Clinical trials study interventions such as experimental drugs, vaccines, medical devices, medical procedures, and behavioral interventions that have not yet been approved by a health authority.
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FAQs
Anyone who meets study requirements – such as gender, age, condition, or treatment history – can potentially join a clinical trial. A member of the research team will screen all participants to confirm they meet the requirements of the trial.
No, you are welcome to contact any clinical trial site.
If a participant is ineligible, they should contact their healthcare provider and discuss treatment alternatives.
If you are living with a condition, joining a clinical trial could give you access to an experimental intervention before it is publicly available. Participation can also play a vital part in helping others who have a similar condition – both now and in the future. Healthy volunteers in trials also contribute to this medical progress.
Yes, there are some risks in participation. The investigational intervention might be less effective than current, standard interventions if one is available for the indication being studied. It could also include side effects. However, precautions are built into the study design to ensure it is as safe as possible. An independent body regularly reviews trial data and will end it if it is unsafe or far less effective than the standard of care or placebo. And you may always leave the trial at any time if you wish.
Every clinical trial is different and will vary in length depending on the study design of that particular trial. During the consent process before enrolling, the research team will explain the specifics about the trial.
Trial sites can include hospitals and medical centers, universities, or doctors’ offices. Some trials have more than one study location, but each location is supported by a full research team.
Each clinical trial has a specific “protocol” that describes how it will study the intervention, including how participants will be divided into groups, required site visits, and the health outcomes being measured. For instance, participants may be randomly assigned to the investigational intervention, the current standard of care intervention, or a placebo. The comparison of data from each group is how safety and efficacy are measured.
Children are eligible for trials that have been designed specifically for them. For greater protection, regulations and ethical standards for these studies are more rigid. Since the bodies of children are still developing, they can react differently to interventions and it’s important to study and understand the differences. In addition, there are many conditions that only affect children.
Not all trials pay participants, but some do compensate for travel, time, and commitment. The amount paid varies.
Due to the many differences in insurance plans across countries, coverage in clinical trials can vary. Please contact your insurance or medical provider to gather information about coverage.
No, participants will not be charged for any clinical trial intervention or related clinical trial procedures. However, there are still routine patient care costs and coverage varies between insurance plans. Some participants may be responsible for copays and payments towards a deductible and some trials may not cover expenses related to travel, transportation, parking, or meals.
Side effects are any undesired or unintended effects of the intervention taken. Your research team will closely monitor any side effects and you always have the option to leave the trial at any time.
Health authorities have strict guidelines that research teams must follow to ensure all participants are treated fairly and safely, and that the trial’s potential benefits outweigh risks. Each study has a “protocol” that includes the necessary protections, and an independent body, who can end the trial at any time, regularly reviews the data
Yes, participants are volunteers and may leave a clinical trial at any time.
As with all medical records, participant privacy and confidentiality in trials are protected by law. The data participants contribute to a study is completely anonymous, and your personal information will never be disclosed.
Before you join a clinical trial, read as much as you can about the condition and possible treatment options. If interested in participating in a clinical trial, you should discuss it with your usual healthcare provider or reach out directly to the clinical research team. Write down questions you want to ask the research team when you meet them for your screening. Important considerations include benefits and risks, what you will have to do during the trial, and for how long.
There are a wide variety of professionals involved with any study, all of which are vital to ensuring safety and success. The principal investigator (PI) leads the trial and directs the team of doctors, nurses, and other healthcare workers. The study coordinator manages day-to-day activities and is the main contact for participants.
Importantly, an independent ethics committee (or Institutional Review Board – IRB) monitors the study to ensure participant protection rules are closely followed, and an independent Data and Safety Monitoring Board (DSMB) periodically reviews data to ensure participant safety and sometimes efficacy.
Participants are always welcome to visit their usual healthcare providers during a trial, and sometimes it is important for them to collaborate with the research team to ensure success.
For the best possible study results, participants should attend each scheduled trial visit. The research team will be able to assist in scheduling each appointment. If you have a conflict, please contact your research team in advance to adjust your schedule.
