Category: Bioethics & Clinical Research
House Bill Introduced on Clinical Trial Database Registry
On August 2nd, H.R. 6272, the “Trial and Experimental Studies Transparency (TEST) Act of 2012” was introduced in the House. TEST would amend the Public Health Service Act to expand the clinical trial registry data bank. Among other requirements, the bill would require all foreign clinical studies to meet the same requirements as domestic trials (if used to support an application for U.S. marketing).
Also, the bill would require that results from most covered trials be posted on the registry data bank within one year of the “primary completion date” of the trial. Delayed submission of results up to two years after trial completion would be allowed for trials on drugs of devices that have no previous history of approval for use. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) would be instructed to provide Congress … Read More »
Still Waiting for Guidance on Informed Consent of Decisionally-Impaired Subjects
A July 11, 2012 article by Gina Kolata in the New York Times describes a recent discovery of a rare gene mutation that protects people from Alzheimer’s disease by slowing the production of beta amyloid. Excessive amounts of beta amyloid in the brain are believed to cause Alzheimer’s. The discovery bolsters hope that drugs, currently in development, that reduce levels of brain amyloid will prove effective in slowing the progression of Alzheimer’s.
The lack of clear guidelines for enrolling in clinical research decisionally-impaired subjects, or those who may become impaired over the course of a study may hinder efforts to conduct trials of Alzheimer’s drugs. In 2010, an Institute of Medicine summary of a workshop on the state of clinical trials in the United States noted that 27% of investigators in the U.S. failed to enroll any subjects in trials in … Read More »
U.S. clinical trial website pairing — a need for privacy safeguards
Fox Trial Finder is a welcomed initiative in ongoing efforts to facilitate clinical trial participation. In a recent interview with ABC’s Diane Sawyer, Michael J. Fox, who suffers from Parkinson’s disease, said that in addition to his support for stem cell research addressing Parkinson’s, he also supports research looking for a cure on other fronts, including drug therapies and diagnostic tests. (Article Link) Toward that end, Fox’s Foundation for Parkinson’s Research recently launched an online initiative called Fox Trial Finder. This website promotes research across the country by pairing patients with clinical trials in their areas, based on the individual’s symptom profile. The foundation’s webpage notes that 30% of all clinical trials fail to recruit even one subject, and that 85% of clinical trials are delayed because of insufficient subject enrollment – so Fox’s initiative (and others like it that … Read More »
New FDA Informed Consent Requirements for Applicable Clinical Trials: Practical Approaches for Implementation
For applicable clinical trials regulated by the U.S. Food and Drug Administration (FDA) that are initiated on or after March 7, 2012, sponsors, investigators and institutional review boards will have to assure compliance with an additional informed consent requirement.1 A revision of FDA regulations requires investigators and sponsors of such clinical trials to include the following statement in informed consents:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Website will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
ClinicalTrials.gov is the National Institutes of Health (NIH) website where all “applicable clinical trials” must be registered and trial results posted in accordance with the U.S. Food Drug Administration Amendment Act of 2007 (FDAAA).2 Registration … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in applicable … Read More »