What happens if I take part

FESCA•Clinical trials and scleroderma•What happens if I take part

It’s natural to have questions when you’re considering something new, especially when it comes to your health.

Research teams are used to participants asking questions and will be happy to help.

Many scleroderma research studies involve testing new treatments, so the examples in the Q&As below focus on medicine trials.

How can I decide whether to take part?

If you decide to take part, you will be closely monitored and supported by the research team.

Deciding not to take part – or leaving the trial at any stage – will not affect the support and care you get from your usual healthcare team.

Before joining, you will be given a patient information sheet explaining:

  • What the study is about
  • What will happen if you take part
  • The possible risks and benefits
  • How your information will be used
  • How long the study will last
  • Your rights, including the right to stop at any time without giving a reason

Key Questions and Answers

Search or filter by topic. Open any question to read the answer.

What happens in a clinical trial for scleroderma?Taking part

Some clinical trials are carefully designed to compare one scleroderma treatment, such as a medication or physiotherapy, with another. This happens in a fair and controlled way to see which one is more effective.

Researchers are not allowed to give you treatment in a scleroderma clinical trial unless you fully understand what is going to happen.

For most trials, you might:

  • travel to the research site or hospital for study visits
  • be given a new treatment or a treatment the doctors are comparing it to
  • get a placebo which looks or even tastes just like the trial treatment but doesn’t have any actual treatment in it (you may not know which you are getting and sometimes the researchers will not know either).
For how long will I need to take part?Taking part

The length of each study for scleroderma varies. Some trials last a few weeks, while others may last several months or longer.

  • Shorter: Some trials involve filling out a questionnaire about your symptoms or quality of life, having blood tests or giving urine samples.
  • Longer: Other clinical trials involve testing new drugs over a longer period of time and extra appointments, or a stay in hospital.

The research team will clearly explain the plan before you agree to take part.

Do I need to avoid pregnancy if I take part?Taking part

Some studies for scleroderma, especially medication trials, need participants to avoid becoming pregnant during the study. This is to protect the baby.

If you are a female of reproductive age – usually under the age of 55 – the research team will talk with you about pregnancy before signing you up for the trial. Men may also have a discussion about future fertility.

Will I be paid for my time and/or expenses?Costs

The terms and conditions vary for each scleroderma study, but many studies will pay reasonable travel costs and expenses.

Some studies for scleroderma also have a budget to provide meals during hospital visits and/or payment for your time, but this depends on the study.

The research team will explain what is available.

What care and support will I get?Safety and support

Your safety is the top priority during every study for scleroderma. If you join a trial, you will continue to get appropriate medical care, and the research team will monitor your health closely.

Some studies may also offer you additional support, such as wellbeing resources or support groups.

What if I get side effects?Safety and support

Before you sign up for a clinical trial, your doctor or researcher will tell you as much as they can about all the known or possible side effects.

Some clinical trials are designed especially to find out about possible side effects.

To help keep you safe, you will be:

  • Given clear information about who to contact if you feel unwell or worried
  • Monitored closely throughout the study, usually with regular check-ups
  • Asked to tell the doctors or research nurses straight away if you notice any side effects, reactions or anything unusual which could be due to treatment – this is so they can support you and decide what to do next.
What if something goes wrong?Safety and support

You will be closely monitored throughout the study to reduce the risks as much as possible.

If you do experience a serious side effect, your scleroderma trial treatment will be stopped straight away and the research healthcare team will look after you.

Protecting your safety is a key part of all clinical trials.

What if I want to stop taking part?Your rights and data

You can leave a scleroderma study at any time. You do not need to give a reason, and your decision will not affect your ongoing healthcare.

What happens to the information collected?Your rights and data

Your personal information (data) including your name, address, phone number and clinical results, are kept confidential.

In most trials, all your information is “coded” so that your details are anonymous and you cannot be identified in the results or in any reports. You also won’t be named in any articles when the trial results are published.

Before you agree to take part, the researchers will explain clearly how your information will be used, stored and protected as part of the consent process.

What is informed consent?Deciding

If you decide to take part, you will be asked to sign an “informed consent” form.

Informed consent is your right to know everything about your role in a clinical trial and confirms that you:

  • Have been given clear, detailed information about the trial
  • Understand the benefits, risks and commitments involved
  • Have had the chance to ask questions

Consent means you agree to take part, but it does not take away your rights.

Participation is voluntary. You have the right to leave the trial at any time.

You should be given a consent form in the language you choose.

