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Annals of Internal Medicine | 2013

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

An-Wen Chan; Jennifer Tetzlaff; Douglas G. Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A. Berlin; Caroline J Doré; Wendy R. Parulekar; William Summerskill; Trish Groves; Kenneth F. Schulz; Harold C. Sox; Frank Rockhold; Drummond Rennie; David Moher

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.


Critical Care Medicine | 1993

Continuous intravenous cimetidine decreases stress-related upper gastrointestinal hemorrhage without promoting pneumonia

L. F. Martin; F. V. M. Booth; Robyn G. Karlstadt; Jeffrey H. Silverstein; D. M. Jacobs; J. Hampsey; S. C. Bowman; C. A. D'ambrosio; Frank Rockhold

ObjectivesTo determine whether a continuous iv infusion of cimetidine, a histamine-2 (H2) receptor antagonist, is needed to prevent upper gastrointestinal (GI) hemorrhage when compared with placebo and if that usage is associated with an increased risk of nosocomial pneumonia. Due to the importance of this latter issue, data were collected to examine the occurrence rate of nosocomial pneumonia under the conditions of this study. DesignA multicenter, double-blind, placebocontrolled study. InterventionsPatients were randomized to receive cimetidine (n = 65) as an iv infusion of 50 to 100 mg/hr or placebo (n = 66). SettingIntensive care units in 20 institutions. PatientsCritically ill patients (n = 131), all of whom had at least one acute stress condition that previously had been associated with the development of upper GI hemorrhage. Measurements and Main ResultsSamples of gastric fluid from nasogastric aspirates were collected every 2 hrs for measurement of pH and were examined for the presence of blood. Upper GI hemorrhage was defined as bright red blood or persistent (continuing for >8 hrs) “coffee ground material” in the nasogastric aspirate. Baseline chest radiographs were performed and sputum specimens were collected from all patients, and those patients without clear signs of pneumonia (positive chest radiograph, positive cough, fever) at baseline were followed prospec-tively for the development of pneumonia while receiving the study medication.Cimetidine-infused patients experienced significantly (p = .009) less upper GI hemorrhage than placebo-infused patients: nine (14%) of 65 cimetidine vs. 22 (33%) of 66 placebo patients. Cimetidine patients demonstrated significantly (p = .0001) higher mean intragastric pH (5.7 vs. 3.9), and had intragastric pH values at >4.0 for a significantly (p = .0001) higher mean percentage of time (82% vs. 41%) than placebo patients. Differences in pH variables were not found between patients who had upper GI hemorrhage and those patients who did not, although there was no patient in the cimetidine group who bled with a pH < 3.5 compared with 11 such patients in the placebo group. Also, the upper GI hemorrhage rate in patients with one risk factor (23%) was similar to that rate in patients with two or more risk factors (25%). Of the 56 cimetidine-infused patients and 61 placebo-infused patients who did not have pneumonia at baseline, no cimeti-dine-infused patient developed pneumonia while four (7%) placebo-infused patients developed pneumonia. ConclusionsThe continuous iv infusion of cimetidine was highly effective in controlling


The New England Journal of Medicine | 2013

Access to Patient-Level Data from GlaxoSmithKline Clinical Trials

Perry Nisen; Frank Rockhold

GlaxoSmithKline is providing access to patient-level clinical trial data under a new policy. This article reviews the data-access plan.


The New England Journal of Medicine | 2008

Electronic Health Records, Medical Research, and the Tower of Babel

Rebecca D. Kush; Edward Helton; Frank Rockhold; C. David Hardison

As medical records and research data are increasingly stored electronically, data standards permitting the integration and analysis of such information have become necessary. Progress is being made in developing and disseminating a common data format.


The Lancet | 2017

Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial

E. Magnus Ohman; Matthew T. Roe; P. Gabriel Steg; Stefan James; Thomas J. Povsic; Jennifer A. White; Frank Rockhold; Alexei Plotnikov; Hardi Mundl; John Strony; Xiang Sun; Steen Husted; Michal Tendera; Gilles Montalescot; M. Cecilia Bahit; Diego Ardissino; Héctor Bueno; Marc J. Claeys; José Carlos Nicolau; Jan H. Cornel; Shinya Goto; Róbert Gábor Kiss; Ümit Güray; Duk-Woo Park; Christoph Bode; Robert C. Welsh; C. Michael Gibson

