Search Strategies for Healthy Subjects

Overseen By Jeremy M Wolfe, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Vision less than 20/25, neuromuscular or visual disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand how people perform visual search tasks when repeated or mixed. Participants will complete four different search tasks, either all at once or one at a time. The trial compares two search methods: repeating the same task 100 times (blocked trials) or mixing all four tasks together (mixed trials). It seeks participants who pass a color vision test, have good eyesight with glasses or contacts, and have no history of muscle or eye disorders. As an unphased trial, this study offers a unique opportunity to contribute to foundational research in visual search behavior.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these search strategies are safe for participants?

A previous study found that most side effects in trials with healthy participants were mild or moderate, with only about 3.7% being serious. This suggests that participants generally tolerate the tasks in the Blocked Trials and Mixed Trials well. These findings indicate that the treatments in this study are likely safe for healthy volunteers, as serious issues are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Search Strategies for Healthy Subjects" trial because it aims to explore how different task organization methods affect cognitive performance. In "Blocked Trials," tasks are grouped in separate blocks, which could help us understand how focused repetition influences learning and efficiency. On the other hand, "Mixed Trials" mix tasks randomly, potentially offering insights into how varied stimuli can enhance adaptability and problem-solving skills. This trial could provide valuable information about optimizing task strategies to improve cognitive function.

What evidence suggests that this trial's treatments could be effective?

In this trial, participants will be assigned to one of two approaches: Blocked Trials or Mixed Trials. Previous studies have used block randomization in Blocked Trials to ensure balanced treatment groups, enhancing the reliability of trial results. For Mixed Trials, research has shown that a mixed-methods approach can effectively test several treatments simultaneously, offering a better understanding of how different tasks or treatments interact. While both methods have strengths, they explore different aspects of visual search behavior. Each approach provides unique insights into how people perform search tasks. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeremy M Wolfe, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is suitable for individuals with Attention Deficit Disorder, healthy volunteers, and those interested in vision research. Specific eligibility criteria are not provided, so it's best to contact the researchers for detailed requirements.

Inclusion Criteria

Pass Ishihara color vision test

Exclusion Criteria

Vision less than 20/25 with correction

I have a history of muscle or vision problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Observers are trained on four different search tasks

1-2 weeks

Experimentation

Participants perform 400 trials in both Mixed and Blocked conditions

4-8 weeks

Follow-up

Participants are monitored for response time and accuracy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blocked Trials
• Mixed trials

Trial Overview

The study examines differences in visual search behavior by comparing 'Mixed trials', where four different tasks change randomly each time, against 'Blocked Trials', where each task is repeated for a block of 100 trials.

How Is the Trial Designed?

Group I: Mixed Trials Experimental Treatment 1 Intervention

There are four search tasks in this experiment. All tasks will be randomly mixed in a single block of 400 trials.

Group II: Blocked Trials Experimental Treatment 1 Intervention

There are four search tasks in this experiment. Each task will be presented in a separate block of 100 trials

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

The new safety monitoring procedure introduced for two-arm blinded clinical trials effectively addresses the FDA's requirements for expedited safety reporting by using a Bayesian hierarchical model to analyze adverse event rates.

This procedure has demonstrated good performance in detecting unexpected rates of adverse events in the treatment group, making it suitable for use in multi-armed clinical trials with blinded data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data. Schnell, PM., Ball, G.[2020]

The FDA recommends that sponsors create a Safety Surveillance Plan to systematically monitor safety data, suggesting two methods: analyzing serious adverse events (SAEs) by treatment group or using a trigger rate for unblinded analysis if SAEs exceed expected background rates.

The article introduces a procedural workflow for a blinded review of safety data, utilizing the Bayesian detection method (BDRIBS) to quantitatively assess risks, and provides tools for visualizing and analyzing safety data across multiple studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation. Waterhouse, B., Hartford, A., Mukhopadhyay, S., et al.[2022]

The active comparator new user design is a preferred method in observational drug safety research because it helps reduce bias by comparing a new drug to a similar treatment that does not affect the outcome, but it can be challenging to implement due to the need for suitable comparators.

This analysis explored alternative study designs for drug safety assessments, demonstrating that various designs can be effectively implemented by adjusting patient selection criteria, which allows researchers to choose the most appropriate design based on specific study factors like treatment patterns and sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection of Comparator Group in Observational Drug Safety Studies: Alternatives to the Active Comparator New User Design. Wintzell, V., Svanström, H., Pasternak, B.[2022]

Citations

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Identifying research priorities for effective retention strategies ...

The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and ...

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withpower.com

withpower.com/trial/phase-attention-5-2024-77ea4

Search Strategies for Healthy Subjects

The research suggests that block randomization, a method used in Blocked Trials, helps ensure balanced treatment groups, which can improve the validity of trial ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0895435622001378

Avoiding searching for outcomes called for additional ...

Excluding outcomes in search strategies can lead to a massive increase in records, making screening unmanageable, and may require alternative strategies.

4.

pmc.ncbi.nlm.nih.gov

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pmc.ncbi.nlm.nih.gov

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Strategies to improve trial retention include those designed to generate maximum data return or compliance and follow‐up procedures that aim to collect data ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9378423/

Reporting of clinical trial safety results in ClinicalTrials.gov ...

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jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/724471

Reporting of Safety Results in Published Reports ...

Restrictions in the reporting of harm-related data were noted in 43 articles (32.3%) with a description of the most common adverse events only ( ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4783291/

Risks of phase I research with healthy participants

Of the 52,798 adverse events (Table 3), 3.7% were severe and 95.8% were mild or moderate, with the numbers adding up to less than 100% because some trials ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714422000581

The challenges of data safety monitoring for a pragmatic ...

Data monitoring committees (DMCs) play a critical role in protecting the safety of participants and integrity of clinical studies.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06933693?term=AREA%5BBasicSearch%5D(trials)&rank=1

Mixed Vs Blocked Search: Four Unique Tasks

They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is ...