How is the treatment given?Taking part

The researchers will be able to tell you how the scleroderma trial treatment will be given – for example, taken in tablet form or as injections, and how often the treatment will be given – for example, daily or weekly.

All these details will be set out in a study plan called a “protocol”.

You will be told if any changes need to be made at any stage.

Will I get better treatment if I agree to enter a trial?Deciding

It’s not always possible to know whether a new scleroderma treatment will be better than a treatment that’s already available. Many trials are designed to compare new treatments with current standard care.

When you are invited to take part in research for a scleroderma treatment, you should always be told what other treatments are available, and the benefits and risks of all the available options.

However, people in trials are often:

  • monitored more closely
  • may have more regular contact with healthcare professionals
  • may have access to new scleroderma treatments that are not available to the public yet.
Will the scleroderma treatment benefit me?Deciding

If you have scleroderma, you will not be offered a scleroderma treatment unless there is a potential benefit.

Your doctor may be able to tell you what percentage of people can be expected to benefit from a new drug. However, everyone responds differently to treatments.

If you don’t get any benefits from a new scleroderma treatment, your doctor will support you to leave the trial and talk through your different options with you.

Will I have any extra investigations or tests?Taking part

Some studies will involve additional tests, such as blood tests, x-rays or scans to monitor your health and see how the treatment works.

Early-stage scleroderma studies may involve having tests more often.

The research team will explain what is involved as each trial is different.

Will I be asked to take part in more than one trial?Taking part

If you join a clinical trial, you may be invited to take part in additional research as a separate project, such as studies looking at quality of life or side effects.

Researchers may ask you to fill in a questionnaire or take part in an interview.

Taking part in these projects is optional, and you can decide what feels right for you.

Will I need more hospital visits?Taking part

The number of hospital visits varies from trial to trial, although many studies do need participants to make more visits than they would if they were having their usual treatment.

If you decide to take part in a trial, your doctor will tell you what’s expected of you and provide a plan that includes the date, time and location of each visit.

The research team will also explain:

  • What each visit will involve – for example, a blood test, x-ray or interview
  • How often you need to attend each time
  • How long each visit will take
  • Whether any appointments can be done locally

You can also ask about travel costs and support.

Will my family doctor be told that I’m taking part in a trial?Taking part

Your research team may want to contact your family doctor (GP) to tell them that you are taking part in a clinical trial for scleroderma. However, this will only be done with your permission.

In many studies, you will see your usual doctor as well as the research team. If this is the case, the two teams will be in regular contact with each other about your progress.

You may also choose to discuss the trial with your usual doctor before deciding whether or not to take part.

What happens when the study ends?After the trial

You can ask what treatment or care will be available to you once the study finishes. The research team may even be able to support you to find an ongoing plan, although this isn’t always possible.

Who is running and funding the research?Deciding

Clinical studies may be funded by:

  • Universities or hospitals
  • Charities
  • Pharmaceutical companies

The research team can explain who is responsible for the study.

Can I find out the results of the trial?After the trial

Yes. You can ask the research team how and when scleroderma clinical trial results will be shared.

Some trials are completed in weeks or months and these results are available quite quickly.

Other trials are carried out over several years and it may be a long time before the final results are known, but you may still be able to find out how the trial is progressing.

Who can I contact if I have any worries?Safety and support

You will be given contact details – usually written down on your patient information sheet – for the research team.

You can contact the team at any time to ask any questions or talk through any concerns.

