Commentary on Sertkaya et al. and Larson et al.
PMID: 26908542 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 8, 2016 Category: Research Authors: Eisenstein EL Tags: Clin Trials Source Type: research

2015 Peer Reviewers.
Authors: PMID: 26908309 [PubMed - in process] (Source: Clinical Trials)
Source: Clinical Trials - February 1, 2016 Category: Research Tags: Clin Trials Source Type: research

Remarks on designs enriching for placebo non-responders.
Abstract BACKGROUND: High response under placebo constitutes a concern in clinical studies, particularly in psychiatry. Discontinuation of placebo responders identified during a placebo run-in is often recommended to avoid failures of clinical trials in the presence of high placebo effects. Evidence for the benefit of this approach is ambiguous. PURPOSE: We investigate under which conditions a placebo lead-in can be beneficial in the context of continuous data, assuming that the data in the placebo run-in and the treatment stage follow a bivariate normal distribution. Placebo responders are defined as patient...
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Rosenkranz GK Tags: Clin Trials Source Type: research

Trial design for evaluating novel treatments during an outbreak of an infectious disease.
This article discusses the designs used for two such clinical trials which have recruited patients in Liberia and Sierra Leone. General principles are outlined for trial designs intended to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again. Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic. PMID: 26768556 [PubMed - as supplied by publisher] (Sou...
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Whitehead J, Olliaro P, Lang T, Horby P Tags: Clin Trials Source Type: research

Clinical research during the Ebola virus disease outbreak in Guinea: Lessons learned and ways forward.
PMID: 26768557 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Beavogui AH, Delamou A, Yansane ML, Konde MK, Diallo AA, Aboulhab J, Bah-Sow OY, Keita S Tags: Clin Trials Source Type: research

Randomized controlled trials in the West African Ebola virus outbreak.
PMID: 26768558 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Upshur R, Fuller J Tags: Clin Trials Source Type: research

Ebola clinical trials: Five lessons learned and a way forward.
PMID: 26768559 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Thielman NM, Cunningham CK, Woods C, Petzold E, Sprenz M, Russell J Tags: Clin Trials Source Type: research

Statistics and logistics: Design of Ebola vaccine trials in West Africa.
PMID: 26768560 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Nason M Tags: Clin Trials Source Type: research

A viewpoint on European Medicines Agency experience with investigational medicinal products for Ebola.
PMID: 26768561 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Cavaleri M, Thomson A, Salmonson T, Hemmings RJ Tags: Clin Trials Source Type: research

Academics are from Mars, humanitarians are from Venus: Finding common ground to improve research during humanitarian emergencies.
PMID: 26768562 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Levine AC Tags: Clin Trials Source Type: research

Evaluating interventions for Ebola: The need for randomized trials.
PMID: 26768563 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Fleming TR, Ellenberg SS Tags: Clin Trials Source Type: research

Conducting clinical trials in outbreak settings: Points to consider.
PMID: 26768564 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Lane HC, Marston HD, Fauci AS Tags: Clin Trials Source Type: research

A US Food and Drug Administration perspective on evaluating medical products for Ebola.
PMID: 26768565 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Russek-Cohen E, Rubin D, Price D, Sun W, Cox E, Borio L Tags: Clin Trials Source Type: research

Clinical validation trial of a diagnostic for Ebola Zaire antigen detection: Design rationale and challenges to implementation.
This article describes a study designed to validate the sensitivity and specificity of the ReEBOVTM Rapid Diagnostic Test using venous whole blood and capillary blood obtained via fingerprick. We present the scientific and clinical rationale for the decisions made in the design of a diagnostic validation study to be conducted in an outbreak setting. The multi-site strategy greatly complicated implementation. In addition, a decrease in cases in one geographic area along with a concomitant increase in other areas made site selection challenging. Initiation of clinical trials during rapidly evolving outbreaks requires signifi...
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Schieffelin J, Moses LM, Shaffer J, Goba A, Grant DS Tags: Clin Trials Source Type: research

