Browsing by Subject "Biomedical Research"
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Item Open Access A case study of inclusion of rural populations in research: Implications for science and health equity.(Clinical and translational science, 2024-08) Noonan, Devon; Lam, Wendy KK; Goodrich, James; Sullivan, Sydney; Bentley-Edwards, Keisha; Koeberl, Dwight; Palipana, Anushka; McClernon, F JosephPrior research highlights that rural populations have been historically underrepresented/excluded from clinical research. The primary objective of this study was to describe the inclusion of rural populations within our research enterprise using Clinical Research Management System demographic information at a large academic medical center in the Southeast. This was a cross-sectional study using participant demographic information for all protocols entered into our Clinical Research Management System between May 2018 and March 2021. Descriptive statistics were used to analyze the representation of rural and non-rural participants and demographic breakdown by age, sex, race, and ethnicity for our entire enterprise and at the state level. We also compared Material Community Deprivation Index levels between urban and rural participants. Results indicated that 19% of the research population was classified as rural and 81% as non-rural for our entire sample, and 17.5% rural and 82.5% urban for our state-level sample. There were significant differences in race, sex, and age between rural and non-rural participants and Material Community Deprivation Indices between rural and non-rural participants. Lessons learned and recommendations for increasing the inclusion of rural populations in research are discussed.Item Open Access A collaborative enterprise for multi-stakeholder participation in the advancement of quantitative imaging.(Radiology, 2011-03) Buckler, Andrew J; Bresolin, Linda; Dunnick, N Reed; Sullivan, Daniel C; GroupMedical imaging has seen substantial and rapid technical advances during the past decade, including advances in image acquisition devices, processing and analysis software, and agents to enhance specificity. Traditionally, medical imaging has defined anatomy, but increasingly newer, more advanced, imaging technologies provide biochemical and physiologic information based on both static and dynamic modalities. These advanced technologies are important not only for detecting disease but for characterizing and assessing change of disease with time or therapy. Because of the rapidity of these advances, research to determine the utility of quantitative imaging in either clinical research or clinical practice has not had time to mature. Methods to appropriately develop, assess, regulate, and reimburse must be established for these advanced technologies. Efficient and methodical processes that meet the needs of stakeholders in the biomedical research community, therapeutics developers, and health care delivery enterprises will ultimately benefit individual patients. To help address this, the authors formed a collaborative program-the Quantitative Imaging Biomarker Alliance. This program draws from the very successful precedent set by the Integrating the Healthcare Enterprise effort but is adapted to the needs of imaging science. Strategic guidance supporting the development, qualification, and deployment of quantitative imaging biomarkers will lead to improved standardization of imaging tests, proof of imaging test performance, and greater use of imaging to predict the biologic behavior of tissue and monitor therapy response. These, in turn, confer value to corporate stakeholders, providing incentives to bring new and innovative products to market.Item Open Access A few remarks on 'Statistical distribution of the difference of two proportions' by Nadarajah and Kotz, Statistics in Medicine 2007; 26(18):3518-3523.(Statistics in medicine, 2011-07) Chen, Yong; Luo, ShengItem Open Access A tale of two callings.(J Clin Invest, 2011-10) Lefkowitz, Robert JItem Open Access Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape: A Conference Report From the American Heart Association Data Summit 2015.