scholarly journals Axial penile rigidity as primary efficacy outcome during multi-institutional in-office dose titration clinical trials with alprostadil alfadex in patients with erectile dysfunction

2000 ◽  
Vol 12 (4) ◽  
pp. 205-211 ◽  
Author(s):  
I Goldstein ◽  
◽  
S Auerbach ◽  
H Padma-Nathan ◽  
J Rajfer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Erectile Dysfunction ◽  
Dose Titration ◽  
Primary Efficacy ◽  
Primary Efficacy Outcome ◽  
Efficacy Outcome

scholarly journals S246. THE EFFECT OF INCORRECT SCALE ADMINISTRATION ON DATA QUALITY IN SCHIZOPHRENIA CLINICAL TRIALS

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S132-S132
Author(s):  
Alan Kott ◽  
David Daniel
Keyword(s):  
Clinical Trials ◽  
Clinical Global Impression ◽  
Primary Outcome Measure ◽  
Primary Efficacy ◽  
Double Blind ◽  
Clinical Global Impression Scale ◽  
Primary Efficacy Outcome ◽  
Pooled Data ◽  
Efficacy Outcome ◽  
Time Stamps

Abstract Background The availability of date and time stamps of interview start times on eCOA systems permits monitoring and documentation of the order of administration of scales and instruments at each visit. The Clinical Global Impression Scale (CGI) is a holistic instrument that synthesizes all information available from the subject, caregivers, medical notes, etc. and is therefore typically required to be rated last at a particular visit. In the current retrospective analysis of double blind eCOA collected schizophrenia data pooled from multiple clinical trials we assessed the percent of visits where CGI was not administered last among other efficacy assessments. Additionally we assessed whether the inappropriate administration order of Clinical Global Impression Scale was associated with discrepancies in the data and change from baseline between the CGI and the primary efficacy outcome. Methods Available eCOA data were pooled from schizophrenia double blind, placebo controlled clinical trials. Within the data, we identified those visits where the CGI was not administered last among other efficacy assessments (inappropriate administration order). Within each trial we identified as discordant those data where the actual primary efficacy score or its change from baseline differed by at least two standard deviations from the expected score after linear regression. For this procedure the CGI- S score used as a predictor and the primary efficacy outcome as dependent variable. Logistic regression was then used on pooled data to explore whether the incorrect order of CGI administration increased the odds of discordant ratings between the CGI and primary outcome measure. Results The dataset consisted of 5,784 paired ratings of the CGI and the primary efficacy outcome. Among these, a total of 4,628 visits allowed to calculate change from baseline. Inappropriate order of CGI administration was identified in a total of 443 visits (7.7% of all visits). Discrepancies between CGI-S and the primary efficacy outcome were identified in 292 visits (5.1% of data) and discrepancies between change from baseline in CGI-S and in the primary efficacy outcome were observed in 249 cases (5.3% of data). The presence of incorrectly administered CGI increased the odds of raw score discrepancy 1.6x (95%CI 1.1–2.4), and the odds of discrepancy in change from baseline 1.8x (95%CI 1.2–2.7), both significant with p <0.01. Discussion Our data indicate a relatively large percent of visits suffer from an incorrect scale administration order. We have previously explored a number of sources of possible noise in schizophrenia clinical trials. Current analyses identified a significant effect of incorrect scale administration on the presence of between scale discordances. Such findings indicate that order of CGI administration should be mandated in schizophrenia clinical trials and enforced by eCOA platforms. Additionally, violations to correct scale administration should be monitored through analytic programs and acted upon in case of repeated occurrences at the rater or site level.

scholarly journals Registration, Publication, and Outcome Reporting among Pivotal Clinical Trials that Supported FDA Approval of High-Risk Medical Devices Before and After FDAAA

2021 ◽  
Author(s):  
Matthew J. Swanson ◽  
James L. Johnston ◽  
Joseph S. Ross
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Medical Devices ◽  
Primary Efficacy ◽  
Cardiovascular Devices ◽  
Primary Efficacy Outcome ◽  
Outcome Reporting ◽  
Fda Approval ◽  
Efficacy Outcome ◽  
Before And After

