Medical Device Daily Washington Editor

WASHINGTON — Public disclosure of proprietary data is a touchy subject for device, diagnostic and drug manufacturers, but if CMS has its way, any companies who receive Medicare dollars in the conduct of their studies may have to post clinical trial data in a public forum or forego those dollars.

The policy is part of a decision memo published last week by the Centers for Medicare & Medicaid Services, titled the Medicare National Clinical Trial Policy (MNCTP). The proposal is open to public comment for 30 days.

MNCTP is the outcome of a meeting last December of the Medicare Evidence Development and Coverage Advisory Committee. The decision memo lists a large number of changes to the guidance, but the two perhaps of greatest interest to the device industry are those outlining clinical trial information disclosure.

In one of these, CMS proposes to require that sponsors list all studies receiving Medicare money at the web site "prior to enrollment of the first study subject," despite industry concerns that such a move might disclose proprietary information.

Given the language referring to study subjects, this will likely apply to Phase II as well as Phase III studies.

In the discussion section of the document, CMS states that this requirement "assures that beneficiaries will have pertinent information about clinical trial research that Medicare supports — an essential component of transparency to facilitate patient-provider informed decision making."

CMS stated further that while it "recognizes the industry's sensitivity to disclosing study information — including study results — to the public," its position is that this sensitivity "must be balanced against the public's desire to obtain information about the studies that their Medicare premiums and tax dollars support."

CMS also proposes to require that a study design include the method and date of release of "all pre-specified outcomes" to the public. The recommendation of MedCAC was that the results be published "regardless of outcome or completion of trial." This would be a new requirement and, as a consequence, "the public was not asked to comment on this issue" up to now, according to the decision memo.

CMS sought input from the Agency for Healthcare Research and Quality (AHRQ; Washington), which took the position that this requirement should extend to data on all outcomes even "if outcomes are negative or study is terminated early."

In the discussion section addressing this requirement, CMS says it is "imperative that studies for which Medicare has made payment of any clinical costs" be published in part because unpublished study data "do not add to the clinical evidence base and cannot be used for medical decision-making."

The agency is working with other entities to assemble "routine outlets for the release of these results," but in the meantime, "we are proposing that that the results for all primary and secondary outcome measures must be made publicly available as the analyses are completed," either via peer-review journals or a web site.

CMS states further that it prefers a government web site for publication of study results, but that in the meantime, "a sponsor-supported database would be considered acceptable if it clearly [identifies] the sponsor, the relationship of the sponsor to the items being studied, and the method of scientific review."

The final language of the decision memo is that the protocol "specifies and fulfills method and timing of public release of all pre-specified outcomes to be measured, including release of outcomes if outcomes are negative or study is terminated early."

Leslie Norwalk, acting CMS co-administrator, said in a statement that the policy proposal "will signal our continued support to provide access for services for beneficiaries by facilitating participation in the full range of qualified, scientifically sound research projects."

As previously, this set of regulations is applicable to trials for devices or treatments that have a therapeutic intent, as opposed to a diagnostic intent. Also, such trials must enroll "patients with diagnosed disease rather than healthy volunteers."

Among the features of the "highly desirable characteristics of any such trials are that the trial is designed to establish that "the intervention potentially improves the participants' health outcomes" and that it does not "unjustifiably duplicate existing studies."

CMS also reiterates that its long-term objectives in crafting the policy are to allow beneficiaries access to therapies "for which the evidence for the effectiveness of the treatment or service is insufficient to allow full, unrestricted access" — that language reinforcing the coverage-with-evidence paradigm that the agency unveiled in 2005.

Among the other imperatives stated in the decision memo is one for addressing health disparities by requiring inclusion of "a representative sample of Medicare beneficiaries by demographic and clinical characteristics" into any Medicare studies. The CMS document notes that, in general, public comments were not in support of this proposal" because of "the administrative burden for well-intentioned providers" and because the demographics of a study "should be driven by clinical characteristics rather than by a desire to mirror the universe of Medicare beneficiaries."

MedCAC is said to have agreed with the CMS position that any study should "explicitly discuss consideration of relevant sub-populations."

AHRQ went further, specifying demographic characteristics for consideration, such as race/ethnicity, age, sex and socioeconomic factors. According to the decision memo, CMS' final word on this is that studies "must have explicitly discussed inclusion criteria and considered relevant sub-populations (as defined by age, gender, race/ethnicity, socioeconomic or other factors.