Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial.
CONCLUSION: A Clinical Endpoint Committee is useful for adjudication of major adverse cardiovascular events in chronic obstructive pulmonary disease trials but requires considerable resources and effort by investigators. This process can be streamlined by reviewing only serious adverse events and filtering by selected Medical Dictionary for Regulatory Activities terms. PMID: 32441114 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - May 22, 2020 Category: Research Authors: Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC Tags: Clin Trials Source Type: research

Comment on Hemming et al.'s 'Stepped-wedge trials should be classified as research for the purpose of ethical review'.
PMID: 32429689 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - May 19, 2020 Category: Research Authors: Lilford RJ, Watson SI Tags: Clin Trials Source Type: research

Response.
PMID: 32429698 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - May 19, 2020 Category: Research Authors: Hemming K, Goldstein CE, Marshall T, Taljaard M, Weijer C Tags: Clin Trials Source Type: research

Adjusting for adherence in randomized trials when adherence is measured as a continuous variable: An application to the Lipid Research Clinics Coronary Primary Prevention Trial.
CONCLUSIONS: Methods which appropriately adjust for time-varying post-randomization variables can explain away much of the bias in the "effect" of adherence to placebo. When considering continuous adherence, investigators should consider several models as estimates may be sensitive to the model chosen. PMID: 32414298 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - May 15, 2020 Category: Research Authors: Wanis KN, Madenci AL, HernĂ¡n MA, Murray EJ Tags: Clin Trials Source Type: research

From screening to ascertainment of the primary outcome using electronic health records: Challenges in the STRIDE trial.
This article discusses some of the challenges in using electronic health records in the conduct of the STRIDE (Strategies to Reduce Injuries and Develop Confidence in Elders) trial, how we handled those challenges, and the lessons we learned for the conduct of future trials looking to employ the electronic health record. PMID: 32408769 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - May 14, 2020 Category: Research Authors: Esserman D Tags: Clin Trials Source Type: research

Exploring factors influencing recruitment results of nurses recruiting diabetes patients for a randomized controlled trial.
CONCLUSION AND IMPLICATIONS: To optimize patient recruitment to clinical trials, suggested intervention targets include the continued inclusion of recruiters after initial recruitment onset and the encouragement of early recruitment success. A personalized approach may aid recruiters to become and remain successful. Primarily, it is important to provide recruiters with sufficient information on trial requirements and to address salient benefits for participation in the trial, both for themselves and for their patients. Finally, teaching recruiters skills on how to overcome barriers may further enhance motivation and recrui...
Source: Clinical Trials - May 5, 2020 Category: Research Authors: Vluggen S, Hoving C, Vonken L, Schaper NC, de Vries H Tags: Clin Trials Source Type: research

Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials.
CONCLUSION: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards. PMID: 32367741 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - May 5, 2020 Category: Research Authors: Taljaard M, Goldstein CE, Giraudeau B, Nicholls SG, Carroll K, Hey SP, Brehaut JC, Jairath V, London AJ, Eldridge SM, Grimshaw JM, Fergusson DA, Weijer C Tags: Clin Trials Source Type: research

Bayesian methods for pilot studies.
CONCLUSION: Applying Bayesian methods to pilot studies' results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial. PMID: 32297539 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - April 16, 2020 Category: Research Authors: Willan AR, Thabane L Tags: Clin Trials Source Type: research

The electronic health record as a clinical trials tool: Opportunities and challenges.
This report describes steps necessary to use the electronic health record as a tool for conducting high-quality clinical research. PMID: 32266833 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - April 8, 2020 Category: Research Authors: Bertagnolli MM, Anderson B, Quina A, Piantadosi S Tags: Clin Trials Source Type: research

Commentary on Bertagnolli et al.: Leveraging electronic health record data for clinical trials-a brave new world.
PMID: 32266836 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - April 8, 2020 Category: Research Authors: Ross JS, Dhruva SS, Shah ND Tags: Clin Trials Source Type: research

Rejoinder.
PMID: 32266839 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - April 8, 2020 Category: Research Authors: Bertagnolli MM, Anderson B, Quina A, Piantadosi S Tags: Clin Trials Source Type: research

