Clinical Research: Benefits, Risks and Safety (2023)

Clinical tests


On this page:

  • What are the potential benefits of participating in clinical trials?
  • What are the potential risks of participating in clinical trials?
  • Do I always receive the experimental treatment in a clinical trial?
  • How is the safety of clinical trial participants protected?

If you are interested in volunteering for clinical research, you may be wondering: What makes a study right for me? How do I know it's safe? Clinical research involves the study of health and disease in humansobservational studies or clinical trials. Participating in a trial or study has many potential benefits and some potential risks as well. Learn more about the benefits and risks of participating in clinical trials and how your safety is protected.

What are the potential benefits of participating in clinical trials?

There are many potential benefits associated with participating in clinical trials, including:

  • Clinical Research: Benefits, Risks and Safety (1)

    You may have the opportunity to help scientists better understand your disease or condition and advance treatments and prevention methods in the future.
  • You may feel like you are taking a more active role in your health.
  • You can learn more about your disease or condition.
  • You may be able to get information about support groups and resources.

In addition, some people participate in clinical trials because they hope to gain access to a potential new treatment for a disease before it is widely available.

(Video) What are the risks and benefits of participating in clinical research?

What are the potential risks of participating in clinical trials?

Clinical trials and research involve some potential risks, including:

  • Research may involve tests that involve risk to participants. For example, certain physical exams can increase your risk of falling, and x-rays can cause a small increase in your risk of cancer.
  • Participating in a survey may also be difficult for you. For example, you may need to have additional or longer doctor's appointments, more procedures, complicated medication instructions, or hospitalization.

Additional risks of participating in clinical trials may include:

  • For those receiving the experimental treatment, it can be uncomfortable or cause side effects (which can range from mild to severe).
  • Experimental treatment may not work or be better than standard treatment.
  • For trials testing a new treatment, such as a new drug or device, you may not be part of the group receiving the experimental treatment. Instead, you may be assigned to the control (or comparison) group. In some studies, the control group is given a placebo, which is given in the same way as the treatment, but has no effect.

Participant confidentiality is a concern in any type of research. People other than the researchers, such as the study sponsors or experts monitoring safety, may have access to medical information related to the study. Precautions are in place to ensure that researchers inform potential participants what information may be shared and how their privacy is protected before they consent to participate in research.

Study coordinators will provide detailed information and answer questions about the risks and benefits of participating in a particular study. Having this information will help you make an informed decision about whether or not to participate.

Do I always receive the experimental treatment in a clinical trial?

Clinical trial volunteers do not always receive the treatment being tested. The gold standard for testing interventions in humans is called a randomized controlled trial. Randomized means that volunteers are randomly assigned—chosen at random—to receive either the experimental intervention (the test group) or a placebo or the current standard of care (the control or comparison group). The researchers then compare the results in each group to determine whether the new treatment is working.

When you enroll in a clinical trial, you can be assigned to either the test group or the control group. While participants in the control group do not receive the experimental treatment, these volunteers are just as important as those in the test group. Without a control group, scientists can't be sure whether an experimental treatment is better than the standard treatment or no treatment.

In many cases, you will only know at the end of the trial whether you are in the test group or the control group. This is because knowing the group assignment can affect the test results. Studies are often "blinded" (or "masked") to avoid this random bias. In a single-blind study, you are not told whether you are in the test group or the control group, but the research team will know. In a double-blind study, neither you nor the research team will know which group you are in until the trial is over. However, if it is medically necessary, it is always possible to find out which group you are in.

What is a placebo?

Whenever possible, clinical trials compare a new treatment for a particular condition with the standard treatment for that condition. If no standard treatment is available, scientists can compare the new treatment with a placebo, which is similar to the drug or treatment being tested but is not intended to actually change anything in your body. A pill that does not contain any medicine is an example of this.

A trial using a placebo is described as a 'placebo-controlled trial'. In this type of study, the test group receives the experimental treatment and the control group receives the placebo.

Placebos are not used if effective treatment is already available or if you are at risk if you do not receive effective treatment. As part of the informed consent process, you will be told if placebos will be used in the study before starting a trial.

(Video) What are the Risks and Benefits of a Clinical Trial?

  • What happens if a clinical trial is terminated early?

    Most clinical trials proceed as planned from start to finish. However, sometimes researchers end trials prematurely. Clinical trials can be interrupted or stopped for a number of reasons:

    • There is clear evidence that some interventions are more effective than others. When this happens, the trial may be stopped so that the new treatment is available to other people as soon as possible.
    • The trial shows that the treatment does not work or causes unexpected and serious side effects.
    • Researchers cannot enroll enough people in the trial to give meaningful results.

