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Questions to Ask Before Participating in a Clinical Trial

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Anushree Reddy

The following are some questions to ask the research team when thinking about a clinical trial. Write down any questions you might have and bring your list with you when you first meet with the research team. Clinical Research Training studies are always in need of volunteers. Without these volunteers, medications and treatments cannot be approved by the concerned authorities and thus cannot reach the patients.  Apart from gaining access to a potential treatment for a particular disease, other perks include receiving care at the topmost facilities, helping science, and making a potential impact on all those living in that particular condition. These studies generally offer generous compensation for your participation.

About the Trial

 

  • What is this study trying to find out?
  • What treatment or tests will I have? Will they hurt? Will you give me the test or lab results?
  • What are the chances I will get the experimental treatment or the placebo?
  • What are the possible risks, side effects, and benefits of the study treatment compared with my current treatment?
  • How will I know if the treatment is working?
  • How long will the clinical trial last?
  • Where will the study take place? Will I have to stay in the hospital?
  • Will you provide a way for me to get to the study site if I need it, such as a rideshare service?
  • Can I do any part of the trial with my regular doctor? Is there a closer clinical trial to me?
  • How will the study affect my everyday life?
  • What steps ensure my privacy?

Medical Care

  • How will you protect my health while I am in the study?
  • What happens if my health problem gets worse during the study?
  • Can I take my regular medicines while in the trial?
  • Who will be in charge of my care while I am in the study? Will I be able to see my own doctor?
  • How will you keep my doctor informed about my participation in the trial?
  • If I withdraw, will this affect my normal care?

Costs and Reimbursement

  • Will being in the study cost me anything? If so, will I be reimbursed for expenses such as travel, parking, or lodging?
  • Will my insurance pay for costs not covered by the research trial, or will I need to pay out of pocket? If I don't have insurance, am I still eligible to participate?
  • Will I need a study partner? If so, how long will he or she need to participate? Will my study partner be compensated for his or her time?

After the Trial Ends

  • Will you follow up on my health after the end of the study?
  • Will you tell me the results of the study?
  • Whom do I call if I have more questions?

 

What Are Clinical Trials and Studies?

Clinical research is medical research involving people. There are two types, observational studies and clinical trials.

Observational studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. These studies may help identify new possibilities for clinical trials.

 

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Design and Conduct of Clinical Trials

Description

This course focuses on the theoretical underpinnings of clinical research and the practical aspects of conducting clinical trials: the rationale for design features of Phase I, II, and III trials, recruitment of participants, techniques for randomization, data collection and endpoints, interim monitoring, and results reporting. Experts will deliver lectures on such topics as pitfalls in design and interpretation, missing data, nonpharmacological trials, and clinical trials involving medical devices. Students will prepare a full proposal for an original clinical trial, using the NIH Research Project (R01) grant format, and will critique proposals of fellow students in a mock study section setting.

 

Topics include

  • Introduction to clinical trials
  • Overview of phase I and II trials
  • Interventions, participants, and outcomes
  • Basic trial designs
  • Sample size and power
  • Early phase trials
  • Adaptive trials
  • Handling missing data
  • Recruitment, retention, and adherence
  • Data analysis overview
  • Interim monitoring, statistical issues
  • Interim monitoring, data monitoring committees
  • Pragmatic trials; multicenter trials
  • Comparative effectiveness trials; point-of-care trials
  • Pitfalls in design and interpretation
  • Clinical trials involving medical devices
  • Mock study section overview and sessions

 

Course Availability

 

The course schedule is displayed for planning purposes – courses can be modified, changed, or cancelled. Course availability will be considered finalized on the first day of open enrollment. For quarterly enrollment dates, please refer to our graduate education section. Therefore, one needs to enroll in clinical research courses to equip themselves to understand the working of clinical trials.

 

 

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Anushree Reddy
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