Commentary on Bertagnolli et al: Clinical trial designs with routinely collected real-world data-issues of data quality and beyond.
PMID: 32266840 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - April 8, 2020 Category: Research Authors: Hemkens LG Tags: Clin Trials Source Type: research

The cluster randomized crossover trial: The effects of attrition in the AB/BA design and how to account for it in sample size calculations.
CONCLUSION: This article provides the methodology of exploring the effect of attrition in cluster randomized crossover trials, and to repair for attrition. As such, it helps researchers plan their trial in an appropriate way and avoid underpowered trials. To use the methodology, prior estimates of the degree of attrition and intraclass correlation coefficients are needed. It is advocated that researchers clearly report the estimates of these quantities to help facilitate planning future trials. PMID: 32191129 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - March 19, 2020 Category: Research Authors: Moerbeek M Tags: Clin Trials Source Type: research

Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network's PROMISE trial for resource-limited regions.
CONCLUSIONS: Experiences from the PROMISE study illustrate the challenges of enrolling in longer term studies in the setting of rapidly evolving prevention and treatment standards priorities. The lessons learned will help the community, site investigators, and study coordinators in the design and implementation of future clinical trials. PMID: 32191142 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - March 19, 2020 Category: Research Authors: Angelidou K, Fowler MG, Flynn P, Coletti A, McCarthy K, Browning R, McIntyre J, Brummel SS, Shapiro DE, Tierney C, PROMISE study team Tags: Clin Trials Source Type: research

Towards more credible shams for physical interventions: A Delphi survey.
CONCLUSION: Experts agreed that, for shams to be believable, consideration of cognitive influences is essential. Contrary to the focus of previous shams for physical interventions, replicating the tactile sensation of the active treatment was not considered an essential part of sham development. Therefore, when designing sham-controlled clinical trials, researchers should carefully consider the cognitive credibility of the entire intervention experience, and not just the indistinguishability of the sham intervention itself. The findings provide new guidance to researchers on important contributors to blinding in physical i...
Source: Clinical Trials - March 10, 2020 Category: Research Authors: Braithwaite FA, Walters JL, Moseley GL, Williams MT, McEvoy MP Tags: Clin Trials Source Type: research

Using predictive analytics to improve pragmatic trial design.
Abstract Clinical trials embedded in health systems can randomize large populations using automated data sources to determine trial eligibility and assess outcomes. The suicide prevention outreach trial used real-world data for trial design and randomized 18,868 individuals in four health systems using patient-reported thoughts of death or self-harm (Patient Health Questionnaire item 9). This took 3.5 years. We consider if using predictive analytics, that is, suicide risk estimates based on prediction models, could improve trial "efficiency." We used data on mental health outpatient visits between 1 Janu...
Source: Clinical Trials - March 10, 2020 Category: Research Authors: Shortreed SM, Simon GE Tags: Clin Trials Source Type: research

Exploration of baseline patient-reported side effect bother from cancer therapy.
CONCLUSION: Patients may enter trials already reporting some bother from side effects. This can make interpretation of results with respect to the investigational agent under study challenging. Patients may skip an item evaluating side effect bother at baseline, suggesting some difficulty with interpretation of what is being asked. Further study of the wording and utility of a baseline side effect bother assessment is warranted. PMID: 32153216 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - March 10, 2020 Category: Research Authors: Roydhouse JK, King-Kallimanis BL, Roy P, Weinstock C, Krol D, Daniels SR, Suzman DL, Beaver JA, Kluetz PG Tags: Clin Trials Source Type: research

An innovative recruitment strategy in a pediatric clinical trial.
PMID: 32114798 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2020 Category: Research Authors: Bhatnagar S, Hoberman A, Kurs-Lasky M, Kearney DH, Haralam MA, Nagg J, Shaikh N Tags: Clin Trials Source Type: research

