Clinicaltrials.gov Sees 300% Increase in Listings, but Quality Remains a Concern

Strategic Insights -

Theresa Toigo, director of FDA's Office of Special Health Issues, reported a significant increase in the number of clinical trials submitted to the Clinicaltrials.gov database since September. However, she emphasized that the quality of these listings remains a concern. Toigo cited the International Committee of Medical Journal Editors' (ICMJE) decision to require trial results to be listed on the database as a major factor contributing to this increase. As of last month, Clinicaltrials.gov had 1,972 trials, with 90% from industry, 8% from institutions, and less than 1% from physicians.

Key Takeaways:

  • Clinicaltrials.gov has seen a 300% increase in listings since September, with 1,972 trials listed as of last month.
  • The ICMJE's decision to require trial results to be listed on Clinicaltrials.gov has been a major factor contributing to this increase.
  • As of last month, Clinicaltrials.gov had 90% of its trials from industry, 8% from institutions, and less than 1% from physicians.
  • The database currently counts 467 private sector sponsors, with 367 from industry, 81 institutions, and 19 trials run by physicians.
  • The number of sponsoring institutions has more than tripled in the last six months.
  • Trials for non-life-threatening conditions are beginning to appear in the database.
  • Drug companies are more apt to list both their name and their trial drug's name.
  • A study of INDs submitted to the Center for Drugs Division of Oncology between May and July 2004 found that 55 trials met the criteria for listing on Clinicaltrials.gov, but 42 were actually listed.

Statistics:

  • 300% increase in listings on Clinicaltrials.gov since September.
  • 47% of listed trials were from industry, 27% from institutions, and 3% from physicians as of last month.
  • 467 private sector sponsors are currently listed on Clinicaltrials.gov.
  • 367 of these sponsors are from industry, 81 from institutions, and 19 from physicians.
  • The number of sponsoring institutions has more than tripled in the last six months.
  • 55 out of 140 trials submitted to the Center for Drugs Division of Oncology between May and July 2004 met the criteria for listing on Clinicaltrials.gov.
  • 42 out of 140 trials submitted to the Center for Drugs Division of Oncology between May and July 2004 were actually listed on Clinicaltrials.gov.

Sources:

  • Theresa Toigo, director of FDA's Office of Special Health Issues, as cited in an interview with the American Conference Institute.
  • International Committee of Medical Journal Editors (ICMJE).
  • FDA Modernization Act of 1997 (FDAMA).
  • Clinicaltrials.gov.
  • Diane West, New York Correspondent.