Trial Manager Q&A (May 2026)

Q: What needs to happen before a trial can begin?

Researchers plan their study by reviewing existing science and work. Researchers design a study plan, known as a protocol, and must get approval from ethics committees and regulators. This is to make sure the trial is safe and necessary. As trial managers, we then work with the selected site teams to complete set up and training of staff to carry out the trial. This includes making sure all required documentation is in place so they can run the trial and collect the data correctly and successfully. Set up at sites can take around 6 months from first contact with the site research department who will be delivering the EJS ACT-PD trial. This can sometimes take longer depending on how the sites work.

Q: What happens once the site is set-up and ready to recruit?

 Once a trial site has been set up and opened to recruitment, the research team will contact people who have completed their Registration of Interest form. This starts with a pre-screening phone call. After the call if the participant is potentially eligible, they will be invited to attend for an in-person screening visit. If all the screening tests show they are safe to take part in the trial, the participant will be ‘randomised’ into the trial and start receiving the trial medication.

Q: What is randomisation and what happens next?

In a clinical trial, randomisation is the process of assigning participants in different treatment groups by chance. A computer will allocate participants randomly (like rolling a dice) to make sure there is no bias. In EJS ACT-PD, the current treatment groups are telmisartan, terazosin and placebo (or ‘dummy drug’). Once a participant has been randomised, they will attend trial appointments with the research team, receive regular supplies of trial medication, and complete trial assessments and answer questions about their health. In EJS ACT-PD, neither you nor any of your doctors or trial team members will know which trial group you have been allocated to. This helps us to make sure the results are accurate.

Q: When will participants be able to join the trial?

For the treatments currently being tested we expect to recruit participants until Summer 2029, so there is plenty of time to be contacted and entered into the trial. However, we intend to add additional treatments into the trial in the future and additional participants will be required, with recruitment taking place beyond 2029. This is because EJS ACT-PD is a platform trial known as a Multi-Arm Multi-Stage (MAMs), which allows new treatments to be added without needing to set up a new trial.

Find out more about MAMs trial design by visiting the ‘What is a MAMS Trial’ page

Q: Why does it take a long time for participants to enter the trial?

Joining a clinical trial can take time because everything must be done carefully, with safety and accuracy as the top priorities. Clinical trials have specific requirements to keep participants safe and to make sure the results are meaningful. Doctors need time to review medical records and test results. Trial visits also need to fit around clinic availability and the participants own commitments.

In EJS ACT-PD, participants complete follow-up for up to 3 years. Research teams stagger the recruitment of participants throughout the year to ensure they teams have the time and required hospital space to complete these follow-up appointments for all participants in the trial. Therefore, each EJS ACT-PD research site recruits up to 2 participants a month. At each visit, the research teams need to give clear information about the trial and complete the visit tests and assessments. By spreading out recruitment, research teams can ensure every participant is treated with care and respect. We do not want to rush participants at these appointments and all are encouraged to ask questions. We understand the process may seem slow, but this is necessary because resources need to be managed so that all participants receive the best possible care and support throughout the trial.