Trials and tribulations: so many potential treatments, so few answers.
Identifieur interne : 000A40 ( Main/Exploration ); précédent : 000A39; suivant : 000A41Trials and tribulations: so many potential treatments, so few answers.
Auteurs : Aaron Gazendam [Canada] ; Nicholas Nucci [Canada] ; Seper Ekhtiari [Canada] ; Chetan Gohal [Canada] ; Meng Zhu [Canada] ; Abbey Payne [Canada] ; Mohit Bhandari [Canada]Source :
- International orthopaedics [ 1432-5195 ] ; 2020.
Descripteurs français
- KwdFr :
- Betacoronavirus (effets des médicaments et des substances chimiques), Essais cliniques comme sujet (MeSH), Humains (MeSH), Hydroxychloroquine (effets indésirables), Hydroxychloroquine (usage thérapeutique), Infections à coronavirus (traitement médicamenteux), Pandémies (MeSH), Pneumopathie virale (traitement médicamenteux).
- MESH :
- effets des médicaments et des substances chimiques : Betacoronavirus.
- effets indésirables : Hydroxychloroquine.
- traitement médicamenteux : Infections à coronavirus, Pneumopathie virale.
- usage thérapeutique : Hydroxychloroquine.
- Essais cliniques comme sujet, Humains, Pandémies.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Hydroxychloroquine.
- drug effects : Betacoronavirus.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- chemical , therapeutic use : Hydroxychloroquine.
- COVID-19, Clinical Trials as Topic, Humans, Pandemics, SARS-CoV-2.
Abstract
PURPOSE
The purpose of this review is to quantify the landscape of current clinical trials ongoing for therapies in the treatment of COVID-19. A secondary purpose is to examine the relationship between public and scientific interests in potential therapies for COVID-19.
METHODS
A systematic search of clinicaltrials.gov was undertaken on April 22, 2020, to identify all currently registered clinical trials investigating potential therapies for patients with COVID-19. Public interest in the various therapies was quantified utilizing Google Trends. Public interest in hydroxychloroquine and chloroquine was plotted against the cumulative number of active clinical trials evaluating antimalarials as potential COVID-19 therapies over time.
RESULTS
There were 341 interventional studies and 208 different therapies actively registered on clinicaltrials.gov whose primary aim is the treatment of COVID-19. The median sample size was 120 patients (range 4-6000) with 154 (45%) trials reporting a planned sample size of 100 patients or less. There was a strong positive correlation (r = 0.76, p = 0.01) between the number of registered clinical trials and the public interest in the top ten proposed therapies. Following the spike in public interest, the average number of new trials increased tenfold with respect to antimalarial therapies.
CONCLUSIONS
The relatively small sample sizes and the number of independent trials investigating similar therapies are concerning. Resources may not be being allocated based on scientific merit and may be driven by public consciousness and speculation. Moving forward, a concerted effort focused on implementing large, well-coordinated and carefully designed multi-armed clinical trials will help to ensure that the most promising therapeutic options are rigorously studied and clinically meaningful results produced.
