Understanding Trial Participation

If you’re considering participating in a clinical trial or considering participation for a friend or loved one, there’s a lot to think about. The topics covered on this page can help you get the information you need to guide your decision.

Topics covered in this section include:

Why should I participate?

Who can participate?

What do I have to consider?

Questions to ask

How are participants protected?

Who is involved in clinical trials?

What happens after a clinical trial is completed?

Why should I participate?

Clinical trials are made possible because of people like you. Volunteer participation of both healthy and those diagnosed with dementia (or other illness) is the only pathway to advances in treatment. Clinical research and clinical trials open new doors to finding new and more effective ways to prevent, diagnose and treat dementia. It is almost impossible for clinical research to find crucial answers without volunteers’ participation. Common motivations for trial participants include:

  • To help advance science and the treatment of their condition
  • To help others with their condition
  • To obtain potentially better treatment
  • To learn more about their condition and its treatment
  • To receive information about the study results after the study has ended
  • To feel part of a community

Who can participate?

Every year, many thousands of people take part in clinical trials. Some of these studies need healthy volunteers and others need participants with a particular disease or condition. All participants are important because without them, the development of new medicines couldn’t continue.

All clinical trials have rules about who can participate, called Inclusion and Exclusion Criteria. Factors that allow someone to participate in a clinical trial are Inclusion Criteria. Those that disqualify someone from participating are called Exclusion Criteria. These criteria are based on things such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Inclusion and Exclusion Criteria are developed with much thought and consideration. They are necessary to prove whether medicines work or not in a specific group of people and to reduce risk of problems by making sure the right participants enter the trial. These criteria are applied to all potential participants in the same way, before they start participating in the study.

What do I have to consider

Every clinical research study is unique. 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.

Questions to ask

It is extremely important to ask questions! The following are examples of questions to ask the research team when thinking about a clinical trial.

It is good to write down any questions you might have and bring your list with you at the meeting with the research team. You may also wish to discuss this decision with your family, friends, or doctor. Feel free to bring a friend or relative with you for support and to hear the responses to your questions. Some examples:

  1. What is the main purpose of this study?
  2. Does the study involve a placebo or a treatment that is already on the market (a placebo is a substance that looks and tastes identical to the actual drug being studied, but does not contain active ingredients. Often called a “sugar pill”)?
  3. What has been learned about the study medication and are any study results published?
  4. How long is the study going to last?
  5. What will I be asked to do as a participant?
  6. Do I have to pay for any part of the study? Will my insurance cover these costs?
  7. Is there any reimbursement for travel costs or childcare?
  8. Will I be able to see my own doctor?
  9. Will I receive any follow-up care after the study has ended?
  10. What are my short-term risks, such as side effects?
  11. What are my possible long-term risks?
  12. What other options do people with my disease have?
  13. What kinds of therapies, procedures and tests will I have during the trial?
  14. Is there any way to know if the treatment is working?
  15. How is my health protected while I am in the study?
  16. What will happen if my health problems get worse during the study?
  17. Is there any possibility/way that the study will affect my everyday life?
  18. If the study medication works for me, can I keep using it after the study?
  19. Can anyone find out whether I’m participating in the clinical trial?
  20. What will happen to my medical care if I stop participating in the study?
  21. Does the physician/investigator (a medical professional, usually a doctor, who is responsible for the overall conduct of the clinical trial at his/her location) have any financial or special interest in the clinical study?
  22. What are the credentials and research experience of the physician and study staff?

How are participants protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is regulated by governments, with built in safeguards to protect the participants. As a participant in clinical trial:

  1. Your rights and welfare are a priority. Clinical researchers are following strict regulatory and ethical guidelines of the government and Ethics Review Board (a group comprised of varying backgrounds that is qualified through experience and the expertise of its members to promote respect for its advice and counsel in safeguarding the rights and the welfare of human subjects).
  2. Your privacy will be respected.  Research data is coded to help maintain your privacy.
  3. You will be in the know. Researchers have the obligation to inform you on the known risks and the benefits before your trial starts (informed consent – before joining, the study is explained to all participants and they are given the chance to ask questions. The purpose of the informed consent process is to protect the rights of study participants and to make sure they are adequately informed of important details about the clinical study). 
  4. You can always ask.  Ask as many questions as you want. We'll always answer.
  5. You can stop participating at any time: You can withdraw from a trial at any time and for any reason.
  6. You are not alone. You will join a community of clinical trial and research participants.
  7. You will make a difference. Your participation helps pharmaceutical companies, universities and the research community to develop new treatments that can make lives better.

