Claims of Equivalence in Medical Research: Are They Supported by the Evidence?

Greene, William L.; Concato, John; Feinstein, Alvan R.

doi:10.7326/0003-4819-132-9-200005020-00006

Cited by 161 publications

(74 citation statements)

References 32 publications

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“…One of the greatest expectations of researchers and clinicians when researching a new drug is to find evidence of superiority of the new drug over the standard treatment being used so that the new product allows a breakthrough in drug therapy for the patients [9]. However, it is also increasingly common for studies to focus on demonstrating that the drug being investigated is just as effective as another drug being considered as a reference.…”

Section: Discussionmentioning

confidence: 99%

Bioequivalence of 150 mg Extended-Release Ketoprofen from Laboratories LETI S.A.V. Test, vs ProfenidBI of Laboratories Sanofi-Aventis Pharmaceuticals LTDA, Prolonged Release, Reference, in Healthy Volunteers*

Annunziato¹,

Yibirín²,

Alfredo³

et al. 2018

OALib

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Objective: To evaluate the bioequivalence between two formulations of ketoprofen after administration of a 150 mg extended release tablet (L.P. ProfenidBI®), 150 mg modified release tablets. Methods: A single-dose cross-over, randomized study was performed under fasting conditions with two treatments, two periods, two sequences (2 × 2) with a 7-day washout period between each dose in 28 healthy volunteers. Subjects were randomly assigned to each of the administration sequences. The pharmacokinetic parameters evaluated were: C max , AUC 0-t and AUC 0-∞ . For the bioequivalence analysis, the AUC 0-t was calculated from the time of administration to the 12 th hour, posology requested for the medication test, by the trapezoidal method; Software: Excel. The means and Confidence Intervals were compared between 80% -125% for the quotient of C max , T max , AUC 0-t and AUC 0-∞ . Results: C max 8.3529 ± 1.9176 μg/mL vs. 7.7175 ± 2.1751 μg/mL, T max 0.75 h vs. 1.25 h, AUC 0-12 25.9560 ± 4.9846 μg/mL/hr vs. 24.9015 ± 5.1507 μg/mL/ hr and AUC 0-∞ 27.0147 ± 5.1099 μg/mL/hr vs. 25.6400 ± 5.1144 μg/mL/h, respectively. 95% IC: C max 106.26% -107.85%, AUC 0-12 101.11% -101.78% and AUC 0-∞ 100.53% -102.94%. Conclusion: The test formulation Ketoprofen 150 mg LP, manufactured by LETI S.A.V. Laboratories, is bioequivalent with respect to the reference product ProfenidBI® 150 mg controlled release tablets, manufactured by Sanofi-Aventis Pharmaceuticals LTDA Laboratories, as the Values obtained from AUC and C max were maintained in the range of 80% -125%.

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Section: Discussionmentioning

confidence: 99%

Bioequivalence of 150 mg Extended-Release Ketoprofen from Laboratories LETI S.A.V. Test, vs ProfenidBI of Laboratories Sanofi-Aventis Pharmaceuticals LTDA, Prolonged Release, Reference, in Healthy Volunteers*

Annunziato¹,

Yibirín²,

Alfredo³

et al. 2018

OALib

View full text Add to dashboard Cite

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“…2-million trials in the Cochrane Central Register of Controlled Trials in 2004 included the words ''equivalence'' or ''noninferiority'' [21]. Given that the overall percentage of controlled trials among all orthopaedic publications ranges between 4% and 8%, the frequency of noninferiority trials and equivalence trials probably is low [41,56].…”

Section: Frequency and Quality Of Noninferiority Trials And Equivalenmentioning

confidence: 99%

“…This can be done via CIs or using statistical tests. However, equivalence testing is two-sided, meaning a new treatment is equivalent only if it is no better and no worse (both within a margin) than the active control, but noninferiority and equivalence often are confused [11,21]. One reason might be the better, more positive ring of being equivalent rather than noninferior, despite the fact that this actually inverts the real situation where a noninferior treatment has potential for superiority, whereas an equivalent treatment, by definition, cannot be better than the active control.…”

Section: Equivalence-they Are Substantively the Samementioning

confidence: 99%

“…However, there are inconsistencies in the literature regarding the use and quality of noninferiority and equivalence trials. One study produced estimates that 67% of equivalence studies published between 1992 and 1996 were inappropriately named [21]. Another study of 90 randomized controlled trials from surgical specialties revealed only 39% met the criteria for establishing equivalence [11].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Rationale for and Methods of Superiority, Noninferiority, or Equivalence Designs in Orthopaedic, Controlled Trials

Vavken

2011

Clinical Orthopaedics &Amp; Related Research

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Background To provide value-based healthcare in orthopaedics, controlled trials are needed to assess the comparative effectiveness of treatments. Typically comparative trials are based on superiority testing using statistical tests that produce a p value. However, as orthopaedic treatments continue to improve, superiority becomes more difficult to show and, perhaps, less important as margins of improvement shrink to clinically irrelevant levels. Alternative methods to compare groups in controlled trials are noninferiority and equivalence. It is important to equip the reader of the orthopaedic literature with the knowledge to understand and critically evaluate the methods and findings of trials attempting to establish superiority, noninferiority, and equivalence. Questions/purposes I will discuss supplemental and alternative methods to superiority for assessment of the outcome of controlled trials in the context of diminishing returns on new therapies over old ones. Methods The three methods-superiority, noninferiority, and equivalence-are presented and compared, with a discussion of implied pitfalls and problems.

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“…For example, if the paper-and-pencil test discussed above was ten times more expensive to administer than the computer-based test, even a very significant difference in outcomes (e.g., +20%) might be acceptable for concluding that the tests are equivalent; Whereas if the paper-and-pencil test was only twice as expensive to administer as the computer based test a difference in outcomes of no more than 5% might be required for concluding that the tests are equivalent. For a further discussion on establishing D readers are referred to Greene, Concato & Feinstein (2000).…”

Section: Introductionmentioning

confidence: 99%

The Effects of Heteroscedasticity on Tests of Equivalence

Gruman

Cribbie

Arpin-Cribbie

2007

J. Mod. App. Stat. Meth.

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Tests of equivalence, which are designed to assess the similarity of group means, are becoming more popular, yet very little is known about the statistical properties of these tests. Monte Carlo methods are used to compare the test of equivalence proposed by Schuirmann with modified tests of equivalence that incorporate a heteroscedastic error term. It was found that the latter were more accurate than the Schuirmann test in detecting equivalence when sample sizes and variances were unequal.

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Claims of Equivalence in Medical Research: Are They Supported by the Evidence?

Cited by 161 publications

References 32 publications

Bioequivalence of 150 mg Extended-Release Ketoprofen from Laboratories LETI S.A.V. Test, vs ProfenidBI of Laboratories Sanofi-Aventis Pharmaceuticals LTDA, Prolonged Release, Reference, in Healthy Volunteers*

Bioequivalence of 150 mg Extended-Release Ketoprofen from Laboratories LETI S.A.V. Test, vs ProfenidBI of Laboratories Sanofi-Aventis Pharmaceuticals LTDA, Prolonged Release, Reference, in Healthy Volunteers*

Rationale for and Methods of Superiority, Noninferiority, or Equivalence Designs in Orthopaedic, Controlled Trials

The Effects of Heteroscedasticity on Tests of Equivalence

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