Field 15. Study Type

  1. Field 15. Study Type
    1. WHO description
    2. Schema
    3. Validation
    4. Labels
    5. Sample Values
    6. Discussion
      1. Fields for observational studies
      2. Who Primary Registry Criteria
      3. Previous discussion moved from issue tracker

WHO description

A single arm study is one in which all participants are given the same intervention. Trials in which participants are assigned to receive one of two or more interventions are NOT single arm studies. Crossover trials are NOT single arm studies.

A trial is "randomized" if participants are assigned to intervention groups using a method based on chance (e.g., random number table, random computer-generated sequence, minimization, adaptive randomization).

Schema

Validation

Labels

EN: Study Type

PT: Tipo de estudo

ES: Tipo de estudio

Sample Values

sample 1
sample 2
sample 3

Discussion

Programa de acesso expandido (expanded access program) (Executive Committee 2009-11-19)

  • yes
  • no

Sugestão de sub-campos para o tipo de estudo (provenientes da Plataforma Brasil - CONEP):

Enfoque principal do estudo / purpose of the study / propósito del estudio (I,O)

  • Diagnóstico (diagnostic)
  • Etiológico (etiological)
  • Prognóstico (prognostic)
  • Prevenção (prevention) prevención
  • Terapêutica / Operatória (treatment/surgery)
  • Outro: _ (other)

Tipo de destinação do estudo / Type of study endpoint / (I,O)

  • |X| Segurança (safety)
  • |X| Eficácia (efficacy)
  • |X| Bioequivalência (bioequivalence)
  • |X| Biodisponibilidade (bioavailability)
  • |X| Farmacocinética (pharmacokinetics)
  • |X| Farmacodinâmica (pharmacodynamics)
  • |X| Farmacogenética (pharmacogenetics)

Fase do ensaio (CIOMS) / Phase / Fase (I)

  • Fase 0 (exploratória) (phase 0)
  • Fase 1 (phase 1)
  • Fase 1/2 (phase 1/2)
  • Fase 2 (phase 2)
  • Fase 2/3 (phase 2/3)
  • Fase 3 (phase 3)
  • Fase 4 (phase 4)
  • N/A (N/A) - default

Desenho da intervenção / intervention assignment / diseño de la intervención: (I)

  • Grupo único (single group)
  • Paralelo (parallel)
  • Cruzado (cross-over)
  • Fatorial (factorial)
  • Outro: (other)

Número de braços / number of arms / numero de brazos (I,O)

_ (enter 1 for single-arm study).

Tipo de mascaramento / type of masking / tipo de enmascaramiento: (I)

  • Aberto (open) abierto
  • Unicego (single blind) simple ciego
  • Duplo-cego (double-blind) doble ciego
  • Triplo-cego (triple-blind) triple ciego

Tipo de alocação / allocation type / tipo de asignación: (I)

  • Não randomizado controlado (non-randomized controlled) controlado no-aleatorizado
  • Randomizado controlado (randomized controlled) controlado aleatorizado
  • N/A (single arm study) N/A (brazo único)

Fields for observational studies

Tipo de estudo / Study type / Tipo de estudio:

  • Intervenção (interventional) intervención (Executive Committee 2009-08-06)
  • Observacional (observational) observacional (Executive Committee 2009-08-06)

Desenho do estudo observacional / observational study design [otherwise skip] / diseño de estudio observacional: (O)

  • Coorte (cohort)
  • Caso-controle (case-control)
  • Caso (case study)
  • Caso-cruzado (crossover)
  • Ecológico ou comunidade (ecologic or community studies)
  • Base familiar (family-based)
  • Outro: (other)

Temporalidade / time perspective / temporalidad: (O)

  • Prospectivo / Prospective
  • Retrospectivo / retrospective
  • Retrospectivo e prospectivo / restropective and prospective
  • Transversal / Cross-sectional
  • Outro / Other

Who Primary Registry Criteria

Content: "If a registry does include these studies [clinical trials registered retrospectively and/or observational studies] then it should be possible to distinguish between prospectively registered interventional trials and other studies".