ABSTRACTBackgroundSelective registration, publication, and outcome reporting of clinical trials distorts the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of FDA-approved medical devices. The purpose of this study is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (Class III) medical devices before and after the U.S. Food and Drug Administration (FDA) Amendment Act (FDAAA) was enacted in 2007.MethodsUsing publicly available data from ClinicalTrials.gov, FDA summaries, and PubMed, we determined registration, publication, and reporting of findings for all pivotal clinical studies supporting FDA approval of new high-risk cardiovascular devices between 2005 and 2020, before and after FDAAA. For published studies, we compared both the primary efficacy outcome with the PMA primary efficacy outcome and the published interpretation of findings with the FDA reviewer’s interpretation (positive, equivocal, or negative).ResultsBetween 2005 and 2020, the FDA approved 156 high-risk cardiovascular devices on the basis of 165 pivotal trials, 48 (29%) of which were categorized as pre-FDAAA and 117 (71%) as post-FDAAA. Post-FDAAA, pivotal clinical trials were more likely to be registered (115 of 117 (98%) vs 24 of 48 (50%); p < 0.001), to report results (98 of 115 (85%) vs 7 of 24 (29%); p < 0.001) on ClinicalTrials.gov, and to be published (100 or 117 (85%) vs 28 of 48 (58%); p < 0.001) in peer-reviewed literature when compared to pre-FDAAA. Among published trials, rates of concordant primary efficacy outcome reporting were not significantly different between pre-FDAAA trials and post-FDAAA trials (24 of 28 (86%) vs 96 of 100 (96%); p = 0.07), nor were rates of concordant trial interpretation (27 of 28 (96%) vs 93 of 100 (93%); p = 0.44).ConclusionsFDAAA was associated with increased registration, results reporting, and publication for trials supporting FDA approval of high-risk medical devices. Among published trials, rates of accurate primary efficacy outcome reporting and trial interpretation were high and no different post-FDAAA.

scholarly journals Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Matthew J. Swanson ◽  
James L. Johnston ◽  
Joseph S. Ross
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Medical Devices ◽  
Primary Efficacy ◽  
Cardiovascular Devices ◽  
Primary Efficacy Outcome ◽  
Outcome Reporting ◽  
Fda Approval ◽  
Efficacy Outcome ◽  
Before And After

Abstract Background Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA)-approved medical devices. The purpose of this study is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (class III) cardiovascular devices before and after the FDA Amendment Act (FDAAA) was enacted in 2007. Methods Using publicly available data from ClinicalTrials.gov, FDA summaries, and PubMed, we determined registration, publication, and reporting of findings for all pivotal clinical studies supporting FDA approval of new high-risk cardiovascular devices between 2005 and 2020, before and after FDAAA. For published studies, we compared both the primary efficacy outcome with the FDA’s Premarket Approval (PMA) primary efficacy outcome and the published interpretation of findings with the FDA reviewer’s interpretation (positive, equivocal, or negative). Results Between 2005 and 2020, the FDA approved 156 high-risk cardiovascular devices on the basis of 165 pivotal trials, 48 (29%) of which were categorized as pre-FDAAA and 117 (71%) as post-FDAAA. Post-FDAAA, pivotal clinical trials were more likely to be registered (115 of 117 (98%) vs 24 of 48 (50%); p < 0.001), to report results (98 of 117 (87%) vs 7 of 48 (15%); p < 0.001) on ClinicalTrials.gov, and to be published (100 or 117 (85%) vs 28 of 48 (58%); p < 0.001) in peer-reviewed literature when compared to pre-FDAAA. Among published trials, rates of concordant primary efficacy outcome reporting were not significantly different between pre-FDAAA trials and post-FDAAA trials (24 of 28 (86%) vs 96 of 100 (96%); p = 0.07), nor were rates of concordant trial interpretation (27 of 28 (96%) vs 93 of 100 (93%); p = 0.44). Conclusions FDAAA was associated with increased registration, result reporting, and publication for trials supporting FDA approval of high-risk medical devices. Among published trials, rates of accurate primary efficacy outcome reporting and trial interpretation were high and no different post-FDAAA.

scholarly journals Thrombolysis with alteplase 3–4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances

2020 ◽  
Vol 25 (5) ◽  
pp. 168-171 ◽  
Author(s):  
Brian Scott Alper ◽  
Gary Foster ◽  
Lehana Thabane ◽  
Alex Rae-Grant ◽  
Meghan Malone-Moses ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Intracranial Haemorrhage ◽  
Trial Data ◽  
Stroke Onset ◽  
Primary Efficacy ◽  
Nihss Score ◽  
Primary Efficacy Outcome ◽  
Efficacy Outcome ◽  
Free Status