(J Am Heart Assoc, 2015-11-05) Antman, Elliott M; Benjamin, Emelia J; Harrington, Robert A; Houser, Steven R; Peterson, Eric D; Bauman, Mary Ann; Brown, Nancy; Bufalino, Vincent; Califf, Robert M; Creager, Mark A; Daugherty, Alan; Demets, David L; Dennis, Bernard P; Ebadollahi, Shahram; Jessup, Mariell; Lauer, Michael S; Lo, Bernard; MacRae, Calum A; McConnell, Michael V; McCray, Alexa T; Mello, Michelle M; Mueller, Eric; Newburger, Jane W; Okun, Sally; Packer, Milton; Philippakis, Anthony; Ping, Peipei; Prasoon, Prad; Roger, Véronique L; Singer, Steve; Temple, Robert; Turner, Melanie B; Vigilante, Kevin; Warner, John; Wayte, Patrick; American Heart Association Data Sharing Summit AttendeesBACKGROUND: A 1.5-day interactive forum was convened to discuss critical issues in the acquisition, analysis, and sharing of data in the field of cardiovascular and stroke science. The discussion will serve as the foundation for the American Heart Association's (AHA's) near-term and future strategies in the Big Data area. The concepts evolving from this forum may also inform other fields of medicine and science. METHODS AND RESULTS: A total of 47 participants representing stakeholders from 7 domains (patients, basic scientists, clinical investigators, population researchers, clinicians and healthcare system administrators, industry, and regulatory authorities) participated in the conference. Presentation topics included updates on data as viewed from conventional medical and nonmedical sources, building and using Big Data repositories, articulation of the goals of data sharing, and principles of responsible data sharing. Facilitated breakout sessions were conducted to examine what each of the 7 stakeholder domains wants from Big Data under ideal circumstances and the possible roles that the AHA might play in meeting their needs. Important areas that are high priorities for further study regarding Big Data include a description of the methodology of how to acquire and analyze findings, validation of the veracity of discoveries from such research, and integration into investigative and clinical care aspects of future cardiovascular and stroke medicine. Potential roles that the AHA might consider include facilitating a standards discussion (eg, tools, methodology, and appropriate data use), providing education (eg, healthcare providers, patients, investigators), and helping build an interoperable digital ecosystem in cardiovascular and stroke science. CONCLUSION: There was a consensus across stakeholder domains that Big Data holds great promise for revolutionizing the way cardiovascular and stroke research is conducted and clinical care is delivered; however, there is a clear need for the creation of a vision of how to use it to achieve the desired goals. Potential roles for the AHA center around facilitating a discussion of standards, providing education, and helping establish a cardiovascular digital ecosystem. This ecosystem should be interoperable and needs to interface with the rapidly growing digital object environment of the modern-day healthcare system.Item Restricted Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets.(PLoS One, 2010-02-19) de Carvalho, EC; Batilana, AP; Simkins, J; Martins, H; Shah, J; Rajgor, D; Shah, A; Rockart, S; Pietrobon, RBACKGROUND: Sharing of epidemiological and clinical data sets among researchers is poor at best, in detriment of science and community at large. The purpose of this paper is therefore to (1) describe a novel Web application designed to share information on study data sets focusing on epidemiological clinical research in a collaborative environment and (2) create a policy model placing this collaborative environment into the current scientific social context. METHODOLOGY: The Database of Databases application was developed based on feedback from epidemiologists and clinical researchers requiring a Web-based platform that would allow for sharing of information about epidemiological and clinical study data sets in a collaborative environment. This platform should ensure that researchers can modify the information. A Model-based predictions of number of publications and funding resulting from combinations of different policy implementation strategies (for metadata and data sharing) were generated using System Dynamics modeling. PRINCIPAL FINDINGS: The application allows researchers to easily upload information about clinical study data sets, which is searchable and modifiable by other users in a wiki environment. All modifications are filtered by the database principal investigator in order to maintain quality control. The application has been extensively tested and currently contains 130 clinical study data sets from the United States, Australia, China and Singapore. Model results indicated that any policy implementation would be better than the current strategy, that metadata sharing is better than data-sharing, and that combined policies achieve the best results in terms of publications. CONCLUSIONS: Based on our empirical observations and resulting model, the social network environment surrounding the application can assist epidemiologists and clinical researchers contribute and search for metadata in a collaborative environment, thus potentially facilitating collaboration efforts among research communities distributed around the globe.Item Open Access Barriers to and facilitators of interventions to counter publication bias: thematic analysis of scholarly articles and stakeholder interviews.