    Even when a clinical trial is terminated early, it can provide researchers with valuable information. For example, scientists can gain insight into how best to design and conduct clinical trials in a particular area of ​​research. In some cases, health information collected during a trial can lead to new potential treatments for researchers to test in the future.

How is the safety of clinical trial participants protected?

(Video) Risks and benefits of participating in a clinical trial | National Kidney Foundation

Based on years of experience and learning from past mistakes,There are strict rules for the safety of participants. Today,elkclinical investigator in the United States is required to monitor and ensure thiselkthe participant is safe. These safeguards are an essential part of the investigation.

Every clinical trial follows a careful study design called a protocol that describes what the researchers will do. The Principal Investigator, or Principal Investigator, is responsible for compliance with the protocol.

Safeguards to protect clinical trial volunteers include Institutional Review Boards, Informed Consent, Data and Safety Monitoring Boards, and Observational Study Monitoring Boards.

  • Most clinical trials in the US require approval by aInstitutional Review Board (IRB). The IRB is made up of doctors, scientists and members of the general public who ensure that study participants are not exposed to unnecessary risk. People on the IRB regularly review the study and its results. They ensure that the risks (or potential harm) to participants do not outweigh the potential benefits of the study.
  • Informed consentit also helps protect participants. Informed consent is the process of learning the most important facts about a study before deciding whether to participate. Research team members explain the research before you start and during the research. They provide an informed consent document with details about the study, such as its purpose, how long it will last, the procedures required and who to contact. The informed consent document also explains the risks and potential benefits. You are free to ask questions, request more information, or withdraw from the study at any time.

Clinical trials and studies also have committees that oversee the safety of the research as it is conducted.

  • Clinical trials testing an intervention are closely supervised by aData Supervision and Security Council. The board is made up of experts who review the results of the research as it progresses. If they find that the experimental treatment doesn't work or harms the participants, they can stop the trial early.
  • Observational Study Monitoring Boardsmonitor the safety of observational studies with large or vulnerable populations or the risks associated with the trials or standard of care.

Several historical incidents have led to mistrust of clinical research. These events have also led to the creation of laws that provide multiple levels of protection for clinical trial participants.

An example is theUS Public Health Service Tuskegee Syphilis Study, which was conducted between 1932 and 1972. In this study, researchers wanted to determine the effects of untreated syphilis. They did not explain the risks of the study and did not obtain informed consent from the participants, who were all black men. They also did not offer study participants penicillin when it became widely available in the mid-1940s, causing preventable disease and suffering. After news of the study leaked in 1972, it led to sweeping changes in standard research practices and guidelines to protect human research participants. Today, IRBs are responsible for reviewing all studies involving individuals to ensure they meet these guidelines and reporting any study design that violates the rules.

Once you have all the information, you can make an informed decision about whether or not to participate in a clinical trial or study. If you decide to volunteer for clinical research, you will be given an informed consent form to sign. By signing the form, you show that you understand the details and want to participate in the study. However, the informed consent form is not a contract. You can leave the study at any time and for any reason.

For more information about clinical research

Clinical research trials and you
National Institutes of Health

US Food and Drug Administration

(Video) Clinical Trials - Benefits, Risks, and Safety

This content is provided by the NIH National Institute on Aging (NIA). NIA scientists and other experts review this content to ensure it is accurate and up-to-date.

Content revision: May 18, 2023


Clinical Research: Benefits, Risks and Safety? ›

Additional risks of participating in clinical trials may include: For those who receive the experimental treatment, it may be uncomfortable or cause side effects (which can range from mild to serious). The experimental treatment might not work, or it may not be better than the standard treatment.

What are the benefits and risks of participating in a clinical trial? ›

  • Play an active role in their own health care.
  • Obtain referrals to a study site.
  • Engage care partners as companions in care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical, sometimes multidisciplinary, care at leading health care facilities during the trial.

What are the risks of participating in a clinical research study? ›

Additional risks of participating in clinical trials may include: For those who receive the experimental treatment, it may be uncomfortable or cause side effects (which can range from mild to serious). The experimental treatment might not work, or it may not be better than the standard treatment.

What are the benefits of clinical research? ›

Possible benefits to participants:

Gain access to new and possibly effective treatments or medicine available only to those participating in the trial. Gain focused health care for a particular disease or health condition. Learn more about your disease or health condition.

What is the benefit-risk assessment in clinical trials? ›

The benefit-risk is a qualitative assessment involving subjective judgment that weighs data and information about the drug's benefits and risks and considers uncertainties within a specific therapeutic and regulatory context.

What are risks and benefits in research? ›

Definitions. Benefit A valued or desired outcome; an advantage. Risk The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

What are 5 research risks? ›

Researchers are expected to take steps to minimize potential risks.
  • Physical risks. Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. ...
  • Psychological risks. ...
  • Social/Economic risks. ...
  • Loss of Confidentiality. ...
  • Legal risks.

