payment for travel can take a few different forms. Trials may offer a stipend to participants to cover transportation costs such as reimbursement for gas, mileage, and mass transit fares. Certain trials may even pay for air travel.
Is working in clinical trials a good career? ›Not only is clinical research a fulfilling career, but it's also a challenging one. Clinical research is responsible for ascertaining how safe and effective drugs, devices and diagnostic products are, and as such it's a demanding role with plenty of responsibility riding on it.
Do doctors make money from clinical trials? ›Compensation is then usually paid to the doctor regardless of whether or not the patient actually enrolls in the trial. This incentive is considered reimbursement for the effort done by the physician to pre-screen and connect the patient to the study.
What disqualifies you from clinical trials? ›What is exclusion criteria? Exclusion criteria is a list of characteristics that disqualify a person from participating in a clinical trial. These characteristics can vary from demographic information like age, gender, or race to something as complex as comorbidities, organ dysfunction, or the use of other medications.
How many clinical trials fail recruiting? ›
85% of clinical trials fail to retain enough patients. The average dropout rate across all clinical trials is around 30% Over two-thirds of sites fail to meet original patient enrollment for a given trial. Up to 50% of sites enroll one or no patients in their studies.
What is the best degree to work in clinical research? ›If this is the career you want to work toward, a major in biology or physics is likely to prepare you well. However, other science-focused degree programs will also offer the foundation of knowledge you need to excel in the field. Chemistry degrees can be useful.
Why do 90% of clinical trials fail? ›On other hand, the clinical drug development failure due to the unmanageable toxicity is most likely due to the fact that it showed toxicity at normal healthy organs even at low dose before the drug can achieve any efficacy in disease-targeted organs.
Can you participate in 2 clinical trials at the same time? ›Participation in multiple trials would make it difficult for researchers to identify the risks and benefits of each therapy on its own. Patients may, however, participate in a tumor-banking trial at the same time that they're taking part in a trial of a new therapy.
What is the average age of clinical trial participants? ›Data from 35 trials were evaluated with 30 trials reporting a weighted mean age of 55.85 years and 5 trials reporting a weighted median age of 55.14 years.
What was the biggest clinical trial ever? ›The polio vaccine trials were among the largest clinical trials ever performed. In the United States, over 600,000 school children were injected with either the vaccine or placebo. More than a million others participated as “observed” controls.
Which clinical trial has 100 success rate? ›A recent clinical trial involving 14 rectal cancer patients at Memorial Sloan Kettering Cancer Center in New York had an incredible 100% success rate. They were given an immunotherapy medication called “Dostarlimab.” 6 months later, the cancer was gone in every single patient.
Which country has the highest enrollment in clinical trials? ›- United States: 148,736.
- France: 30,080.
- Canada: 24,581.
- China: 23,509.
- Germany: 22,215.
- United Kingdom: 21,163.
- Spain: 16,492.
- Italy: 16,140.
There are several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials, and natural history studies.
How long does it take to get from FDA to Phase 3 clinical trial? ›Following successful completion of a Phase 3 trial, a New Drug Application (NDA) can be submitted to the FDA to request review for approval. The FDA will then take 6-10 months to review all of the data submitted and either accept or deny the NDA.
What is the difference between clinical research and clinical trials? ›
A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective.
Do clinical trial results have to be published? ›The WHO also has requirements for publishing clinical trial data: results must be published open access within 12 months in a peer-reviewed journal or made publicly available within 24 months, and they must be posted on a clinical trial registry within 12 months.
Is ClinicalTrials.gov a database? ›ClinicalTrials.gov is a registry and results database of privately and publicly funded clinical studies conducted around the world. The resource is provided by the U.S. National Library of Medicine.
How long do clinical trials take? ›There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage. But this time span varies a lot. There are many factors that affect how long it takes for a drug to be licensed.
What is one of the most common problems in randomized controlled trials? ›Randomized controlled trials (RCTs) have well-known problems with realism or validity (a problem that researchers try to fix using field experiments, but it's not always possible to have a realistic field experiment either), and cost/ethics/feasibility (which pushes researchers toward smaller experiments in more ...
How much does it cost to run an RCT? ›Overall costs of an RCT, as provided in 16 articles, ranged from USD 43-103,254 per patient, and USD 0.2-611.5 Mio per RCT but the methodology of gathering these overall estimates remained unclear in 12 out of 16 articles (75%).
What is double blinding in research? ›(DUH-bul-blind STUH-dee) A type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over. This makes results of the study less likely to be biased.
What is the biggest barrier to clinical trials? ›Recruiting study participants is one of the most challenging tasks in the clinical trial process, and arguably one of the biggest barriers to success in clinical research. Low enrollment is a chronic problem for many studies.
What makes a clinical trial strong? ›A good experiment, like a good clinical trial, often has blind controls or double-blind randomization to compare the end results. The goal for a well-controlled experiment is for it to be repeated many times with the same or statistically similar results.