(BMC Health Serv Res, 2014-11-13) Kien, Christina; Nußbaumer, Barbara; Thaler, Kylie J; Griebler, Ursula; Van Noord, Megan G; Wagner, Petra; Gartlehner, Gerald; UNCOVER Project ConsortiumBACKGROUND: When the nature and direction of research results affect their chances of publication, a distortion of the evidence base - termed publication bias - results. Despite considerable recent efforts to implement measures to reduce the non-publication of trials, publication bias is still a major problem in medical research. The objective of our study was to identify barriers to and facilitators of interventions to prevent or reduce publication bias. METHODS: We systematically reviewed the scholarly literature and extracted data from articles. Further, we performed semi-structured interviews with stakeholders. We performed an inductive thematic analysis to identify barriers to and facilitators of interventions to counter publication bias. RESULTS: The systematic review identified 39 articles. Thirty-four of 89 invited interview partners agreed to be interviewed. We clustered interventions into four categories: prospective trial registration, incentives for reporting in peer-reviewed journals or research reports, public availability of individual patient-level data, and peer-review/editorial processes. Barriers we identified included economic and personal interests, lack of financial resources for a global comprehensive trial registry, and different legal systems. Facilitators identified included: raising awareness of the effects of publication bias, providing incentives to make data publically available, and implementing laws to enforce prospective registration and reporting of clinical trial results. CONCLUSIONS: Publication bias is a complex problem that reflects the complex system in which it occurs. The cooperation amongst stakeholders to increase public awareness of the problem, better tailoring of incentives to publish, and ultimately legislative regulations have the greatest potential for reducing publication bias.Item Open Access Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT).(BMC pediatrics, 2010-04-30) Wallander, Jan L; McClure, Elizabeth; Biasini, Fred; Goudar, Shivaprasad S; Pasha, Omrana; Chomba, Elwyn; Shearer, Darlene; Wright, Linda; Thorsten, Vanessa; Chakraborty, Hrishikesh; Dhaded, Sangappa M; Mahantshetti, Niranjana S; Bellad, Roopa M; Abbasi, Zahid; Carlo, Waldemar; BRAIN-HIT InvestigatorsThis randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia.This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors.The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential to inform about strategies for reducing neurodevelopmental disabilities in at-risk young children in low and middle income countries.Item Open Access Complications in the surgical treatment of 19,360 cases of pediatric scoliosis: a review of the Scoliosis Research Society Morbidity and Mortality database.(Spine, 2011-08) Reames, Davis L; Smith, Justin S; Fu, Kai-Ming G; Polly, David W; Ames, Christopher P; Berven, Sigurd H; Perra, Joseph H; Glassman, Steven D; McCarthy, Richard E; Knapp, Raymond D; Heary, Robert; Shaffrey, Christopher I; Scoliosis Research Society Morbidity and Mortality CommitteeStudy design
Retrospective review of a multicenter database.Objective
To determine the complication rates associated with surgical treatment of pediatric scoliosis and to assess variables associated with increased complication rates.Summary of background data
Wide variability is reported for complications associated with the operative treatment of pediatric scoliosis. Limited number of patients, surgeons, and diagnoses occur in most reports. The Scoliosis Research Society Morbidity and Mortality (M&M) database aggregates deidentified data, permitting determination of complication rates from large numbers of patients and surgeons.Methods
Cases of pediatric scoliosis (age ≤18 years), entered into the Scoliosis Research Society M&M database between 2004 and 2007, were analyzed. Age, scoliosis type, type of instrumentation used, and complications were assessed.Results
A total of 19,360 cases fulfilled inclusion criteria. Of these, complications occurred in 1971 (10.2%) cases. Overall complication rates differed significantly among idiopathic, congenital, and neuromuscular cases (P < 0.001). Neuromuscular scoliosis had the highest rate of complications (17.9%), followed by congenital scoliosis (10.6%) and idiopathic scoliosis (6.3%). Rates of neurologic deficit also differed significantly based on the etiology of scoliosis (P < 0.001), with the highest rate among congenital cases (2.0%), followed by neuromuscular types (1.1%) and idiopathic scoliosis (0.8%). Neur-omuscular scoliosis and congenital scoliosis had the highest rates of mortality (0.3% each), followed by idiopathic scoliosis (0.02%). Higher rates of new neurologic deficits were associated with revision procedures (P < 0.001) and with the use of corrective osteotomies (P < 0.001). The rates of new neurologic deficit were significantly higher for procedures using anterior screw-only constructs (2.0%) or wire-only constructs (1.7%), compared with pedicle screw-only constructs (0.7%) (P < 0.001).Conclusion
