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Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level (iFIT)

9 czerwca 2026 zaktualizowane przez: University of Leeds

iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma

iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1226

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Zjednoczone Królestwo
      • Bristol, Zjednoczone Królestwo, BS2 8ED
      • Eastbourne, Zjednoczone Królestwo, BN21 2UD
      • Leeds, Zjednoczone Królestwo, LS9 7TF
      • London, Zjednoczone Królestwo, SM2 5PT

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Eligibility criteria for registration:

Inclusion criteria for registration:

  1. Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.
  2. Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,
  3. Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,
  4. Aged 18 years or greater,
  5. Able to provide full informed consent, and
  6. Prepared to comply with pregnancy prevention plan.

Exclusion criteria for registration:

  1. Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),
  2. Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,
  3. Previous treatment for myeloma, except as specified in the protocol,
  4. Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or
  5. Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring.

Additional eligibility criteria for randomisation into iFIT1/iFIT2/iFIT3 pathways, as follows:

Inclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways:

  • Completed 6 cycles of DRd induction therapy after registering within the iFIT study,
  • Able to provide full informed consent, and
  • Prepared to comply with pregnancy prevention plan.

Inclusion criteria specific to randomisation pathways:

  • Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3),
  • Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3),
  • Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2),
  • Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2),
  • Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3),
  • Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1),
  • Categorised as FRAIL according to the IMWG frailty index (iFIT2), and
  • Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1).

Exclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways:

  • Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed,
  • Received a stem cell transplant,
  • Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and
  • Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose.

Exclusion criteria specific to randomisation pathways:

  • Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2),
  • Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and
  • Further exclusion criteria related to safety of interventions (iFIT1).

Full inclusion and exclusion criteria are listed in the protocol.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: DRd induction
All participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Lenalidomide
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • Revlimid
  • R
Lek: Dexamethasone
Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • D
Aktywny komparator: iFIT1 - DRd to PD
Participants assigned to the iFIT1 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease. Dexamethasone may be stopped due to toxicity.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Lenalidomide
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • Revlimid
  • R
Lek: Dexamethasone
Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • D
Eksperymentalny: iFIT1 - Daratumumab plus teclistamab (Dara-Tec)
Participants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and teclistamab for a fixed duration and then be actively monitored until progressive disease.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Teclistamab
Participants will receive teclistamab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • Tec
Eksperymentalny: iFIT1 - Daratumumab plus talquetamab (Dara-Tal)
Participants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and talquetamab for a fixed duration and then be actively monitored until progressive disease.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Talquetamab
Participants will receive talquetamab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • Tal
Aktywny komparator: iFIT2 - DRd to PD
Participants assigned to the iFIT2 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Lenalidomide
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • Revlimid
  • R
Lek: Dexamethasone
Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • D
Eksperymentalny: iFIT2 - DR to PD
Participants assigned to the iFIT2 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Lenalidomide
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • Revlimid
  • R
Aktywny komparator: iFIT3 - DR to PD
Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Lenalidomide
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • Revlimid
  • R
Eksperymentalny: iFIT3 - DR for 18 cycles
Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide for 18 cycles, and then be actively monitored until progressive disease.
Lek: Daratumumab
Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.
Inne nazwy:
  • D
  • Daro
Lek: Lenalidomide
Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.
Inne nazwy:
  • Revlimid
  • R

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
iFIT1: Progression-free survival (PFS)
Ramy czasowe: From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
The time from iFIT1 randomisation to progression or death from any cause. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
iFIT2: Event-free survival (EFS)
Ramy czasowe: From iFIT2 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
The time from iFIT2 randomisation to the first of the following events: grade 4 haematological AEs, grade 3 and 4 non-haematological AEs (including SPMs), discontinuation of trial treatment, progression or death. Participants event-free at the time of analysis will be censored at their last date known to be alive and event-free.
From iFIT2 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
iFIT3: Progression-free survival (PFS) and participant-reported overall health and quality of life (QoL) - co-primary outcomes
Ramy czasowe: PFS: from iFIT3 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation. QoL: measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT3 randomisation.

PFS: The time from iFIT3 randomisation to progression or death from any cause. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.