Statistical considerations for a trial of Ebola virus disease therapeutics.
This article describes the Ebola virus disease medical countermeasures trial design and the thinking behind it. PMID: 26768567 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Proschan MA, Dodd LE, Price D Tags: Clin Trials Source Type: research

Simulation-guided phase 3 trial design to evaluate vaccine effectiveness to prevent Ebola virus disease infection: Statistical considerations, design rationale, and challenges.
Abstract Starting in December 2013, West Africa was overwhelmed with the deadliest outbreak of Ebola virus known to date, resulting in more than 27,500 cases and 11,000 deaths. In response to the epidemic, development of a heterologous prime-boost vaccine regimen was accelerated and involved preparation of a phase 3 effectiveness study. While individually randomized controlled trials are widely acknowledged as the gold standard for demonstrating the efficacy of a candidate vaccine, there was considerable debate on the ethical appropriateness of these designs in the context of an epidemic. A suitable phase 3 trial ...
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Vandebosch A, Mogg R, Goeyvaerts N, Truyers C, Greenwood B, Watson-Jones D, Herrera-Taracena G, Parys W, Vangeneugden T Tags: Clin Trials Source Type: research

A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response.
Abstract The outbreak of Ebola virus disease in West Africa is the largest ever recorded. Numerous treatment alternatives for Ebola have been considered, including widely available repurposed drugs, but initiation of enrollment into clinical trials has been limited. The proposed trial is an adaptive platform design. Multiple agents and combinations will be investigated simultaneously. Additionally, new agents may enter the trial as they become available, and failing agents may be removed. In order to accommodate the many possible agents and combinations, a critical feature of this design is the use of response ada...
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Berry SM, Petzold EA, Dull P, Thielman NM, Cunningham CK, Corey GR, McClain MT, Hoover DL, Russell J, Griffiss JM, Woods CW Tags: Clin Trials Source Type: research

Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014-2015 outbreak.
Abstract The Ebola virus disease outbreak in 2014-2015 led to a huge caseload with a high case fatality rate. No specific treatments were available beyond supportive care for conditions such as dehydration and shock. Evaluation of treatment with convalescent plasma from Ebola survivors was identified as a priority. We evaluated this intervention in an emergency setting, where randomization was unacceptable. The original trial design was an open-label study comparing patients receiving convalescent plasma and supportive care to patients receiving supportive care alone. The comparison group comprised patients recrui...
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Edwards T, Semple MG, De Weggheleire A, Claeys Y, De Crop M, Menten J, Ravinetto R, Temmerman S, Lynen L, Bah EI, Smith PG, van Griensven J, Ebola_Tx Consortium Tags: Clin Trials Source Type: research

Clinical trials during the Ebola crisis.
PMID: 26768571 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Dodd LE Tags: Clin Trials Source Type: research

Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges.
Abstract The index case of the Ebola virus disease epidemic in West Africa is believed to have originated in Guinea. By June 2014, Guinea, Liberia, and Sierra Leone were in the midst of a full-blown and complex global health emergency. The devastating effects of this Ebola epidemic in West Africa put the global health response in acute focus for urgent international interventions. Accordingly, in October 2014, a World Health Organization high-level meeting endorsed the concept of a phase 2/3 clinical trial in Liberia to study Ebola vaccines. As a follow-up to the global response, in November 2014, the Government o...
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Kennedy SB, Neaton JD, Lane HC, Kieh MW, Massaquoi MB, Touchette NA, Nason MC, Follmann DA, Boley FK, Johnson MP, Larson G, Kateh FN, Nyenswah TG Tags: Clin Trials Source Type: research

Ethical challenges to responding to the Ebola epidemic: the World Health Organization experience.
PMID: 26768573 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 14, 2016 Category: Research Authors: Saxena A, Gomes M Tags: Clin Trials Source Type: research

Commentary on Zvonareva et al.
PMID: 26555682 [PubMed - in process] (Source: Clinical Trials)
Source: Clinical Trials - November 13, 2015 Category: Research Authors: Dresser R Tags: Clin Trials Source Type: research