Estimated costs of pivotal trials for U.S. Food and Drug Administration-approved cancer drugs, 2015-2017.
The objectives of this study are (1) to characterize select features of trials for oncology products approved by the U.S. Food and Drug Administration between 2015 and 2017; and (2) to quantify the costs of these trials and how such costs varied based on trial characteristics. METHODS: We identified novel oncology therapeutic drugs, and their respective pivotal trials, approved between 2015 and 2017 using annual summary reports from the Food and Drug Administration. Cost estimates for each pivotal trial were calculated using IQVIA's CostPro, a clinical trial cost estimating tool based on executed contracts between pha...
Source: Clinical Trials - February 29, 2020 Category: Research Authors: Hsiue EH, Moore TJ, Alexander GC Tags: Clin Trials Source Type: research

Commentary on Hsiue et al: Cost savings and data limitations of new cancer drug studies.
PMID: 32070123 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 19, 2020 Category: Research Authors: Bach PB Tags: Clin Trials Source Type: research

The costs of cancer drugs.
PMID: 32070133 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 19, 2020 Category: Research Authors: Begg CB Tags: Clin Trials Source Type: research

A review of available software for adaptive clinical trial design.
CONCLUSIONS: There is much room for improvement in the provision of software alongside adaptive design publications. In addition, while progress has been made, well-established software for various types of trial adaptation remains sparsely available. PMID: 32063024 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 17, 2020 Category: Research Authors: Grayling MJ, Wheeler GM Tags: Clin Trials Source Type: research

Adding new experimental arms to randomised clinical trials: Impact on error rates.
CONCLUSIONS: The findings we present in this article can be used to design trials with pre-planned deferred arms or to add new pairwise comparisons within an ongoing platform trial where control of the pairwise error rate or familywise type I error rate (for a subset of pairwise comparisons) is required. PMID: 32063029 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 17, 2020 Category: Research Authors: Choodari-Oskooei B, Bratton DJ, Gannon MR, Meade AM, Sydes MR, Parmar MK Tags: Clin Trials Source Type: research

Designing clinical trials with (restricted) mean survival time endpoint: Practical considerations.
CONCLUSION: The restricted mean survival time is a survival endpoint that is meaningful to investigators and to patients and at the same time requires less restrictive assumptions. The biggest challenge with this endpoint is selection of the restriction time. We recommend selecting a restriction time that is clinically relevant to the disease and the clinical setting of the trial of interest. The practical considerations and the R package provided in this work are readily available tools that researchers can use to design trials with restricted mean survival time as the primary endpoint. PMID: 32063031 [PubMed - as su...
Source: Clinical Trials - February 17, 2020 Category: Research Authors: Eaton A, Therneau T, Le-Rademacher J Tags: Clin Trials Source Type: research

Regulatory-grade clinical trial design using real-world data.
Abstract Real-world data and evidence provide the potential to address the effectiveness and safety of drugs. The U.S. Food & Drug Administration has initiated a program to evaluate the potential use of real-world evidence for regulatory uses. Whether a study is designed for regulatory purposes or for other purposes, existing regulation and guidance provide a reference for high-quality studies. Clarifying the study objectives and the role of real-world data in the study are important considerations. Robustness and transparency of the analysis allow for greater understanding and acceptance of the study results....
Source: Clinical Trials - February 17, 2020 Category: Research Authors: Levenson MS Tags: Clin Trials Source Type: research

Economic vulnerability and payment for research participation.
Abstract There has been significant analysis of the ethical and regulatory issues involved with paying research participants, but less attention has been focused specifically on paying economically vulnerable individuals and the unique challenges it may present. This is important, as individuals of lower socio-economic standing are present in all disease groups and study populations. Moreover, clinical research is often conducted in economically under-developed locales, such as lower- or middle-income countries as well as impoverished locales of otherwise wealthy nations (such as, for example, rural Appalachia in ...
Source: Clinical Trials - February 17, 2020 Category: Research Authors: Gelinas L, White SA, Bierer BE Tags: Clin Trials Source Type: research

Compliance of French academic clinical trials with the Clinical Trial Facilitation and Coordination Group recommendations on contraception and pregnancy testing requirements.
CONCLUSION: French academic sponsors barely met the recommendations on contraception and pregnancy testing potentially leading to potential embryofetal risks in case of pregnancy. They need to implement these recommendations quickly. PMID: 32026710 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 6, 2020 Category: Research Authors: Crepin S, Chiffoleau A, Gavard M, Olivier-Abbal P, Roussillon C, Ruault S, Muller C, Peyro-Saint-Paul L, Ouk T, Franceschi MP, Mouchel C, Duranton S, Petitpain N, Coubret-Dumas A Tags: Clin Trials Source Type: research

