Sage-Tips

What happens when a clinical trial ends?

Trial results After a clinical trial is completed, the researchers will carefully examine and analyse all of the information gathered during the trial. In most cases, the results of these trials are published in scientific or medical journals.

Do all clinical trials get published?

Researchers, doctors, and patients can instead learn about trial outcomes from peer-reviewed publications, they say. But thousands of trials are never published, particularly when they find treatments ineffective, history has shown.

Why would industry withhold the results of clinical trials?

The movement to ensure that clinical trial results don’t end up in drawers has found an important global ally. But withholding results leads to “publication bias,” which causes treatments to seem more or less effective than they really are, and it can put volunteers in future trials at risk unnecessarily.

Are clinical trial results public?

Through ClinicalTrials.gov, key facts about registered trials, including study design, administrative information, and results summaries (for completed trials), are now readily available to researchers, medical professionals, potential trial participants, and the public at large.

Why do clinical trials stop?

Ethically, clinical trials must sometimes be stopped early when the results show no justification for exposing human subjects to additional potential risk by continuing the trial. The study may then be suspended by the FDA, the sponsor, and/or the IRB until the risk-benefit ratio is reevaluated.

How long does clinical trials last?

Phase 1 trials, which examine the safety and dosage of a treatment, typically last several months. Phase 2 trials, which examine the efficacy and side effects of a treatment, typically last several months to two years.

How do I find out my trial results?

Paperwork in a file is usually filed with the most recent paperwork on top and the original filing on the bottom. The Judgment will tell you the outcome of the trial. The Sentencing (or similarly named document) will tell you what the “punishment” is if the person was found guilty.

Where are clinical trial results published?

Study results are often published in medical journals. On ClinicalTrials.gov, publication citations are displayed at the bottom of the Study Details tab of the study record, under the More Information heading.

Who owns clinical trial data?

At the present time, clinical trial data reside with the sponsor of the trial, which is usually a company or an academic institution. A great deal has been written about the failure of the clinical trial system as it currently operates (2–4).

Do drug companies pay for clinical trials?

The sponsor of the study (such as the government, drug makers or technology companies) typically pays for all costs involved with a clinical research study. This includes supplying the new treatment, as well as any special testing, possible extra physician visits, and research costs involved in the clinical studies.

WHO report on public disclosure of clinical trial results?

The WHO Joint Statement requires that all clinical trials be registered and the results disclosed publicly in a timely manner.

Can clinical trials be stopped?

What happens after a clinical trial is completed?

After a clinical trial is completed, the research team carefully analyzes information collected during the study to make decisions about the findings and any need for further testing, but the next steps can vary based on what phase of testing the trial was in.

What do we know about outcomes in cliclinical research?

Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement.

Why should I access my data from a clinical trial?

Accessing data from your participation in the study may be helpful for future doctor’s appointments or enrolling in another clinical trial. Since there are often many different hospitals where the study is being run, the clinical trial isn’t necessarily finished after you’re through participating.

What happens if a research study is not published?

If studies reporting this are not published, other researchers may repeat trials on it, thereby putting more trial participants and, potentially, patients at risk (p. 1577). 19, 20 (Ben Goldacre provides a particular example of this in respect of V Ioxx (p. 95 f). 21)