Trial Registration for Public Trust: Making the Case for Medical Devices

Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration

The Database for Aggregate Analysis of ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical Specialty

BACKGROUND: The ClinicalTrials.gov registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalTrials.gov as a research resource. METHODS/PRINCIPAL RESULTS: The purpose of our project was twofold. First, we sought to extend the usability of ClinicalTrials.gov for research purposes by developing a database for aggregate analysis of ClinicalTrials.gov (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed and annotated MeSH and non-MeSH disease condition terms, and an algorithm was created to classify studies into clinical specialties based on both MeSH and non-MeSH annotations. False positives and false negatives were evaluated by comparing algorithmic classification with manual classification for three specialties. CONCLUSIONS/SIGNIFICANCE: The resulting AACT database features study design attributes parsed into discrete fields, integrated metadata, and an integrated MeSH thesaurus, and is available for download as Oracle extracts (.dmp file and text format). This publicly-accessible dataset will facilitate analysis of studies and permit detailed characterization and analysis of the U.S. clinical trials enterprise as a whole. In addition, the methodology we present for creating specialty datasets may facilitate other efforts to analyze studies by specialty groups

Opinions on registering trial details: a survey of academic researchers

<p>Abstract</p> <p>Background</p> <p>The World Health Organization (WHO) has established a set of items related to study design and administrative information that should build the minimum set of data in a study register. A more comprehensive data set for registration is currently developed by the Ottawa Group. Since nothing is known about the attitudes of academic researchers towards prospective study registration, we surveyed academic researchers about their opinion regarding the registration of study details proposed by the WHO and the Ottawa Group.</p> <p>Methods</p> <p>This was a web-based survey of academic researchers currently running an investigator-initiated clinical study which is registered with clinicaltrials.gov. In July 2006 we contacted 1299 principal investigators of clinical studies by e-mail explaining the purpose of the survey and a link to access a 52-item questionnaire based on the proposed minimum data set by the Ottawa Group. Two reminder e-mails were sent each two weeks apart. Association between willingness to disclose study details and study phase was assessed using the chi-squared test for trend. To explore the potential influence of non-response bias we used logistic regression to assess associations between factors associated with non-response and the willingness to register study details.</p> <p>Results</p> <p>Overall response was low as only 282/1299 (22%) principal investigators participated in the survey. Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly. Consequently, only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group. Logistic regression indicated no association between characteristics of non-responders and willingness to disclose details.</p> <p>Conclusion</p> <p>Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group. Disclosing the study protocol and financial agreements was found to be most problematic. Future discussions on trial registration should not only focus on industry but also on academic researchers.</p

Mentorship needs at academic institutions in resource-limited settings: a survey at makerere university college of health sciences

<p>Abstract</p> <p>Background</p> <p>Mentoring is a core component of medical education and career success. There is increasing global emphasis on mentorship of young scientists in order to train and develop the next leaders in global health. However, mentoring efforts are challenged by the high clinical, research and administrative demands. We evaluated the status and nature of mentoring practices at Makerere University College of Health Sciences (MAKCHS).</p> <p>Methods</p> <p>Pre-tested, self-administered questionnaires were sent by email to all Fogarty alumni at the MAKCHS (mentors) and each of them was requested to complete and email back the questionnaire. In addition to training level and number of mentors, the questionnaires had open-ended questions covering themes such as; status of mentorship, challenges faced by mentors and strategies to improve and sustain mentorship within MAKCHS. Similarly, open-ended questionnaires were sent and received by email from all graduate students (mentees) registered with the Uganda Society for Health Scientists (USHS). Qualitative data from mentors and mentees was analyzed manually according to the pre-determined themes.</p> <p>Results</p> <p>Twenty- two out of 100 mentors responded (14 email and 8 hard copy responses). Up to 77% (17/22) of mentors had Master's-level training and only 18% (4/22) had doctorate-level training. About 40% of the mentors had ≥ two mentees while 27% had none. Qualitative results showed that mentors needed support in terms of training in mentoring skills and logistical/financial support to carry out successful mentorship. Junior scientists and students reported that mentorship is not yet institutionalized and it is currently occurring in an adhoc manner. There was lack of awareness of roles of mentors and mentees. The mentors mentioned the limited number of practicing mentors at the college and thus the need for training courses and guidelines for faculty members in regard to mentorship at academic institutions.</p> <p>Conclusions</p> <p>Both mentors and mentees were willing to improve mentorship practices at MAKCHS. There is need for institutional commitment to uphold and sustain the mentorship best practices. We recommend a collaborative approach by the stakeholders in global health promotion to build local capacity in mentoring African health professionals.</p

Building capacity for HIV/AIDS program leadership and management in Uganda through mentored Fellowships

