You are here

Article Text

Article menu
Health policy
Protocol
Impact of the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials: protocol for a scoping review
  1. Wenru Shang1,2,3,
  2. Lili Wei4,
  3. Yujia Liu5,
  4. Haosheng Pu1,
  5. Xiuxia Li1,2,3,
  6. Junqiang Niu3,6,
  7. Long Ge1,2,3,
  8. Cuncun Lu7,
  9. Kehu Yang1,2,3
  1. 1Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, P. R. China
  2. 2WHO Collaborating Center for Guideline Implementation and Knowledge Translation, Lanzhou University, Lanzhou, P. R. China
  3. 3Collaborative Innovation Center, First Hospital of Lanzhou University, Lanzhou, P.R.China
  4. 4School of Business and Management, Gansu University of Traditional Chinese Medicine, Lanzhou, P. R. China
  5. 5First school of Clinical Medicine, Gansu University of Traditional Chinese Medicine, Lanzhou, P. R. China
  6. 6Traditional Chinese Medicine Department, First Hospital of Lanzhou University, Lanzhou, P. R. China
  7. 7Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Lanzhou, P. R. China
  1. Correspondence to Professor Kehu Yang; kehuyangebm2006{at}126.com; Dr Cuncun Lu; cuncunlu2017{at}163.com

Abstract

Introduction The COVID-19 pandemic posed a detrimental impact on the conduct of non-COVID-19 related clinical trials, raising concerns about the completeness of these studies and waste of resources. While several measures and strategies have been suggested to address these issues, a thorough and timely summarisation is still lacking. Therefore, our aim is to conduct a scoping review to summarise the negative effects of COVID-19 on non-COVID-19 clinical trials, outline the effective measures for mitigating these impacts, and provide insights for future pandemics.

Methods and analysis This scoping review will be conducted in line with the Joanna Briggs Institute’s scoping review methodological framework, and the results will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Relevant articles will be searched in PubMed, Embase and the Cochrane Library from 1 December 2019 to 1 July 2023. We will also screen the reference lists of the included studies manually to identify more potentially relevant articles. Articles focusing on the adverse impacts of COVID-19 on non-COVID-19 clinical trials and effective measures for mitigating them will be included. Two investigators will perform study selection and data extraction independently. A narrative summary as well as a descriptive analysis of the basic characteristics and key results of the included studies will be performed.

Ethics and dissemination Ethical approval is not required, as this scoping review will be completed based only on published literature. The findings of this scoping review will be disseminated through a peer-reviewed publication and/or conference presentations.

  • Clinical Decision-Making
  • Clinical Trial
  • COVID-19
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2023-074128

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    Introduction

    Approximately 3 years have transpired since the WHO initially became aware of a cluster of pneumonia cases with an unknown origin in Wuhan, China, which subsequently led to the emergence of the COVID-19.1–3 On 5 May 2023, WHO Director-General Dr. Tedros Adhanom Ghebreyesus announced the cessation of COVID-19’s classification as a Public Health Emergency of International Concern.4 It is crucial to acknowledge, however, that despite this change, COVID-19 perseveres as a paramount global health threat.5 COVID-19, caused by the highly transmissible SARS-CoV-2, rapidly spreads among both humans and animals. This contagious disease can lead to various respiratory, gastrointestinal, and central nervous system illnesses. Moreover, it demonstrates its ability to adapt to new environments through mutations, as evidenced by the emergence of variants like Alpha, Delta, and the more recent Omicron variant.6 According to the WHO, as of June 2023, there have been over 767 million confirmed cases of COVID-19 and more than 6.9 million COVID-19 related deaths globally.7

    During the initial 2 years of the COVID-19 pandemic, a series of up-scaling and down-scaling containment measures were adopted by different countries and regions to control viral transmission, including travel restrictions (both domestic and international), social distancing, closure of schools, restrictions on mass gatherings, quarantine, adherence to personal hygiene, mandated use of face masks and implementation of infection control measures in healthcare.8–10 However, the implementation of these measures had unforeseen repercussions, leading to the immediate suspension, delay, or concealment of many clinical trials. As a result, all stages (i.e., from trial design to publication of the results) of non-COVID-19 clinical trials were significantly affected.11–13 For example, the need for social distancing and quarantine measures created challenges for participants and trial personnel, as it limited their ability to attend in-person study visits and follow-ups. This hindered the progression of participant recruitment and data collection of clinical trials.14–16 Large trial centers, which typically run multiple trials simultaneously and enroll a considerable number of patients across different sites, were also forced to halt their operations due to the restrictions and safety concerns posed by the pandemic.17 18 As a consequence, the global conduct of non-COVID-19 clinical trials experienced a substantial setback. In addition, at the outset of the pandemic, the publication of clinical research unrelated to the pandemic faced significant delays, primarily attributed to the redirection of resources, funding, and attention toward COVID-19-related studies, consequently diverting efforts away from non-COVID-19 clinical research.19 20