Ethics Review Boards (ERBs)

Every research study is reviewed by an ERB or Ethics Committee, which is made up of scientists, non-scientist professionals and members of the public. 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 minimised and are reasonable in relation to any potential benefits, among other things.

Informed Consent

Before participating in a study, participants are provided information about the study and are given the chance to ask questions. This process is called Informed Consent. The purpose of the Informed Consent process is to make sure participants are adequately informed of important details about the clinical study so they can make an informed choice about their participation. Informed Consent begins before a research volunteer agrees to participate in a trial and continues throughout the study.

The Informed Consent document describes the study to research participants. It includes details about the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. Participants sign the document before they enter the study, but only after having read and discussed it with the research team and demonstrating an understanding of the information provided. In some cases, there will be multiple Informed Consent documents throughout the study as changes are made to the study protocol or new safety information becomes available. Signing the document(s) and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

Who is involved in clinical trials?

The Sponsor

This is the person or organisation who initiates the clinical trial. Sponsors can include doctors, medical institutions, hospitals, government agencies, and pharmaceutical companies, among others.

The Site

The clinic or institution where a clinical trial takes place is often referred to as the “site”. In many cases, a sponsor will have a multi-centre study, which means that the sponsor has partnered with many sites in various geographic regions to all conduct the same clinical trial.

The Principal Investigator

The principal investigator (“PI”) is the person responsible for all aspects of the study at the research site. The PI is usually a medical doctor. One of the primary responsibilities of the PI is to create and oversee a research study team of healthcare professionals, including other doctors, who help to perform the research at the site. Each study team member must be qualified by education, training, and experience for his or her designated role on the study team.

The Study Coordinator

Research assistants for clinical trials are called study coordinators or clinical research coordinators. A study coordinator’s job is to support the investigator, including corresponding with Ethics Review Board (ERB), identifying eligible patients, participating in the Informed Consent process, scheduling study visits, and maintaining study files.

The Participant

Also referred to as the patient, volunteer, or study subject, the participant is the person that has agreed to take part in a clinical trial.

The Ethics Review Board

A group of people with varying backgrounds that relies on their experience and expertise that ensures the rights and welfare of participants are protected.

What happens after a clinical trial is completed?

You join the community.

As a clinical study participant, you belong to a large community of volunteers around the world. Together study participants help researchers answer important health questions and discover new medical treatments.

You can discuss continuing treatment.

After your participation has ended, you and your doctor/researcher should work together to determine the best next steps in your care. Sometimes studies are designed to provide access to the study medication for longer periods after the study is over. However, this is the exception, not the rule, so please discuss it with your study doctor.

The trial might move forward and might not.

What happens after the trial results are analysed depends on the phase of the trial. After a Phase 1 or 2 trial the results will tell the researchers whether to move on to the next phase or to stop testing because the drug was unsafe or ineffective. When a Phase 3 trial is complete, the researchers examine the data and decide whether the results have medical importance. In any case, the researchers will carefully and extensively examine any information collected during the trial and then will conclude about the meaning of the findings and any further actions.   

The drug can become approved for use.

Once a new drug or treatment has been proven safe and effective during all three phases, it may become approved for use. To do so, researchers need to submit the research results to authorities (like the FDA in the USA or the EMA in the European Union) in order for them to agree to make the drug available for patients. But not all experimental drugs or treatments will be approved.

The results may be published in a peer-reviewed article.

Most of the time results from clinical trials are published in peer-reviewed scientific journals. A peer review process is a structured process where experts review the report of the results before it is published to ensure that the process, the analysis and conclusions are of good quality.

In any case, participants can ask the research team members if the study results have been or will be published.

You may be able to access results of the research.

Obtaining the results of your trial will depend upon both the company responsible for the research and the site where it was conducted. The majority of companies are working on the best way to provide the results in a manner and timeframe that is meaningful and responsible. You may also access trial results on www.clinicaltrials.gov. Published study results are also available by searching for the study's official name or Protocol ID number in the US National Library of Medicine's PubMed® database.

Keep in mind that trial results can take some time to be available. Though you may have completed your participation in a clinical trial, the same trial may still be ongoing for the other volunteers in that study. And while some trials are completed in a week, other trials take several years.

Where next?

Content adapted with kind permission from Eli Lilly and Company, National Institutes of Health (NIH) and Center for Information and Study on Clinical Research Participation.