Information growth for sequential monitoring of clinical trials with a stepped wedge cluster randomized design and unknown intracluster correlation.
CONCLUSION: Taking the study design into account and using either an estimate of the intracluster correlation from the ongoing study or other data in the same clusters should allow for easy implementation of group sequential methods in future stepped wedge designs. PMID: 32026713 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 6, 2020 Category: Research Authors: Brown SP, Shoben AB Tags: Clin Trials Source Type: research

Discordant attitudes and beliefs about cancer clinical trial participation between physicians, research staff, and cancer patients.
Abstract BACKGROUND/AIMS: Essential to bringing innovative cancer treatments to patients is voluntary participation in clinical trials but approximately 8% of American cancer patients are enrolled onto a trial. We used a domain-oriented framework to assess barriers to cancer clinical trial enrollment. METHODS: Physicians (MD, DO, fellows, residents) and research staff (physician assistants, nurse practitioners, staff and research nurses, clinical assistants, and program coordinators) involved in clinical research at a comprehensive cancer center completed an online survey in 2017; adult cancer patients not cu...
Source: Clinical Trials - February 3, 2020 Category: Research Authors: Hillyer GC, Beauchemin M, Hershman DL, Kelsen M, Brogan FL, Sandoval R, Schmitt KM, Reyes A, Terry MB, Lassman AB, Schwartz GK Tags: Clin Trials Source Type: research

Role of health plan administrative claims data in participant recruitment for pragmatic clinical trials: An Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) example.
CONCLUSION: This study showed the ability of a health plan within Patient-Centered Clinical Data Research Network to identify potential study participants with administrative claims, and use different outreach methods to facilitate recruitment and enrollment for pragmatic clinical trials. PMID: 32009464 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 3, 2020 Category: Research Authors: Shi Q, Shambhu S, Marshall A, Rose-Kennedy E, Robertson H, Paullin M, Jones WS, Cziraky M, Haynes K Tags: Clin Trials Source Type: research

Broadening community engagement in clinical research: Designing and assessing a pilot crowdsourcing project to obtain community feedback on an HIV clinical trial.
CONCLUSION: There is sufficient lay community interest in open calls for feedback on the design and conduct of clinical trials, making crowdsourcing both a novel and feasible engagement strategy. Clinical trial researchers are encouraged to consider the opportunities of implementing crowdsourcing to inform trial processes from a community perspective. PMID: 32009466 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - February 3, 2020 Category: Research Authors: Day S, Mathews A, Blumberg M, Vu T, Rennie S, Tucker JD Tags: Clin Trials Source Type: research

Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial.
CONCLUSION: Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention. PMID: 31984762 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 27, 2020 Category: Research Authors: Glassman AR, Beaulieu WT, Stockdale CR, Beck RW, Bressler NM, Labriola LT, Melia M, Oliver K, Sun JK Tags: Clin Trials Source Type: research

How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge.
CONCLUSION: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training-whether online or face to face-does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area. PMID: 31984765 ...
Source: Clinical Trials - January 27, 2020 Category: Research Authors: Mozersky JT, Antes AL, Baldwin K, Jenkerson M, DuBois JM Tags: Clin Trials Source Type: research

To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial.
CONCLUSION: Contrary to prior adult studies, there is no clear relationship between caregiver intentions and study compliance. Findings elucidate the complexities of caregiver-child interactions during pediatric trial participation. PMID: 31984781 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - January 27, 2020 Category: Research Authors: Sullivan JA, Wiese AM, Boone KM, Rausch J, Keim SA Tags: Clin Trials Source Type: research

