8 research outputs found
ANALYZING THE IMPACT OF INTERNATIONAL TRADE ON ECONOMIC STABILITY IN NIGERIA USING THE ARDL METHOD
No full textThis study examined the impact of international trade on economic stability in Nigeria using time-series data and econometric models, including autoregressive distributed lag (ARDL) models, with a dataset spanning from 1981 to 2022. The analysis reveals that higher inflation rates and exchange rate fluctuations have a statistically significant negative effect on economic stability. Specifically, increased inflation correlates with decreased economic stability, highlighting the need for effective inflation management. Exchange rate volatility also has an adverse effect on stability, emphasizing the need for exchange rate stabilization measures. In contrast, the import-to-consumption ratio significantly impacts economic stability, while the import-to-production ratio does not exhibit a significant effect. The study suggests that promoting domestic production through policy incentives and technological investments can reduce import dependence and mitigate trade imbalances. The policy implications emphasize the importance of robust monetary and fiscal policies to control inflation, stabilize the exchange rate, and support domestic production. Addressing these factors is essential for maintaining economic stability and promoting sustainable growth in Nigeri
Does Nigeria’s Growth in Education Increase with Expansionary Monetary Policy?
No full textThis study investigated whether expansionary monetary policy contributed to Nigeria’s educational growth through cointegration using the auto-regressive distributed lag (ARDL) method for the years 1981–2021. The bounds tests indicate that the variables of interest are long-term correlated. The corresponding equilibrium correction supported the existence of a long-term relationship. The findings also show that, in the short run, there is no Granger causality between interest rates, inflation, and education growth. Empirical analysis reveals a highly significant relationship between these macroeconomic variables and the growth of education. Furthermore, the findings show that the high interest rate won’t have a significant impact on low-income Nigerians because Nigeria’s private sector receives relatively little domestic credit. The paper recommends that the government develop and implement policies that ensure favourable interest rates for financing education. This could entail offering grants, scholarships, or low-interest student loans in order to increase the accessibility and affordability of education
Post-publication critique at top-ranked journals across scientific disciplines: A cross-sectional assessment of policies and practice
No full textJournals exert considerable control over letters, commentaries and online comments that criticize prior research (post-publication critique). We assessed policies (Study One) and practice (Study Two) related to post-publication critique at 15 top-ranked journals in each of 22 scientific disciplines (N = 330 journals). Two-hundred and seven (63%) journals accepted post-publication critique and often imposed limits on length (median 1000, interquartile range (IQR) 500-1200 words) and time-to-submit (median 12, IQR 4-26 weeks). The most restrictive limits were 175 words and two weeks; some policies imposed no limits. Of 2066 randomly sampled research articles published in 2018 by journals accepting post-publication critique, 39 (1.9%, 95% confidence interval [1.4, 2.6]) were linked to at least one post-publication critique (there were 58 post-publication critiques in total). Of the 58 post-publication critiques, 44 received an author reply, of which 41 asserted that original conclusions were unchanged. Clinical Medicine had the most active culture of post-publication critique: all journals accepted post-publication critique and published the most post-publication critique overall, but also imposed the strictest limits on length (median 400, IQR 400-550 words) and time-to-submit (median 4, IQR 4-6 weeks). Our findings suggest that top-ranked academic journals often pose serious barriers to the cultivation, documentation and dissemination of post-publication critique
A cross-disciplinary assessment of post-publication peer review policies and practice in influential scientific journals
No full textJournals exert considerable control over letters, commentaries and online comments that criticize prior research (post-publication critique). We assessed policies (Study One) and practice (Study Two) related to post-publication critique at 15 top-ranked journals in each of 22 scientific disciplines (N = 330 journals). Two-hundred and seven (63%) journals accepted post-publication critique and often imposed limits on length (median 1000, interquartile range (IQR) 500–1200 words) and time-to-submit (median 12, IQR 4–26 weeks). The most restrictive limits were 175 words and two weeks; some policies imposed no limits. Of 2066 randomly sampled research articles published in 2018 by journals accepting post-publication critique, 39 (1.9%, 95% confidence interval [1.4, 2.6]) were linked to at least one post-publication critique (there were 58 post-publication critiques in total). Of the 58 post-publication critiques, 44 received an author reply, of which 41 asserted that original conclusions were unchanged. Clinical Medicine had the most active culture of post-publication critique: all journals accepted post-publication critique and published the most post-publication critique overall, but also imposed the strictest limits on length (median 400, IQR 400–550 words) and time-to-submit (median 4, IQR 4–6 weeks). Our findings suggest that top-ranked academic journals often pose serious barriers to the cultivation, documentation and dissemination of post-publication critique
A cross-disciplinary assessment of post-publication peer review policies and practice in influential scientific journals
No full textJournals exert considerable control over letters, commentaries and online comments that criticize prior research (post-publication critique). We assessed policies (Study One) and practice (Study Two) related to post-publication critique at 15 top-ranked journals in each of 22 scientific disciplines (N = 330 journals). Two-hundred and seven (63%) journals accepted post-publication critique and often imposed limits on length (median 1000, interquartile range (IQR) 500–1200 words) and time-to-submit (median 12, IQR 4–26 weeks). The most restrictive limits were 175 words and two weeks; some policies imposed no limits. Of 2066 randomly sampled research articles published in 2018 by journals accepting post-publication critique, 39 (1.9%, 95% confidence interval [1.4, 2.6]) were linked to at least one post-publication critique (there were 58 post-publication critiques in total). Of the 58 post-publication critiques, 44 received an author reply, of which 41 asserted that original conclusions were unchanged. Clinical Medicine had the most active culture of post-publication critique: all journals accepted post-publication critique and published the most post-publication critique overall, but also imposed the strictest limits on length (median 400, IQR 400–550 words) and time-to-submit (median 4, IQR 4–6 weeks). Our findings suggest that top-ranked academic journals often pose serious barriers to the cultivation, documentation and dissemination of post-publication critique
