SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
FREEAbstract
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.
The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
The protocol of a clinical trial plays a key role in study planning, conduct, interpretation, oversight, and external review by detailing the plans from ethics approval to dissemination of results. A well-written protocol facilitates an appropriate assessment of scientific, ethical, and safety issues before a trial begins; consistency and rigor of trial conduct; and full appraisal of the conduct and results after trial completion. The importance of protocols has been emphasized by journal editors (1–6), peer reviewers (7–10), researchers (11–15), and public advocates (16).
Despite the central role of protocols, a systematic review revealed that existing guidelines for protocol content vary greatly in their scope and recommendations, seldom describe how the guidelines were developed, and rarely cite broad stakeholder involvement or empirical evidence to support their recommendations (17). These limitations may partly explain why an opportunity exists to improve the quality of protocols. Many protocols for randomized trials do not adequately describe the primary outcomes (inadequate for 25% of trials) (18, 19), treatment allocation methods (inadequate for 54% to 79%) (20, 21), use of blinding (inadequate for 9% to 34%) (21, 22), methods for reporting adverse events (inadequate for 41%) (23), components of sample size calculations (inadequate for 4% to 40%) (21, 24), data analysis plans (inadequate for 20% to 77%) (21, 24–26), publication policies (inadequate for 7%) (27), and roles of sponsors and investigators in study design or data access (inadequate for 89% to 100%) (28, 29). The problems that underlie these protocol deficiencies may in turn lead to avoidable protocol amendments, poor trial conduct, and inadequate reporting in trial publications (15, 30).
In response to these gaps in protocol content and guidance, we launched the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) initiative in 2007. This international project aims to improve the completeness of trial protocols by producing evidence-based recommendations for a minimum set of items to be addressed in protocols. The SPIRIT 2013 Statement includes a 33-item checklist (Table 1) and diagram (Figure). An associated explanatory paper (SPIRIT 2013 Explanation and Elaboration) (31) details the rationale and supporting evidence for each checklist item, along with guidance and model examples from actual protocols.
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Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration (31) for examples. This template is copyrighted by the SPIRIT Group and is reproduced with permission. SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials.
* List specific time points in this row.
Development of the SPIRIT 2013 Statement
The SPIRIT 2013 Statement was developed in broad consultation with 115 key stakeholders, including trial investigators (n = 30); health care professionals (n = 31); methodologists (n = 34); statisticians (n = 16); trial coordinators (n = 14); journal editors (n = 15); and representatives from the research ethics community (n = 17), industry and nonindustry funders (n = 7), and regulatory agencies (n = 3), whose roles are not mutually exclusive. As detailed later, the SPIRIT guideline was developed through 2 systematic reviews, a formal Delphi consensus process, 2 face-to-face consensus meetings, and pilot-testing (32).
The SPIRIT checklist evolved through several iterations. The process began with a preliminary checklist of 59 items derived from a systematic review of existing protocol guidelines (17). In 2007, 96 expert panelists from 17 low- (n = 1), middle- (n = 6), and high-income (n = 10) countries refined this initial checklist over 3 iterative Delphi consensus survey rounds by e-mail (33). Panelists rated each item on a scale of 1 (not important) to 10 (very important), suggested new items, and provided comments that were circulated in subsequent rounds. Items with a median score of 8 or higher in the final round were included, whereas those rated 5 or lower were excluded. Items rated between 5 and 8 were retained for further discussion at the consensus meetings.
After the Delphi survey, 16 members of the SPIRIT Group (named as authors of this paper) met in December 2007 in Ottawa, Ontario, Canada, and 14 members met in September 2009 in Toronto, Ontario, Canada, to review the survey results, discuss controversial items, and refine the draft checklist. After each meeting, the revised checklist was recirculated to the SPIRIT Group for additional feedback.
A second systematic review identified empirical evidence about the relevance of specific protocol items to trial conduct or risk of bias. The results of this review informed the decision to include or exclude items on the SPIRIT checklist. This review also provided the evidence base of studies cited in the SPIRIT 2013 Explanation and Elaboration paper (31). Some items had little or no identified empirical evidence (for example, the title) and are included in the checklist on the basis of a strong pragmatic or ethical rationale.
Finally, we pilot-tested the draft checklist in 2010 and 2011 with University of Toronto graduate students who used the document to develop trial protocols as part of a master's-level course on clinical trial methods. Their feedback on the content, format, and usefulness of the checklist was obtained through an anonymous survey and incorporated into the final SPIRIT checklist.
