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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Clinical researchers face numerous challenges&#44; while receiving &#60;2&#37; of the National Institutes of Health funding in previous years&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">1&#8211;5</span></a> A search for the terms &#8220;critically ill&#8221; and &#8220;ICU&#8221; and &#8220;randomized&#8221; in PubMed between 2010 and 2021 rendered 2&#44;585 publications&#59; only 3&#37; of those included &#8220;cancer&#46;&#8221; We conducted a single-center&#44; randomized controlled clinical trial&#44; and included adult cancer patients who met the Sepsis-3 septic shock definition within 12<span class="elsevierStyleHsp" style=""></span>h of ICU admission&#46; Patients were randomized to either standard of care or Early Metabolic Resuscitation &#40;dextrose 50&#37;&#44; amino acids&#44; and micronutrients&#41;&#46; The sample size &#40;112 patients&#44; 56 per group&#41; provided 90&#37; power to detect a 30&#37; absolute reduction in 28-day mortality&#46; The complete methodology is available at ClinicalTrials&#46;gov &#40;<a href="ctgov:NCT03895853">NCT03895853</a>&#41;&#46; During the available enrollment month&#44; 56&#47;194 cancer patients had sepsis and shock&#46; Among them&#44; 32 met inclusion criteria&#44; but 94&#37; had at least one exclusion criteria &#40;<a class="elsevierStyleCrossRefs" href="#fig0005">Figs&#46; 1A&#44; B and 2</a>&#41;&#59; only two patients were enrolled&#47;randomized to standard of care&#46; On May 4&#44; 2020&#44; the study was terminated due to overwhelming obstacles &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">Despite significant planning&#44; we report the failure of the trial associated with a combination of unforeseen events&#46; Using a previously described matrix&#44; we organized the discussion of these obstacles in six groups<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">2</span></a>&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">A&#41;</span><p id="par0015" class="elsevierStylePara elsevierViewall">External factors&#46; The study start was delayed for over three months because of two unexpected and consecutive institution-wide audits conducted by the <span class="elsevierStyleItalic">Centers for Medicare and Medicaid Services</span> and the <span class="elsevierStyleItalic">Joint Commission</span>&#46; The audits distracted dozens of teams from clinical research to address the additional workload caused by the regulatory activities&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">B&#41;</span><p id="par0020" class="elsevierStylePara elsevierViewall">Specific unit needs&#46; The complex and intensively involved protocol demanded scrupulous re-education of the participating healthcare personnel due to the delays in starting the trial caused by the audits&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">C&#41;</span><p id="par0025" class="elsevierStylePara elsevierViewall">Study-related factors&#46; Previous studies have identified the difficulty of defining diseases in the intensive care environment&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> Defining sepsis and septic shock has been a critical point of discussion for the experts in the field that has evolved over time&#46; In our study&#44; almost half of the patients did not meet the Sepsis-3 criteria because 43&#37; had normal lactate despite shock and vasopressors&#46; Moreover&#44; between the Sepsis-3 definition and the exclusion criteria&#44; most of the screened patients &#40;96&#46;4&#37;&#41; became ineligible&#44; thus impacting enrollment and potential generalizability of the trial&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">4</span></a></p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">D&#41;</span><p id="par0030" class="elsevierStylePara elsevierViewall">Study population&#46; Our institution is a referral comprehensive cancer center&#46; We manage high volumes of complex cancer patients that are admitted to our unit&#44; many of whom arrive in multi-organ failure with SOFA scores above 12 and Do-Not-Resuscitate &#40;DNR&#41; orders &#40;21&#46;9&#37;&#41; at the time of diagnosis&#46; Both the SOFA and DNR status are frequent reasons for the exclusion of critically ill cancer patients in clinical trials&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">E&#41;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Resources&#44; including an unexpected national shortage of the branched-chain amino acid solution after enrolling two patients&#44; forced us to stop enrollment&#46; Once the protocol was ready to restart enrollment&#44; another external and unexpected factor surfaced&#46; The COVID-19 pandemic was declared&#44; and all clinical research activities in the hospital were paused&#46; As the study prolonged&#44; our funding could no longer sustain the 4-member team&#44; which was created to recruit and enroll patients 24&#47;7&#44; as