    Numerous studies have been published to explore the impact of the COVID-19 pandemic on non-COVID-19 clinical research.14 21–25 For example, Sathian et al conducted a systematic review by searching databases from January 2020 to September 2020 to evaluate the global impact of the COVID-19 pandemic on clinical trials and research. Their analysis included six articles, revealing that the pandemic has had a negative impact on trial programs. This impact includes delays in subject enrolment, operational gaps in ongoing clinical trials, and disruptions in timelines and operations at sites conducting non-COVID-19 clinical trials.14 Gaudino et al found that during the initial months of the COVID-19 pandemic, the rate of clinical trials that were stopped increased significantly compared with the pre-pandemic era.21 In addition, Audisio et al made a systematic analysis to assess the impact of the COVID-19 pandemic specifically on non-COVID-19 randomized controlled trials (RCTs).25 Their study found a notable increase in the cessation of non-COVID-19 RCTs without changes in RCT completion. There was also a sharp decline in the initiation rate of new RCTs at the beginning of the pandemic. However, it is worth noting that while several studies have examined the impact of the pandemic on clinical trials, many of them have primarily focused on the early stages of the pandemic, and they often did not address how to mitigate this adverse impact.

    Strengths and limitations of this study

    • We will adhere to a rigorous methodology based on the methodological framework for scoping reviews provided by the Joanna Briggs Institute.

    • This review will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

    • The review will not include non-peer-reviewed articles and grey literature such as government materials.

    • The review will only include studies written in English, which may introduce language bias and limit the representativeness of the findings.

    As circumstances change and the COVID-19 restrictions have largely been lifted, researchers and research institutions have actively responded to the challenges posed by the pandemic embraced some guidelines and adapted methods to ensure the continuity of clinical trials. Notably, the US Food and Drug Administration issued the Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency guidance, which provided valuable insights into this matter.26 Decentralised clinical trials have gained prominence as an effective approach.27 However, a timely and comprehensive review that thoroughly summarises the adverse effects of COVID-19 on the conduct of non-COVID-19 related clinical trials, as well as effective measures to mitigate these effects, is still lacking. A scoping review, regarded as a valid tool to map the available evidence on a wide research topic to organize the key concepts and their relationship and to analyze knowledge gaps, can therefore be considered a suitable approach to bridge this research gap.28 We therefore designed this scoping review to summarise the negative effects of COVID-19 on non-COVID-19 clinical trials as well as to identify effective measures for mitigating these impacts, also in preparation for future pandemics.

    Methods and analysis

    We will apply the methodology of a scoping review to summarise the existing literature on the negative effects of the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials, as well as to outline effective measures for mitigating these impacts. To ensure reporting transparency, the present protocol is reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist29 30; and the final results will be presented in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews (PRISMA-ScR). To ensure the high methodological quality of this scoping review, we will follow the most recent methodological framework for conducting a scoping review developed by the Joanna Briggs Institute (JBI).31 This framework builds on previous frameworks proposed by Arksey and O’Malley32 and Levac et al.33 The development will be done accordingly in the following steps: identifying the research question(s); developing a comprehensive search strategy; identifying relevant studies; selecting the studies; charting the data; and collating, summarising, and reporting the results.

    Step 1: identifying the research question

    The aim of this scoping review is to summarise existing evidence regarding the adverse effects of the COVID-19 pandemic on various aspects of conducting non-COVID-19 clinical trials. Specifically, we will address the impact of the pandemic on participant recruitment, data collection, statistical analysis, trial design, regulatory considerations and publication of results. Moreover, the effective measures for mitigating these impacts will also be summarised.

    This scoping review aims to answer the following questions:

    • What are the adverse effects of the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials at different stages, specifically in terms of participant recruitment, data collection, statistical analysis, trial design, regulatory considerations, and publication of results?

    • What effective measures are available to alleviate, mitigate, and control the adverse effects caused by the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials, both during and after the pandemic?