ObjectivesAlteplase is commonly recommended for acute ischaemic stroke within 4.5 hours after stroke onset. The Third European Cooperative Acute Stroke Study (ECASS III) is the only trial reporting statistically significant efficacy for clinical outcomes for alteplase use 3–4.5 hours after stroke onset. However, baseline imbalances in history of prior stroke and stroke severity score may confound this apparent finding of efficacy. We reanalysed the ECASS III trial data adjusting for baseline imbalances to determine the robustness or sensitivity of the efficacy estimates.DesignReanalysis of randomised placebo-controlled trial. We obtained access to the ECASS III trial data and replicated the previously reported analyses to confirm our understanding of the data. We adjusted for baseline imbalances using multivariable analyses and stratified analyses and performed sensitivity analysis for missing data.SettingEmergency care.Participants821 adults with acute ischaemic stroke who could be treated 3–4.5 hours after symptom onset.InterventionsIntravenous alteplase (0.9 mg/kg of body weight) or placebo.Main outcome measuresThe original primary efficacy outcome was modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability) and the original secondary efficacy outcome was a global outcome based on a composite of functional end points, both at 90 days. Adjusted analyses were only reported for the primary efficacy outcome and the original study protocol did not specify methods for adjusted analyses. Our adjusted reanalysis included these outcomes, symptom-free status (mRS 0), dependence-free status (mRS 0–2), mortality (mRS 6) and change across the mRS 0–6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage at 7 days.ResultsWe replicated previously reported unadjusted analyses but discovered they were based on a modified interpretation of the National Institutes of Health Stroke Scale (NIHSS) score. The secondary efficacy outcome was no longer significant using the original NIHSS score. Previously reported adjusted analyses could only be replicated with significant effects for the primary efficacy outcome by using statistical approaches not reported in the trial protocol or statistical analysis plan. In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.ConclusionsReanalysis of the ECASS III trial data with multiple approaches adjusting for baseline imbalances does not support any significant benefits and continues to support harms for the use of alteplase 3–4.5 hours after stroke onset. Clinicians, patients and policymakers should reconsider interpretations and decisions regarding management of acute ischaemic stroke that were based on ECASS III results.Trial registration numberNCT00153036.

Efficacy and Safety of Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism Following Total Hip Arthroplasty: STARS J-V trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3320-3320 ◽  
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai ◽  
Yukihiro Koretsune ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Major Bleeding ◽  
Thromboembolic Events ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Primary Efficacy Outcome ◽  
Treatment Groups ◽  
Efficacy Outcome ◽  
Lead Investigator

Abstract Abstract 3320 Introduction: Edoxaban is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. The aim of this non-inferiority trial was to determine the efficacy and safety of edoxaban compared with enoxaparin sodium (enoxaparin) after total hip arthroplasty (THA) in Japan. Methods: This was a randomized, double-blind, double-dummy, enoxaparin-controlled, multicenter trial. Patients were randomized to oral edoxaban 30 mg once daily (QD) or subcutaneous enoxaparin 2,000 IU, equivalent to 20 mg, twice daily (BID) for 11 to 14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery which is the Japanese standard of care. The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT), and pulmonary embolism (PE). The primary safety outcome was the incidence of major and clinically relevant non-major bleeding. Results: A total of 610 patients were randomized. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 62.8 years and mean body weight was 57.4 kg (Efficacy analysis set). The primary efficacy outcome occurred in 6 of 255 (2.4%) patients receiving edoxaban and 17 of 248 (6.9%) patients receiving enoxaparin (relative risk reduction=65.7%; absolute risk difference -4.5%, 95% CI, -8.6% to -0.9%; P<0.001 for non-inferiority; P=0.0157 for superiority). The thromboembolic events were all asymptomatic DVT (Table). No symptomatic DVT or PE was observed in both treatment groups. The incidence of major and clinically relevant non-major bleeding events was 2.6% (8/303) vs 3.7% (11/301) in the edoxaban and enoxaparin groups, respectively (P=0.475). Major bleeding occurred in 0.7% of the edoxaban group and 2.0% of the enoxaparin group. The rates of elevated serum aminotransferase levels of more than 3 times the upper limit of normal was 2.6% with edoxaban versus 10% with enoxaparin. Conclusions: The STARS J-V trial demonstrated that oral edoxaban 30 mg QD has efficacy superior to enoxaparin 2,000 IU BID in the prevention of thromboembolic events following THA and is associated with a similar incidence of major and clinically relevant non-major bleeding events. Disclosures: Fuji: Astellas: Consultancy; Showa Ikakogyo: Consultancy; Daiichi Sankyo: Consultancy; Bayer: Consultancy. Fujita:Daiichi Sankyo: Consultancy; Astellas: Consultancy; GlaxoSmithkline: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy. Koretsune:Daiichi Sankyo: Consultancy, National Lead Investigator. Yamashita:Daiichi Sankyo: Consultancy, National Lead Investigator; Otsuka Pharmaceutical: Paid instructor; Sanofi-aventis: Paid instructor; Teijin Pharma: Paid instructor. Nakamura:Daiichi Sankyo: Consultancy; GlaxoSmithkline: Consultancy; Astellas: Consultancy.