(use this area to post further suggestions)

Fields suggested by WHO Best practice - Study type

  • controle / control
  • placebo / placebo/ placebo
  • ativo / active / activo
  • não-controlado / uncontrolled / non-controlado
  • histórico / historical / histórico
  • comparação de dose / dose comparison / comparación de dosis

Fields suggested by WHO Best practice - Study type & Plataforma Brasil

  • Quem está sendo mascarado / Who is masked
  • sujeito da pesquisa / participant / participante
  • colaborador profissional / profesional colaborator/ colaborador
  • investigador / investigator / investigador
  • estatístico bioestatistico analista de dados / statistician or data analystis
  • consultor
  • assessor

Previous discussion moved from issue tracker

I checked the definitions used by Current Controlled Trials and Clinical Trials for the intervention field cited bellow:

Current Controlled Trials For an interventional trial: Enter the specific names of the interventions and the comparator/controls being studied. If the intervention consists of several separate treatments, please list them all. If an active control is used, be sure to enter in the name of this control, or enter "placebo" or "no treatment" as applicable. For each intervention, describe other intervention details as applicable (drug name [generic], dose, duration, frequency, mode of administration, etc). For an observational trial: Please provide a brief summary of your methodology, providing details of the tests that will be run, or any other pertinent information. For all treatment arms, whether interventional or observational, please provide the total duration of treatment, and the total duration of follow-up. No field limit.

Clinical Trials Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.

Some examples of studies captured from cliniclatrials.gov:

Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America - intervention: biological (Falciparum Malaria Protein 1 with AS02A adjuvant)

Rapid tests for Malaria - intervention: procedure (Rapid diagnostic test, Microscopy, Clinical diagnosis for malaria); device (training in use of rapid diagnostic tests (RDTs) for malaria, Field microscopy and Paracheck Pf®)

Active Surveillance, Radical Prostatectomy, or Radiation Therapy in Treating Patients With Localized Prostate Cancer: drug (cyproterone acetate, releasing hormone agonist therapy); other (medical chart review, questionnaire administration), procedure (assessment of therapy complications, observation, quality-of-life assessment, therapeutic conventional surgery, therapeutic lymphadenectomy); radiation (3-dimensional conformal radiation therapy)

Changed 7 months ago by anonymous ¶

Intervention fields in the ANZCTR registry form:

Description of intervention(s) exposure - free text (if the intervention consists of several separate treatments, list them all in one line separated by commas (e.g., "low-fat diet, exercise").

Intervention code:

• Not applicable – observational study • Diagnosis • Early detection / screening • Prevention • Treatment: four options (drugs, surgery, devices, other) • Reahabilitation • Lifestyle • Behaviour • Other interventions

Comparator/control treatment: free text

Control: Choose the most appropriate description of the study’s control group from the list (Placebo, Active, Uncontrolled, Historical, Dose comparison)

Changed 7 months ago by anonymous ¶

All the previous comments were about intervention type. For classification of study types, the ANZCTR uses two options: interventional, observational.

Changed 7 months ago by anonymous ¶

Plataforma Brasil

Among the categories defined in the study type field at Plataforma Brasil, only clinical studies are relevant to our purpose. These clinical studies are classified as diagnostic, etiological, prognostic, prevention, treatment/surgery and other. In portuguese (spanish): diagnóstico (diagnóstico), etiológico (etiológico), prognóstico (prognóstico), prevenção (prevención), terapêutica / Operatória (tratamiento/cirúrgico, outro (otro).

Changed 7 months ago by jlaguardia@cict.fiocruz.br

Sugestão de campos estruturados para inclusão no REBRAC/RECLAC

1.Países de recrutamento / Countries of Recruitment

2.Study Type

• Observacional (observational) • Intervenção (interventional)

3. Propósito do estudo / purpose of the study

• Diagnóstico (diagnostic) • Etiológico (etiological) • Prognóstico (prognostic) • Prevenção (prevention) • Terapêutica / Operatória (treatment/surgery) • Outro: _ (other)

4. Desenho do estudo observacional / observational study design [otherwise skip]

• Coorte (cohort) • Caso-controle (case-control) • Caso (case study) • Caso-cruzado (crossover) • Ecológico ou comunidade (ecological) • Base familiar (family-based) • Outro: (other)