Definition of a Clinical Trial Protocol
Although every study requires a protocol, the precise definition of a protocol varies among individual investigators, sponsors, and other stakeholders. For the SPIRIT initiative, the protocol is defined as a document that provides sufficient detail to enable understanding of the background, rationale, objectives, study population, interventions, methods, statistical analyses, ethical considerations, dissemination plans, and administration of the trial; replication of key aspects of trial methods and conduct; and appraisal of the trial's scientific and ethical rigor from ethics approval to dissemination of results.
The protocol is more than a list of items. It should be a cohesive document that provides appropriate context and narrative to fully understand the elements of the trial. For example, the description of a complex intervention may need to include training materials and figures to enable replication by persons with appropriate expertise.
The full protocol must be submitted for approval by an institutional review board (IRB) or research ethics committee (34). It is recommended that trial investigators or sponsors address the SPIRIT checklist items in the protocol before submission. If the details for certain items have not yet been finalized, then this should be stated in the protocol and the items updated as they evolve.
The protocol is a “living” document that is often modified during the trial. A transparent audit trail with dates of important changes in trial design and conduct is an essential part of the scientific record. Trial investigators and sponsors are expected to adhere to the protocol as approved by the IRB and to document amendments made in the most recent protocol version. Important protocol amendments should be reported to IRBs and trial registries as they occur and subsequently be described in trial reports.
Scope of the SPIRIT 2013 Statement
The SPIRIT 2013 Statement applies to the content of a clinical trial protocol, including its appendices. A clinical trial is a prospective study in which 1 or more interventions are assigned to human participants to assess the effects on health-related outcomes. The primary scope of SPIRIT 2013 relates to randomized trials, but the same considerations substantially apply to all types of clinical trials, regardless of study design, intervention, or topic.
The SPIRIT 2013 Statement provides guidance for minimum protocol content. Certain circumstances may warrant additional protocol items. For example, a factorial study design may require specific justification; crossover trials have unique statistical considerations, such as carryover effects; and industry-sponsored trials may have additional regulatory requirements.
The protocol and its appendices are often the sole repository of detailed information relevant to every SPIRIT checklist item. Using existing trial protocols, we have been able to identify model examples of every item (31), which illustrates the feasibility of addressing all checklist items in a single protocol document. For some trials, relevant details may appear in related documents, such as statistical analysis plans, case record forms, operations manuals, or investigator contracts (35, 36). In these instances, the protocol should outline the key principles and refer to the separate documents so that their existence is known.
The SPIRIT 2013 Statement primarily relates to the content of the protocol rather than its format, which is often subject to local regulations, traditions, or standard operating procedures. Nevertheless, adherence to certain formatting conventions, such as a table of contents; section headings; glossary; list of abbreviations; list of references; and a schematic schedule of enrollment, interventions, and assessments, will facilitate protocol review (Figure).
Finally, the intent of SPIRIT 2013 is to promote transparency and a full description of what is planned—not to prescribe how a trial should be designed or conducted. The checklist should not be used to judge trial quality, because the protocol of a poorly designed trial may address all checklist items by fully describing its inadequate design features. Nevertheless, the use of SPIRIT 2013 may improve the validity and success of trials by reminding investigators about important issues to consider during the planning stages.
Relation to Existing Clinical Trial Guidance
With its systematic development process, consultation with international stakeholders, and explanatory paper citing relevant empirical evidence (31), SPIRIT 2013 builds on other international guidance applicable to clinical trial protocols. It adheres to the ethical principles mandated by the 2008 Declaration of Helsinki, particularly the requirement that the protocol address specific ethical considerations, such as competing interests (34).
In addition, SPIRIT 2013 encompasses the protocol items recommended by the International Conference on Harmonisation Good Clinical Practice E6 guidance, written in 1996 for clinical trials whose data are intended for submission to regulatory authorities (37). The SPIRIT Statement builds on the Good Clinical Practice guidance by providing additional recommendations on specific key protocol items (for example, allocation concealment, trial registration, and consent processes). In contrast to SPIRIT, the Good Clinical Practice guidance used informal consensus methods, has unclear contributorship, and lacks citation of supporting empirical evidence (38).
The SPIRIT 2013 Statement also supports trial registration requirements from the World Health Organization (39), the International Committee of Medical Journal Editors (40), legislation pertaining to ClinicalTrials.gov (41), the European Commission (42), and others. For example, item 2b of the SPIRIT checklist recommends that the protocol list the World Health Organization Trial Registration Data Set (Appendix Table), which is the minimum amount of information that the International Committee of Medical Journal Editors mandates for trial registries. Having this data set in its own protocol section is intended not only to serve as a form of trial summary but also to help improve the quality of information in registry entries. Registration-specific data could be easily identified in the protocol section and copied into the registry fields. In addition, protocol amendments applicable to this section could prompt investigators to update their registry data.
