If you want to have informed discussions with your doctor or other healthcare team members about clinical trial endpoints or clinical trials in general, consider the following questions to jumpstart your conversation:

Key Questions About Clinical Trial Endpoints

• What are the primary endpoints of this clinical trial, and why were they chosen?
  (This helps clarify the main goals of the trial and how success will be measured.)
• How do the endpoints relate to patient outcomes, like survival or quality of life?
  (Understanding this connection can help you know how the treatment may affect your overall health and daily life.)
• What secondary or surrogate endpoints are being measured, and what do they indicate about the treatment’s effectiveness?
  (Secondary endpoints provide additional insights into the treatment’s potential benefits or risks.)
• How will progression-free survival (PFS) and overall survival (OS) be monitored, and what do these terms mean in this context?
  (PFS and OS are common myeloma endpoints, and knowing what they mean helps set realistic expectations.)
• What quality of life (QoL) measures are included, and how are they assessed?
  (This helps gauge how the treatment might impact your daily life and well-being.)
• What happens if the trial reaches its endpoints early? What are my next treatment options after this trial? (Some trials may allow for early results, which could impact the availability of the treatment.)
• How will minimal residual disease (MRD) be measured, and what does MRD negativity mean for my outcome?
  (MRD negativity is an important indicator in myeloma, and understanding it can clarify the depth of response.)
• What if the endpoints aren’t met—how would that affect treatment options for me and other patients?
  (This question provides insight into the trial’s implications on future care decisions.)
• How does the trial endpoint data impact regulatory approvals, and could it affect access to this treatment?
  (Knowing this helps you understand how trial results may lead to wider availability of the treatment.)

General Clinical Trial Questions

• What is the purpose of this clinical trial, and what are researchers hoping to achieve?
  (This helps clarify the overall goals of the study and why the trial might be beneficial.)
• What phase is this trial in, and what does that mean for me as a participant?
  (Each phase has different goals and risks, so knowing this can help set expectations.)
• What are the inclusion and exclusion criteria, and how do they apply to my situation?
  (This question helps determine if the trial is a good fit based on your health status and history.)
• What are the potential benefits and risks of joining this trial?
  (Understanding potential outcomes helps patients make informed decisions.)
• How is this treatment different from the standard therapies available to me?
  (This can provide context on why the trial may offer unique benefits or outcomes.)
• What will my participation involve on a day-to-day basis?
  (Knowing about time commitments, travel, or specific requirements can help patients prepare for the trial.)
• How will my health be monitored throughout the trial, and who will be my main point of contact?
  (This helps patients understand the support they will receive and who to reach out to with concerns.)
• If I experience side effects or complications, how will they be managed?
  (This ensures that patients know the resources available to address any adverse effects.)
• Are there costs involved, and will my insurance cover them?
  (Understanding potential financial commitments is crucial for informed decision-making.)
• Can I withdraw from the trial at any time, and what would that involve?
  (This reassures patients that they can leave the trial if needed without penalty.)
• Will I have access to the treatment after the trial ends if it works well for me?
  (This question helps clarify what options are available if the treatment is beneficial.)