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HHS finalized ClinicalTrial.gov rules encourage healthcare improvement and public benefit by increasing transparency and accountability across the industry.
HHS finalized reporting rules on ClinicalTrials.gov to expand and clarify what clinical trial data legally needs to be made public by clinical trial sponsors.
“Broadly speaking, this announcement is yet another reminder that the government is actively pursuing measures to encourage healthcare improvement and public benefit by increasing transparency and accountability across the industry,” says Rita Numerof, PhD, co-founder and president of Numerof & Associates.
Managed care medical and pharmacy directors will be able to request and expect to receive documentation of more clinical trial results.
“Medical and pharmacy directors will be able to go to ClinicalTrials.govto learn which trials are in process with respect to drugs of interest, and anticipate use of that documentation in pharmacy and therapeutics [P&T] consideration,” says Elan Rubinstein, PharmD, MPH, principal of EB Rubinstein Associates, a pharmaceutical management consulting firm. “While they can do this now, not all clinical trials are currently registered at the ClinicalTrials.gov website.”
While clinical researchers in the U.S. have been required to register trials and report trial information on ClinicalTrials.gov for several years, compliance rates have remained low. According to a study published in PLoS Medicine, the results of clinical trials are going unpublished as much as half the time, and those that are published leave out some key details.
To achieve these goals, the final rule requires the following:
· Interventional trials involving drugs, biologicals, and medical devices must be registered on ClinicalTrials.gov no later than 21 days after the first human subject is enrolled. The rule provides a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information.
· Researchers have one year from a trial's completion date to submit results, including adverse events, and must report any updates to the trial data at least once a year.
· Researchers must provide more information about failed trials.
· Researchers must provide more information about the methodology, results, and participants, including race and ethnicity.
· Researchers will have 90 days to comply after it takes effect and if researchers don’t, they could face civil monetary penalties up to $10,000 a day, and have their federal funding pulled.
However, despite clearly defined repercussions for researchers who violate this final rule, it remains to be seen how closely the government monitors compliance, according to Numerof. “The FDA has indicated that it does not plan to dedicate significant resources to ensure compliance beyond sending ‘warning letters,’” she says.
According to Numerof, if implemented and enforced properly, this rule has important implications for clinical researchers, including the following:
· Researchers will no longer have the luxury of deciding which summary results are worth reporting.
· Researchers will need to give greater consideration to whether a trial is worth conducting now that data from even failed studies will be made publically available.
“HHS’ final rule makes information about clinical trials widely available to the public, including patients and providers,” Numerof says. “Expanding information regarding clinical trial registration and results on ClinicalTrials.gov improves patients' ability to find clinical trials in which they may be able to participate and access investigational therapies. More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions.”
In addition to the clear benefits for patients and providers, HHS’s final rule has the potential to provide managed care executives greater access to critical information that can help guide formulary decision-making and ensure the best treatment for each patient, according to experts.
This is pertinent to managed care executives who are medical and pharmacy directors charged with making coverage and formulary decisions for their organizations about how particular drugs should be used and about policies that should be created to manage that use, according to Rubinstein.
“Organizations’ P&T committees considering the role of a particular drug or therapeutic class will often request drug-related research from pharmaceutical manufacturers,” he says.
The P&T committee will itself gather documentation from the medical literature and from organizations that develop evidence-based clinical guidelines and pathways-such as the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), Oregon Health & Science University’s Drug Effectiveness Review Project (DERP), and many of the professional associations.
“Because the process of development of evidence-based clinical guidelines and pathways is dependent on full and timely access to clinical trials results, unavailability of this documentation may yield inaccurate guidelines and pathways, which may influence managed care drug use decisions and policies,” Rubinstein says.
The final rule is scheduled to go into effect Jan. 18, 2017, and there are some important considerations for managed care executives:
#1. If the medical evidence base grows, it would be useful in guiding market access and reimbursement decisions, according to Numerof. The final rule requires the submission of results information for all applicable clinical trials, regardless of the product’s approval status.
“Thus, managed care may now have greater access to information from trials of unapproved products, which can be used to inform risk and benefit assessments-e.g., decisions to either support or decline requests for off-label product use,” she says.
#2. Greater consistency and specificity in data reporting and study design could help support market access and reimbursement decision-making, according to Numerof.
“The final rule creates a clearly defined framework for reporting outcome measures and adverse events as well as requires a copy of the full protocol,” she says. “Not only is this information important to allow for the proper interpretation of a study’s results, but consistency in how this information is reported will offer managed care executives greater confidence when comparing a product with alternative treatment options.”
#3. Information regarding patient demographics can be used to support payers’ targeting efforts, helping to ensure the right patient gets the right treatment.
“The regulation expands the requirements for submitting results information to include any baseline information on race and ethnic background that was assessed,” Numerof says.