The latest bill, known as the Trial and Experimental Studies Transparency (TEST) Act of 2013, seeks to address a number of loopholes in the registration and publication of trial data in the US online database. Currently, a portion of clinical trials used for US drug approvals -- including some conducted in foreign countries, as well as Phase I and feasibility studies -- are not required to be registered with clinicaltrials.gov. Clinical trial protocols and informed consent documents are also not included in a list of documents submitted to clinicaltrials.gov, but would be added under the bill.
The addition of such documents could pose privacy and proprietary investment issues, as well as add a significant burden for the companies running the trials, some experts claim. However, others such as the Patient Consumer and Public Health Coalition, have said that an increase in the flow of more specific trial data could save industry resources and redundancy.
“If we were issuing a grade on the clinical trials report card, it would be Incomplete,” said Rep. Ed Markey (D-Mass.), senior member of the Energy and Commerce Committee, who introduced the bill. “Unreported results and missing registrations leave participants, doctors and researchers vulnerable.”
Although it’s nearly identical to a bill introduced by Rep. Markey last August, the latest version would require all biomedical studies on humans to be registered before the first human participant is enrolled. It would also add new restrictions on trials conducted in foreign countries as any trial supporting an NDA (new drug application) for marketing in the US would need to be registered and reported in the database.
Rep. Rosa DeLauro (D-CT) said, “Closing loopholes and strengthening reporting standards will help both Americans who want to do their due diligence on a particular drug or device and researchers evaluating the safety or efficacy of a drug.”
EMA Example
But efforts in the US to expand the reporting requirements for trial sponsors and pharmaceutical companies could hit the same roadblocks Europe has seen recently.
In late April, the General Court of the European Union ordered the EMA (European Medicines Agency) to not provide documents for two requests until the court makes a final ruling on the agency’s ability to grant access to clinical and non-clinical information.
These interim rulings were part of court cases brought by pharma companies AbbVie and InterMune, which are challenging the EMA’s decisions to grant access to trial data, including clinical study reports, submitted as part of marketing authorisation applications. The EMA first authorized the release of such information in its 2010 access-to-documents policy.
The EMA said “it notes with regret the decisions of the President of the General Court to grant interim relief to AbbVie and InterMune and to order the EMA not to release the concerned documents until a final judgement in the main cases is made.”
But the agency is still working with clinical trial advisory groups to develop a policy granting proactive access to clinical trial data while considering multiple stakeholder opinions.
As for how this could impact CROs, Dr. Jeffrey Spaeder, Chief Medical and Scientific Officer of Quintiles, told us that there are a number of initiatives underway to increase transparency around clinical trials. He noted that greater use of real world data will be critical, as well as more interactions with regulators.