Sources (70)
  1. Baer AR, Good M, Schapira L. A new look at informed consent for cancer clinical trials. J Oncol Pract. 2011;7(4):267–270. https://pmc.ncbi.nlm.nih.gov/articles/PMC3140452/“Prospective participants need to be adequately informed and given the opportunity to ask questions and consult with relatives or friends without feeling pressured or rushed.”
  2. Scleroderma Research Foundation. Clinical trials and scleroderma FAQ https://srfcure.org/living-with-scleroderma/participate-in-our-research/clinical-trials/clinical-trials-faq/“Clinical trials are research studies designed to test new treatments or approaches… These studies often involve new drugs, drug combinations, or alternative methods of delivering existing therapies.”
  3. Nclusiv. Patient information sheets for research studies: compliance guide https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including: The purpose of the research and why the participant has been invited; What participation will involve in terms of procedures, duration, and expectations; Potential benefits and risks of participation; Confidentiality provisions and data handling procedures; The voluntary nature of participation and right to withdraw; Complaint procedures and contact information.”
  4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Monitoring of clinical trials https://ichgcp.net/monitoring“Monitoring is carried out to ensure that the rights and well-being of participants are protected and that trials are conducted safely and correctly.”
  5. Oxford University Hospitals NHS Foundation Trust. Consent https://www.ouh.nhs.uk/researchers/conduct/consent/“Participants must be told that they are ‘free to withdraw from the trial at any time for any reason without prejudice to future care’.”
  6. Cancer Research UK. Randomised trials https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/randomised-trials“Randomised trials have at least 2 different treatment groups… one group has the standard treatment… the other group has a new treatment… The results… are then compared to find out how well the new treatment works.”
  7. Center for Information and Study on Clinical Research Participation. Common myths about clinical trials https://www.ciscrp.org/wp-content/uploads/2024/09/Common-Myths-about-CT-Brochure_2024-08-23_EdCtr_Screen-Reader-Accessible.pdf“Researchers are not allowed to give you treatment in a trial unless you fully understand what is going to happen.”
  8. Mental Health America. What to expect during a clinical trial https://mhanational.org/what-to-expect-during-a-clinical-trial/“Clinical trials may require participants to travel to appointments over time, and sometimes attend visits at hospitals or medical facilities.”
  9. Cancer Research UK. Randomised trials https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/randomised-trialsRandomised trials “have at least 2 different treatment groups… one group has the standard treatment… the other group has a new treatment… The results… are then compared to find out how well the new treatment works.”
  10. Center for Information and Study on Clinical Research Participation. What is a Placebo? And why are placebos used in clinical trials? https://www.ciscrp.org/wp-content/uploads/2024/11/WIAP_TBF-EN-US-V1.0_2024_11_15_panels-1.pdf“A placebo (pla-SEE-bow) looks like a trial treatment but does not have the actual trial treatment in it. […] A placebo does not contain the active ingredients that the trial treatment contains. […] A placebo is made to look identical to the trial treatment whether it is a pill, capsule, or injection.”
  11. Miami Clinical Research. How long do clinical trials last? Understanding the timeline https://miamiclinicalresearch.com/how-long-do-clinical-trials-last-understanding-the-timeline/“The length of a clinical trial can vary… Some trials last just a few weeks, while others may continue for months – or even years.”
  12. Cancer Research UK. Quality of life studies https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-you-should-be-told-about-a-clinical-trial/quality-of-life-studies“The research team may ask you to complete questionnaires about how the treatment affects your daily life.”
  13. Mental Health America. What to expect during a clinical trial https://mhanational.org/what-to-expect-during-a-clinical-trial/“Depending on the type of treatment being studied, you may be asked to provide a blood or urine sample…”
  14. Cancer Research UK. Randomised trials https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/randomised-trials“Randomised trials have at least 2 different treatment groups… one group has the standard treatment… the other group has a new treatment… The results… are then compared to find out how well the new treatment works.”
  15. Mental Health America. What to expect during a clinical trial https://mhanational.org/what-to-expect-during-a-clinical-trial/“In some instances, a clinical trial could require you to stay for an extended period of time at a hospital or another medical facility.”
  16. Baer AR, Good M, Schapira L. A new look at informed consent for cancer clinical trials. J Oncol Pract. 2011;7(4):267–270. https://pmc.ncbi.nlm.nih.gov/articles/PMC3140452/“Prospective participants need to be adequately informed and given the opportunity to ask questions and consult with relatives or friends without feeling pressured or rushed.”
  17. Inclusion of women who are pregnant, lactating, or of reproductive potential in clinical trials: The Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01497-7/abstract“Randomised controlled trials have commonly excluded women who are pregnant or lactating… justified by an ideology of protection… in response to cases of drug-related fetal harm.”