BACKGROUND Dual antiplatelet therapy (DAPT), aspirin plus a P2Y12 inhibitor, is the standard antithrombotic treatment following acute coronary syndromes. The factor Xa inhibitor rivaroxaban reduced mortality and ischaemic events when added to DAPT, but caused increased bleeding. The safety of a dual pathway antithrombotic therapy approach combining low-dose rivaroxaban (in place of aspirin) with a P2Y12 inhibitor has not been assesssed in acute coronary syndromes. We aimed to assess rivaroxaban 2·5 mg twice daily versus aspirin 100 mg daily, in addition to clopidogrel or ticagrelor (chosen at investigator discretion before randomisation), for patients with acute coronary syndromes started within 10 days after presentation and continued for 6-12 months. METHODS In this double-blind, multicentre, randomised trial (GEMINI-ACS-1) done at 371 clinical centres in 21 countries, eligible patients were older than 18 years with unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI), with positive cardiac biomarkers and either ischaemic electrocardiographic changes or an atherosclerotic culprit lesion identified during angiography. Participants were randomly assigned (1:1) within 10 days after admission for the index acute coronary syndromes event to either aspirin or rivaroxaban based on a computer-generated randomisation schedule. Randomisation was balanced by using randomly permuted blocks with size of four and was stratified based on the background P2Y12 inhibitor (clopidogrel or ticagrelor) intended to be used at the time of randomisation. Investigators and patients were masked to treatment assignment. Patients received a minimum of 180 days of double-blind treatment with rivaroxaban 2·5 mg twice daily or aspirin 100 mg daily. The choice of clopidogrel or ticagrelor during trial conduct was not randomised and was based on investigator preference. The primary endpoint was thrombolysis in myocardial infarction (TIMI) clinically significant bleeding not related to coronary artery bypass grafting (CABG; major, minor, or requiring medical attention) up to day 390. Primary analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT02293395. FINDINGS Between April 22, 2015, and Oct 14, 2016, 3037 patients with acute coronary syndromes were randomly assigned; 1518 to receive aspirin and 1519 to receive rivaroxaban. 1704 patients (56%) were in the ticagrelor and 1333 (44%) in the clopidogrel strata. Median duration of treatment was 291 days (IQR 239-354). TIMI non-CABG clinically significant bleeding was similar with rivaroxaban versus aspirin therapy (total 154 patients [5%]; 80 participants [5%] of 1519 vs 74 participants [5%] of 1518; HR 1·09 [95% CI 0·80-1·50]; p=0·5840). INTERPRETATION A dual pathway antithrombotic therapy approach combining low-dose rivaroxaban with a P2Y12 inhibitor for the treatment of patients with acute coronary syndromes had similar risk of clinically significant bleeding as aspirin and a P2Y12 inhibitor. A larger, adequately powered trial would be required to definitively assess the efficacy and safety of this approach. FUNDING Janssen Research & Development and Bayer AG.


Journal of Intensive Care Medicine | 1990

Comparison of Cimetidine and Placebo for the Prophylaxis of Upper Gastrointestinal Bleeding Due to Stress-related Gastric Mucosal Damage in the Intensive Care Unit

Robyn G. Karlstadt; Thomas J. Iberti; Jeffrey H. Silverstein; Leslie Lindenberg; Peter Rright-Asare; Frank Rockhold; M. D. Young

A multicenter, randomized, double-blind, placebo- controlled study was conducted with 87 patients in in tensive care units to study the effectiveness of constant infusions of cimetidine (50 mg/hr) in the prophylaxis of stress-related mucosal bleeding. Fifty-four patients re ceived cimetidine and 33 received placebo. The groups were comparable by age, sex, and severity of illness. One (2%) of the 54 patients receiving cimetidine had upper gastrointestinal hemorrhage and 7 (21%) of the 33 patients receiving placebo had upper gastrointestinal hemorrhage (p = 0.002). The risk of bleeding for every 100 patient days in intensive care units was reduced by 94% in the patients receiving cimetidine. Constant infu sion cimetidine was well tolerated. Only one patient (cimetidine) developed pneumonia during the study, but it was not considered to be related to drug therapy. No patients experienced adverse drug interactions. Two patients (4%) experienced reversible side effects from treatment. Cimetidine, administered as a continuous in travenous 50-mg/hour infusion, is safe and significantly more effective than placebo for preventing upper gas trointestinal bleeding in critically ill patients.


Journal of Cardiovascular Pharmacology | 1981

Cellular Electrophysiology of Clofilium, a New Antifibrillatory Agent, in Normal and Ischemic Canine Purkinje Fibers

Mitchell I. Steinberg; Mark E. Sullivan; Sally A. Wiest; Frank Rockhold; Bryan B. Molloy

Summary Intracellular electrophysiological studies were performed on isolated canine cardiac tissues to investigate further the reported ability of clofilium (3 × 10-8- 10-6 M) to selectively increase action potential duration (APD) and refractoriness. In Purkinje fibers from normal dogs, clofilium did not influence (1) the rate of rise of the action potential (Vmax) elicited from normal or depolarized (10 mM potassium) resting potentials, (2) the Vmax of premature potentials elicited during the repolarization phase of a previous action potential or (3) the rate of diastolic depolarization of spontaneously firing Purkinje fibers. The diastolic interval was altered by inserting a single premature impulse during diastole or by varying the basic cycle length. Clofilium (3 × 10-7 M) slightly reduced the time constant for the relation between diastolic interval and APD in concentrations that caused a maximal increase in APD of nonpremature impulses. In dogs subjected to occlusion of the left anterior descending coronary artery 48 hr before study, the APD of surviving Purkinje fibers was longer in the infarcted zone than in the normal zone. Clofilium (3 × 10-8 M) increased APD in both zones but more so in the normal area, thus reducing the disparity of APD between zones. Similarly, clofilium (3 × 10-8 and 3 × 10-7 M) increased the effective refractory period in both zones but more so in the normal area. The increase of APD and refractoriness in normal as well as depolarized or ischemic tissues in the absence of marked changes in Vmax and conduction may decrease the likelihood of reentrant arrhythmias and underlie the antifibrillatory effects in anesthetized dogs.