Feasibility and clinical impact of sharing patient-reported symptom toxicities and performance status with clinical investigators during a phase 2 cancer treatment trial.
CONCLUSION: Clinicians will frequently agree with patient-reported symptoms and performance status, and will use this information to guide documentation and symptom management. (ClinicalTrials.gov: NCT00807573). PMID: 26542025 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - November 4, 2015 Category: Research Authors: Basch E, Wood WA, Schrag D, Sima CS, Shaw M, Rogak LJ, Kris MG, Shouery M, Bennett A, Atkinson T, Pietanza MC Tags: Clin Trials Source Type: research

Benefits and barriers to participating in longitudinal research of youth-onset type 2 diabetes: Results from the TODAY retention survey.
CONCLUSIONS: Similar to other published reports, a supportive relationship with study staff was commonly endorsed as a benefit of engagement in the longitudinal study, suggesting that rapport, staff consistency, and relationship quality are important components of optimal retention. Moreover, our findings suggest the value of trying to remove logistical barriers, such as transportation and scheduling challenges, in order to promote long-term participation in research. Further research is recommended to evaluate factors that contribute to attrition versus retention in an a priori manner within longitudinal studies, especial...
Source: Clinical Trials - November 3, 2015 Category: Research Authors: Walders-Abramson N, Anderson B, Larkin ME, Chang N, Venditti E, Bzdick S, Tryggestad JB, Tan K, Geffner ME, Hirst K Tags: Clin Trials Source Type: research

Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP.
CONCLUSION: The STEPP methodology can be used to study complex patterns of treatment effect heterogeneity, as illustrated in the Breast International Group 1-98 randomized clinical trial. For the subpopulation treatment effect pattern plot analysis, we recommend a minimum of 20 events within each subpopulation. PMID: 26493094 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 22, 2015 Category: Research Authors: Lazar AA, Bonetti M, Cole BF, Yip WK, Gelber RD Tags: Clin Trials Source Type: research

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.
CONCLUSION: A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. PMID: 26464429 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 13, 2015 Category: Research Authors: Zhao W, Pauls K Tags: Clin Trials Source Type: research

Should consent forms used in clinical trials be translated into the local dialects? A survey among past participants in rural Ghana.
Abstract BACKGROUND: Obtaining informed consent is part of the expression of the principle of participant autonomy during clinical trials. It is critical that participants understand the content of informed consent forms and remain in a position to seek independent advice on its content. We conducted a survey among past participants of a clinical trial in the Kassena-Nankana Districts of rural northern Ghana about the usefulness of informed consent forms that are written in the local dialects. The written forms of local dialects are largely undeveloped. METHOD: We contacted a randomly selected sample of careg...
Source: Clinical Trials - October 9, 2015 Category: Research Authors: Baiden F, Akazili J, Chatio S, Achana FS, Oduro AR, Ravinetto R, Hodgson A Tags: Clin Trials Source Type: research

Editorial.
PMID: 26428469 [PubMed - in process] (Source: Clinical Trials)
Source: Clinical Trials - October 1, 2015 Category: Research Authors: Begg CB, Goodman SN Tags: Clin Trials Source Type: research

An interview with David Sackett, 2014-2015.
PMID: 26428470 [PubMed - in process] (Source: Clinical Trials)
Source: Clinical Trials - October 1, 2015 Category: Research Authors: Haynes RB, Goodman SN Tags: Clin Trials Source Type: research

Randomized trials can be minimal risk: Commentary on Kim Miller.
PMID: 26419904 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - September 29, 2015 Category: Research Authors: Magnus D, Wilfond B Tags: Clin Trials Source Type: research

Recruiting community health centers into pragmatic research: Findings from STOP CRC.
CONCLUSION: Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research. PMID: 26419905 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - September 29, 2015 Category: Research Authors: Coronado GD, Retecki S, Schneider J, Taplin SH, Burdick T, Green BB Tags: Clin Trials Source Type: research