What are the three most important forms of misconduct in clinical trials? ›In accordance with U.S. federal policy, there are three forms of research misconduct: plagiarism, fabrication, and falsification.
Do you need a PHD to be a clinical trial manager? ›
Degree and Education Requirements
A minimum of a bachelor's degree in life science or closely related field is the minimum requirement for individuals seeking to become a clinical trial manager.
That being said, the pay range for participation in a research study can vary widely. On average, you can expect to be paid anywhere from $50-$300 per day to participate in a study. The total amount you will be paid will depend on the length of the trial and the treatment or procedures performed.
How much can I make from clinical trials? ›| Annual Salary | Monthly Pay | |
|---|---|---|
| Top Earners | $159,000 | $13,250 |
| 75th Percentile | $125,500 | $10,458 |
| Average | $98,544 | $8,212 |
| 25th Percentile | $62,500 | $5,208 |
Factors that may affect the granting of consent to participate in a clinical trial included: uncertainty of the patient, randomisation and the use of a placebo, the relationship between the person asking for informed consent and the patient, and the dissemination of information during the informed consent procedure.
How often do clinical trials go wrong? ›Why does 90% of clinical drug development fail? Only 1 out of 10 drug candidates successfully passes clinical trial testing and regulatory approval.
Why are people afraid of clinical trials? ›1) Uncertainty of treatment – Fear of being treated as a guinea pig and getting a placebo is the most common factor that pulls patients away from clinical trials. However, it is important for patients to understand that clinical trials usually run parallel to their regular clinical care.
What happens if someone dies during a clinical trial? ›Injury or death unrelated to trial
Accidental injuries and death are sometimes seen in subjects enrolled in clinical trials. These cases should not be considered for compensation. The Rule 122 DAB does not provide for compensation for such cases, but does provide for free treatment at the expense of the sponsor.
Participation in a clinical trial is voluntary, which means you can leave a clinical trial at any time.
Does the FDA pay for clinical trials? ›Most clinical trial participant payments fall into one of four categories: reimbursement, compensation, bonus, or incentive. The FDA is generally comfortable with sponsors reimbursing clinical trial participants for costs they must incur.
What is the basic knowledge of clinical research? ›Clinical research is the study of health and illness in people. It looks at new ways to prevent, detect, treat, or understand disease.
How can I be successful in clinical research? ›
- Develop your understanding of best research practices. ...
- Recognize how to effectively track and interpret your data. ...
- Consider the patient safety and ethical concerns involved in your research efforts. ...
- Familiarize yourself with regulatory guidelines.
In the “3+3+3” design, a third cohort of three patients is added if two of six patients in the first two cohorts experience a dose-limiting toxicity at a certain dose level. The trial terminates if at least three of nine patients experience a dose-limiting toxicity.
What is the difference between a clinical trial and a clinical study? ›Clinical Trial
Clinical studies, on the other hand, are more generalizable and can include both interventional and non-interventional studies; however, clinical studies DO NOT involve investigational medicinal products (IMPs), as opposed to clinical trials.
- Cardiovascular & Circulatory Diseases. ...
- Digestive Diseases. ...
- Musculoskeletal Diseases. 38,607.
- Infectious Diseases. 37,067.
- Endocrinology & Metabolic Disease. 32,702.
- Nervous System Diseases. 31,934.
- Mental Health & Behavioral Disorders. 26,752.
- Respiratory Diseases. 17,569.
- Pilot studies and feasibility studies.
- Prevention trials.
- Screening trials.
- Treatment trials.
- Multi-arm multi-stage (MAMS) trials.
- Cohort studies.
- Case control studies.
- Cross sectional studies.
To certify compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological product, and device applications and submissions.
How long do clinical trials last? ›There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage. But this time span varies a lot. There are many factors that affect how long it takes for a drug to be licensed.
What is your strongest skill as a clinical researcher? ›Strong analytical skills: Clinical researchers must be able to analyze and interpret complex scientific data in order to draw meaningful conclusions from their research. This requires strong analytical skills and the ability to think critically.
What is an example of a clinical trial? ›For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).
What are the two types of clinical research? ›- Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.
- Prevention Research looks for better ways to prevent disorders from developing or returning.
How hard is clinical research? ›
Not only is clinical research a fulfilling career, but it's also a challenging one. Clinical research is responsible for ascertaining how safe and effective drugs, devices and diagnostic products are, and as such it's a demanding role with plenty of responsibility riding on it.
Which job is best in clinical research? ›- Clinical Data Manager (CDM)
- Clinical Research Associate (CRA)
- Clinical Research Coordinator.
- Clinical Research Scientist.
- Clinical Trial Manager.
- Clinical Trial Monitor.
- Pharmacovigilance Associate (PVA)
- Regulatory Affairs Manager (RAM)
- Communication. As a CRA, you are the key liaison between management, the study site, and the sponsor. ...
- Relationship management. ...
- Attention to detail. ...
- Critical thinking. ...
- Time management. ...
- Stress management.