QoL: The GHS/QoL scale score of the EORTC QLQ-C30 questionnaire. The QoL primary endpoint is measured at 30 months (2.5 years) after iFIT3 randomisation.
PFS: from iFIT3 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation. QoL: measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT3 randomisation.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression-free survival (PFS; iFIT2 only)
Ramy czasowe: From iFIT2 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
The time from iFIT2 randomisation to progression or death from any cause. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
From iFIT2 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
Time to progression (TTP)
Ramy czasowe: From iFIT1/iFIT2/iFIT3 randomisation to TTP event, assessed up to a maximum of 10.5 years post-randomisation.
The time from iFIT1/iFIT2/iFIT3 randomisation to first documented evidence of disease progression. Participants who died without progression will be censored at their date of death. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
From iFIT1/iFIT2/iFIT3 randomisation to TTP event, assessed up to a maximum of 10.5 years post-randomisation.
Time to second PFS event (PFS2)
Ramy czasowe: From iFIT1/iFIT2/iFIT3 randomisation to PFS2 event, assessed up to a maximum of 10.5 years post-randomisation.
The time from iFIT1/iFIT2/iFIT3 randomisation to the second documented evidence of progressive disease or death from any cause. Participants alive and for whom a second progression has not been observed at the time of analysis will be censored at their last known date to be alive and second progression-free.
From iFIT1/iFIT2/iFIT3 randomisation to PFS2 event, assessed up to a maximum of 10.5 years post-randomisation.
Overall survival (OS)
Ramy czasowe: From iFIT1/iFIT2/iFIT3 randomisation to OS event, assessed up to a maximum of 10.5 years post-randomisation.
The time from iFIT1/iFIT2/iFIT3 randomisation to death from any cause. Participants alive at the time of analysis will be censored at their last known date to be alive.
From iFIT1/iFIT2/iFIT3 randomisation to OS event, assessed up to a maximum of 10.5 years post-randomisation.
Event-free survival (EFS; iFIT1 only)
Ramy czasowe: From iFIT1 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
The time from iFIT1 randomisation to the first of the following events: grade 4 haematological AEs (anaemia, neutropenia, thrombocytopenia), grade 3 and 4 non-haematological AEs (including SPMs), discontinuation of trial treatment, progression, or death. Participants event-free at the time of analysis will be censored at their last date known to be alive and event-free.
From iFIT1 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
Survival after progression
Ramy czasowe: From disease progression to death, assessed up to a maximum of 10.5 years post-randomisation.
The time from first documented evidence of disease progression to death from any cause. Participants alive at the time of analysis will be censored at their last known date to be alive. This endpoint is only defined for those who experience progression.
From disease progression to death, assessed up to a maximum of 10.5 years post-randomisation.
Time to next treatment (TTNT)
Ramy czasowe: From registration to TTNT event, assessed up to a maximum of 10.5 years post-randomisation.
The time from registration to the date of commencement of next treatment. Participants who do not receive next line treatment will be censored at the date of the last assessment or follow-up visit where they are known to have received no new therapy.
From registration to TTNT event, assessed up to a maximum of 10.5 years post-randomisation.
Overall response rate (ORR)
Ramy czasowe: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Overall response rate using the disease response category (sCR, CR, VGPR, PR, MR, SD, or PD).
Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Attainment of ≥VGPR
Ramy czasowe: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Attainment of ≥VGPR using the binary disease response category (≥VGPR: sCR, CR, VGPR vs. <VGPR: PR, MR, SD, PD).
Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Attainment of MRD negativity
Ramy czasowe: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Attainment of MRD negativity using the binary MRD status category (negative vs. positive) measured using flow cytometry. MRD negativity is defined as at least a serological VGPR and MRD negative bone marrow aspirate at the 10^-5 threshold.
Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
Maximum response
Ramy czasowe: From iFIT1/iFIT2/iFIT3 randomisation up to a maximum of 6.5 years post-randomisation.
The maximum response attained.
From iFIT1/iFIT2/iFIT3 randomisation up to a maximum of 6.5 years post-randomisation.
Time to improved response
Ramy czasowe: From iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, up to a maximum of 6.5 years post-randomisation.
The time from iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, where the baseline response is that recorded at the start of randomised treatment (iFIT1/iFIT2/iFIT3 cycle 1, day 1). Participants whose disease progresses or who die before an improved response is recorded will be censored at the time of progression or death, respectively. Participants alive with no improved response recorded at the time of analysis will be censored at their last known date to be alive.
From iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, up to a maximum of 6.5 years post-randomisation.
Treatment compliance
Ramy czasowe: From registration to the end of trial treatment, up to a maximum of 7 years post-registration.
Treatment compliance including whether all cycles of treatment were completed, the number of cycles completed, the total dose of each trial medication received, the number and causes of dose omissions, dose delays, and dose reductions.
From registration to the end of trial treatment, up to a maximum of 7 years post-registration.