What is the biggest challenge in clinical research? ›

Key takeaways include: Patient recruitment, including patient retention and population diversity, tops the list of challenges that 55% of respondents face.

What is safety of participants in research? ›

Researchers have a generic responsibility to protect participants from any harm arising from research. As a general rule, people participating in research should not be exposed to risks that are greater than, or additional to, those that they encounter as part of their normal lifestyles.

What are examples of clinical benefits? ›

Examples of Clinical Benefits

For example, a total hip replacement has clear and direct clinical benefits to the patient: reduction of pain and improved hip function. These can be measured using various clinical measures, such as Harris Hip Scores.

What is the main goal of clinical research? ›

The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who take part in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patients in clinical trials.

What are the benefits of clinical decision support in healthcare? ›

Clinical decision support provides timely information, usually at the point of care, to help inform decisions about a patient's care. Clinical decision support can effectively improve patient outcomes and lead to higher-quality health care.

What are the three types of risk-benefit analysis? ›

Summary of risk types
  • Statistical Risk: determined through analysis of previous studies and available data.
  • Perceived Risk: the risk level as considered intuitively by individuals.
  • Projected Risk: risk calculated using models based on historical studies.

What is the purpose of clinical risk assessment? ›

A clinical risk tool that assesses violence of individuals with mental or personality disorders. This tool is used by forensic services within the Trust and can only be used by those with specialist training in its use. Risk tools provide a means to systematically identify potential risk and protective factors.

What should a risk-benefit analysis include? ›

Estimate the probability that a given harm may occur and its severity; Explain measures that will be taken to prevent and minimize potential risks and discomforts; Describe the benefits that may accrue directly to subjects; and. Discuss and the potential societal benefits that may be expected from the research.

What is risk and safety in research? ›

Risk to researcher of being in a comprising situation, in which there might be accusations of improper behaviour. Health and safety risks: risks of harm to health, physical injury or psychological harm to participants or the researcher.

What is risk assessment and safety in research? ›

The purpose of the risk assessment is to identify potential hazards, and hence control measures that might be needed. This is to help ensure the health and safety of the Researcher and of any other person that might be affected by the work.

What is an example of a risk benefit? ›

Example of Risk-Benefit Analysis

On the risk side, when one drives or gets on the road in general, there is a risk of getting caught in a traffic accident and getting badly injured. On the benefit side, driving is very important for people to go places either for work, to buy groceries, or to connect with others.

What is important about taking risks? ›

Risk means taking a chance, trying something new, and possibly failing or succeeding, but we must all experience risk in our lives. Taking chances is one of the most crucial ways of helping to advance one's skills and gaining experience.

Is it better to be safe or take risks? ›

Harder, better, faster, stronger

Taking risks can change you fundamentally. They make you braver, stronger, and more confident. They show that you have what it takes to make a decision, commit, and create the life you want. You build faith in yourself knowing you have done it before and can do it again.

How do you minimize risk in research? ›

Reducing Risk
  1. Consent. The participant is often the best judge as to what is an acceptable amount of risk (though there are participants where this is not the case; please see Vulnerable Participants and Risk-Sensitive Populations). ...
  2. Data collection and storage. ...
  3. Expertise. ...
  4. Planning for the Undesirable or Unexpected.

What is risk in medical research? ›

A risk is a possible harm in which the probability of harm may be predictable to a certain degree but never controllable with certainty. The chance that pervades the risk to human subjects in biomedical research is also associated with the benefit that may accrue from it.

What are ethical risks in research? ›

Potential for harm

Social harm: Participation can involve social risks, public embarrassment, or stigma. Physical harm: Pain or injury can result from the study procedures. Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

What are the main ethical issues in clinical trials? ›

A major ethical concern related to clinical trials is whether participants are fully informed about the risks entailed in the trials and the likelihood that they will not personally benefit from the research.

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.

Why is safety important in research? ›

Safety research is a continuous effort to improve upon existing products, tools, materials, systems and equipment to ensure safe execution of a task. Enhancing safety measures is an area of constant focus for companies and regulators alike, as efforts are made to minimise accidents and risks in the workplace.

What are the 3 ethical principles for protecting study participants? ›

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

What is safety analysis in clinical trials? ›

The Safety Population is used for the analysis of safety, including adverse events, toxicity and laboratory evaluations. A patient should be included if, and only if, they actually received a study treatment (even if it is a placebo).

What are the 4 major types of benefits? ›

There are four major types of employee benefits many employers offer: medical insurance, life insurance, disability insurance, and retirement plans.