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The SPIRIT 2013 Statement mirrors applicable items from CONSORT 2010 (Consolidated Standards of Reporting Trials) (43). Consistent wording and structure used for items common to both checklists will facilitate the transition from a SPIRIT-based protocol to a final report based on CONSORT. The SPIRIT Group has also engaged leaders of other initiatives relevant to protocol standards, such as trial registries, the Clinical Data Interchange Standards Consortium Protocol Representation Group, and Pragmatic Randomized Controlled Trials in HealthCare, to align international efforts in promoting transparency and high-quality protocol content.
Potential Effect
An extensive range of stakeholders could benefit from widespread use of the SPIRIT 2013 Statement and its explanatory paper (Table 2). Pilot-testing and informal feedback have shown that it is particularly valuable for trial investigators when they draft their protocols. It can also serve as an informational resource for new investigators, peer reviewers, and IRB members.
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There is also potential benefit for trial implementation. The excessive delay from the time of protocol development to ethics approval and the start of participant recruitment remains a major concern for clinical trials (44). Improved completeness of protocols could help increase the efficiency of protocol review by reducing avoidable queries to investigators about incomplete or unclear information. With full documentation of key information and increased awareness of important considerations before the trial begins, the use of SPIRIT may also help to reduce the number and burden of subsequent protocol amendments—many of which can be avoided with careful protocol drafting and development (15). Widespread adoption of SPIRIT 2013 as a single standard by IRBs, funding agencies, regulatory agencies, and journals could simplify the work of trial investigators and sponsors, who could fulfill the common application requirements of multiple stakeholders with a single SPIRIT-based protocol. Better protocols would also help trial personnel to implement the study as the protocol authors intended.
Furthermore, adherence to SPIRIT 2013 could help ensure that protocols contain the requisite information for critical appraisal and trial interpretation. High-quality protocols can provide important information about trial methods and conduct that is not available from journals or trial registries (45–47). As a transparent record of the researchers' original intent, comparisons of protocols with final trial reports can help to identify selective reporting of results and undisclosed amendments (48), such as changes to primary outcomes (19, 49). However, clinical trial protocols are not generally accessible to the public (45). The SPIRIT 2013 Statement will have a greater effect when protocols are publicly available to facilitate full evaluation of trial validity and applicability (11, 12, 14, 50).
The SPIRIT 2013 guideline needs the support of key stakeholders to achieve its greatest impact (Table 2), as seen with widely adopted reporting guidelines, such as CONSORT (51). We will post the names of organizations that have endorsed SPIRIT 2013 on the SPIRIT Web site (www.spirit-statement.org) and provide resources to facilitate implementation. Widespread adoption of the SPIRIT recommendations can help improve protocol drafting, content, and implementation; facilitate registration, efficiency, and appraisal of trials; and ultimately enhance transparency for the benefit of patient care.
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Author, Article and Disclosure Information
From Women's College Research Institute, Women's College Hospital, and Keenan Research Centre at the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Ottawa Methods Centre, Ottawa Hospital Research Institute, Ethics Office, Canadian Institutes of Health Research, and University of Ottawa, Ottawa, Ontario, Canada; Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom; Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark; University of Utah School of Medicine, Salt Lake City, Utah; Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Janssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, Titusville, New Jersey; UK Medical Research Council Clinical Trials Unit, The Lancet, and BMJ, London, United Kingdom; NCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, Ontario, Canada; Quantitative Sciences, FHI 360, and GlaxoSmithKline, Research Triangle Park, North Carolina; The Dartmouth Institute for Health Policy and Clinical Practice, The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; The PR Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco, California.
Disclaimer: Dr. Krleža-Jerić was formerly employed by the Canadian Institutes of Health Research (Knowledge Translation Branch), and Dr. Parulekar is affiliated with the NCIC Clinical Trials Group. The funders otherwise had no input into the design and conduct of the project; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. Dr. Berlin is employed by the Janssen Pharmaceutical Companies of Johnson & Johnson, Dr. Sox is Editor Emeritus of Annals of Internal Medicine, and Dr. Rockhold is employed by GlaxoSmithKline.
Acknowledgment: The authors thank Drs. Mona Loufty and Patricia Parkin for pilot-testing the SPIRIT checklist with their graduate course students. The authors also acknowledge the participation of Dr. Geneviève Dubois-Flynn in the 2009 SPIRIT meeting.