In this review of a large multicenter database of surgically treated pediatric scoliosis, neuromuscular scoliosis had the highest morbidity, but relatively high complication rates occurred in all groups. These data may be useful for preoperative counseling and surgical decision-making in the treatment of pediatric scoliosis.Item Open Access Conflicts of Interest and Outcomes of Cardiovascular Trials.(Am J Cardiol, 2016-03-01) Riaz, Haris; Khan, Muhammad Shahzeb; Riaz, Irbaz Bin; Raza, Sajjad; Khan, Abdur Rahman; Krasuski, Richard AConflicts of interests have long been recognized as potential sources of influence in the conduct and reporting of clinical trials. This controversy was again rekindled after the publication of the latest statin guidelines and a series of studies regarding competing interests in leading medical journals. We investigate the association between declared author conflicts and the outcomes of large cardiovascular trials. We searched the Medline (PubMed) database to identify "phase 2" and "phase 3" clinical trials using the search term "cardiovascular" over the past decade using "10 years" as the filter. We perceived the competing interest as present regardless of the nature such as consulting fees, honoraria, travel imbursements, stock holding, and employment. Of the 699 titles retrieved, 114 studies met the inclusion criteria. Nearly 80% of studies had at least a single author with competing interests. The 114 studies had a total of 1,433 investigators, of which 725 had declared conflicts of interests (50.6%). A total of 66 studies (58%) had half or >50 percent of investigators who had some conflicts of interests. Of these studies, 54 studies had favorable outcomes and only 12 had unfavorable outcomes (p <0.001). Among the type of competing interests, consulting or personal fees was the most common present in 58 investigators (51%). This was followed by research grants present in 55 the researchers (48%). Among 25 (22%) studies, at least one investigator reported stakes in the industry, of which only 2 studies had unfavorable outcomes for the intervention being investigated. Just 1 of the 25 clinical trials with a sample size of >1,000 had no investigators with competing interests. In conclusion, authors conflicts are associated with favorable outcomes in cardiovascular outcome trials.Item Open Access Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.(Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography, 2016-12) Crowley, Anna Lisa; Yow, Eric; Barnhart, Huiman X; Daubert, Melissa A; Bigelow, Robert; Sullivan, Daniel C; Pencina, Michael; Douglas, Pamela SBackground
There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results.Methods
Twenty unique clinical studies were identified reporting echocardiographic data quality for determinations of left ventricular (LV) volumes (n = 13), ejection fraction (n = 12), mass (n = 9), outflow tract diameter (n = 3), and mitral Doppler peak early velocity (n = 4). To better understand the range of possible estimates of data quality and to compare their utility, reported reproducibility measures were tabulated, and de novo estimates were then calculated for missing measures, including intraclass correlation coefficient (ICC), 95% limits of agreement, coefficient of variation (CV), coverage probability, and total deviation index, for each variable for each study.Results
The studies varied in approaches to reproducibility testing, sample size, and metrics assessed and values reported. Reported metrics included mean difference and its SD (n = 7 studies), ICC (n = 5), CV (n = 4), and Bland-Altman limits of agreement (n = 4). Once de novo estimates of all missing indices were determined, reasonable reproducibility targets for each were identified as those achieved by the majority of studies. These included, for LV end-diastolic volume, ICC > 0.95, CV < 7%, and coverage probability > 0.93 within 30 mL; for LV ejection fraction, ICC > 0.85, CV < 8%, and coverage probability > 0.85 within 10%; and for LV mass, ICC > 0.85, CV < 10%, and coverage probability > 0.60 within 20 g.Conclusions