5. Fase do ensaio (CIOMS) / Phase

• Fase 0 (exploratória) (phase 0) • Fase 1 (phase 1) • Fase ½ (phase 1/2) • Fase 2 (phase 2) • Fase2/3 (phase 2/3) • Fase 3 (phase 3) • Fase 4 (phase 4) • N/A (N/A)

6. Tipo de destinação do estudo / Type of study endpoint

• Segurança (safety) • Eficácia (efficacy) • Segurança/Eficácia?? (safety/efficacy) • Bioequivalência (bioequivalence) • Biodisponibilidade (biodisponibility) • Farmacocinética (pharmacokinetics) • Farmacodinâmica (pharmacodynamics) • Farmacocinética/ Farmacodinâmica (pharmacokinetics/pharmacodynamics) • Farmacogenética (pharmacogenetics) • Farmacogenética/Farmacocinética?? (pharmacogenetics/pharmacokinetics) • Farmacogenética/Farmacodinâmica?? (pharmacgenetics/pharmacodynamics) • Farmacocinética/Farmacodinâmica/Farmacogenética?? (pharmacogenetics/pharmacgenetics/pharmacodynamics)

7. Desenho da intervenção / intervention assignment:

• Grupo único (single group) • Paralelo (parallel) • Cruzado (cross-over) • Fatorial (factorial) • Outro: (other)

8. Tipo de intervenção / intervention type (choose all that apply from the list). • Droga (drug) • Dispositivos (inclusive dispositivo ineficaz) (device) • Biológica/Vacina?? (biological / vaccine) • Procedimento/operatória/cirurgia (procedure/surgery) • Radiação (radiation) • Comportamental (p.ex. psicoterapia, aconselhamento de estilo de vida) (behavioural, lifestyle counseling) • Genética (genetics) • Suplementação alimentar (dietary supplement) • Outro (other) : _

9. Tipo de mascaramento / type of masking

• Aberto (open) • Unicego (single blind) • Duplo-cego (double-blind) • Triplo-cego (triple-blind)

10. Quem está sendo mascarado /who is(are) blinded/masked: (choose all that apply from the list).

• Sujeito da pesquisa (research subject) • Colaborador/Profissional (collaborator/professional) • Investigador (researcher) • Estatístico/Bioestatístico/Analista?? de dados (statistitian/biostatistitian/data analyst) • Consultor (consultant) • Assessor (advisor)

11. Tipo de alocação / allocation type

• Não randomizado controlado (non-randomized controlled) • Randomizado controlado (randomized controlled) • N/A (single arm study)

12. Status de recrutamento / Recruitment Status: • Não iniciou (pending) • Recrutando (recruiting) • Suspenso (suspended) • Concluido (completed) • Outro (other)

Os campos 3, 4, 5, 6, 7, 8, 9, 10 e 11 foram retirados da Plataforma Brasil. Faltam incluir os campos de descrição da intervenção que teriam tabelas discutidas na última reunião com o Cláudio, bem como as respectivas tabelas. A tabela a ser utilizada no campo 1 também foi mencionada.

Changed 7 months ago by Claudio Nishizawa <claudio.nishizawa@anvisa.gov.br> ¶

Replying to fabio.santos:

What is the controlled vocabulary for the Study Type field? (TrialRegistrationDataSet field 15).

We need the terms in English, Portuguese and Spanish.

It´ll be a combination of multiple fildsets, each one compose the type from its perspective. in reply to: ↑ 9 Changed 7 months ago by Claudio Nishizawa <claudio.nishizawa@anvisa.gov.br> ¶

Replying to Claudio Nishizawa <claudio.nishizawa@…>:

Replying to fabio.santos:

What is the controlled vocabulary for the Study Type field? (TrialRegistrationDataSet field 15).

We need the terms in English, Portuguese and Spanish.

CN: It´ll be a combination of multiple fieldsets, each one compose the type from its perspective.

LR: We need to know (1) the precise name of all the controlled vocabularies to be used, (2) whether the vocabulary is available in English, Portuguese and Spanish, (3) whether we have a license to use it and (4) the source for obtaining the vocabulary in digital format.

LR: Please let us move this discussion out of this ticket to the StudyTypeField page in the Wiki.

Part of: TrialRegistrationDataSet