Grant Support: Financial support for the SPIRIT meetings was provided by the Canadian Institutes of Health Research (grant DET-106068), National Cancer Institute of Canada (now Canadian Cancer Society Research Institute), and Canadian Agency for Drugs and Technologies in Health. The Canadian Institutes of Health Research has also funded ongoing dissemination activities (grant MET-117434).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1905.
Corresponding Author: An-Wen Chan, MD, DPhil, Women's College Research Institute, Women's College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada; e-mail, [email protected].
Current Author Addresses: Dr. Chan: Women's College Research Institute, Women's College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada.
Ms. Tetzlaff: Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.
Dr. Altman: Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, United Kingdom.
Dr. Laupacis: Keenan Research Centre at the Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada.
Drs. Gøtzsche and Hróbjartsson: Nordic Cochrane Centre, Rigshospitalet Department 3343, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.
Dr. Krleža-Jerić: Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario K1H 8M5, Canada.
Dr. Mann: Division of Medical Ethics and Humanities, University of Utah School of Medicine, 75 South 2000 East #108, Salt Lake City, UT 84132.
Dr. Dickersin: Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Mail Room W5010, Baltimore, MD 21205.
Dr. Berlin: Janssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, 1125 Trenton Harbourton Road, Titusville, NJ 08560.
Ms. Doré: UK Medical Research Council Clinical Trials Unit, 125 Kingsway, London WC2B 6NH, United Kingdom.
Dr. Parulekar: NCIC Clinical Trials Group, Cancer Research Institute, Queen's University, 10 Stuart Street, Kingston, Ontario K7L 3N6, Canada.
Dr. Summerskill: The Lancet, 32 Jamestown Road, London NW1 7BY, United Kingdom.
Dr. Groves: BMJ, BMA House, Tavistock Square, London WC1H 9JP, United Kingdom.
Dr. Schulz: Quantitative Sciences, FHI 360, Research Triangle Park, 2224 East NC Highway 54, Durham, NC 27713.
Dr. Sox: The Dartmouth Institute for Health Policy and Clinical Practice, The Geisel School of Medicine at Dartmouth, HB 7500, Hanover, NH 03755.
Dr. Rockhold: GlaxoSmithKline, 5 Moore Drive, PO Box 13398, Research Triangle Park, NC 27709.
Dr. Rennie: The Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, 3333 California Street, Laurel Heights 265, San Francisco, CA 94143-0936.
Dr. Moher: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.
Author Contributions: Conception and design: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, P.C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, H. Mann, K. Dickersin, J.A. Berlin, W.R. Parulekar, K.F. Schulz, H.C. Sox, D. Rennie, D. Moher.
Analysis and interpretation of the data: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, P.C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, K. Dickersin, C.J. Doré, W.R. Parulekar, T. Groves, K.F. Schulz, F.W. Rockhold, D. Rennie, D. Moher.
Drafting of the article: A.-W. Chan, J.M. Tetzlaff, P.C. Gøtzsche, H. Mann, K. Dickersin, J.A. Berlin, C.J. Doré, W.R. Parulekar, K.F. Schulz.
Critical revision of the article for important intellectual content: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, K. Krleža-Jerić, A. Hróbjartsson, H. Mann, K. Dickersin, J.A. Berlin, C.J. Doré, W.R. Parulekar, W.S.M. Summerskill, T. Groves, K.F. Schulz, H.C. Sox, F.W. Rockhold, D. Rennie, D. Moher.
Final approval of the article: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, P.C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, H. Mann, K. Dickersin, J.A. Berlin, C.J. Doré, W.R. Parulekar, W.S.M. Summerskill, T. Groves, K.F. Schulz, H.C. Sox, F.W. Rockhold, D. Rennie, D. Moher.
Provision of study materials or patients: K. Krleža-Jerić, K. Dickersin.
Statistical expertise: D.G. Altman, P.C. Gøtzsche, C.J. Doré, K.F. Schulz, F.W. Rockhold.
Obtaining of funding: A.-W. Chan, A. Laupacis, D. Moher.
Administrative, technical, or logistic support: A.-W. Chan, P.C. Gøtzsche, K. Krleža-Jerić.
Collection and assembly of data: A.-W. Chan, J.M. Tetzlaff, P.C. Gøtzsche, A. Hróbjartsson, K. Dickersin, C.J. Doré, W.R. Parulekar, K.F. Schulz.
This article was published at www.annals.org on 8 January 2013.
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