    Step 2: developing a comprehensive search strategy

    To ensure transparency and maximize the reproducibility of the literature searches, we will follow the PRISMA Statement for Reporting Literature Searches when reporting the different components of the search.34 Relevant peer-reviewed articles will be systematically searched in PubMed, Embase, and the Cochrane Library from 1 December 2019 until 1 July 2023. The search strategy for PubMed was developed using Medical Subject Headings and free text terms related to COVID-19, clinical trials as well as impact (e.g., “discontinuation”, “disruption”, “termination” and “reactivation”). These terms were adapted to other databases according to their requirements. The detailed search strategies for all selected databases are provided in the online supplemental appendix A, and the search will be updated during the process as necessary to ensure the inclusion of all relevant studies. In addition, we will also review the reference lists of included studies to ensure that all relevant literature has been identified. If more information about a study is needed, we will contact the authors.

    Step 3: identifying relevant studies

    Inclusion and exclusion criteria

    We will include all articles that:

    • Focus on the adverse effects of the COVID-19 pandemic on any aspect of the conduct of non-COVID-19 clinical trials, including participant recruitment, data collection, statistical analysis, trial design, regulatory considerations, and publication of results; or present a range of effective measures (eg, remote monitoring, virtual visits) to mitigate the adverse impacts of the COVID-19 pandemic on non-COVID-19 clinical trials.

    • Were published in peer-reviewed journals.

    • Were published between 1 December 2019 and 1 July 2023.

    We will make no restrictions on the methods used (qualitative, quantitative, or mixed). Both primary studies and reviews are eligible for inclusion.

    We will exclude all studies that are not published in the English language, as well as commentaries, newsletters, conference proceedings, abstracts, and grey literature.

    Patient and public involvement statement

    Patients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research.

    Step 4: selecting the studies

    All identified citations will be imported into Endnote X V.9.3.3 for deduplication. Two investigators (WS and CL) will screen the titles and abstracts, obtain the full texts of potentially eligible studies, and assess them for final inclusion. Disagreements will be resolved through discussion and, if necessary, adjudication by a third investigator (KY). The number of studies included and excluded at each stage, along with the reasons for this decision, will be summarised and recorded in a PRISMA flow diagram.

    Step 5: charting the data

    The next stage of the scoping review process is data extraction using a data charting extraction form. Data from studies that meet the inclusion criteria will be extracted by two investigators (WS and WL) independently, entered into a predesigned Microsoft Excel spreadsheet, and confirmed by a third investigator (LC) to ensure the quality of the extraction. Any disagreements that arise between the investigators will be resolved through discussion or with a third investigator. If required, the corresponding authors of the included studies will be contacted for additional information. The following information will be extracted:

    • Basic characteristics: title, first author, year of publication, country of the corresponding author, name and discipline classification of the journal.

    • Details of the study: study design, population, sample size, setting, study duration, and data sources, if applicable.

    • Key results: any adverse effects of the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials, along with effective measures to mitigate these impacts.

    This data extraction form will be modified and revised as necessary during the extraction process. Any changes to the data extraction form will be documented and explained in the full scoping review. We will not evaluate the methodological quality or risk of bias of the included articles, as these are out of scope for a scoping review as pointed out in the JBI manual.31

    Step 6: collating, summarising and reporting the results

    In line with the recommendations set out in PRISMA-ScR, both quantitative and qualitative synthesis will be performed to summarise the results of this review. Basic numerical data from basic characteristics and implementation details will be analyzed descriptively using frequencies and percentages. We will present the distribution of studies according to the year of publication, country, journal and discipline classification, sample size, study design, and type of data source. A narrative summary method will be used to present the key outcomes of this study, focusing on the adverse effects of the COVID-19 pandemic on different aspects of conducting non-COVID-19 clinical trials and effective measures to mitigate these impacts. The final format for presenting the results will be determined based on the extracted data and consultation among the research team members. Microsoft Excel 2016 will be used to analyze the data and summarise the results.

