• India Requires Disclosure of Sponsor/Investigator Payments

    Applications for approval of clinical trials in India must now include information concerning the agreement as to the payments that will be made by the sponsor to the trial investigator, according to a notice issued by India's Central Drugs Standard Control Organization (CDSCO) on 30 August 2013. India's Good Clinical Practices (GCP) regulations require the sponsor to conclude a contract with the trial investigator or institution, which must define the relationship bet...
  • FDA Guidance Clarifies Process for Disclosing Conflicts of Interest in Trials

    A guidance document released by the US Food and Drug Administration (FDA) looks to clarify the requirements associated with the disclosure of financial holdings by clinical investigators that could influence the outcome of a trial. The guidance specifically looks at the requirements of 21 CFR 54 , Financial Disclosure by Clinical Investigator . That section notes that FDA might find a study to be inadequate if it does not account for the effects of potential investigat...
  • Bill Delaying Transparency Measures Passed Into Law

    US legislators have delayed the implementation of legislation that would have required dozens of high-ranking officials at the US Food and Drug Administration and other federal agencies to disclose potentially dangerous personal information. The act, known as the Stop Trading on Congressional Knowledge (STOCK) Act was originally brought up by legislators after a CBS 60 Minutes investigation suggested some members of Congress were using insider information to ...
  • Top FDA Officials' Financial Records Could Soon be Made Publicly Available

    Tens of thousands of high-level staff members at all federal agencies, including hundreds at the US Food and Drug Administration (FDA), will soon be required to publicly disclose their financial information under the terms of a recently passed piece of legislation known as the Stop Trading on Congressional Knowledge (STOCK) Act , reports The Washington Post . But the impending deadline has more than a few federal officials, including numerous scientists , cryi...
  • Agency Looks to Overhaul Voluntary Fraud Reporting Program

    • 18 June 2012
    It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve running afoul of federal regulations against the improper marketing of pharmaceutical products and medical devices, both of which have caused billions in fines to the industry in recent years. What happens next, explains the US Department of Health and Human Services' Office ...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...
  • New Guidance on Conflict of Interest Disclosures for Advisory Committees

    The US Food and Drug Administration (FDA) released new draft guidance on 8 March about the availability of conflict of interest information and waiver information for members of advisory committees. The guidance also establishes a procedure for disclosing financial interest and granting conflict-of-interest (COI) waivers to special Government employees (SGEs) and regular employees. The guidance also provides a standardized mechanism for public disclosure of such document...
  • Feature ArticlesFeature Articles

    Sunshine Comes to Clinical Trials: Sponsors, CROs, Physicians and Teaching Hospitals Need to Prepare for Federal Financial Disclosure

    A provision of the healthcare reform law has created a new need for clinical trial sponsors and other participants to be open about financial relationships. On 19 December 2011, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would require applicable manufacturers, including many clinical trial sponsors, to disclose certain financial relationships with physicians and teaching hospitals. The concept is nothing new, as the rule implement...
  • FDA Responds to Conflict of Interest Uproar

    The US Food and Drug Administration (FDA) responded to critics of an FDA advisory board decision on Tuesday, saying that critics of the decision exhibited a "lack of understanding about our selection and evaluation process, as well as federally mandated limitations on the type on information [FDA] can share" with the public. Utilizing the new FDA Voice blog, Jill Hartzler, acting associate commissioner for special medical programs, sought to clarify the agency's conf...