Health Care Policies: NIH Final Rule
New requirements on final clinical trial registration and reporting were released on September 16th. These new rulings could have a massive impact on the fate of trials. In some cases, the NIH may freeze grant funding if they fail to make the grade. The NIH is currently the largest public funder for these clinical trials, with an annual spend of $3 billion. This should appear as no shock to the many companies and research institutions involved. The draft outlines have been publicly available since the end of 2014.
These rules are essentially getting tougher to try and combat low compliance rates within academic institutions. These institutions are not always fully registering the studies or their results. Doing so would legitimize recent advances in life science research. This puts the NIH in line with the Department of Health and Human Services, who have similar rules for FDA approval on medical products. These healthcare policies are seen as a significant investment in clinical research.
The Problem Of Weak Reporting And The Important Of These New Healthcare Policies.
A recent study published in the BMJ states that 43% of clinical trials at academic medical centers saw their result go unpublished for up to two years after the study ended This is where the NIH and other organizations want to see a major crackdown. If the evidence is ready, it should be made public so further progress can be made. The FDA commissioner spoke of the ethical implications relating to this non-disclosure of information.
Saying that “if you do an experiment on a person and get consent, you have an obligation to make your results known.” Mark Barnes, the co-chairman of Harvard’s project to improve multinational clinical trials said “the final rule proceeds to expand the coverage and the detail required for registering trials”. He added his approval that it is “consistent with international trends toward transparency of clinical trial processes and data”.
The Aim Here Is Simply To Produce Better Clinical Trials And Improve Relations Between All Sides.
It is all about improving transparency and enhance public trust. The first steps towards this current system began in 2004 when the public was outraged by drug companies hiding negative results. It is hoped that not only will more results now be seen. They will come from better sources.
The best recent advances in life science research come from the honest, ethical parties will an active agenda. These rules may weed out the bad institutions and open up the way for better findings. It all depends on how well these under-performing academic institutions take to these new rules. Some may already be on course to full compliance and large studies. Others may struggle to meet the new guidelines.
What Is New With These New Rulings And Healthcare Policies?
The new final rule contains the following clauses that institutions need to abide by:
The requirement that organizations must submit the clinical trial protocol, statistical analysis and results in information submission at the same time.
The requirements that institutions must now report on adverse events that occur as well as the race and ethnicity of the subject.
The requirement that organization must formally register their study on ClinicalTrials.gov within 21 days of enrolling the first participant.
The clause that the NIH can withhold grant funding for federally funded trials if the required reporting cannot be verified.
The clause that the NIH can oppose a civil monetary penalty on those that fail to meet the requirements. This could be as much as $10,000 per day.
The clause that the NIH can now suspend or terminate of grant or contract funding on non-compliant institutions.
This is just a sample of the necessary rules and regulations and the significant changes. The formal press release is much more extensive and identifies more ways to validate recent advancements in life sciences research
This sizable monetary penalty is quite a strong enforcement mechanism, as is the threat of suspension or termination. There is also a non-compliance section of the Clinicaltrials.gov website that would essentially shame all those that don’t follow the rules. The NIH insist that they will not pull the plug on trials mid-way, claiming it to be unethical. But they can stop future funding for institutions that don’t comply.
When Does The Final Rule Come Into Force And Should Academic Institutions Be Concerned?
These new guidelines will be put into effect from January 18th, 2017, with companies liable for 90 days afterward. At the same time, the NIH will take on their new approach to funding. This means that they will be casting a harsher eye on institutions that fail to cooperate.
Some will question whether 90 days is enough. Some organizations are acutely aware of the cost involved in bringing these new rules into effect. Some will need to find new resources and funding to comply. Those that were aware of the proposals should have had to foresight to plan ahead, but many could be caught out.
There is also an added concern with the deadlines. Results must be submitted within a year of the primary completion date. This means the date that results were collected from the final subject. This is a concern for some that may be used to the current system. However, there are caveats that they should keep in mind. There is the chance to delay the submission of results up to two years.
This can only happen if it can be proved that the product isn’t yet approved, licensed or cleared for marketing by the FDA. This also applies if the product is still under development by the manufacturer. There is also the chance to request extensions on the results information submission deadline if there is the good reason.
Could The Final Rule Make A Difference?
Recent advancements in life science research have changed the world of healthcare in significant ways. However, we have to wonder how much has gone unseen under those old rules. It is hoped that not only will these new policies improve transparency between institutions and the NIH. They will aid progression. More results from better studies can only be a good thing for the future of American healthcare.