    Potential impact of this scoping review

    Clinical trials serve as the foundation for evidence synthesis and informing clinical decision-making; therefore, ensuring the quality of clinical trials is of utmost importance. Failure or delay in publishing the results of trials, as well as conducting trials of low quality, do not only lead to the wastage of valuable research resources but also result in significant delays in translating the findings into clinical practice, thereby potentially harming the patients’ well-being.35 36 Although a variety of studies have highlighted the adverse effects of the COVID-19 pandemic on non-COVID-19 clinical trials, including delayed or hindered recruitment, trial interruption or delay, as well as delayed publication of the results, the available evidence remains fragmented, lacking a comprehensive overview of the overall impact, as well as corresponding measures to mitigate the impact. Therefore, we have designed this scoping review to provide a timely and comprehensive summary of the evidence on the adverse effects of the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials, along with effective measures to mitigate these impacts. Our study will contribute to a better understanding of the clinical trial conduct and provide valuable insights for researchers, clinicians and other stakeholders involved in the conduct of clinical trials, and help to prepare for future pandemics.

    This scoping review possesses several strengths. First, it aims to include a wide range of articles without limitations on study design to offer an up-to-date and comprehensive understanding of the adverse impact of the COVID-19 pandemic on the conduction of non-COVID-19 clinical trials and effective measures to mitigate these impacts. By including various types of studies applying quantitative, qualitative, and mixed methods, the review can provide a more holistic and inclusive analysis of the topic. Second, the study selection process will be robust, with a comprehensive search strategy implemented across three major databases: PubMed, Embase, and the Cochrane Library. In addition, the reference lists of the included publications will be hand-searched. Thus, this approach ensures a thorough identification of relevant studies and enhances the likelihood of capturing a diverse and representative range of literature. The combination of these databases has been shown to be adequate and efficient for conducting reviews on healthcare-related topics.

    Potential limitations

    However, there are some anticipated limitations in this scoping review. First, the inclusion of only peer-reviewed articles written in English, which may introduce language and publication bias, potentially excluding relevant studies published in other languages or non-peer-reviewed sources. However, given that English is the most used language in scientific communication globally, English-language studies can already provide a substantial amount of evidence to present a comprehensive picture of the impact of the COVID-19 pandemic on non-COVID-19 clinical trials. Second, as this is a scoping review, we will not assess the methodological quality or risk of bias of included studies. Moreover, the primary aim of this scoping review is to map the existing evidence and provide an overview of the adverse effects of the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials, along with effective measures to mitigate these impacts rather than conducting a critical appraisal of the included studies.

    In conclusion, the scoping review aims to provide timely and comprehensive findings to inform researchers, practitioners, and policymakers about the adverse effects of the COVID-19 pandemic on the conduct of non-COVID-19 clinical trials. It also provides an overview of effective measures to mitigate these impacts, both during and beyond the pandemic. The insights derived from this review will help guide future strategies and approaches to ensure the integrity and success of clinical trials in the face of ongoing or future public health crises.

    Ethics and dissemination

    Since this scoping review involves neither human participants nor unpublished data, it does not require approval from a human research ethics committee. The findings of this scoping review will be disseminated through a peer-reviewed publication and/or conference presentations.

    Any amendments to this protocol made during the review process will be recorded by the authors, along with the reasons for the amendment.

    Ethics statements

    Patient consent for publication

    Acknowledgments

    We thank Dr. Janne Estill from Estill Epidemiology Consulting OÜ for their edits to our protocol.