Assessment of data quality in echocardiographic clinical research is infrequent, and methods vary substantially. A first step to standardizing echocardiographic quality reporting is to standardize assessments and reporting metrics. Potential benefits include clearer communication of data quality and the identification of achievable targets to benchmark quality improvement initiatives.Item Open Access Electronic health records, medical research, and the Tower of Babel.(N Engl J Med, 2008-04-17) Kush, Rebecca D; Helton, Edward; Rockhold, Frank W; Hardison, C DavidItem Open Access Evidence2Practice (E2P): Leveraging Implementation Science to Promote Careers in HIV Research Among Students From Historically Black Colleges and Universities.(Journal of acquired immune deficiency syndromes (1999), 2023-10) Okeke, Nwora Lance; Ware, Kenric B; Campbell, Russell; Taylor, Jamilah; Hung, Frances; Questell, Caroline; Brickler, Mildred P; Smith, Ukamaka D; Nawas, George T; Hanlen-Rosado, Emily; Chan, Cliburn; Bosworth, Hayden B; Aifah, Angela; Corneli, AmyBackground
The HIV research workforce is not representative of populations most affected by the epidemic. Innovative educational programs are needed to motivate diverse student populations to pursue careers in HIV research.Methods
The Duke University Center for AIDS Research Evidence2Practice (E2P) program is a 3-day interactive workshop that introduces students from Historically Black Colleges and Universities (HBCU) to HIV pre-exposure prophylaxis, implementation science, and human-centered design. Participants develop 1-page action plans to increase awareness and uptake of pre-exposure prophylaxis on their campus. The program was evaluated using a partially mixed-method concurrent equal status study design with pre-program and post-program surveys and in-depth interviews.Results
Among the 52 participating students, 44 completed the preworkshop survey, 45 completed the postworkshop survey, and 10 participated in an in-depth interview. Most participants identified as Black or African American and cisgender female. Participating in the E2P program was associated with: (1) an increase in median interest in pursuing a career in HIV research (P < 0.01) and (2) a decrease in median perceived difficulty in starting a career in HIV research (P < 0.01). Several students described that a lack of knowledge about initiating an HIV research career, a perceived lack of qualifications and knowledge about HIV science, and limited experience were major barriers to considering careers in HIV research.Conclusions
The E2P program enhanced HBCU students' interest in careers related to HIV research and improved their self-efficacy to pursue such careers. On-campus educational enrichment initiatives, led by active HIV researchers and clinicians, should be a critical part of diversifying the HIV workforce.Item Open Access Global chronic disease research training for fellows: perspectives, challenges, and opportunities.(Circulation, 2010-03-23) Bloomfield, Gerald; Huffman, Mark DItem Open Access Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.(Cancer Prev Res (Phila), 2008-07) Moe, Jeffrey LChemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, which have limited investment in their research and development (R&D). These barriers include above-average clinical trial scales, lengthy time frames between discovery and Food and Drug Administration approval, liability risks (because they are given to healthy individuals), and a growing funding gap for early-stage candidates. The longer time frames and risks associated with chemoprevention also cause exclusivity time on core patents to be limited or subject to significant uncertainties. We conclude that chemoprevention uniquely challenges the structure of incentives embodied in the economic, regulatory, and patent policies for the biopharmaceutical industry. Many of these policy issues are illustrated by the recently Food and Drug Administration-approved preventive agents Gardasil and raloxifene. Our recommendations to increase R&D investment in chemoprevention agents include (a) increased data exclusivity times on new biological and chemical drugs to compensate for longer gestation periods and increasing R&D costs; chemoprevention is at the far end of the distribution in this regard; (b) policies such as early-stage research grants and clinical development tax credits targeted specifically to chemoprevention agents (these are policies that have been very successful in increasing R&D investment for orphan drugs); and (c) a no-fault liability insurance program like that currently in place for children's vaccines.Item Open Access Improving the Emergency Care Research Investigator Pipeline: SAEM/ACEP Recommendations.(Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2015-07) Ranney, Megan L; Limkakeng, Alexander T; Carr, Brendan; Zink, Brian; Kaji, Amy H; ACEP SAEM Research Committees (approved by ACEP-SAEM Board of Directors)Item Open Access Okukkera Ng'omuzungu (lost in translation): understanding the social value of global health research for HIV/AIDS research participants in Uganda.