Table 2.
Key considerations for selected data elements in reporting master protocol research programs (MPRPs) to ClinicalTrials.gov using multiple substudy records
| Selected data element | Brief description | Notes for substudy records |
|---|---|---|
| Registration (summary of key protocol items) 18 | ||
| Brief title and acronym | A short title for the clinical study written in language intended for the lay public and including information on the condition, participants, and interventions | For each substudy, provide information specific to that substudy and indicate that the substudy is part of an MPRP: include any acronym or other identifying title for both the MPRP and the substudy. Example (NCT02193282): Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (ALCHEMIST treatment trial) |
| Identify a central screening study, indicate that it is part of an MPRP, and include any acronym or other identifying title for the MPRP. Example (NCT02194738): Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (ALCHEMIST screening trial) | ||
| Overall recruitment status | Select one: not yet recruiting; recruiting; enrolling by invitation; active, not recruiting; completed; suspended; terminated; withdrawn | Indicate the status for each substudy, updating it within 30 days of a change |
| Select “recruiting” only while the specific substudy is seeking new participants. Example (ALCHEMIST): of four MPRP related records, the screening study has a status of “recruiting” (NCT02194738), two substudies are “active, not recruiting” (NCT02595944 and NCT02193282), and one substudy is “recruiting” (NCT02201992) | ||
| Study start date | Estimated date when the clinical study opens for recruitment of participants or the actual date when the first participant enrolled | For each substudy, enter the estimated date or the actual date |
| Primary completion date and study completion date | Date when the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, and the date when data collection was completed for all of the primary outcomes, respectively | For each substudy, enter the date when final collection of data for the final participant occurred for that substudy. Example (ALCHEMIST): screening study record (NCT02194738) estimates a primary completion date of 28 September 2026; three substudies list estimated primary completion dates of 1 July 2024 (NCT02595944), 10 October 2026 (NCT02193282), and 1 May 2022 (NCT02201992) |
| Brief summary | A short description of the clinical study, including a brief statement of the hypothesis, written in language intended for the lay public | For each substudy, provide a non-technical description, including the aim of the substudy; identification as a substudy in an MPRP; explanation of enrollment through a centralized eligibility screening process and the NCT number of the MPRP screening record, if applicable |
| Enrollment | Estimated or actual total number of participants enrolled; the term “enrolled” indicates an individual’s agreement to participate after completing the informed consent process | For each substudy, initially provide the total estimated number of participants to be enrolled, then update the record with the actual number after enrollment ends. Include the estimated and actual number of participants from the shared control group used for comparison as a control arm, as specified in the protocol or analysis plan |
| Arms, groups, and interventions | Prespecified group or subgroup of participants and the specific interventions (including no intervention or standard of care) that they are assigned to receive, according to the protocol | For each substudy, specify the arms to which participants will be allocated and provide a name for and description of the interventions associated with each arm. List the control arm, including any shared control arm, for each substudy if it is prespecified to be included as a comparator in the analysis of results |
| Outcome measures | Planned measures that are important to evaluating the effects of the intervention | For each substudy, include all prespecified primary and secondary outcome measures. Example (NCT03213665): The primary outcome for National Cancer Institute’s Paediatric MATCH is the objective response rate (time frame up to two years) |
| Primary and secondary outcomes for each substudy should be included in the substudy record, even if they are the same for multiple substudies in the MPRP | ||
| Eligibility | Limited list of key inclusion and exclusion criteria for the selection of participants in the clinical study | For each substudy, describe the key criteria for participants to be assigned to that substudy (eg, specific biomarker, disease characteristics) |
| If participants must go through a centralized screening process, list the NCT number and brief title or acronym of the screening record as the first inclusion criterion in each substudy Example (NCT04439279): MATCH-Subprotocol R’s first inclusion criterion is that patients must have met applicable eligibility criteria in the Master MATCH Protocol (NCT02465060) before registration to treatment subprotocol. | ||
| Central contact person (or facility contact) | A person who can answer questions about enrollment at any study location | For each substudy provide appropriate contact information |
| If a central screening process is used, ensure that the person whose contact information is provided can answer questions about centralized screening | ||
| References | Citations and links to publications and websites that are relevant to the protocol | For each substudy, include any references that help users to understand the relation between the substudy and the overall MPRP design |
| Uploaded study documents (full study protocol document and statistical analysis plan) 19 | ||
| Document upload information | Full study protocol, statistical analysis plan, and informed consent forms | For each substudy, we recommend that the protocol document and appendices for that substudy be uploaded during study registration to assist users in understanding the substudy’s design, plans for data collection and analysis, and relation to the overall MPRP |
| For each substudy, the final protocol and statistical analysis plan are submitted at the time of results submission | ||
| Results (summary results information) 19 | ||
| General | Results information, provided in modules as tables with study arms as columns and summary results as rows, is generally expected to be submitted by one year after the primary completion date | For each substudy, provide results information after the primary completion date is reached |
| Include control arm data in each substudy record as prespecified in the analysis plan. Data reported for the control arm derived from the shared control group will likely vary across substudies based on when a substudy took place and when the data were analyzed. Creating separate records for each substudy facilitates clear reporting of the relevant participants from the control group included in each substudy analysis | ||
| Participant flow | A summary table of participants’ progress, by assignment group, including the number of participants who started and completed the study; analogous to a CONSORT flow diagram | For each substudy specify the arms to which participants in that substudy were assigned. If relevant, include the control arm with participants from the shared control group |
| Identify the total number of participants that started and completed each arm of the substudy | ||
| Baseline characteristics | A summary table of demographic and baseline measures, by arm and for the overall study, including all relevant measures (eg, age, sex, race, and ethnicity) | For each substudy, specify the number of participants analyzed at baseline and the baseline characteristics, by arm. If relevant, include the control arm with collected baseline measures from the shared control group |
| Outcome measures | A summary table with descriptive information for each primary and secondary outcome measure, by arm, including any scientifically appropriate statistical analyses | For each substudy, specify the number of participants analyzed, by arm, and report the results of outcome measures evaluating the effect of an intervention on participants |
| An MPRP can use the same or different outcome measures across substudies. If relevant, include the control arm with collected data from the shared control group | ||
| Adverse event information | Three summary tables of anticipated and unanticipated adverse events for all cause mortality (all deaths); serious adverse events; and other (not including serious) adverse events | For each substudy, specify the overall percentage of participants (number affected or number at risk) with adverse events in each arm and identify each adverse event by system organ class. If relevant, include the control arm with collected data from the shared control group |
| Other | ||
| Study record updates33 | Made at least once a year, with some data elements required sooner after a change | Update each substudy record regularly and with any important changes to the study protocol |
| External to the study record—publications and other sources34 | Include NCT numbers in abstracts of publications and other communications | For the substudy, include the NCT numbers of both the screening record and the specific substudy record |