    References

    1. ↵
      1. WHO
      . Statement on the second meeting of the International Health Regulations(2005)Emergency committee regarding the outbreak of novel Coronavirus (2019-nCoV). Available: https://www.who.int/newsroom/detail/30-01-2020-statement-on-thesecond-meeting-of-the-international-healthregulations-(2005)-emergency-committeeregarding-the-outbreak-of-novel-coronavirus-(2019-ncov) [Accessed 29 Jun 2023].
    2. ↵
      1. Brom F,
      2. de Hoog J,
      3. Knottnerus JA, et al
      . Coronavirus disease 2019 scenarios for a long-term strategy under fundamental uncertainty. J Clin Epidemiol 2022;148:196–9. doi:10.1016/j.jclinepi.2022.02.012
      OpenUrl
    3. ↵
      1. Myoung J
      . Two years of COVID-19 pandemic: where are we now J Microbiol 2022;60:235–7. doi:10.1007/s12275-022-1679-x
      OpenUrl
    4. ↵
      COVID-19 is no longer constitutes a public health emergency of international Concer? Available: online:https://www.paho.org/en/news/8-5-2023-covid-19-no-longer-constitutes-public-health-emergency-international-concern [Accessed 29 Jun 2023].
    5. ↵
      COVID-19 is no longer a public health emergency of international Concern.Does this mean the pandemic is over? Available: https://www.gavi.org/vaccineswork/covid-19-no-longer-public-health-emergency-international-concern-does-mean-pandemic [Accessed 29 Jun 2023].
    6. ↵
      1. Lauring AS,
      2. Tenforde MW,
      3. Chappell JD, et al
      . Clinical severity of, and effectiveness of mRNA vaccines against, COVID-19 from omicron, delta, and alpha SARS-Cov-2 variants in the United States: prospective observational study. BMJ 2022;376:e069761. doi:10.1136/bmj-2021-069761
    7. ↵
      Coronavirus disease 2019 (COVID-19): global situation, number of confirmed cases, Available: https://covid19.who.int/ [Accessed 29 Jun 2023].
    8. ↵
      1. Li J,
      2. Li S,
      3. Cao W, et al
      . Appraisal of China’s response to the outbreak of COVID-19 in comparison with SARS. Front Public Health 2021;9:679540. doi:10.3389/fpubh.2021.679540
      OpenUrl
    9. ↵
      1. Deb P,
      2. Furceri D,
      3. Ostry JD, et al
      . The economic effects of COVID-19 containment measures. Open Econ Rev 2022;33:1–32. doi:10.1007/s11079-021-09638-2
      OpenUrlCrossRef
    10. ↵
      1. Alonso S,
      2. Català M,
      3. López D, et al
      . Individual prevention and containment measures in schools in Catalonia, Spain, and community transmission of SARS-Cov-2 after school re-opening. PLoS One 2022;17:e0263741. doi:10.1371/journal.pone.0263741
    11. ↵
      1. Pommier V,
      2. Abassi H,
      3. Lavastre K, et al
      . Impact of COVID-19 disease on clinical research in pediatric and congenital cardiology. Arch Pediatr 2022;29:347–53. doi:10.1016/j.arcped.2022.03.004
      OpenUrl
    12. ↵
      1. Upadhaya S,
      2. Yu JX,
      3. Oliva C, et al
      . Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov 2020;19:376–7. doi:10.1038/d41573-020-00093-1
      OpenUrlCrossRefPubMed
    13. ↵
      1. Ledford H
      . Coronavirus shuts down trials of drugs for multiple other diseases. Nature 2020;580:15–6. doi:10.1038/d41586-020-00889-6
      OpenUrlPubMed
    14. ↵
      1. Sathian B,
      2. Asim M,
      3. Banerjee I, et al
      . Impact of COVID-19 on clinical trials and clinical research: a systematic review. Nepal J Epidemiol 2020;10:878–87. doi:10.3126/nje.v10i3.31622
      OpenUrlCrossRefPubMed
    15. ↵
      1. Nishiwaki S,
      2. Ando Y
      . n.d. COVID-19 pandemic and trends in clinical trials: a multi-region and global perspective. Front Med;8. doi:10.3389/fmed.2021.812370
    16. ↵
      1. Bagiella E,
      2. Bhatt DL,
      3. Gaudino M
      . The consequences of the COVID-19 pandemic on non-COVID-19 clinical trials. J Am Coll Cardiol 2020;76:342–5. doi:10.1016/j.jacc.2020.05.041
      OpenUrlFREE Full Text
    17. ↵
      1. Hodgson CL,
      2. Cooper DJ,
      3. Arabi Y, et al
      . Maximal recruitment open lung ventilation in acute respiratory distress syndrome (PHARLAP). a phase II, multicenter randomized controlled clinical trial. Am J Respir Crit Care Med 2019;200:1363–72. doi:10.1164/rccm.201901-0109OC
      OpenUrlCrossRefPubMed
    18. ↵
      1. Lopes RD,
      2. de Barros e Silva PGM,
      3. Furtado RHM, et al
      . Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-Dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial. The Lancet 2021;397:2253–63. doi:10.1016/S0140-6736(21)01203-4
