Clinical Trial Rules Aim To Improve Public Reporting Of Results

Research about different aspects of drugs and therapies’ impacts on human life is essential to get ready for treatment and prevention of any kind of disease. In this regard, access to the results of clinical trials to the public is of key importance and plays a significant role in making people aware of the authenticity of the respective drugs or therapies.

Why improve Regulations about clinical reporting?

Inadequate reporting or non-publication of clinical trials results always cause loss of evidence bases. It has found that a large number of drug companies and health researchers do not publish their results or withhold specific data and show that discovered solutions or drugs will not work or will have side effects for human health in order to hold their monopoly in the health industry. According to health experts, this is a harmful aspect of inadequate reporting as it might cost human lives and issues to patient care.

Low quality reporting and lesser access to the public not only decrease the importance of respective studies and cannot benefit health institutions to perform perfect treatment of the respective disease. To cope with the issue, the FDA and NIH have proposed amendments in clinical trial rules in order to enforce researchers to publicize the results and to increase financial punishments for violating them. These regulations will help the health industry in getting the best possible researches and better solutions for treating potential diseases.

In this regard, the director of NIH Francis Collins while announcing the regulations said that when a lot of volunteers are putting themselves in risks and thousands of dollars are invested in these studies, their result must be available to the public to take advantage of the prevention against diseases.

Phases of Clinical trial rules

The US National Institutes of Health and Food and Drug has devised these regulations in two phases majorly to improve the public reporting of results of these trials to benefiting people in getting better health care facilities. They will determine the phases of clinical trials and will ensure the publicizing their result within a specified time period.

Phase 1: Transparency Assurance

Participants of a trail must be aware of the side effects and key aspects of the respective treatment to decide for their participation and for this transparency is very essential. According to the NIH’s director, complete reporting of data will not only play an important role in satisfying the participants of a clinical trial but will also benefit researchers to avoid failures of experiments and getting the best possible results.

The proposed regulations will be extending FDA amendments Act 2007 that enforces researchers to publish their results from studies including FDA permitted drugs on the official website of ClinicalTrials.gov within the thirty days of approval and finalization. Another proposal by the government authorities will also enforce researchers and respective drug companies to publish all the results for all FDA approved drugs or therapies.

Health experts are appreciating this move as they believe that it will bound researchers to stay complied with the enforced clinical trial rules and hopefully the industry will also follow the regulation when they will be stated in clear words. However, some of the experts such as Jennifer Miller of Duke University in Durham have certain ambiguities about these regulations. She says that a large number of sponsors of these worldwide clinical trials and more specifically in the USA as they do not post their results to the said website for public even for the FDA approved drugs. So, she suggests that the government can impose heavy penalties such as $10000 for every day of non-compliance and without such strict punishments; the proposed extension in FDAAA will be of no use.

Phase 2: Compliance with set criteria

In this phase government authorities go a step ahead by demanding federally sponsored investigators to publish the outcomes of a phase I clinical studies, which concentrate on the protection of a drug or therapy instead of its effectiveness. Researchers will also be required to register and report the outcomes of trials that assess clinical methods or non-medical involvements, such as changes in public-policy anticipated to control smoking.

According to NIH statements, this rule will enable NIH and FDA to withdraw funding to the external institution if they will not comply with it. NIH will try to resolve issues with the respective institutions before withdrawing findings.

A large number of experts are happy with this initiative by governments as it will help the health industry to cure every potential disease in better ways. Experts believe that it will help in revealing the results of trails that will save and money of researchers that are looking to develop similar therapies in the money even if the respective drug never comes to the market.

Although experts have different opinions about the utility of the proposed clinical trial regulations. But when it comes to improving access to the result publicly these regulations can play an important role. The fear of heavy penalties and cancelation of federal funding will encourage researchers and drug companies to post their results for clinical trials near me. In other words, these regulations have the potential to change the trends of public reporting of clinical trials outcomes.