Background: Around the world, health professionals and program managers are leading and managing public and private health organizations with little or no formal management and leadership training and experience. Objective: To describe an innovative 2-year, long-term apprenticeship Fellowship training program implemented by Makerere University School of Public Health (MakSPH) to strengthen capacity for leadership and management of HIV/AIDS programs in Uganda. Implementation process: The program, which began in 2002, is a 2-year, full-time, non-degree Fellowship. It is open to Ugandan nationals with postgraduate training in health-related disciplines. Enrolled Fellows are attached to host institutions implementing HIV/AIDS programs and placed under the supervision of host institution and academic mentors. Fellows spend 75% of their apprenticeship at the host institutions while the remaining 25% is dedicated to didactic short courses conducted at MakSPH to enhance their knowledge base. Achievements: Overall, 77 Fellows have been enrolled since 2002. Of the 57 Fellows who were admitted between 2002 and 2008, 94.7% (54) completed the Fellowship successfully and 50 (92.3%) are employed in senior leadership and management positions in Uganda and internationally. Eighty-eight percent of those employed (44/54) work in institutions registered in Uganda, indicating a high level of in-country retention. Nineteen of the 20 Fellows who were admitted between 2009 and 2010 are still undergoing training. A total of 67 institutions have hosted Fellows since 2002. The host institutions have benefited through staff training and technical expertise from the Fellows as well as through grant support to Fellows to develop and implement innovative pilot projects. The success of the program hinges on support from mentors, stakeholder involvement, and the hands-on approach employed in training. Conclusion: The Fellowship Program offers a unique opportunity for hands-on training in HIV/AIDS program leadership and management for both Fellows and host institutions

Do trialists endorse clinical trial registration? Survey of a Pubmed sample

<p>Abstract</p> <p>Introduction</p> <p>Despite intense interest in trial registration, there is a wide gap between theoretical postulates on trial registration and its implementation worldwide.</p> <p>Objective</p> <p>We aimed to evaluate trialists views about current international guidelines on trial registration, including the World Health Organization's (WHO) International Clinical Trials Registry Platform (ICTRP) policies and the Ottawa Statement, as well as their intention to register any future clinical trials they conduct.</p> <p>Methods</p> <p>We identified all 40,158 PUBMED-indexed clinical trials published from May 2005 to May 2006 using an advanced search strategy. From a random sample of 500 confirmed clinical trials, corresponding authors with e-mail contact addresses were surveyed.</p> <p>Results</p> <p>A total of 275 (60%) questionnaires from 45 countries were completed. 31% of the respondents had received only nonindustry funding during the past ten years, while 5% and 61% had received only industry or mixed funding respectively. Approximately two third of participants supported registration of all 20 WHO Data Set items, and endorsed the Ottawa Statement part 1 and part 2. Delayed public disclosure of some essential data in instances where they may be considered sensitive for competitive commercial reasons was supported by 30% of the participants, whereas immediate disclosure was supported by 53%. Only 21% of participants had registered all of their ongoing trials since 2005, while 47% stated that they would provide the 20 WHO Data Set items to a publicly accessible register for all their future clinical trials; a significantly higher proportion of participants who received only nonindustry funding (62%) was found among those who would always provide the 20 WHO items for future trials, compared to 42% of participants who received mixed or only industry funding. Among those who were undecided about endorsing registration. One third of participants expressed a lack of sufficient knowledge as the primary reason.</p> <p>Conclusion</p> <p>Although disagreement was apparent on certain issues, our findings illustrate that trial registration is gradually becoming part of the current research paradigm internationally. Our results also suggest that researchers require more knowledge to inform their decision to comply with the International standards at this early stage of voluntary trial registration.</p

Representation of women's health in general medical versus women's health specialty journals: a content analysis

BACKGROUND: Women's health, traditionally defined, emphasises reproductive and maternal conditions without consideration of social contexts. Advocates urge a broader conceptualisation. The medical literature influences the definitions and delivery of women's health care. We compared how women's health was represented in leading general medical (GM) versus women's health specialty (WS) journals. METHODS: Original investigations published between January 1 – June 30, 1999 in leading GM (n = 514) and WS (n = 82) journals were compared. Data were collected from 99 GM and 82 WS articles on women's health. Independent reviewers conducted content analyses of sample characteristics, study design, and health topic. Each article was classified as "Traditional" (e.g. menstruation, breast cancer), "Non-traditional" (e.g. abuse, osteoporosis), or "Both." RESULTS: Of the GM articles, 53 (53.5%) focused solely on a traditional women's health topic; half were reproductive and half female cancers. In contrast, 22 (26.8%) WS articles were traditionally focused. A non-traditional topic was the sole focus of 27 (27.3%) GM articles versus 34 (41.5%) WS articles. One-fifth of GM and one-third of WS articles addressed both. RCTs dominated the GM articles, while 40% of WS articles used qualitative or mixed study designs. Leading sources of women's death and disability were not well covered in either type of journal. CONCLUSIONS: Most GM articles drew on a narrow definition of women's health. WS journals provided more balanced coverage, addressing social concerns in addition to "navel-to-knees" women's health. Since GM journals have wide impact, editorial decisions and peer review processes should promote a broader conceptualisation of women's health