What to expect When Joining a Clinical Trial

What to Expect as a Participant

Potential participants go through a series of steps to learn more about the trial and ensure they match the requirements. These series of steps help the potential participants make an educated decision about participating in a clinical trial.

Pre-screen

When someone finds a trial they are interested in they will typically complete an online pre-screening questionnaire to determine if the trial is a good fit. If so, they will be referred to a local research site, or a physician office conducting the trial, for further screening.

Consent

If a patient would like to move forward with a more in-depth screening, they first need to review the informed consent form (ICF). This form will include information on:

The frequency of visits to the trial site.
What will be required at the visits (e.g., physical exams, questionnaires, additional procedures).
Possible side effects and risks of trial participation.

It is important patients ask their researcher, doctor, and research staff any questions about participation they may have. If a patient reviews the information and would like to move forward, they must sign an informed consent form. By signing this form, the patient is acknowledging they understand the clinical trial process and their rights and responsibilities, including the ability to leave the study at any time.

Screening

During participant screening, researchers may check medical history and conduct a physical exam to make sure all requirements for joining the trial are met. The screening process will differ for each study based on the eligibility criteria that determine who can participate.

Trial Start

If the patient qualifies for the trial after the screening process, they may be enrolled into the clinical trial as a participant. Researchers will walk the participant through the next steps, which may include receiving their investigational drug or therapeutic, instructions on what the participant needs to do at home, and when their next visit will be.

Participation

During the clinical trial, the participant may have routine visits to the research team where various exams, questionnaires, and/or additional procedures may be conducted. A participant’s overall health and safety will be continually monitored during the entire length of the study.

Trial Conclusion

Once participation has ended, research staff will discuss the next steps with the participant. This could include meeting with your regular healthcare provider to determine further care options.

Time

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 needed for participation, including the frequency and duration of appointments. A patient’s participation may last a few months or a few years, depending on the condition, intervention duration, and study requirements.

Monetary Investment

Trial participants may not pay extra out-of-pocket costs for their study medication in an Otsuka clinical trial. Many trials provide financial compensation for a participant’s time and travel expenses related to the trial, such as transportation, housing, and meals, but not all trials do. It is important for your research team to discuss with you the financial commitment of participating in a specific clinical trial.

What to Expect as a Parent or Caregiver of a Clinical Trial Participant

Children may have different responses to interventions compared to adults, so it is important for researchers to include all age groups in trials. While the reasons and steps for enrolling a child in a study are similar to enrolling an adult, it’s understandable there may be more concerns and considerations. When considering enrolling a child, researchers will outline all aspects of the study including the intervention, benefits and risks, necessary procedures, and length of time.

Parents/caregivers must sign an informed consent form indicating they understand what is involved in the clinical trial and their and their child’s rights and responsibilities. Children must also be given an overview of participation in an age-appropriate way. Depending on the child’s age, children may also be asked to provide an assent, meaning they agree to take part in the trial.

Throughout the study, research team members, including doctors and nurses will monitor the child’s health. When the trial concludes, the team will work with the child’s family to ensure appropriate ongoing care continues.

For more information about pediatric and adolescent clinical trials, please view this infographic.