What are 3 examples of medical benefits? ›

These include doctors' services, inpatient and outpatient hospital care, prescription drug coverage, pregnancy and childbirth, mental health services, and more. Some plans cover more services. Plans must offer dental coverage for children. Dental benefits for adults are optional.

What is clinical benefit response? ›

Clinical benefit rate (CBR) is defined as the percentage of advanced cancer patients who achieve complete response, partial response, or at least six months of stable disease as a result of therapy [44].

What is the most important goal of research? ›

The ultimate aims of research are to generate measurable and testable data, gradually adding to the accumulation of human knowledge.

Why is it important for people to participate in clinical trials? ›

The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

What are the three major goals of research? ›

Research is the examination of a particular topic using a diversity of reliable, scholarly resources. The three main goals of research are establishing facts, analyzing information, and reaching new conclusions. The three main actions of doing research are searching for, reviewing, and assessing information.

What is the risk of clinical decision support? ›

Alarm fatigue, physician burnout, and medication errors are all detrimental side effects of unintuitive clinical decision support technology, with these events having a harmful impact on patient outcomes and organizations' bottom lines.

What are the top three clinical decision support systems? ›

Top 10 clinical decision support system installs by market share
RankVendorExplore dataset
1Epic Systems CorporationExplore
2Change HealthcareExplore
3Oracle CernerExplore
6 more rows
Jan 20, 2023

What are the benefits of decision support? ›

Decision support system benefits

Decision support systems can help to reduce errors and make workflow more efficient. By reducing the time needed to make important decisions, decision support systems can streamline the process and result in more tasks accomplished during a shift.

What is understanding the risks in participating in a clinical trial and agreeing to participate known as? ›

Informed consent is one of the most important aspects of research ethics.

Why is it important to participate in clinical trials? ›

The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

What are drug benefits and risks? ›

The benefits of medicines are the helpful effects you get, such as easing pain, controlling blood sugar, lowering blood pressure, or curing an infection. The risks of medicines are the possible unwanted or unexpected effects that might happen to you when you use them.

What are key risk indicators in clinical trials? ›

Key risk indicators (KRIs) are metrics designed to identify risks of specific interest to study teams and considered an essential component of centralized monitoring.

Which phase of clinical trial deals with safety efficacy or effectiveness? ›

Phase III. Phase III studies are conducted at multiple centers with several hundred to several thousand patients for whom the drug is intended. Massive testing of a drug provides continued generation of data on a drug's safety and efficacy.

Who is responsible for the risk assessment of a clinical trial? ›

Who is responsible for managing risk in a clinical trial? The Sponsor-Investigator is responsible for evaluating all risks to participants and the trial data before the trial starts and developing a plan to control the risks to an acceptable level.

What is most important in clinical trials? ›

Informed consent is the process of giving clinical trial participants all of the facts about a trial. This happens before they agree to take part and during the course of the trial. Informed consent includes details about the treatments and tests you may receive and the benefits and risks they may have.

What is most important for a successful clinical trial? ›

The clinical trial must have a communication strategy in place to effectively track the project progress. What communication also involves is getting regular feedback from the various investigators who are working on the different aspects of the project at the same time.

What is the value of a clinical trial? ›

These trials (or clinical studies) test and assess potential treatments such as drugs, medical devices, or biologics (vaccines, gene and cellular therapies, insulin, etc.) in human volunteers to determine approval for widespread use. Researchers must complete numerous steps to ensure product safety and efficacy.

What are 3 risk factors for drug use? ›

Risk factors
  • Family history of addiction. Drug addiction is more common in some families and likely involves an increased risk based on genes. ...
  • Mental health disorder. ...
  • Peer pressure. ...
  • Lack of family involvement. ...
  • Early use. ...
  • Taking a highly addictive drug.
Oct 4, 2022

What are the 3 most common risk factors for drug use? ›

Risk Factors for High-Risk Substance Use

Family history of substance use. Favorable parental attitudes towards the behavior. Poor parental monitoring.

What are 2 risk factors for drug use? ›

For example, risk factors such as poverty and family dysfunction can contribute to the development of mental and/or substance use disorders later in life. Risk and protective factors within one particular context—such as the family—may also influence or be influenced by factors in another context.


1. Clinical Trials: A Study Coordinator on Weighing the Risks and Benefits.
(Courageous Parents Network)
2. The Safety and Ethics of Clinical Research
3. Clinical Trials - Benefits, Risks, and Safety (PCL102)
(Joseph Lee)
4. The Risks and Benefits of Participating in an MPN Clinical Trial
(Patient Empowerment Network)
5. What Are the Risks and Benefits of Joining a Clinical Trial?
(Patient Empowerment Network)
6. Should You Participate in a Clinical Trial?
(Cleveland Clinic)


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