Toxicity and safety as graded by NCI-CTCAE v5
Ramy czasowe: From registration up to a maximum of 11 years post-registration. SAEs may be reported up to 60 days post-last dose of protocol treatment/cycle of active monitoring.
Toxicity and safety based on the adverse events reported as graded by NCI-CTCAE v5. Pregnancies will also be reported.
From registration up to a maximum of 11 years post-registration. SAEs may be reported up to 60 days post-last dose of protocol treatment/cycle of active monitoring.
Incidence of secondary primary malignancies
Ramy czasowe: Measured during standard of care induction DRd treatment and following iFIT1/ iFIT2/iFIT3 randomisation, up to a maximum of 11 years post-registration.
The number and details of all other cancers, defined as secondary primary malignancies.
Measured during standard of care induction DRd treatment and following iFIT1/ iFIT2/iFIT3 randomisation, up to a maximum of 11 years post-registration.
Incidence, rate, and type of infections as graded by NCI-CTCAE v5
Ramy czasowe: Measured during standard of care induction DRd treatment and following iFIT1/iFIT2/iFIT3 randomisation, up to a maximum of 7 years post-registration.
Measured using the proportion of participants experiencing an infection of any type or grade as graded by NCI-CTCAE v5.
Measured during standard of care induction DRd treatment and following iFIT1/iFIT2/iFIT3 randomisation, up to a maximum of 7 years post-registration.
Quality of life using questionnaires
Ramy czasowe: Measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and timepoints up to 30 months post-randomisation. The IL414 is measured at the induction timepoints and in iFIT1, and the STTA after 6 28-day cycles of induction and in iFIT1.
Measured using the EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-IL413 questionnaires. This will also be measured using the EORTC QLQ IL414 questionnaire and the Scale of Subjective Total Taste Acuity (STTA) at specified timepoints only.
Measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and timepoints up to 30 months post-randomisation. The IL414 is measured at the induction timepoints and in iFIT1, and the STTA after 6 28-day cycles of induction and in iFIT1.
Objective measures of function
Ramy czasowe: Measured at the start of cycle 1, after 3 28-day cycles, and after 6 28-day cycles of standard of care induction DRd.
Measured using the 4 metre walk test and mini-cog assessments.
Measured at the start of cycle 1, after 3 28-day cycles, and after 6 28-day cycles of standard of care induction DRd.
Cost-utility
Ramy czasowe: Measured at the start of cycle 1 of DRd induction, after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT1/iFIT2/iFIT3 randomisation.
Measured using costs, QALYs and net health benefit (QALYs below £20,000).
Measured at the start of cycle 1 of DRd induction, after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT1/iFIT2/iFIT3 randomisation.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Exploratory endpoint - investigation into bone disease and therapy
Ramy czasowe: From registration up to a maximum of 7 years post-registration.
Observe and understand current UK bone therapy practice and investigate how it impacts on various bone and clinical myeloma outcomes, in order to generate hypotheses to inform future research in this area. This includes bone therapy planned and prescribed, dental assessment received, and bone disease (including SREs) experienced.
From registration up to a maximum of 7 years post-registration.
Exploratory endpoint - infection interactions and infection risk (iFIT1 only)
Ramy czasowe: From iFIT1 randomisation up to a maximum of 6.5 years post-randomisation.
Certain genetic characteristics and medical history are suspected to influence the incidence and rate of infections. These will be investigated under this endpoint including iVIG usage and vaccination history. The ability to predict prospectively which participants are most at risk of infections could support the implementation of novel immunotherapies in practice. This will also be investigated under this endpoint.
From iFIT1 randomisation up to a maximum of 6.5 years post-randomisation.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Leeds

Współpracownicy

Johnson & Johnson
Cancer Research UK
Blood Cancer UK

Śledczy

  • Krzesło do nauki: Gordon Cook, Leeds Institute of Clinical Trials Research
  • Krzesło do nauki: Charlotte Pawlyn, Institute of Cancer Research, United Kingdom

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 maja 2033

Ukończenie studiów (Szacowany)

1 maja 2037

Daty rejestracji na studia

Pierwszy przesłany

2 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1010810

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance).

The conditions of release for aggregate data may differ from those applying to individual participant data. Requests for aggregate data should also be sent to the above email address to discuss and agree suitable requirements for release.

Ramy czasowe udostępniania IPD

Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on for as long as CTRU retains the data.

Kryteria dostępu do udostępniania IPD

Data will be released for legitimate secondary research purposes, where the Chief Investigators, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (scientific rigour and information governance and security), and that suitable resources are available. Data will be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No IPD will be released before an appropriate agreement is in place governing data retention, usually stipulating that data recipients must delete their copy of the data at the end of the project.

The CTRU believes it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, key trial documents and any other information required to reuse the datasets.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

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