  18. Duke University Health System, Reproductive Risk Considerations in Research: Contraception, Breastfeeding, Fertility, Unintended Pregnancy and Consent Process https://irb.duhs.duke.edu/sites/default/files/2022-04/myers_contraception_and_other_considerations_7-2-2019.pdf“For research purposes, women are not considered “of childbearing potential” if they have completed menopause, defined as: Age > 55 years old.”
  19. European Patients’ Academy on Therapeutic Innovation. Compensation in clinical trials https://toolbox.eupati.eu/resources/compensation-in-clinical-trials/“Although not always a standard, in many clinical trials participants receive some form of compensation for their participation. This may take the form of […] reimbursement of travel expenses.”
  20. European Patients’ Academy on Therapeutic Innovation. Compensation in clinical trials https://toolbox.eupati.eu/resources/compensation-in-clinical-trials/“Although not always a standard, in many clinical trials participants receive some form of compensation for their participation. This may take the form of money, or the reimbursement of […] food or food vouchers, or other services.”
  21. ICH Guideline for Good Clinical Practice – Monitoring: ICH GCP https://ichgcp.net/monitoring“The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected.”
  22. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Monitoring of clinical trials https://ichgcp.net/monitoring“Monitoring is carried out to ensure that the rights and well-being of participants are protected and that trials are conducted safely and correctly.”
  23. Harvard Catalyst. Supporting participants https://catalyst.harvard.edu/community-engagement/supporting-participants/“Action steps for including resources to Support Research Participants: Create a list of supports for study participants that suits your recruitment population; Include this information in your recruitment and consent materials and continue to share it throughout the study; Tailor the dissemination of these resources to your audience. For example, not everyone will be able to access a website. Instead, create handouts in multiple languages; Train study staff to review and connect resources with participants.”
  24. Oxford University Hospitals NHS Foundation Trust. Consent https://www.ouh.nhs.uk/researchers/conduct/consent/“Written and verbal versions of the information will be presented to the subject detailing no less than: […] the known side effects and any risks involved.”
  25. National Cancer Institute. Phase I clinical trial https://www.cancer.gov/publications/dictionaries/cancer-terms/def/phase-i-clinical-trial“A phase I clinical trial tests the safety, side effects, best dose, and timing of a new treatment.”
  26. Nclusiv. Patient information sheets for research studies: compliance guide https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including: […] contact information.”
  27. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Monitoring of clinical trials https://ichgcp.net/monitoring“Monitoring is carried out to ensure that the rights and well-being of participants are protected and that trials are conducted safely and correctly.”
  28. Advancing Health. Serious adverse events & safety reporting 101 https://www.advancinghealth.ubc.ca/research-in-action/serious-adverse-events-safety-reporting-101/“Trial protocols should define how all safety events should be managed throughout the study. They provide information on what events have to be reported and if events are unexpected, based on the information found in the Investigational Product (IP) Investigators Brochure or Product Monograph. […] During every study visit the investigator must document all the adverse events observed by study staff and reported by the participant during the visit.”
  29. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Monitoring of clinical trials https://ichgcp.net/monitoring“Monitoring is carried out to ensure that the rights and well-being of participants are protected and that trials are conducted safely and correctly.”
  30. Meyer Cancer Center. Ending trials early https://meyercancer.weill.cornell.edu/EndingTrialsEarly“A trial might be stopped […] if the people taking part are having unexpected and severe side effects.”
  31. ICH Guideline for Good Clinical Practice – Monitoring: ICH GCP https://ichgcp.net/monitoring“The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected.”
  32. Oxford University Hospitals NHS Foundation Trust. Consent https://www.ouh.nhs.uk/researchers/conduct/consent/“Written and verbal versions of the information will be presented to the subject detailing no less than the fact that they are free to withdraw from the trial at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.”
  33. Pfizer Clinical Trials. Protecting your safety and privacy https://www.pfizerclinicaltrials.com/about/protecting-your-safety-and-privacy“As a participant in a clinical trial, you have many rights. Among them are the rights to: have your identity remain confidential and understand how it is being protected.”
  34. Human Research Protection Program (HRPP). Not human subjects research https://irb.ucsf.edu/not-human-subjects-research“Research using coded private information may not involve identifiable individuals because investigators cannot readily ascertain the identities of the individuals to whom the data… belong.”
  35. International Committee of Medical Journal Editors. Protection of research participants https://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html“Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication.”
  36. Nclusiv. Patient information sheets for research studies: compliance guide https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including: […] Confidentiality provisions and data handling procedures.”
  37. Your child and clinical trials – guide for CF parents: Cystic Fibrosis Foundation https://www.cff.org/research-clinical-trials/your-child-and-clinical-trials-guide-cf-parents“What is informed consent? It's your right to know everything about your child's role in a clinical trial.”