(Global public health, 2010-01) Stewart, K; Sewankambo, NAs major global governance entities begin to re-assess the structure and goals of health research in resource-poor settings, social science can make a vital contribution by expanding the traditional field of research ethics to include new concepts such as the social value of global health research. This essay recasts the definition of social value in health research by shifting away from the official spaces where research occurs and towards the meaning of research as it is produced in the everyday spaces inhabited by the local community. We present three cases that reveal the local view of the social value of health research for Ugandans: autonomy and consent; the concept of risk; and what appears to be a classic case of therapeutic misconception between researcher and informant. Ultimately what we see, we argue, is the fundamental collision of the logic of biomedical research with the logic of local social relationships, that is, researchers perform their role as a transaction, while participants anticipate their involvement in research to be transformative. When we expand the analysis of the impact of research from the research/participant dyad to shifting community networks, we conclude that didactic models, such as the therapeutic misconception, are of limited utility for understanding the social value of global health research in resource-poor settings.Item Open Access Overcoming Challenges to Research Success in Cardiothoracic Anesthesiology Fellowship Training.(Journal of cardiothoracic and vascular anesthesia, 2024-10) Bottiger, Brandi A; Ghadimi, Kamrouz; Cherry, Anne; Mazzeffi, MichaelItem Open Access PARTAKE survey of public knowledge and perceptions of clinical research in India.(PLoS One, 2013) Burt, Tal; Dhillon, Savita; Sharma, Pooja; Khan, Danish; Mv, Deepa; Alam, Sazid; Jain, Sarika; Alapati, Bhavana; Mittal, Sanjay; Singh, PadamBACKGROUND: A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE - Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. OBJECTIVE: To study public knowledge and perceptions of clinical research. METHODS: A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. RESULTS: Interviewees were 18-84 old (mean: 39.6, SD ± 16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): 'research benefits society' (94.1%/3.5%/2.3%), 'the government protects against unethical clinical research' (56.7%/26.3%/16.9%), 'research hospitals provide better care' (67.2%/8.7%/23.9%), 'confidentiality is adequately protected' (54.1%/12.3%/33.5%), 'participation in research is voluntary' (85.3%/5.8%/8.7%); 'participants treated like 'guinea pigs'' (20.7%/53.2%/26.0%), and 'compensation for participation is adequate' (24.7%/12.9%/62.3%). CONCLUSIONS: Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues.Item Open Access Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.(Journal of the American Heart Association, 2013-09-26) Alexander, Karen P; Kong, David F; Starr, Aijing Z; Kramer, Judith; Chiswell, Karen; Tasneem, Asba; Califf, Robert MCardiovascular medicine is widely regarded as a vanguard for evidence-based drug and technology development. Our goal was to describe the cardiovascular clinical research portfolio from ClinicalTrials.gov.We identified 40 970 clinical research studies registered between 2007 and 2010 in which patients received diagnostic, therapeutic, or other interventions per protocol. By annotating 18 491 descriptors from the National Library of Medicine's Medical Subject Heading thesaurus and 1220 free-text terms to select those relevant to cardiovascular disease, we identified studies that related to the diagnosis, treatment, or prevention of diseases of the heart and peripheral arteries in adults (n = 2325 [66%] included from review of 3503 potential studies). The study intervention involved a drug in 44.6%, a device or procedure in 39.3%, behavioral intervention in 8.1%, and biological or genetic interventions in 3.0% of the trials. More than half of the trials were postmarket approval (phase 4, 25.6%) or not part of drug development (no phase, 34.5%). Nearly half of all studies (46.3%) anticipated enrolling 100 patients or fewer. The majority of studies assessed biomarkers or surrogate outcomes, with just 31.8% reporting a clinical event as a primary outcome.Cardiovascular studies registered on ClinicalTrials.gov span a range of study designs. Data have limited verification or standardization and require manual processes to describe and categorize studies. The preponderance of small and late-phase studies raises questions regarding the strength of evidence likely to be generated by the current portfolio and the potential efficiency to be gained by more research consolidation.