Participants will continue ongoing care through their primary healthcare provider, however the experimental intervention from the trial may not be available after it ends. Each study is different.
After your participation ends, the study may continue for months or years. Usually, your specific results will not be shared with you until the trial ends and sometimes they will never be shared. Final clinical trial results are often published on clinicaltrials.gov or in scientific publications. Check with your research team to learn more.
Clinical trials study interventions such as experimental drugs, vaccines, medical devices, medical procedures, and behavioral interventions that have not yet been approved by a health authority.
Anyone who meets study requirements – such as gender, age, condition, or treatment history – can potentially join a clinical trial. A member of the research team will screen all participants to confirm they meet the requirements of the trial.
No, you are welcome to contact any clinical trial site.
If a participant is ineligible, they should contact their healthcare provider and discuss treatment alternatives.
If you are living with a condition, joining a clinical trial could give you access to an experimental intervention before it is publicly available. Participation can also play a vital part in helping others who have a similar condition – both now and in the future. Healthy volunteers in trials also contribute to this medical progress.
Yes, there are some risks in participation. The investigational intervention might be less effective than current, standard interventions if one is available for the indication being studied. It could also include side effects. However, precautions are built into the study design to ensure it is as safe as possible. An independent body regularly reviews trial data and will end it if it is unsafe or far less effective than the standard of care or placebo. And you may always leave the trial at any time if you wish.
Every clinical trial is different and will vary in length depending on the study design of that particular trial. During the consent process before enrolling, the research team will explain the specifics about the trial.
Trial sites can include hospitals and medical centers, universities, or doctors’ offices. Some trials have more than one study location, but each location is supported by a full research team.
Each clinical trial has a specific “protocol” that describes how it will study the intervention, including how participants will be divided into groups, required site visits, and the health outcomes being measured. For instance, participants may be randomly assigned to the investigational intervention, the current standard of care intervention, or a placebo. The comparison of data from each group is how safety and efficacy are measured.
Children are eligible for trials that have been designed specifically for them. For greater protection, regulations and ethical standards for these studies are more rigid. Since the bodies of children are still developing, they can react differently to interventions and it’s important to study and understand the differences. In addition, there are many conditions that only affect children.
Not all trials pay participants, but some do compensate for travel, time, and commitment. The amount paid varies.
Due to the many differences in insurance plans across countries, coverage in clinical trials can vary. Please contact your insurance or medical provider to gather information about coverage.
No, participants will not be charged for any clinical trial intervention or related clinical trial procedures. However, there are still routine patient care costs and coverage varies between insurance plans. Some participants may be responsible for copays and payments towards a deductible and some trials may not cover expenses related to travel, transportation, parking, or meals.
Trial Terms Glossary
Discussion Guide for Patients
We appreciate you taking the time to think about joining a clinical trial. We understand that this may be a difficult and emotional time for you, filled with a lot of information.
It is important to know that taking part in clinical trials is always completely voluntary. Research teams aim to update participants regularly, but you may still have questions. To help you guide these conversations with your research team, we have outlined some questions below that may be helpful for you to ask your study doctor and study coordinator. If you have any concerns with your safety, please immediately contact your study doctor and research team.
How might this effect my daily life?
Will I still be able to take part in activities that are important to me?
How do I prepare for each visit?
What kinds of test and experimental treatments are involved?
What precautions should I take in order to be able to complete study procedures and keep myself safe?
Who will be in charge of my care?
Financial Considerations
Due to the wide variety of interventions and conditions, all trials have different timelines. Before enrolling, the research team will outline the specific amount of time you will be participating. It could be only a few months or a few years, depending on the condition, intervention duration, and study requirements.
In general, trial participants do not pay extra out-of-pocket costs for an intervention in a clinical trial. However, there are still routine patient care costs and coverage varies between insurance plans. Some participants may be responsible for copays and payments toward a deductible. Some trials may or may not cover expenses such as travel, transportation, parking, or meals. You will learn more about these factors during pre-trial screening.
For clinical trial side effects or product inquiry reporting, please contact and talk with your study doctor or study coordinator to follow the reporting requirements and timelines specified in the applicable clinical trial protocol.
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