Poor reporting of scientific leadership information in clinical trial registers.

BACKGROUND: In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. METHODOLOGY/PRINCIPAL FINDINGS: We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. CONCLUSIONS/SIGNIFICANCE: Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial registration to ensure completion of mandatory contact information fields identifying scientific leadership.

Haunted manuscripts: ghost authorship in the medical literature.

Ghost authorship occurs when an individual who contributed substantially to a manuscript is not named in the byline or acknowledgments. Ghost authors may be employed by industry to prepare clinical trial results for publication. An expert is then "hired" as author so as to lend an air of credibility and neutrality to the manuscript. Ghost authorship is difficult to detect, and most articles that have been identified as ghostwritten were revealed as such only after investigative work by lawyers, journalists, or scientists. Ghost authorship is ethically questionable in that it may be used to mask conflicts of interest with industry. As it has been demonstrated that industry sponsorship of clinical trials may be associated with outcomes favorable to industry, this is problematic. Evidence-based medicine requires that clinical decisions be based on empirical evidence published in peer-reviewed medical journals. If physicians base their decisions on dubious research data, this can have negative consequences for patients. Ghost authorship also compromises academic integrity. A "film credit" concept of authority is one solution to the problems posed by ghost authorship. Other approaches have been taken by the United Kingdom and Denmark. A solution is necessary, as the relationship between authorship and accountability must be maintained.

Institutional review boards and multisite studies in health services research: is there a better way?

OBJECTIVE: The following paper examines the issue of whether the current system for ethics review of multisite health services research protocols is adequate, or whether there exist alternative methods that should be considered. PRINCIPAL FINDINGS: (1) Investigators at different sites in a multisite project often have very different experiences with respect to the requirements and requests of the review board. Other problems include the waste of time and resources spent on document preparation for review boards, and delays in the commencement of research activities. (2) There are several possible reasons why there is variability in ethics review. These include the absence of standardized forms, differences in the background and experiences of board members, the influence of institutional or professional culture, and regional thinking. (3) Given the limited benefits derived from the variability in recommendations of multiple boards and the numerous problems encountered in seeking ethics approval from multiple boards suggest that some sort of reform is in order. CONCLUSIONS: The increasing number of multisite, health services research studies calls for a centralized system of ethics review. The local review model is simply not conducive to multisite studies, and jeopardizes the integrity of the research process. Centralized multisite review boards, together with standardized documents and procedure, electronic access to documentation, and training for board members are all possible solutions. Changes to the current system are necessary not only to facilitate the conduct of multisite research, but also to preserve the integrity of the ethics approval process in general.

Potential interactions between herbal medicines and conventional drug therapies used by older adults attending a memory clinic.

OBJECTIVE: Herbal medicines and conventional drug therapies are often taken in combination. The objective of our study was to identify the range of natural health products and conventional drug therapies used by older adults (aged 65 years and over) attending a memory clinic, and to specifically evaluate the frequency of potential interactions between herbal medicines and conventional drug therapies. DESIGN: We interviewed consecutive patients attending the Memory Disorders Clinic at the Baycrest Centre for Geriatric Care, a University of Toronto teaching hospital, between 4 July and 15 August 2000. Patients were asked to bring to their appointment all natural health products (i.e. herbal medicines, vitamins and minerals) and conventional drug therapies (i.e. prescription and over-the-counter) they were currently using. We collected information on current and previously used natural health products and current conventional drug therapies. Patients were classified as having the potential for an interaction if they were using a current herbal medicine in combination with a conventional drug therapy and the interaction had been reported previously in the medical literature. PARTICIPANTS: We interviewed 195 consecutive patients attending the Memory Disorders Clinic at the Baycrest Centre for Geriatric Care, Toronto, Ontario, Canada. RESULTS: Of the 195 patients in our sample, 33 (17%) were 'current users', 19 (10%) were 'past users', and 143 (73%) were 'never users' of herbal medicines. Among the 52 patients who were 'current or past users', the most frequently used herbal medicines were ginkgo (Ginkgo biloba) [39 users], garlic (n = 10), glucosamine sulphate (n = 9) and echinacea (n = 8). Among the 33 patients who were current users, the most commonly used herbal medicines were Ginkgo biloba (n = 22), glucosamine sulphate (n = 8) and garlic (n = 6). Among the 33 current users, we identified 11 potential herb-drug interactions in nine patients. The 11 herb-drug interactions we identified were between ginkgo and aspirin (acetylsalicylic acid) [n = 8], ginkgo and trazodone (n = 1), ginseng and amlodipine (n = 1) and valerian and lorazepam (n = 1). CONCLUSIONS: Herbal medicines are widely used. Almost one-third of current users of herbal medicines were at risk of a herb-drug interaction. The most common potential herb-drug interaction was between ginkgo and aspirin. This finding has important potential implications because both of these products are regularly used by older people. Physicians and other healthcare providers should be aware of potential herb-drug interactions and should monitor and inform their patients accordingly.

Comparison of review articles published in peer-reviewed and throwaway journals.

CONTEXT: To compare the quality, presentation, readability, and clinical relevance of review articles published in peer-reviewed and "throwaway" journals. METHODS: We reviewed articles that focused on the diagnosis or treatment of a medical condition published between January 1 and December 31, 1998, in the 5 leading peer-reviewed general medical journals and high-circulation throwaway journals. Reviewers independently assessed the methodologic and reporting quality, and evaluated each article's presentation and readability. Clinical relevance was evaluated independently by 6 physicians. RESULTS: Of the 394 articles in our sample, 16 (4.1%) were peer-reviewed systematic reviews, 135 (34.3%) were peer-reviewed nonsystematic reviews, and 243 (61.7%) were nonsystematic reviews published in throwaway journals. The mean (SD) quality scores were highest for peer-reviewed articles (0.94 [0.09] for systematic reviews and 0.30 [0.19] for nonsystematic reviews) compared with throwaway journal articles (0.23 [0.03], F(2,391) = 280.8, P<.001). Throwaway journal articles used more tables (P =.02), figures (P =.01), photographs (P<.001), color (P<.001), and larger font sizes (P<.001) compared with peer-reviewed articles. Readability scores were more often in the college or higher range for peer-reviewed journals compared with the throwaway journal articles (104 [77.0%] vs 156 [64.2%]; P =.01). Peer-reviewed article titles were judged less relevant to clinical practice than throwaway journal article titles (P<.001). CONCLUSIONS: Although lower in methodologic and reporting quality, review articles published in throwaway journals have characteristics that appeal to physician readers.