| Title |
Application and impact of run-in studies
|
|---|---|
| Published in |
Journal of General Internal Medicine, February 2018
|
| DOI | 10.1007/s11606-018-4344-7 |
| Pubmed ID | |
| Authors |
Michael Fralick, Jerry Avorn, Jessica M. Franklin, Abdurrahman Abdurrob, Aaron S. Kesselheim |
| Abstract |
A run-in phase is often employed prior to randomization in a clinical trial to exclude non-adherent patients, placebo responders, active drug non-responders, or patients who do not tolerate the active drug. This may impact the generalizability of trial results. To determine if clinical outcomes differed between randomized controlled trials with run-in phases compared with randomized controlled trials of the same medication without run-in phases. From 2006 to 2014, the Food and Drug Administration approved 258 new medications. Sitaglitpin, saxagliptin, linagliptin, and alogliptin were among the only drugs with a common mechanism of action that each had multiple clinical trials, some of which had run-in phases and some of which did not. We identified all published randomized controlled trials for these four medications from MEDLINE and EMBASE as well as prior systematic reviews. We extracted key measures of medication efficacy (reduction in hemoglobin A1C) and safety (serious adverse events) from qualifying trials. Study results were pooled for each medication using random effects meta-analysis. We identified 106 qualifying trials for DPP4 inhibitors, of which 88 had run-in phases and 18 did not. The average run-in phase duration was 4.0 weeks (range 1-21), and 73% of run-in phases administered placebo rather than active drug. The reduction in hemoglobin A1C compared to baseline was similar for trials with and without run-in phases (0.70%, 95% confidence interval [CI] 0.65-0.75 vs 0.76%, 95% CI 0.69-0.84, p = 0.27). The proportion of patients with serious adverse events was also similar for trials with and without run-in phases (4%, 95% CI: 3-5% vs 3%, 95% CI: 1-4%, p = 0.35). Trials with run-in phases provided similar estimates for medication efficacy and safety compared to trials without run-in phases. Because run-in phases are costly and time-consuming, these results call their utility into question for clinical trials of short duration. |
X Demographics
The data shown below were collected from the profiles of 16 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 5 | 31% |
| Canada | 2 | 13% |
| India | 1 | 6% |
| Unknown | 8 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 6 | 38% |
| Scientists | 5 | 31% |
| Practitioners (doctors, other healthcare professionals) | 4 | 25% |
| Science communicators (journalists, bloggers, editors) | 1 | 6% |
Mendeley readers
The data shown below were compiled from readership statistics for 32 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 32 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 5 | 16% |
| Student > Master | 4 | 13% |
| Student > Ph. D. Student | 3 | 9% |
| Student > Bachelor | 2 | 6% |
| Student > Postgraduate | 2 | 6% |
| Other | 6 | 19% |
| Unknown | 10 | 31% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 12 | 38% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 6% |
| Unspecified | 1 | 3% |
| Nursing and Health Professions | 1 | 3% |
| Biochemistry, Genetics and Molecular Biology | 1 | 3% |
| Other | 2 | 6% |
| Unknown | 13 | 41% |
Attention Score in Context
This research output has an Altmetric Attention Score of 16. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 29 September 2021.
All research outputs
#2,179,990
of 25,022,483 outputs
Outputs from Journal of General Internal Medicine
#1,629
of 8,092 outputs
Outputs of similar age
#55,019
of 485,577 outputs
Outputs of similar age from Journal of General Internal Medicine
#46
of 146 outputs
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