A comparison of confidence interval methods for the intraclass correlation coefficient in community-based cluster randomization trials with a binary outcome.
Abstract BACKGROUND: Many investigators rely on previously published point estimates of the intraclass correlation coefficient rather than on their associated confidence intervals to determine the required size of a newly planned cluster randomized trial. Although confidence interval methods for the intraclass correlation coefficient that can be applied to community-based trials have been developed for a continuous outcome variable, fewer methods exist for a binary outcome variable. The aim of this study is to evaluate confidence interval methods for the intraclass correlation coefficient applied to binary outcome...
Source: Clinical Trials - September 28, 2015 Category: Research Authors: Braschel MC, Svec I, Darlington GA, Donner A Tags: Clin Trials Source Type: research

Ethical complexities in standard of care randomized trials: A case study of morning versus nighttime dosing of blood pressure drugs.
CONCLUSION: The Standard of Care Principle is ethically inadequate and misleading even when it is applied to the pragmatic randomized clinical trial proposed as a paradigm case for its application. PMID: 26400874 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - September 22, 2015 Category: Research Authors: Kim SY, Miller FG Tags: Clin Trials Source Type: research

Fallacies of last observation carried forward analyses.
CONCLUSION: All analyses using last observation carried forward are of questionable veracity, if not being outright specious (definition: appearing to be true but actually false). It is hoped that future studies will make a more vigorous attempt to minimize the amount of missing data and that more valid statistical analyses will be employed in cases where missing data occur. Last observation carried forward should not be employed in any analyses. PMID: 26400875 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - September 22, 2015 Category: Research Authors: Lachin JM Tags: Clin Trials Source Type: research

Recruiting and retaining young adults in a weight gain prevention trial: Lessons learned from the CHOICES study.
CONCLUSION: Two-year colleges and their students are interested in participating in weight-related trials and partnering with universities for research. Researchers must work closely with administrators to identify benefits to their institutions and to resolve student-level barriers to recruitment and retention. Our experiences from the Choosing Healthy Options in College Environments and Settings study should be useful in identifying effective recruitment and retention methods for weight gain prevention trials among young adults. PMID: 26378096 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - September 16, 2015 Category: Research Authors: Moe SG, Lytle LA, Nanney MS, Linde JA, Laska MN Tags: Clin Trials Source Type: research

Exploring the ethical and regulatory issues in pragmatic clinical trials.
Abstract The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise ...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Califf RM, Sugarman J Tags: Clin Trials Source Type: research

Use of altered informed consent in pragmatic clinical research.
Abstract There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or c...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: McKinney RE, Beskow LM, Ford DE, Lantos JD, McCall J, Patrick-Lake B, Pletcher MJ, Rath B, Schmidt H, Weinfurt K Tags: Clin Trials Source Type: research

Harmonization and streamlining of research oversight for pragmatic clinical trials.
Abstract The oversight of research involving human participants is a complex process that requires institutional review board review as well as multiple non-institutional review board institutional reviews. This multifaceted process is particularly challenging for multisite research when each site independently completes all required local reviews. The lack of inter-institutional standardization can result in different review outcomes for the same protocol, which can delay study operations from start-up to study completion. Hence, there have been strong calls to harmonize and thus streamline the research oversight...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: O'Rourke PP, Carrithers J, Patrick-Lake B, Rice TW, Corsmo J, Hart R, Drezner MK, Lantos JD Tags: Clin Trials Source Type: research

Data monitoring committees for pragmatic clinical trials.
Abstract In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an ...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Ellenberg SS, Culbertson R, Gillen DL, Goodman S, Schrandt S, Zirkle M Tags: Clin Trials Source Type: research

Harms, benefits, and the nature of interventions in pragmatic clinical trials.
Abstract To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implemen...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Ali J, Andrews JE, Somkin CP, Rabinovich CE Tags: Clin Trials Source Type: research

The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.
Abstract Policies have been developed to protect vulnerable populations in clinical research, including the US federal research regulations (45 Code of Federal Regulations 46 Subparts B, C, and D). These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. The aim has been to protect these populations from harm, often by creating regulatory and ethical checks that may limit their participation in many clinical trials. The recent increase in pragmatic clinical trials r...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Welch MJ, Lally R, Miller JE, Pittman S, Brodsky L, Caplan AL, Uhlenbrauck G, Louzao DM, Fischer JH, Wilfond B Tags: Clin Trials Source Type: research