DOI: 10.1007/s00264-020-04625-7
PubMed: 32447429
PubMed Central: PMC7245574
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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wicri:level="4"><nlm:affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada. Aaron.gazendam@gmail.com.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Nucci, Nicholas" sort="Nucci, Nicholas" uniqKey="Nucci N" first="Nicholas" last="Nucci">Nicholas Nucci</name><affiliation wicri:level="1"><nlm:affiliation>Northern Ontario School of Medicine, Lakehead University, Thunder Bay, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Northern Ontario School of Medicine, Lakehead University, Thunder Bay</wicri:regionArea><wicri:noRegion>Thunder Bay</wicri:noRegion></affiliation></author><author><name sortKey="Ekhtiari, Seper" sort="Ekhtiari, Seper" uniqKey="Ekhtiari S" first="Seper" last="Ekhtiari">Seper Ekhtiari</name><affiliation wicri:level="4"><nlm:affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Gohal, Chetan" sort="Gohal, Chetan" uniqKey="Gohal C" first="Chetan" last="Gohal">Chetan Gohal</name><affiliation wicri:level="4"><nlm:affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Zhu, Meng" sort="Zhu, Meng" uniqKey="Zhu M" first="Meng" last="Zhu">Meng Zhu</name><affiliation wicri:level="1"><nlm:affiliation>OrthoEvidence, Burlington, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>OrthoEvidence, Burlington, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Payne, Abbey" sort="Payne, Abbey" uniqKey="Payne A" first="Abbey" last="Payne">Abbey Payne</name><affiliation wicri:level="1"><nlm:affiliation>OrthoEvidence, Burlington, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>OrthoEvidence, Burlington, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Bhandari, Mohit" sort="Bhandari, Mohit" uniqKey="Bhandari M" first="Mohit" last="Bhandari">Mohit Bhandari</name><affiliation wicri:level="4"><nlm:affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>OrthoEvidence, Burlington, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>OrthoEvidence, Burlington, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author></analytic><series><title level="j">International orthopaedics</title><idno type="eISSN">1432-5195</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Betacoronavirus (drug effects)</term><term>COVID-19 (MeSH)</term><term>Clinical Trials as Topic (MeSH)</term><term>Coronavirus Infections (drug therapy)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (adverse effects)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (drug therapy)</term><term>SARS-CoV-2 (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Betacoronavirus (effets des médicaments et des substances chimiques)</term><term>Essais cliniques comme sujet (MeSH)</term><term>Humains (MeSH)</term><term>Hydroxychloroquine (effets indésirables)</term><term>Hydroxychloroquine (usage thérapeutique)</term><term>Infections à coronavirus (traitement médicamenteux)</term><term>Pandémies (MeSH)</term><term>Pneumopathie virale (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Betacoronavirus</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>COVID-19</term><term>Clinical Trials as Topic</term><term>Humans</term><term>Pandemics</term><term>SARS-CoV-2</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais cliniques comme sujet</term><term>Humains</term><term>Pandémies</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>PURPOSE</b></p><p>The purpose of this review is to quantify the landscape of current clinical trials ongoing for therapies in the treatment of COVID-19. A secondary purpose is to examine the relationship between public and scientific interests in potential therapies for COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A systematic search of clinicaltrials.gov was undertaken on April 22, 2020, to identify all currently registered clinical trials investigating potential therapies for patients with COVID-19. Public interest in the various therapies was quantified utilizing Google Trends. Public interest in hydroxychloroquine and chloroquine was plotted against the cumulative number of active clinical trials evaluating antimalarials as potential COVID-19 therapies over time.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>There were 341 interventional studies and 208 different therapies actively registered on clinicaltrials.gov whose primary aim is the treatment of COVID-19. The median sample size was 120 patients (range 4-6000) with 154 (45%) trials reporting a planned sample size of 100 patients or less. There was a strong positive correlation (r = 0.76, p = 0.01) between the number of registered clinical trials and the public interest in the top ten proposed therapies. Following the spike in public interest, the average number of new trials increased tenfold with respect to antimalarial therapies.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>The relatively small sample sizes and the number of independent trials investigating similar therapies are concerning. Resources may not be being allocated based on scientific merit and may be driven by public consciousness and speculation. Moving forward, a concerted effort focused on implementing large, well-coordinated and carefully designed multi-armed clinical trials will help to ensure that the most promising therapeutic options are rigorously studied and clinically meaningful results produced.