A Review of Interventional Trials

INTERVENTIONAL TRIALS: A REVIEW Quality of Study Designs | Trends Studies & EnrollmentSource: ClinicalTrials.govData Download Date: December 26, 2016 Publication Date: January 7, 2017Analytical tool: IBM Watson

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Participants are assigned to receive one or more interventions, or none at all, as assigned in the protocol, so that researchers can evaluate their effects on biomedical or health-related outcomes.

Interventions can be diagnostic, therapeutic, or behavioral.

January 5, 2017


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ts• How are study designs changing over time? • Is the level of evidence produced improving? • What are the trends in quality parameters of study designs?• Can quality of studies be measured using the available data?

• What are the trends for number of studies? • How trends in number of trials compares to enrollment? • Which interventions are studied the most? • Who are the sponsors of clinical trials? • Where the funding comes from? • What are the main reasons to conduct clinical trials? • What are the endpoints? What are the trends, are they changing? • What is the primary purpose? Are the trends changing? How? • Are the results available? In what form?

INTERVENTIONSDrugs | Biological | Device | Procedure | Radiation Behavioral | Dietary Supplement | Genetic | Other



Clinical trials by InterventionsNumber of trials Enrolled patients

Behavioral Biological Device Dietary supplement Drug Genetic Other Procedure Radiation


Clinical trials by InterventionsBreakdown by phase (Number of Studies)



Clinical trials by InterventionsBreakdown by phase (Enrollment)


Number of Enrolled Patients: Results skewed by several studies with very high number of subjects including three studies with unlimited number of participants (99,999,999)

Clinical trials by InterventionsTrends by Start Date & Completion Date



PHASESPhase 0 | Phase 1 | Phase 2 | Phase 3 | Phase 4



Clinical trials by PhasesPhase 0 Phase 1 Phase 1|2 Phase 2 Phase 2|3 Phase 3 Phase 4 Blank

Number of trials Enrolled patients

Phase 0: Exploratory study involving very limited human exposure to the drug (screening, microdose studies).

Phase 1: Studies conducted with healthy volunteers to find most important safety issues see how the drug is metabolized and excreted.

Phase 2: Studies that gather preliminary data on effectiveness. Safety continues to be evaluated.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages.

Phase 4: Studies occurring after FDA has approved a drug for marketing to gather additional information about a drug's safety, efficacy, or optimal use.

Clinical trials by PhasesTrends by Start Date & Completion Date


Phase 0 Phase 1 Phase 1|2 Phase 2 Phase 2|3 Phase 3 Phase 4 Blank

DESIGN: PRIMARY PURPOSEBasic Science | Diagnostic | Educational | Prevention | Screening Health Science Research | Treatment | Supportive Care



Clinical trials by Primary Purpose

Basic Science Diagnostic Educational/Counseling/TrainingHealth Services Research Prevention Screening Supportive Care Treatment Blank



Clinical trials by Primary PurposeBreakdown by phase (Number of Studies)



Clinical trials by Primary PurposeBreakdown by phase (Enrollment)



Clinical trials by Primary PurposeTrends by Start Date & Completion Date


FUNDINGIndustry | NIH | Other | U.S. Federal AgenciesCombined Funding



Clinical trials by FundingNumber of trials Enrolled patients

Industry Industry + other entities NIH NIH + other entities Other Other + other entities U.S. Federal Agencies U.S. Fed + other entities


Clinical trials by FundingBreakdown by phase (Number of Studies)



Clinical trials by FundingBreakdown by phase (Enrollment)



Clinical trials by FundingTrends by Start Date & Completion Date



DESIGN: ENDPOINT CLASSIFICATION PK/PD | Safety | Efficacy | BA/BE



Clinical trials by Endpoint ClassificationNumber of trials Enrolled patients

Bio-availability study Bio-equivalence study Efficacy study Pharmaco-dynamic study Pharmaco-kinetic study PK/PD Safety study Safety/Efficacy study Blank



Clinical trials by Endpoint ClassificationBreakdown by phase (Number of Studies)


Clinical trials by Endpoint ClassificationBreakdown by phase (Enrollment)



Clinical trials by Endpoint Classification Trends by Start Date & Completion Date


QUALITY ATTRIBUTESAllocation | Intervention Model | Masking



QUALITY of EVIDENCELEVEL I LEVEL II LEVEL III LEVEL IV LEVEL V

High quality randomized trials

Lesser quality RCT Case control study Case series Expert opinion

High quality prospective studies

Prospective or comparative study

Retrospective comparative study

Case control study (diagnostic studies)

Testing previously developed diagnostic criteria on consecutive

patients

Retrospective study, lesser quality

prospective study

Study of non-consecutive patients inconsistently applied

reference gold standard

Poor reference standard

Sensible costs and alternatives

Untreated controls from an RCT

Analyses with no sensitivity analyses.