Francois et al&#46; suggested&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a></p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">F&#41;</span><p id="par0040" class="elsevierStylePara elsevierViewall">Clinicians&#46; A sudden deterioration of the health condition of the primary investigator led to his leave of absence during the pandemic&#46;</p></li></ul></p><p id="par0045" class="elsevierStylePara elsevierViewall">From the above factors&#44; the study-related category encompasses a challenge that should be thoroughly addressed when planning a randomized controlled trial&#46; The difficulty of finding eligible patients is not a phenomenon unique to our trial&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a> Therefore&#44; we suggest that anticipating the number of potential participants is essential&#46; Additionally&#44; we encourage the investigators to perform an exhaustive run-through screening which could illustrate the times of the day when patients become eligible and the most common reasons for exclusion&#46; As specific unit transfer dynamics differ widely&#44; knowing the best times for recruitment before starting the trial would allow planning to facilitate the enrollment process&#46; This will guide the investigators in determining whether 24&#47;7 coverage is necessary&#46; Additionally&#44; we recommend examining the reasons for exclusions of the simulated screening&#44; which can also facilitate discussions on whether the exclusion criteria could be loosened up to increase enrollment rate without compromising safety&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Among the obstacles described&#44; the main reason for the termination of the trial was the COVID-19 crisis&#46; The pandemic has had a devastating effect on the research community as a whole&#46; Both basic science and clinical research have been disrupted by the reasonable efforts taken to protect all the stakeholders and prevent the spread of the virus&#46; However&#44; stopping operations of clinical trials that were addressing vital and relevant clinical problems is an issue by itself&#44;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> particularly the studies involving vulnerable populations&#46; By February 2021&#44; over 1200 clinical trials had reported a disruption of their operations&#44; most of them even suspending the enrollment altogether&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a> The pandemic has shown the multiple ways that the designing&#44; conducting&#44; and reporting of clinical trials can improve&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> Furthermore&#44; as the research community has been adapting to the pandemic&#44; the number of clinical trials that have resumed enrollment has started to rise&#46; The lessons learned will make researchers embark in modern ways to streamline processes that could result in a more efficient and resilient community in the future&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The complexity and prohibitive costs of clinical trials have increased exponentially in the last few years&#46; Our tale should be a cautionary message for future study designs in this population&#46; In addition to the increasing internal and external regulatory hurdles or unforeseeable chain of unfortunate events&#44; enrolling critically ill cancer patients in clinical trials is extremely challenging with rates as low as 2&#8211;5&#37; reported in previous studies&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a> Some of these events are rare&#44; and robust mitigation plans are not cost-effective or feasible&#59; therefore&#44; only limited precautions can be put in place&#46; Prior feasibility studies&#44; far-sighted planning of study implementation&#44; enrollment forecasting&#44; and allocation of the needed resources have never been more important&#46; In fact&#44; all of them are essential if we want to prevent continuously excluding this population from future trials&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Authors&#8217; contributions</span><p id="par0060" class="elsevierStylePara elsevierViewall">Doctors Nates and de Villalobos had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data&#46; Concept and design&#58; de Villalobos&#44; Nates&#46; Acquisition&#44; analysis&#44; or interpretation of data&#58; All authors&#46; Drafting of the manuscript&#58; All authors&#46; Critical revision of the manuscript for important intellectual content&#58; 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Scientific letter
Tribulations of conducting critically ill cancer patients research: Lessons from a failed septic shock trial and Murphy's law
Tribulaciones de la investigación en pacientes críticos con cáncer: lecciones de un ensayo clínico fallido sobre el shock Séptico y la Ley de Murphy
M.P. Reyes, J.A. Cuenca, J. Heatter, P.R. Martin, D.H.d. Villalobos, J.L. Nates
Corresponding author
jlnates@mdanderson.org

Corresponding author.
