logo
logo
Sign in

Sponsors of clinical trials may report data late or never

avatar
Anushree Reddy

Just 41 percent of clinical trials listed on a research registry in the United States reported their results within a year of their completion, a new analysis has found And roughly one in three trials reported no results at all.

The problem is even more pronounced among the subset of trials that focus on autism, a Spectrum analysis has found. Only 20 percent of those trials reported their results on time.Delayed or absent reporting of clinical-trial results can deprive both scientists and laypeople of critical information about the effectiveness and side effects of treatments.

 

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.As the best clinical research courses based on clinical trials strive to investigate if a potential treatment is both safe and effective, there is a certain level of risk associated with it.  When the recruited volunteers are chosen, there is a possibility that the treatment shall not be effective, and the volunteer can also be subjected to certain side-effects.

 

The Food and Drug Administration (FDA) Amendments Act of 2007 requires researchers to register trials of treatments on clinicaltrials.gov and to post their results within a year of completion, regardless of what they find or whether they also plan to publish them in a peer-reviewed journal.In January 2017, the government added a ‘final rule’ that said trial sponsors who did not comply with the requirements could be fined $10,000 a day. (That figure, which is pegged to inflation, has since risen.)

The concerned authorities constantly review the protocols of every trial to ensure that it is done ethically and the patients' rights are protected. Apart from this, the FDA provides oversight for clinical trial testing of medical devices or drugs. Prior to human clinical trials, the FDA reviews the applications for the new treatments and medications to ensure that the studies and researches have protections in place for the volunteers. The completely informed consent forms of the patients are one of the most important pieces of the puzzle of any clinical trial that protects the volunteers.  Any changes in the mind of the volunteers enable them to withdraw from the trail immediately, ensuring their complete safety.

Conclusion

Clinical research trainings are given to every professional involved in the trial. Clinical research trainings are continuously updated based on the disease and development of technology to ensure the complete safety of the participants of the trial.

 

 

collect
0
avatar
Anushree Reddy
guide
Zupyak is the world’s largest content marketing community, with over 400 000 members and 3 million articles. Explore and get your content discovered.
Read more