Journal of Clinical Gastroenterology | 1990

Cimetidine 800 mg twice daily for healing erosions and ulcers in gastroesophageal reflux disease

Robert H. Palmer; William O. Frank; Frank Rockhold; Jeffrey D. Wetherington; M. D. Young

Although H2-receptor antagonists have been the mainstay of therapy for gastroesophageal reflux disease (GERD), none of these agents has been approved by the FDA as effective in healing lesions. Since proton pump inhibitors may be associated with long-term disadvantages, a healing regimen with cimetidine would be useful clinically. This multicenter, randomized, double-blind study was conducted to evaluate the efficacy of cimetidine 800 mg b.i.d. in healing lesions and in providing symptomatic relief in patients with ulcerative or erosive esophagitis. Patients with ≥8 heartburn episodes during a 1-week screening period, reflux confirmed by esophageal pH monitoring, and esophageal ulcers or erosions confirmed by endoscopy were randomized to treatment with placebo or cimetidine for 12 weeks. Cimetidine provided significantly greater (p < 0.01) improvement (74% vs. 51%) and complete healing (67% vs. 36%) of esophageal lesions than did placebo. In these patients with erosive or ulcerative esophagitis, the median time to achieve 24 h without heartburn was 13 days with cimetidine and 30 days with placebo (p = 0.01). The mean heartburn severity score in the cimetidine group decreased rapidly during the first week and was consistently lower than in the placebo group. Cimetidine, 800 mg twice daily, is effective in promoting healing of esophageal ulcers and erosions and in providing heartburn relief in patients with symptomatic erosive/ulcerative GERD.


Clinical Pharmacology & Therapeutics | 1988

Vasodilator monotherapy in the treatment of hypertension: Comparative efficacy and safety of pinacidil, a potassium channel opener, and prazosin

Michael R. Goldberg; Cynthia S Sushak; Frank Rockhold; W. Leigh Thompson

We compared antihypertensive effects of monotherapy with pinacidil (N = 197) or prazosin (N = 204) in a randomized, parallel, double‐blind dose‐titration study in which hydrochlorothiazide or propranolol could be added for adverse events or lack of efficacy. Pinacidil (12.5 to 75 mg b.i.d.) was a more potent vasodilator, producing a mean decrease in supine diastolic blood pressure (baseline = 102 to 103 ± 9 mm Hg) of 18.8 ± 10.0 (SD) mm Hg compared with 15.5 ± 9.2 mm Hg with prazosin (1 to 10 mg b.i.d.; p < 0.001). Patients responding to each drug had similar average blood pressure levels during 12‐hour monitoring (137/85 mm Hg). More patients taking pinacidil required hydrochlorothiazide for edema (p = 0.008) and more taking prazosin required hydrochlorothiazide and propranolol for lack of efficacy (p < 0.001). Tachycardia (15% to 20%) and palpitation (13% to 15%) were frequent events with both drugs. Edema (38.2% vs 22.3%) was more frequent with pinacidil (p < 0.001) and postural hypotension (4.7% vs 1.0%) and asthenia (20.2% vs 13.2%) were more frequent with prazosin (p = 0.025; 0.062). No significant laboratory toxicity was noted. In conclusion, both pinacidil and prazosin are effective as monotherapy for hypertension. Monotherapy with pinacidil is limited by adverse events related to vasodilatation and monotherapy with prazosin is limited by lack of efficacy.


Clinical Trials | 2014

Bumps and bridges on the road to responsible sharing of clinical trial data

Jesse A. Berlin; Sandra Morris; Frank Rockhold; Lisa Askie; Davina Ghersi; Joanne Waldstreicher

Background Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing data also allows for questions to be addressed at the meta-analysis level that cannot be addressed within individual studies. Purpose In this article, we offer some practical recommendations that will allow researchers to readily combine datasets from different studies and sources, thereby enabling meta-analyses that could have significant impact on advancing medicine. Methods The authors relied on their collective experience in the conduct and reporting of clinical trials to define the areas of potential concern related to responsible sharing of clinical trial data. We conducted a review of the literature and engaged in an iterative consensus-building process. Results To further the goal of responsible sharing of clinical trial data, collaboration on a consistent set of data standards and methods across both industry and academia is sorely needed. Protection of participant privacy is a paramount principle. The additional questions of who maintains, funds, and oversees databases of participant-level data will be important to resolve. Requiring researchers to register their requests for participant-level data and to provide details of their intended research would allow others to evaluate the proposed research plan, consistent with the principles of science and transparency. Limitations The recommendations represent the views of the individual authors. We recognize that other approaches to data sharing that have been advocated are also based on sound ethical and scientific principles.

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William R. Hiatt

University of Colorado Denver

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