scholarly journals Dabigatran Etexilate or Warfarin in the Treatment of Acute Venous Thromboembolism in Western European Patients: A Pooled Analysis of RE-COVER® and RE-COVER II™

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4730-4730
Author(s):  
Sebastian Schellong ◽  
Henry Eriksson ◽  
Samuel Z. Goldhaber ◽  
Martin Feuring ◽  
Stefan Hantel ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Research Funding ◽  
Dabigatran Etexilate ◽  
Primary Efficacy ◽  
Bleeding Events ◽  
Primary Efficacy Outcome ◽  
Efficacy Outcome ◽  
Safety Outcomes ◽  
Western European ◽  
Acute Venous Thromboembolism

Abstract Introduction: In the RE-COVER®/RE-COVER II™ global randomized trials investigating the treatment of acute venous thromboembolism (VTE), efficacy and safety outcomes of dabigatran etexilate (dabigatran) versus warfarin were compared. This sub-analysis of pooled RE-COVER®/RE-COVER II™ data compares the safety and efficacy of dabigatran versus warfarin in the Western European sub-population. Methods: In the RE-COVER®/RE-COVER II™ trials, patients with acute VTE, initially receiving parenteral anticoagulation, were randomized to warfarin (INR 2-3) or dabigatran (150 mg twice daily) for 6 months and followed up for 30 days. The primary efficacy outcome was recurrent, symptomatic VTE/VTE-related death. Safety outcomes were major bleeding events (MBEs), a composite of MBEs or clinically relevant non-major bleeding events (MBEs/CRBEs) and any bleeding during the 6-month, oral-only treatment period. All outcomes were centrally adjudicated. Data from the Western European sub-population were analyzed using a Cox regression model with factor treatment stratified by study, assuming different baseline hazards per study. Results: This sub-analysis included 1239 patients for the efficacy analysis (dabigatran n = 613; warfarin n = 626) and 1192 patients for safety (dabigatran n = 588; warfarin n = 604) from all 13 Western European countries participating in the RE-COVER®/RE-COVER II™ trials. For the primary efficacy outcome, the rate of VTE/VTE-related death in patients receiving dabigatran was 2.1% (n = 13) compared with 2.9% (n = 18) in those receiving warfarin. However, this difference did not reach statistical significance (hazard ratio [HR] 0.74; 95% confidence interval [CI], 0.36-1.5). Of the safety outcomes, rates of MBEs were similar between both treatment groups (1.4% for dabigatran [n = 8] and 1.3% for warfarin [n = 8]; HR 1.02; 95% CI, 0.38-2.71). Rates of MBEs/CRBEs were significantly lower in patients receiving dabigatran than in those receiving warfarin at 5.1% (n = 30) and 9.4% (n = 57), respectively (HR 0.52; 95% CI, 0.34-0.82). Any bleeding events were also statistically lower in the dabigatran group (17.5%; n = 103) compared with warfarin (23.8%; n = 144) (HR 0.7; 95% CI, 0.54-0.90). Conclusions: In this Western European sub-analysis of pooled data from the RE-COVER®/ RE-COVER II™ trials, dabigatran was as effective as warfarin in the treatment of acute VTE. There was a significant reduction in MBE/CRBE and in any bleeding events in the dabigatran treatment group. Disclosures Schellong: Boehringer Ingelheim: Consultancy. Eriksson:Boehringer Ingelheim: Consultancy. Goldhaber:Boehringer Ingelheim: Consultancy, Research Funding. Feuring:Boehringer Ingelheim: Employment. Hantel:Boehringer Ingelheim Pharma GmbH and Co. KG: Employment. Kreuzer:Boehringer Ingelheim Pharma GmbH and Co. KG: Employment. Schulman:Boehringer Ingelheim: Honoraria, Research Funding; Bayer: Honoraria; Baxter: Honoraria; Octapharma: Research Funding. Kakkar:Boehringer Ingelheim: Consultancy, Honoraria, Research Funding.

Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. LBA-1-LBA-1
Author(s):  
Harry Roger Buller ◽  
Claudette Bethune ◽  
Sanjay Bhanot ◽  
David Gailani ◽  
Brett P. Monia ◽  
...  
Keyword(s):  
Health Care ◽  
Total Knee Arthroplasty ◽  
Knee Arthroplasty ◽  
Antisense Oligonucleotide ◽  
Research Funding ◽  
Primary Efficacy ◽  
Intrinsic Pathway ◽  
Primary Efficacy Outcome ◽  
Efficacy Outcome ◽  
Total Knee

Abstract BACKGROUND: Patients undergoing total knee arthroplasty are at risk for postoperative venous thromboembolism (VTE). The pathogenesis of postoperative VTE is incompletely understood, but tissue factor exposed at the surgical site is thought to be the major driver through the extrinsic pathway of coagulation. Experimental data indicate that reducing factor XI (FXI), a key component of the intrinsic pathway, attenuates thrombosis without causing bleeding, but the role of FXI in postoperative VTE in humans is unknown. There is evidence that patients with congenital FXI deficiency are at a reduced risk of VTE. FXI levels can be lowered with ISIS 416858 (FXI-ASO), an antisense oligonucleotide that specifically reduces human FXI mRNA expression in the liver. To determine whether lowering FXI levels prevents VTE without increasing the risk of bleeding, we compared several doses of FXI-ASO with enoxaparin on the rates of postoperative VTE and bleeding in patients undergoing total knee arthroplasty. METHODS: We randomized 300 patients to one of two FXI-ASO regimens (200 or 300 mg) or to 40 mg enoxaparin once daily in an open-label, parallel group study. FXI-ASO was administered as 9 subcutaneous injections starting 36 days before surgery with the last dose given 3 days postoperatively. Enoxaparin was to be continued for at least 8 days postoperatively. The primary efficacy outcome was the incidence of VTE detected by mandatory bilateral venography (performed on days 8 to 12 postoperatively) or symptomatic events. The principal safety outcome was major and clinically relevant nonmajor bleeding. All outcomes were adjudicated by a committee blinded to treatment allocation. RESULTS: FXI-ASO prolonged the activated partial thromboplastin time in a dose-dependent manner, but had no effect on the prothrombin time. Around the time of surgery, mean FXI activities were 0.38 ± 0.01, 0.20 ± 0.01 and 0.93 ± 0.02 units/ml in patients given the 200 and 300 mg FXI-ASO regimens and enoxaparin, respectively. In contrast, levels of FXII, FIX and FVIII, other components of the intrinsic pathway, were unaffected by FXI-ASO. The primary efficacy outcome occurred in 36 of 134 (26.9%) and 3 of 71 (4.2%) patients given the 200 and 300 mg FXI-ASO regimens, respectively, compared with 21 of 69 (30.4%) patients in the enoxaparin group. The 200 mg regimen was non-inferior, while the 300 mg regimen was superior to enoxaparin (P<0.001). Bleeding occurred in 2.8%, 2.6% and 8.3% of patients in the 200 mg, 300 mg, and enoxaparin groups, respectively. Preoperative and postoperative hemoglobin values and transfusion requirements were similar in the three treatment groups. CONCLUSIONS: This study is the first to show that FXI contributes to postoperative VTE and that lowering FXI levels is very effective for its prevention and appears to be safe. Additional studies are needed to confirm the safety of FXI-ASO, although the fact that patients receiving this therapy safely underwent major orthopedic surgery is reassuring. Our findings support the concept that thrombosis and hemostasis can be dissociated with strategies that target FXI. The profile of FXI-ASO renders it an appealing option for treatment of patients with a wide range of chronic thrombotic conditions. Disclosures Buller: Isis Pharmaceuticals Daiichi-Sankyo Bayer Health-Care Pfizer Bristol-Myers-Squibb: Consultancy, Honoraria. Bethune:Isis Pharmaceuticals: Employment. Bhanot:Isis Pharmaceuticals: Employment. Gailani:Aronora: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Dyax: Consultancy, Research Funding; Instrument Laboratory: Consultancy, Research Funding; Isis: Consultancy; Merck: Consultancy; Novartis: Consultancy. Monia:Isis Pharmaceuticals, Inc.: Employment. Raskob:Bayer Healthcare: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Janssen Pharmaceuticals: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; ISIS Pharmaceuticals: Consultancy, Honoraria. Segers:Isis Pharmaceuticals Daiichi-Sankyo Bayer Health-Care Pfizer Bristol-Myers-Squibb: Medical Director ofAcademic Research Organization which received services fees for the scientific coordination of clinical studies Other. Weitz:Pfizer, Inc.: Consultancy, Honoraria.

Sign in / Sign up

Export Citation Format

Share Document