      OpenUrlCrossRefPubMed
    19. ↵
      1. Raynaud M,
      2. Goutaudier V,
      3. Louis K, et al
      . Impact of the COVID-19 pandemic on publication Dynamics and non-COVID-19 research production. BMC Med Res Methodol 2021;21:1–10. doi:10.1186/s12874-021-01404-9
      OpenUrlCrossRefPubMed
    20. ↵
      1. Jung RG,
      2. Di Santo P,
      3. Clifford C, et al
      . Methodological quality of COVID-19 clinical research. Nat Commun 2021;12:943. doi:10.1038/s41467-021-21220-5
    21. ↵
      1. Gaudino M,
      2. Arvind V,
      3. Hameed I, et al
      . Effects of the COVID-19 pandemic on active non-COVID clinical trials. J Am Coll Cardiol 2020;76:1605–6. doi:10.1016/j.jacc.2020.07.051
      OpenUrlFREE Full Text
    22. ↵
      1. Tuttle KR
      . Impact of the COVID-19 pandemic on clinical research. Nat Rev Nephrol 2020;16:562–4. doi:10.1038/s41581-020-00336-9
      OpenUrlPubMed
    23. ↵
      1. Nishiwaki S,
      2. Ando Y
      . COVID-19 pandemic and trends in clinical trials: A multi-region and global perspective. Front Med (Lausanne) 2021;8:812370. doi:10.3389/fmed.2021.812370
    24. ↵
      1. Bhutkar R,
      2. El-Den S,
      3. O’Reilly CL, et al
      . The impact of COVID-19 on clinical research at Australian and New Zealand universities: a qualitative study. Collegian May 8, 2023. doi:10.1016/j.colegn.2023.05.002
    25. ↵
      1. Audisio K,
      2. Lia H,
      3. Robinson NB, et al
      . Impact of the COVID-19 pandemic on non-COVID-19 clinical trials. J Cardiovasc Dev Dis 2022;9:19. doi:10.3390/jcdd9010019
    26. ↵
      Conduct of clinical trials of medical products during the COVID-19 public health emergency, Available: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency [Accessed Aug 2021].
    27. ↵
      1. Goodson N,
      2. Wicks P,
      3. Morgan J, et al
      . Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. NPJ Digit Med 2022;5:58. doi:10.1038/s41746-022-00603-y
    28. ↵
      1. Lv M,
      2. Luo X,
      3. Estill J, et al
      . COVID-19 evidence and recommendations working group. coronavirus disease (COVID-19): a scoping review. Euro Surveill 2020;25:15. doi:10.2807/1560-7917.ES.2020.25.15.2000125
      OpenUrl
    29. ↵
      1. Moher D,
      2. Shamseer L,
      3. Clarke M, et al
      . Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1. doi:10.1186/2046-4053-4-1
    30. ↵
      1. Shamseer L,
      2. Moher D,
      3. Clarke M, et al
      . Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ 2015;350:g7647. doi:10.1136/bmj.g7647
    31. ↵
      1. Peters MDJ,
      2. Godfrey CM,
      3. McInerney P
      . Chapter 11: Scoping review (2020 version). In: Joanna Briggs Institute reviewer’s manual. 2020. doi:10.46658/JBIRM-190-01
    32. ↵
      1. Arksey H,
      2. O’Malley L
      . Scoping studies: towards a methodological frameworkInt J. Int J2005;8:19–32. doi:10.1080/1364557032000119616
      OpenUrl
    33. ↵
      1. Levac D,
      2. Colquhoun H,
      3. O’Brien KK
      . Scoping studies: advancing the methodology. Implement Sci 2010;5:69. doi:10.1186/1748-5908-5-69
      OpenUrlCrossRefPubMed
    34. ↵
      1. Rethlefsen ML,
      2. Kirtley S,
      3. Waffenschmidt S, et al
      . PRISMA-S group. PRISMA-S: an extension to the PRISMA statement for reporting literature searches in systematic reviews. Syst Rev 2021;10:39. doi:10.1186/s13643-020-01542-z
    35. ↵
      1. Chapman SJ,
      2. Aldaffaa M,
      3. Downey CL, et al
      . Research waste in surgical randomized controlled trials. Br J Surg 2019;106:1464–71. doi:10.1002/bjs.11266
      OpenUrlPubMed
    36. ↵
      1. Speich B,
      2. Gryaznov D,
      3. Busse JW, et al
      . Nonregistration, discontinuation, and nonpublication of randomized trials: a repeated metaresearch analysis. PLoS Med 2022;19:e1003980. doi:10.1371/journal.pmed.1003980

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Contributors CL and KY conceived the idea for the review, with inputs from JN, LG, and XL. WS and CL were responsible for the design and drafting of the scoping protocol. The introduction and methods sections were collaboratively drafted by WS, CL, and LW, while WS, HP, and YL jointly contributed to the ethics and dissemination section. All authors contributed to subsequent revisions and approved the protocol prior to its submission.

    • Funding The study was funded by the Natural Science Foundation of Gansu Province (Project No. 22JR5RA510).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.