  38. Your child and clinical trials – guide for CF parents: Cystic Fibrosis Foundation https://www.cff.org/research-clinical-trials/your-child-and-clinical-trials-guide-cf-parents“What is informed consent? It's your right to know everything about your child's role in a clinical trial. Through the informed consent process, you will receive key information about the study: the purpose, the types of treatments and procedures involved...”
  39. Your child and clinical trials – guide for CF parents: Cystic Fibrosis Foundation https://www.cff.org/research-clinical-trials/your-child-and-clinical-trials-guide-cf-parents“What is informed consent? It's your right to know everything about your child's role in a clinical trial. Through the informed consent process, you will receive key information about […] the potential benefits and risks.”
  40. Baer AR, Good M, Schapira L. A new look at informed consent for cancer clinical trials. J Oncol Pract. 2011;7(4):267–270. https://pmc.ncbi.nlm.nih.gov/articles/PMC3140452/“Prospective participants need to be adequately informed and given the opportunity to ask questions and consult with relatives or friends without feeling pressured or rushed.”
  41. Health Research Authority (HRA). General principles of consent https://www.hra-decisiontools.org.uk/consent/principles-general.html“ It is important that you clearly present the voluntary nature of participation to potential participants during the consent process and in your Participant Information Sheet. […] Consent must be given voluntarily: not under any form of duress or undue influence from health professionals, family or friends.”
  42. Oxford University Hospitals NHS Foundation Trust. Consent https://www.ouh.nhs.uk/researchers/conduct/consent/“Written and verbal versions of the information will be presented to the subject detailing no less than […] the fact that they are free to withdraw from the trial at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.”
  43. Information parents receive when invited to enrol their child in a clinical trial: Oxford Health Experiences Institute (HEXI) https://www.hexi.ox.ac.uk/clinical-trials-parents-experiences/information-parents-receive-when-invited-to-enrol-their-child“If English is not your first language, the trial should be explained to you in your preferred language and you should be given a consent form in that language.”
  44. Cancer Research UK. What you should be told about a clinical trial https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-you-should-be-told-about-a-clinical-trial“Before you take part, the trial team must tell you: […] what the different treatment groups are […] what tests or check ups you will have […] where you are likely to have treatment and whether you will need to stay in hospital or not.”
  45. Cancer Research UK. How clinical trials are approved https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/how-clinical-trials-are-planned-and-organised/how-clinical-trials-are-approved“A protocol is the detailed plan of a trial. It outlines how the trial will be run.”
  46. Food and Drug Administration (FDA). Improving informed consent https://www.fda.gov/media/184261/download“Informed consent is an ongoing exchange of information with each prospective participant – for example, if a protocol changes additional information can be provided to participants.”
  47. Cochrane. New treatments versus established treatments in randomized https://www.cochrane.org/evidence/MR000024_new-treatments-versus-established-treatments-randomized-trials“When new treatments are compared with established treatments in randomized trials we can expect slightly more than half will prove to be better, and slightly less than half will prove to be worse than established treatments.”
  48. Scleroderma Research Foundation. Clinical trials and scleroderma FAQ https://srfcure.org/living-with-scleroderma/participate-in-our-research/clinical-trials/clinical-trials-faq/“Clinical trials are research studies designed to test new treatments or approaches… These studies often involve new drugs, drug combinations, or alternative methods of delivering existing therapies.”
  49. Nclusiv. Patient information sheets for research studies: compliance guide https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including: The purpose of the research and why the participant has been invited; What participation will involve in terms of procedures, duration, and expectations; Potential benefits and risks of participation.”
  50. National Institutes of Health (NIH). Why should I participate in a clinical trial? https://www.nih.gov/health-information/nih-clinical-research-trials-you/why-should-i-participate-clinical-trial“People participate in clinical trials for a variety of reasons. […] Participants with an illness or disease also participate to […] possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.”
  51. Center for Information and Study on Clinical Research Participation. Common myths about clinical trials https://www.ciscrp.org/wp-content/uploads/2024/09/Common-Myths-about-CT-Brochure_2024-08-23_EdCtr_Screen-Reader-Accessible.pdf“Many clinical trials use new treatments that are not available to the public.”
  52. National Institutes of Health. Guiding principles for ethical research https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research“Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.”
  53. Evaluation of person-level heterogeneity of treatment effects in published multiperson N-of-1 studies: systematic review and reanalysis. https://bmjopen.bmj.com/content/8/5/e017641“Individual patients with the same condition may respond differently to similar treatments. […] Our analysis suggests that person-level heterogeneity of treatment effects (THE) is common and often substantial.”