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">32447429</PMID><DateCompleted><Year>2020</Year><Month>08</Month><Day>14</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1432-5195</ISSN><JournalIssue CitedMedium="Internet"><Volume>44</Volume><Issue>8</Issue><PubDate><Year>2020</Year><Month>08</Month></PubDate></JournalIssue><Title>International orthopaedics</Title><ISOAbbreviation>Int Orthop</ISOAbbreviation></Journal><ArticleTitle>Trials and tribulations: so many potential treatments, so few answers.</ArticleTitle><Pagination><MedlinePgn>1467-1471</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s00264-020-04625-7</ELocationID><Abstract><AbstractText Label="PURPOSE">The purpose of this review is to quantify the landscape of current clinical trials ongoing for therapies in the treatment of COVID-19. A secondary purpose is to examine the relationship between public and scientific interests in potential therapies for COVID-19.</AbstractText><AbstractText Label="METHODS">A systematic search of clinicaltrials.gov was undertaken on April 22, 2020, to identify all currently registered clinical trials investigating potential therapies for patients with COVID-19. Public interest in the various therapies was quantified utilizing Google Trends. Public interest in hydroxychloroquine and chloroquine was plotted against the cumulative number of active clinical trials evaluating antimalarials as potential COVID-19 therapies over time.</AbstractText><AbstractText Label="RESULTS">There were 341 interventional studies and 208 different therapies actively registered on clinicaltrials.gov whose primary aim is the treatment of COVID-19. The median sample size was 120 patients (range 4-6000) with 154 (45%) trials reporting a planned sample size of 100 patients or less. There was a strong positive correlation (r = 0.76, p = 0.01) between the number of registered clinical trials and the public interest in the top ten proposed therapies. Following the spike in public interest, the average number of new trials increased tenfold with respect to antimalarial therapies.</AbstractText><AbstractText Label="CONCLUSIONS">The relatively small sample sizes and the number of independent trials investigating similar therapies are concerning. Resources may not be being allocated based on scientific merit and may be driven by public consciousness and speculation. Moving forward, a concerted effort focused on implementing large, well-coordinated and carefully designed multi-armed clinical trials will help to ensure that the most promising therapeutic options are rigorously studied and clinically meaningful results produced.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gazendam</LastName><ForeName>Aaron</ForeName><Initials>A</Initials><Identifier Source="ORCID">0000-0002-2615-4919</Identifier><AffiliationInfo><Affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada. Aaron.gazendam@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nucci</LastName><ForeName>Nicholas</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Northern Ontario School of Medicine, Lakehead University, Thunder Bay, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ekhtiari</LastName><ForeName>Seper</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gohal</LastName><ForeName>Chetan</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhu</LastName><ForeName>Meng</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>OrthoEvidence, Burlington, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Payne</LastName><ForeName>Abbey</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>OrthoEvidence, Burlington, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bhandari</LastName><ForeName>Mohit</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>OrthoEvidence, Burlington, Ontario, Canada.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>05</Month><Day>24</Day></ArticleDate></Article><MedlineJournalInfo><Country>Germany</Country><MedlineTA>Int Orthop</MedlineTA><NlmUniqueID>7705431</NlmUniqueID><ISSNLinking>0341-2695</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="Y">Betacoronavirus</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002986" MajorTopicYN="N">Clinical Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="Y">Coronavirus Infections</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="Y">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="Y">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName></MeshHeading></MeshHeadingList><KeywordList 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name="Canada"><region name="Ontario"><name sortKey="Gazendam, Aaron" sort="Gazendam, Aaron" uniqKey="Gazendam A" first="Aaron" last="Gazendam">Aaron Gazendam</name></region><name sortKey="Bhandari, Mohit" sort="Bhandari, Mohit" uniqKey="Bhandari M" first="Mohit" last="Bhandari">Mohit Bhandari</name><name sortKey="Bhandari, Mohit" sort="Bhandari, Mohit" uniqKey="Bhandari M" first="Mohit" last="Bhandari">Mohit Bhandari</name><name sortKey="Ekhtiari, Seper" sort="Ekhtiari, Seper" uniqKey="Ekhtiari S" first="Seper" last="Ekhtiari">Seper Ekhtiari</name><name sortKey="Gohal, Chetan" sort="Gohal, Chetan" uniqKey="Gohal C" first="Chetan" last="Gohal">Chetan Gohal</name><name sortKey="Nucci, Nicholas" sort="Nucci, Nicholas" uniqKey="Nucci N" first="Nicholas" last="Nucci">Nicholas Nucci</name><name sortKey="Payne, Abbey" sort="Payne, Abbey" uniqKey="Payne A" first="Abbey" last="Payne">Abbey Payne</name><name sortKey="Zhu, Meng" sort="Zhu, Meng" uniqKey="Zhu M" first="Meng" last="Zhu">Meng 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