The US FDA is enhancing its clinical trial transparency policy

The FDA announces today (January 16, 2018) that

  • Starting from January 2018, clinical study reports (CSRs) and other information of pivotal clinical trials of some of the recently approved drugs will become available to the public on its new website.
  • The ClinicalTrials.gov identifier numbers (NCT#) of clinical trials will be linked to drug application materials that the FDA uses for drug approval

Regarding its Clinical Data Summary Pilot Program, the FDA clarifies that

  • Only portions of the CSR (eg, summary of clinical evidence) will be posted on its website;
  • The protocol and amendments and the statistical analysis plan for each study will also be posted; but
  • Raw data will not be posted.

 


FDA Commissioner’s Plan for Helping Lower Drug-development Costs

FDA Commissioner, Scott Gottlieb, introduced his plan for helping reduce drug-development costs while speaking at the 2017 RAPS annual conference held on September 11-12 in Washington DC.

Here are highlights of his plan for the FDA to help reduce costs related to drug development and drug approval.

  • Improve the efficiency of the early stage (pre-clinical) of drug development
  • Modernize the agency’s workflow and drug-review process
  • Streamline the process of how the agency collects clinical information
  • Modify traditional clinical trial designs and utilize adaptive and “seamless” approaches, such as combined-phase studies (eg, a large, continuous trial for one developmental drug with potentials for multiple indications)
  • Advance the use of “Master Protocols”
  • Encourage communication between all stakeholders involved in drug development
  • Utilize the power of high-performance computing and harness the potentials of AI

To help lower overall drug prices, Gottlieb noted that the industry and the FDA need to

  • Bring more competition, including generic competition, to the drug market,
  • Improve the efficiency of the drug development process, and
  • Take actions to prevent companies from gaming the system to “extend their drug monopolies.”

Click here to access his full speech.