Values from many studies with multiway sensitivity analyses

Development of diagnostic criteria on consecutive patients,

Analyses based on limited alternatives,

costs & poor estimates

Systematic review of Level I studies

Systematic review of L2 studies or L1 studies

with inconsistent results.

Systematic review of L3 studies.

Source: Elsevier

http://cdn.elsevier.com/promis_misc/Levels_of_Evidence.pdf

DESIGN: ALLOCATIONRandomized | Non-Randomized | Single-Arm Trials



Clinical trials by Allocation Number of trials Enrolled patientsAllocation: A clinical trial

design strategy used to assign participants to an arm of a study.

Randomized Controlled Trial: Participants are assigned to intervention groups by chance

Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method, such as physician choice

Number of Enrolled Patients: Results skewed by three studies with unlimited number of participants (99,999,999)

Non-randomizedRandomized Single arm study


Clinical trials by AllocationBreakdown by phase (number of studies)


Clinical trials by AllocationTrends by Start Date & Completion Date



DESIGN: INTERVENTION MODELParallel | Cross-Over | Factorial | Single-Group



Clinical trials by Intervention Model Parallel Study Design: Two or more groups of participants receive different interventions "in parallel“.

Cross-over Study Design: Groups of participants receive two or more interventions in a particular order. So during the trial, participants "cross over" from one drug to the other.

Single Group Study Design: All participants receive the same intervention.

Factorial Study Design: Groups of participants receive one of several combinations of interventions so during the trial, all possible combinations of the two drugs are given to different groups of participants.


Crossover Factorial Parallel Single Group Blank


Clinical trials by Intervention Model Breakdown by phase (number of studies)



Clinical trials by Intervention Model Breakdown by phase (Enrollment)



Clinical trials by Intervention ModelTrends by Start Date & Completion Date



DESIGN: MASKINGDouble-Blind | Single-Blind | Open Label



Clinical trials by MaskingOpen Label: Describes a clinical trial in which masking is not used, and all parties involved in the trial know which participants have been assigned which interventions.

Single Blind: A type of Masking in which one party involved in the clinical trial, typically the investigator or participants, does not know which participants have been assigned which interventions.

Double Blind: A type of Masking in which two or more parties do not know which participants have been assigned which interventions. Typically, the parties include the investigator and participants, but sometimes also the assessor or caregiver. .

Double Blind Open Label Single Blind Blank



Clinical trials by MaskingBreakdown by phase (Number of studies)



Clinical trials by MaskingBreakdown by phase (Enrollment)



Clinical trials by MaskingTrends by Start Date & Completion Date



RECRUITMENTRecruiting | Enrolling by Invitation |Active, not Recruiting Completed | Suspended | Terminated | Withdrawn



Clinical trials by RecruitmentNumber of trials Enrolled patients

Active, not recruiting Completed Enrolling by invitation Not yet recruiting Recruiting Suspended Terminated Unknown status Withdrawn


Clinical trials by RecruitmentBreakdown by phase (Number of Studies)



Clinical trials by RecruitmentBreakdown by phase (Enrollment)



Clinical trials by RecruitmentTrends by Start Date & Completion Date


DEMOGRAPHICS: GENDERMale | Female | Both



Clinical trials by GenderNumber of trials Enrolled patients

Both Female Male Blank


Clinical trials by GenderBreakdown by phase (Number of Studies)



Clinical trials by GenderBreakdown by phase (Enrollment)



Clinical trials by GenderTrends by Start Date & Completion Date



STUDY RESULTSAvailability of study results for completed studiesReporting format



Clinical trials by ResultsHas results No results available



Clinical trials by ResultsBreakdown by phase (Number of All Studies)

Has results No results available


Clinical trials by ResultsBreakdown by phase (Enrollment)

Has results No results available Number of Enrolled Patients:

Results skewed by several studies with very high number of subjects including three studies with unlimited number of participants (99,999,999)

Clinical trials by ResultsTrends by Start Date & Completion Date


Has results No results available


Future ConsiderationsPublished and registered trials have to be reconcilable (publication bias)

Standard format of reporting for completed trials to allow accurate assessment

Enforceable publication of results of clinical trials including negative studies

Assessment of level of evidence each trial provides


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A Review of Interventional Trials

Health & Medicine