Privacy and confidentiality in pragmatic clinical trials.
Abstract With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ide...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: McGraw D, Greene SM, Miner CS, Staman KL, Welch MJ, Rubel A Tags: Clin Trials Source Type: research

Gatekeepers for pragmatic clinical trials.
This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. T...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Whicher DM, Miller JE, Dunham KM, Joffe S Tags: Clin Trials Source Type: research

The Food and Drug Administration and pragmatic clinical trials of marketed medical products.
Abstract Pragmatic clinical trials can help answer questions of comparative effectiveness for interventions routinely used in medical practice. Pragmatic clinical trials may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity of the data upon which approval of medical products is made. The Food and Drug Administration has broad jurisdiction over drugs and medical devices (whether or not...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Anderson ML, Griffin J, Goldkind SF, Zeitler EP, Wing L, Al-Khatib SM, Sherman RE Tags: Clin Trials Source Type: research

Oversight on the borderline: Quality improvement and pragmatic research.
Abstract Pragmatic research that compares interventions to improve the organization and delivery of health care may overlap, in both goals and methods, with quality improvement activities. When activities have attributes of both research and quality improvement, confusion often arises about what ethical oversight is, or should be, required. For routine quality improvement, in which the delivery of health care is modified in minor ways that create only minimal risks, oversight by local clinical or administrative leaders utilizing institutional policies may be sufficient. However, additional consideration should be ...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Finkelstein JA, Brickman AL, Capron A, Ford DE, Gombosev A, Greene SM, Iafrate RP, Kolaczkowski L, Pallin SC, Pletcher MJ, Staman KL, Vazquez MA, Sugarman J Tags: Clin Trials Source Type: research

Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials.
Abstract Institutional review boards, which are charged with overseeing research, must classify the riskiness of proposed research according to a federal regulation known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration codified in 21 CFR 50. If an institutional review board determines that a clinical trial constitutes "minimal risk," there are important practical implications: the institutional review board may then allow a waiver or alteration of the informed consent process; the study may be carried out in certain vulnerable populations; or the...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Lantos JD, Wendler D, Septimus E, Wahba S, Madigan R, Bliss G Tags: Clin Trials Source Type: research

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.
Abstract Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to ...
Source: Clinical Trials - September 15, 2015 Category: Research Authors: Smalley JB, Merritt MW, Al-Khatib SM, McCall D, Staman KL, Stepnowsky C Tags: Clin Trials Source Type: research

Risks of phase I research with healthy participants: A systematic review.
CONCLUSION: We conclude that phase I trials do cause mild and moderate harms but pose low risks of severe harm. To ensure that this conclusion also applies to unpublished trials, it is important to increase trial transparency. PMID: 26350571 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - September 8, 2015 Category: Research Authors: Johnson RA, Rid A, Emanuel E, Wendler D Tags: Clin Trials Source Type: research

Application of the Wei-Lachin multivariate one-directional test to multiple event-time outcomes.
CONCLUSION: The Wei-Lachin multivariate one-directional test may be more powerful than the traditional analysis of a composite outcome defined as the time to the first component outcomes experienced by each subject. PMID: 26336199 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - September 2, 2015 Category: Research Authors: Lachin JM, Bebu I Tags: Clin Trials Source Type: research

Description of the types and content of phase 1 clinical trial consent conversations in practice.
CONCLUSION: We identified and described four types of consent conversations. Our novel findings include (1) four different types of conversations with one (priming) not mentioned before and (2) a change of focus from describing the content of one phase 1 consent conversation to describing the content of different types. These in-depth descriptions provide the foundation for future research to determine whether the four types of conversations occur in sequence, thus describing the structure of the consent process and providing the basis for coaching interventions to alert physicians to the appropriate content for each type ...
Source: Clinical Trials - August 28, 2015 Category: Research Authors: Wall L, Farmer ZL, Webb MW, Dixon MD, Nooka A, Pentz RD Tags: Clin Trials Source Type: research