Related Experiment Video
Updated: Feb 14, 2026
06:14
In Vivo Protocol of Controlled Subconcussive Head Impacts for the Validation of Field Study Data
Published on: April 18, 2019
6.9K
Application and impact of run-in studies
Michael Fralick1,2,3, Jerry Avorn4,5, Jessica M Franklin4,5
1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA, 02120, USA. mif823@mail.harvard.edu.
Journal of General Internal Medicine
|February 17, 2018
Summary
Run-in phases in clinical trials do not significantly alter medication efficacy or safety outcomes. These lengthy phases may not be necessary, questioning their utility and cost-effectiveness in research.
Area of Science:
- Clinical Trials Methodology
- Pharmacology
- Evidence-Based Medicine
Background:
- Run-in phases are common in clinical trials to screen participants.
- These phases can exclude patients, potentially affecting generalizability.
- Concerns exist regarding the necessity and impact of run-in periods.
Purpose of the Study:
- To compare clinical outcomes in randomized controlled trials (RCTs) with and without run-in phases.
- To assess the impact of run-in phases on medication efficacy and safety.
- To evaluate the utility of run-in phases in DPP-4 inhibitor trials.
Main Methods:
- Systematic review and meta-analysis of published RCTs for four DPP-4 inhibitors (sitagliptin, saxagliptin, linagliptin, alogliptin).
- Data extraction included hemoglobin A1C reduction and serious adverse events.
- Pooled results using random effects meta-analysis.
Main Results:
- 106 trials were identified; 88 included run-in phases (average 4.0 weeks).
- No significant differences in hemoglobin A1C reduction between trials with and without run-in phases.
- Similar proportions of serious adverse events were observed in both trial types.
Conclusions:
- Run-in phases did not significantly alter efficacy or safety findings in DPP-4 inhibitor trials.
- The cost and time associated with run-in phases may outweigh their benefits.
- The utility of run-in phases in short-duration clinical trials warrants reconsideration.
Related Concept Videos
01:19Impact of Groups on Groups
264
Social psychologists analyze how groups influence one another, shaping social structures and interactions through both cooperation and competition. These dynamics manifest in various ways, ranging from economic partnerships to intergroup conflicts that shape societal structures and perceptions.Cooperation and Competition in Intergroup RelationsIntergroup relationships vary across contexts, sometimes fostering cooperation and mutual benefit while at other times leading to conflict and...
264
01:30Impact
519
Impact occurs when two bodies collide, leading to the application of impulsive forces between them. Analyzing impact mechanics involves considering two colliding particles moving along a line known as the line of impact, which passes through their centers and is perpendicular to the contact plane.
When particles with different initial velocities collide, they induce deformation by applying equal and opposite impulses. At the point of maximum deformation, the particles move together with...
When particles with different initial velocities collide, they induce deformation by applying equal and opposite impulses. At the point of maximum deformation, the particles move together with...
519
01:28Impact of Groups on Individuals
377
Groups play a fundamental role in shaping individual behavior, as they establish norms that guide interactions and decision-making. Social psychology examines how individuals conform to group expectations, often adjusting their attitudes and actions to align with group norms. These norms can be formal, such as workplace policies, or informal, such as unspoken social expectations within a fraternity.Conformity and Social InfluenceConformity arises when individuals modify their behaviors or...
377
01:25Impact of Individuals on a Group
346
In social psychology, the interplay between individuals and groups is a central concern, particularly regarding how individual actions and characteristics influence group processes and outcomes. While much research emphasizes the group's power in shaping individual behavior, it is equally significant to understand how individuals contribute to the functioning, development, and success of groups.Individual Roles in Group Productivity and Decision-MakingIndividuals are not passive participants in...
346
01:30Impact of Schemas
223
Schemas are cognitive structures that provide a framework for interpreting and organizing social information. They help individuals navigate complex environments by offering expectations about people, events, and behaviors. Schemas influence attention, encoding, and retrieval processes, thereby shaping the entire trajectory of information processing in social contexts.Attention and Cognitive LoadDuring initial attention, schemas function as filters that prioritize schema-consistent information,...
223
01:30Types of Impact
1.1K
Impacts can be classified in various forms, primarily under two subgroups: central impact and oblique impact. A central impact occurs when two objects collide head-on, possessing opposite velocities aligned along the line of impact. Conversely, an oblique impact occurs when two objects collide at an angle, resulting in a modification of both direction and velocity.
The coefficient of restitution is a metric for understanding the dynamics of impacts. It quantifies the ratio of relative velocity...
The coefficient of restitution is a metric for understanding the dynamics of impacts. It quantifies the ratio of relative velocity...
1.1K