Department of Critical Care Medicine, Division of Anesthesiology, Critical Care, and Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The timeline shows the sequence of events faced by our trial&#46; The study active period went from November 2019 to February 2020&#46; During this period &#40;yellow&#41;&#44; 586 patients were admitted to the ICU&#59; of them&#44; 135 patients had sepsis and shock&#46; However&#44; we were able to enroll patients only during the first month of study activity &#40;orange&#41; due to shortage of the amino-acid solution&#44; which was part of the intervention&#46; The flow diagram corresponds to this one-month period&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Clinical researchers face numerous challenges&#44; while receiving &#60;2&#37; of the National Institutes of Health funding in previous years&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">1&#8211;5</span></a> A search for the terms &#8220;critically ill&#8221; and &#8220;ICU&#8221; and &#8220;randomized&#8221; in PubMed between 2010 and 2021 rendered 2&#44;585 publications&#59; only 3&#37; of those included &#8220;cancer&#46;&#8221; We conducted a single-center&#44; randomized controlled clinical trial&#44; and included adult cancer patients who met the Sepsis-3 septic shock definition within 12<span class="elsevierStyleHsp" style=""></span>h of ICU admission&#46; Patients were randomized to either standard of care or Early Metabolic Resuscitation &#40;dextrose 50&#37;&#44; amino acids&#44; and micronutrients&#41;&#46; The sample size &#40;112 patients&#44; 56 per group&#41; provided 90&#37; power to detect a 30&#37; absolute reduction in 28-day mortality&#46; The complete methodology is available at ClinicalTrials&#46;gov &#40;<a href="ctgov:NCT03895853">NCT03895853</a>&#41;&#46; During the available enrollment month&#44; 56&#47;194 cancer patients had sepsis and shock&#46; Among them&#44; 32 met inclusion criteria&#44; but 94&#37; had at least one exclusion criteria &#40;<a class="elsevierStyleCrossRefs" href="#fig0005">Figs&#46; 1A&#44; B and 2</a>&#41;&#59; only two patients were enrolled&#47;randomized to standard of care&#46; On May 4&#44; 2020&#44; the study was terminated due to overwhelming obstacles &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">Despite significant planning&#44; we report the failure of the trial associated with a combination of unforeseen events&#46; Using a previously described matrix&#44; we organized the discussion of these obstacles in six groups<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">2</span></a>&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">A&#41;</span><p id="par0015" class="elsevierStylePara elsevierViewall">External factors&#46; The study start was delayed for over three months because of two unexpected and consecutive institution-wide audits conducted by the <span class="elsevierStyleItalic">Centers for Medicare and Medicaid Services</span> and the <span class="elsevierStyleItalic">Joint Commission</span>&#46; The audits distracted dozens of teams from clinical research to address the additional workload caused by the regulatory activities&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">B&#41;</span><p id="par0020" class="elsevierStylePara elsevierViewall">Specific unit needs&#46; The complex and intensively involved protocol demanded scrupulous re-education of the participating healthcare personnel due to the delays in starting the trial caused by the audits&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">C&#41;</span><p id="par0025" class="elsevierStylePara elsevierViewall">Study-related factors&#46; Previous studies have identified the difficulty of defining diseases in the intensive care environment&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> Defining sepsis and septic shock has been a critical point of discussion for the experts in the field that has evolved over time&#46; In our study&#44; almost half of the patients did not meet the Sepsis-3 criteria because 43&#37; had normal lactate despite shock and vasopressors&#46; Moreover&#44; between the Sepsis-3 definition and the exclusion criteria&#44; most of the screened patients &#40;96&#46;4&#37;&#41; became ineligible&#44; thus impacting enrollment and potential generalizability of the trial&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">4</span></a></p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">D&#41;</span><p id="par0030" class="elsevierStylePara elsevierViewall">Study population&#46; Our institution is a referral comprehensive cancer center&#46; We manage high volumes of complex cancer patients that are admitted to our unit&#44; many of whom arrive in multi-organ failure with SOFA scores above 12 and Do-Not-Resuscitate &#40;DNR&#41; orders &#40;21&#46;9&#37;&#41; at the time of diagnosis&#46; Both the SOFA and DNR status are frequent reasons for the exclusion of critically ill cancer patients in clinical trials&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">E&#41;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Resources&#44; including an unexpected national shortage of the branched-chain amino acid solution after enrolling two patients&#44; forced us to stop enrollment&#46; Once the protocol was ready to restart enrollment&#44; another external and unexpected factor surfaced&#46; The COVID-19 pandemic was declared&#44; and all clinical research activities in the hospital were paused&#46; As the study prolonged&#44; our funding could no longer sustain the 4-member team&#44; which was created to recruit and enroll