Trial marketing in the Pan-Canadian Early Detection of Lung Cancer Study.
CONCLUSION: A survey of trial candidates provides useful information regarding personal motivation, media use, and lifestyle. Unpaid media events appear superior in generating recruitment, while print media may be superior to radio and television in selecting eligible recruits. The utility of individual print media characteristics appears to differ from the commercial advertising literature. Further research on marketing in clinical trials is encouraged to improve recruitment ( ClinicalTrials.gov registration: NCT00751660, https://clinicaltrials.gov/ct2/show/NCT00751660 ). PMID: 31894702 [PubMed - as supplied by publi...
Source: Clinical Trials - January 2, 2020 Category: Research Authors: Rudkowski JL, Pond GR, Tremblay A, Johnston M, Goss G, Nicholas G, Martel S, Bhatia R, Liu G, Schmidt H, Tammemagi MC, Atkar-Khattra S, Tsao MS, Lam S, Goffin JR Tags: Clin Trials Source Type: research

Designing and evaluating dose-escalation studies made easy: The MoDEsT web app.
CONCLUSION: Enabling both methodologists and clinicians to understand and apply model-based study designs with ease is a key factor towards their routine use in early-phase studies. We hope that MoDEsT will enable incorporation of Bayesian decision procedures for dose escalation at the earliest stage of clinical trial design, thus increasing their use in early-phase trials. PMID: 31856600 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - December 19, 2019 Category: Research Authors: Pallmann P, Wan F, Mander AP, Wheeler GM, Yap C, Clive S, Hampson LV, Jaki T Tags: Clin Trials Source Type: research

Using a Delphi survey to gain an international consensus on the challenges of conducting trials with adults with intellectual disabilities.
CONCLUSION: This is the first international survey exploring the experiences of researchers conducting randomised controlled trials with adults with intellectual disabilities. Many of the barriers and challenges reported can be overcome with creativity and some additional resources. Other challenges, including attitudes towards conducting trials with disabled populations, maybe harder to overcome. These findings have implications for conducting trials with other populations with cognitive or communication difficulties. Implications for disability researchers, funding bodies and ethical review panels are discussed. PMI...
Source: Clinical Trials - December 19, 2019 Category: Research Authors: Mulhall P, Taggart L, Coates V, McAloon T Tags: Clin Trials Source Type: research

Adaptive dose-finding based on safety and feasibility in early-phase clinical trials of adoptive cell immunotherapy.
CONCLUSION: We have developed a new practical adaptive dose-finding method to assess feasibility in early-phase adoptive cell therapy trials. A design that incorporates feasibility, as a function of the quantity and quality of the product manufactured, in addition to safety will have an impact on the recommended phase II doses in studies that evaluate patient outcomes. PMID: 31856602 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - December 19, 2019 Category: Research Authors: Wages NA, Fadul CE Tags: Clin Trials Source Type: research

Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings.
CONCLUSION: In the setting where the benefit of a previously established beneficial treatment is questioned, a non-inferiority design that includes placebo as the tested treatment option can be the most appropriate design option. PMID: 31814441 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - December 8, 2019 Category: Research Authors: May S, Brown SP, Schmicker RH, Emerson SS, Nkwopara E, Ginsburg AS Tags: Clin Trials Source Type: research

Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews.
PMID: 31709809 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - November 10, 2019 Category: Research Authors: Liu P, Ross JS, Ioannidis JP, Dhruva SS, Vasiliou V, Wallach JD Tags: Clin Trials Source Type: research

Nonparticipation reasons in a randomized international trial of a new latent tuberculosis infection regimen.
CONCLUSION: Educational efforts addressing clinical research concerns and beliefs about medication and health, as well as study protocols that accommodate patient-related concerns (e.g. work, school, and lifestyle) might increase willingness to enter clinical trials. Findings from this evaluation can support development of communication and education materials for clinical trial sites at the beginning of a trial to allow study staff to address potential participant concerns during study screening. PMID: 31690107 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - November 6, 2019 Category: Research Authors: Hedges KNC, Borisov AS, Saukkonen JJ, Scott NA, Hecker EJ, Bozeman L, Dukes Hamilton C, Kerrigan A, Bessler P, Moreno-Martinez A, Arevalo B, Goldberg SV Tags: Clin Trials Source Type: research