  54. Black Doctor. Can I leave a clinical trial? https://blackdoctor.com/leave-a-clinical-trial/“You can leave a clinical trial at any time. […] Your doctor or research team may help transition you to a standard treatment appropriate for your condition.”
  55. Mental Health America. What to expect during a clinical trial https://mhanational.org/what-to-expect-during-a-clinical-trial/“You will probably have a quick physical exam where someone from the trial team checks your vital signs (temperature, blood pressure, etc) […] Depending on the type of treatment being studied, you may be asked to provide a blood or urine sample or get imaging done.”
  56. University of Cincinnati College of Medicine. Trial phases 1, 2 & 3 defined https://med.uc.edu/depart/psychiatry/research/clinical-research/crm/trial-phases-1-2-3-defined“Phase I trials are concerned primarily with establishing a new drug's safety and dose range […] through frequent blood draws (usually in an inpatient environment) to check for the level of drug in the blood plasma. […] … one or more groups of subjects, […] are closely monitored for harmful side effects.”
  57. Baer AR, Good M, Schapira L. A new look at informed consent for cancer clinical trials. J Oncol Pract. 2011;7(4):267–270. https://pmc.ncbi.nlm.nih.gov/articles/PMC3140452/“Prospective participants need to be adequately informed and given the opportunity to ask questions and consult with relatives or friends without feeling pressured or rushed.”
  58. Cancer Research UK. Quality of life studies https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-you-should-be-told-about-a-clinical-trial/quality-of-life-studies“Many trials include a quality of life assessment, especially if the trial is comparing treatments. It may be included as part of the main trial. Sometimes it is a separate quality of life study (a sub study).”
  59. Cancer Research UK. Quality of life studies https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-you-should-be-told-about-a-clinical-trial/quality-of-life-studies“The research team may ask you to complete questionnaires about how the treatment affects your daily life.”
  60. Miami Clinical Research. How long do clinical trials last? Understanding the timeline https://miamiclinicalresearch.com/how-long-do-clinical-trials-last-understanding-the-timeline/“The length of a clinical trial can vary… Some trials last just a few weeks, while others may continue for months – or even years.”
  61. National Heart, Lung, and Blood Institute (NHLBI). Clinical trials – benefits, risks, and safety measures https://www.nhlbi.nih.gov/research/clinical-trials/safety-benefits-risks“The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.”
  62. Nclusiv. Patient information sheets for research studies: compliance guide https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including: The purpose of the research and why the participant has been invited; What participation will involve in terms of procedures, duration, and expectations; Potential benefits and risks of participation.”
  63. Baer AR, Good M, Schapira L. A new look at informed consent for cancer clinical trials. J Oncol Pract. 2011;7(4):267–270. https://pmc.ncbi.nlm.nih.gov/articles/PMC3140452/“Prospective participants need to be adequately informed and given the opportunity to ask questions and consult with relatives or friends without feeling pressured or rushed.”
  64. The Health and Care Professions Council. Consent and confidentiality https://www.hcpc-uk.org/standards/meeting-our-standards/confidentiality/guidance-on-confidentiality/consent-and-confidentiality/“Identifiable information is disclosed for a number of reasons. It can happen when you refer a service user to another health and care professional or when a service user asks for information to be given to a third party. It is important that you get the service user’s permission, or ‘consent’, before you share or disclose their information or use it for reasons which are not related to the care or services you provide for them.”
  65. National Cancer Institute. Clinical trial facts. https://www.cancer.gov/research/participate/clinical-trials/facts“You can often continue to see your current care team alongside the study team while taking part in a trial. Always ask the study team how they will keep your current oncologist informed about your care during the study.”
  66. Funding – Health Research Authority. https://www.hra.nhs.uk/planning-and-improving-research/research-planning/funding/“Funding for research can come a variety of sources, including: commercial funders, including industry and private companies and non-commercial funders such as government departments, research councils, charities, National Institute of Health in USA (NIH) and the European Commission.”
  67. Health Research Authority. Informing participants https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/research-transparency/informing-participants/“Research participants have a right to know the findings of the research they took part in. Providing them with a summary of the findings acknowledges and appropriately respects the contribution they have made.”
  68. Miami Clinical Research. How long do clinical trials last? Understanding the timeline https://miamiclinicalresearch.com/how-long-do-clinical-trials-last-understanding-the-timeline/“The length of a clinical trial can vary… Some trials last just a few weeks, while others may continue for months – or even years.”
  69. Miami Clinical Research. How long do clinical trials last? Understanding the timeline https://miamiclinicalresearch.com/how-long-do-clinical-trials-last-understanding-the-timeline/“The length of a clinical trial can vary… Some trials last just a few weeks, while others may continue for months – or even years.”
  70. Nclusiv. Patient information sheets for research studies: compliance guide https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including […] contact information.”