patients 24&#47;7&#44; as Francois et al&#46; suggested&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a></p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">F&#41;</span><p id="par0040" class="elsevierStylePara elsevierViewall">Clinicians&#46; A sudden deterioration of the health condition of the primary investigator led to his leave of absence during the pandemic&#46;</p></li></ul></p><p id="par0045" class="elsevierStylePara elsevierViewall">From the above factors&#44; the study-related category encompasses a challenge that should be thoroughly addressed when planning a randomized controlled trial&#46; The difficulty of finding eligible patients is not a phenomenon unique to our trial&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a> Therefore&#44; we suggest that anticipating the number of potential participants is essential&#46; Additionally&#44; we encourage the investigators to perform an exhaustive run-through screening which could illustrate the times of the day when patients become eligible and the most common reasons for exclusion&#46; As specific unit transfer dynamics differ widely&#44; knowing the best times for recruitment before starting the trial would allow planning to facilitate the enrollment process&#46; This will guide the investigators in determining whether 24&#47;7 coverage is necessary&#46; Additionally&#44; we recommend examining the reasons for exclusions of the simulated screening&#44; which can also facilitate discussions on whether the exclusion criteria could be loosened up to increase enrollment rate without compromising safety&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Among the obstacles described&#44; the main reason for the termination of the trial was the COVID-19 crisis&#46; The pandemic has had a devastating effect on the research community as a whole&#46; Both basic science and clinical research have been disrupted by the reasonable efforts taken to protect all the stakeholders and prevent the spread of the virus&#46; However&#44; stopping operations of clinical trials that were addressing vital and relevant clinical problems is an issue by itself&#44;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> particularly the studies involving vulnerable populations&#46; By February 2021&#44; over 1200 clinical trials had reported a disruption of their operations&#44; most of them even suspending the enrollment altogether&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a> The pandemic has shown the multiple ways that the designing&#44; conducting&#44; and reporting of clinical trials can improve&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> Furthermore&#44; as the research community has been adapting to the pandemic&#44; the number of clinical trials that have resumed enrollment has started to rise&#46; The lessons learned will make researchers embark in modern ways to streamline processes that could result in a more efficient and resilient community in the future&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The complexity and prohibitive costs of clinical trials have increased exponentially in the last few years&#46; Our tale should be a cautionary message for future study designs in this population&#46; In addition to the increasing internal and external regulatory hurdles or unforeseeable chain of unfortunate events&#44; enrolling critically ill cancer patients in clinical trials is extremely challenging with rates as low as 2&#8211;5&#37; reported in previous studies&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a> Some of these events are rare&#44; and robust mitigation plans are not cost-effective or feasible&#59; therefore&#44; only limited precautions can be put in place&#46; Prior feasibility studies&#44; far-sighted planning of study implementation&#44; enrollment forecasting&#44; and allocation of the needed resources have never been more important&#46; In fact&#44; all of them are essential if we want to prevent continuously excluding this population from future trials&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Authors&#8217; contributions</span><p id="par0060" class="elsevierStylePara elsevierViewall">Doctors Nates and de Villalobos had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data&#46; Concept and design&#58; de Villalobos&#44; Nates&#46; Acquisition&#44; analysis&#44; or interpretation of data&#58; All authors&#46; Drafting of the manuscript&#58; All authors&#46; Critical revision of the manuscript for important intellectual content&#58; de Villalobos&#44; Nates&#46; Obtained funding&#58; de Villalobos&#44; Nates&#46; Supervision&#58; de Villalobos&#44; Nates&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Funding</span><p id="par0065" class="elsevierStylePara elsevierViewall">This work was supported by <span class="elsevierStyleGrantSponsor" id="gs1">The University of Texas MD Anderson Cancer Center Grant Resources</span>&#44; and the <span class="elsevierStyleGrantSponsor" id="gs2">NIH&#47;NCI</span> award number P30CA016672&#46; The funders had no role in the design and conduct of the study&#44; preparation of the manuscript&#44; and the decision to submit the manuscript for publication&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflict of interests</span><p id="par0070" class="elsevierStylePara elsevierViewall">The authors declare that there is no conflict of interest&#46;</p></span></span>"
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Article information
ISSN: 21735727
Original language: English
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