A third trial oversight committee: Functions, benefits and issues.
CONCLUSION: A third oversight committee has benefits for trial oversight and conduct, and a revised charter will facilitate greater standardisation and wider adoption. PMID: 31665920 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 30, 2019 Category: Research Authors: Lane JA, Gamble C, Cragg WJ, Tembo D, Sydes MR Tags: Clin Trials Source Type: research

Informal professionalization of healthy participants in phase I clinical trials in Russia.
CONCLUSIONS: A way of better protecting healthy trial participants begins with recognizing their skills, knowledge, and the centrality of the contribution they are making to pharmaceutical research. Currently, the expertise of experienced trial participants is recognized on the work floor only; therefore, the professionalization we described is informal. Yet, the informal professionalization process is inherently risky as it does not involve any change in the formal conditions of trial participants' work. Instituting formal measures for protecting healthy trial participants as skilled workers combined with recognition of t...
Source: Clinical Trials - October 24, 2019 Category: Research Authors: Zvonareva O, Pimenov I, Kutishenko N, Mareev I, Martsevich S, Kulikov E Tags: Clin Trials Source Type: research

A randomized evaluation of on-site monitoring nested in a multinational randomized trial.
CONCLUSION: On-site monitoring led to the identification of more eligibility and consent violations and START clinical events being reported more than 6 months from occurrence as compared to no on-site monitoring. Considering the nature of the excess monitoring outcomes identified at sites receiving on-site monitoring, as well as the cost of on-site monitoring, the value to the START study was limited. PMID: 31647325 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 24, 2019 Category: Research Authors: Wyman Engen N, Huppler Hullsiek K, Belloso WH, Finley E, Hudson F, Denning E, Carey C, Pearson M, Kagan J Tags: Clin Trials Source Type: research

Closed testing of each group versus the others combined in a multiple group analysis.
CONCLUSION: Testing each of the multiple treatments versus the average of the others is readily and efficiently conducted under the closed testing principle and may be especially useful in the assessment of studies of comparative effectiveness. PMID: 31647326 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 24, 2019 Category: Research Authors: Lachin JM, Bebu I Tags: Clin Trials Source Type: research

Commentary on Engen et al: Risk-based, dynamic, process-oriented monitoring strategies and their burden.
PMID: 31647327 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 24, 2019 Category: Research Authors: Bertolet M, Brooks MM, Carson JL Tags: Clin Trials Source Type: research

Comparison of methods for control allocation in multiple arm studies using response adaptive randomization.
CONCLUSION: Selection of control allocation in multiple arm response adaptive randomization has a large effect on the performance of the design. Some disparate comparisons of response adaptive randomization to alternative paradigms may be partially explained by these results. In future comparisons, control allocation for multiple arm response adaptive randomization should be chosen to keep in mind the appropriate match between control allocation in response adaptive randomization and the metric or metrics of interest. PMID: 31630567 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 19, 2019 Category: Research Authors: Viele K, Broglio K, McGlothlin A, Saville BR Tags: Clin Trials Source Type: research

Comparison between protocols and publications for prognostic and predictive cancer biomarker studies.
CONCLUSION: Protocols are generally not accessible or not used for cancer biomarker studies. Publications were often explicitly discordant with protocols, particularly regarding biomarkers and endpoints. Our findings point to common unaddressed risk of bias in publications of major journals reporting the relationship between cancer biomarkers and clinical endpoints. PMID: 31588779 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 5, 2019 Category: Research Authors: Doussau A, Vinarov E, Barsanti-Innes B, Kimmelman J Tags: Clin Trials Source Type: research

Commentary on Zvonareva et al.: Exploring the many meanings of "professional" in research participation.
Commentary on Zvonareva et al.: Exploring the many meanings of "professional" in research participation. Clin Trials. 2019 Oct 05;:1740774519877850 Authors: Fisher JA PMID: 31588783 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 5, 2019 Category: Research Authors: Fisher JA Tags: Clin Trials Source Type: research

Rejoinder.
PMID: 31581812 [PubMed - as supplied by publisher] (Source: Clinical Trials)
Source: Clinical Trials - October 3, 2019 Category: Research Authors: Ji L, McShane LM, Krailo M, Sposto R Tags: Clin Trials Source Type: research