Post-publication critique at top-ranked journals across scientific disciplines: a cross-sectional assessment of policies and practice
No full textJournals exert considerable control over letters, commentaries and online comments that criticize prior research (post-publication critique). We assessed policies (Study One) and practice (Study Two) related to post-publication critique at 15 top-ranked journals in each of 22 scientific disciplines (N = 330 journals). Two-hundred and seven (63%) journals accepted post-publication critique and often imposed limits on length (median 1000, interquartile range (IQR) 500–1200 words) and time-to-submit (median 12, IQR 4–26 weeks). The most restrictive limits were 175 words and two weeks; some policies imposed no limits. Of 2066 randomly sampled research articles published in 2018 by journals accepting post-publication critique, 39 (1.9%, 95% confidence interval [1.4, 2.6]) were linked to at least one post-publication critique (there were 58 post-publication critiques in total). Of the 58 post-publication critiques, 44 received an author reply, of which 41 asserted that original conclusions were unchanged. Clinical Medicine had the most active culture of post-publication critique: all journals accepted post-publication critique and published the most post-publication critique overall, but also imposed the strictest limits on length (median 400, IQR 400–550 words) and time-to-submit (median 4, IQR 4–6 weeks). Our findings suggest that top-ranked academic journals often pose serious barriers to the cultivation, documentation and dissemination of post-publication critique
supplementary_information.docx from Post-publication critique at top-ranked journals across scientific disciplines: a cross-sectional assessment of policies and practice
No full textJournals exert considerable control over letters, commentaries and online comments that criticize prior research (post-publication critique). We assessed policies (Study One) and practice (Study Two) related to post-publication critique at 15 top-ranked journals in each of 22 scientific disciplines (N = 330 journals). Two-hundred and seven (63%) journals accepted post-publication critique and often imposed limits on length (median 1000, interquartile range (IQR) 500–1200 words) and time-to-submit (median 12, IQR 4–26 weeks). The most restrictive limits were 175 words and two weeks; some policies imposed no limits. Of 2066 randomly sampled research articles published in 2018 by journals accepting post-publication critique, 39 (1.9%, 95% confidence interval [1.4, 2.6]) were linked to at least one post-publication critique (there were 58 post-publication critiques in total). Of the 58 post-publication critiques, 44 received an author reply, of which 41 asserted that original conclusions were unchanged. Clinical Medicine had the most active culture of post-publication critique: all journals accepted post-publication critique and published the most post-publication critique overall, but also imposed the strictest limits on length (median 400, IQR 400–550 words) and time-to-submit (median 4, IQR 4–6 weeks). Our findings suggest that top-ranked academic journals often pose serious barriers to the cultivation, documentation and dissemination of post-publication critique
Concordance between EMA good clinical practice inspections and medical literature concerning drugs that have not received marketing authorization in the European Union
No full textIntroduction:
Medical literature, especially that related to clinical trials, is considered the primary source of information used by physicians to help make decisions. An essential element ensuring the integrity of the literature is peer review, which validates the publication of a clinical trial. However, sometimes criticisms or comments escape this step, leading to the publication of clinical trials with errors (1–3). In such cases, post-publication peer review (PPPR) can help correct the literature. Nonetheless, it seems that journals do not facilitate PPPR comments, for example, by imposing editorial rules with word or time constraints relative to the initial article's publication (4). Yet, most medical journal editors adhere to the Committee for Publication Ethics (COPE) recommendations (5), which encourage and promote PPPR. COPE also provides information on how to respond to reported criticisms of articles. Despite this, articles presenting erroneous information in the literature are poorly corrected (6). For instance, when a questionable practice such as changing the primary endpoint of a clinical trial was identified and brought to the attention of editors of reputable journals, too few actions were taken (7). This again contradicts the COPE guidelines.
The Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the European Union evaluate drugs before they are marketed. These agencies have unique information that can aid PPPR and also pre-publication peer review since they can conduct Good Clinical Practice (GCP) inspections at clinical study sites, while journals cannot verify the truthfulness and quality of the information presented by authors. The report of these inspections, when identifying deficiencies, is crucial and should be known by the end-users who will ultimately use the drugs in their daily practice. However, it seems that these inspection reports are disconnected from the evidence published in the medical literature. In 2015, C. Seife identified 57 clinical trials resulting in 78 publications where a GCP inspection by the FDA found deviations from GCP recommendations that could cast doubt on the quality of the information presented in the medical literature (8). Yet, in 2015, at the time of C. Seife's publication, 96% of the articles he identified did not mention these inspections either natively or through an expression of concern or erratum (8).
Unlike the FDA, the EMA does not directly publish GCP inspection reports, but these are mentioned in the European public assessment reports (EPAR). EPAR are made by the Committee for Medicinal Products for Human Use (CHMP). When the result of a GCP inspection impacts the CHMP's decision to grant or not a marketing authorization, the EPAR generally mentions it. The EMA publishes EPARs for drugs whether they are accepted, rejected, or if the marketing application has been withdrawn (9,10).
The objective of our study is to determine if the EPAR for drugs submitted to the EMA contain information from GCP inspections that contradicts the medical literature data.
Methods:
Selection of CHMP assessments (EPAR):
The assessments of the CHMP are publicly available on the EMA website, under the name of European public assessment reports (EPAR) (11). Using the search function on the EMA website, we will filter the published assessments using the filters "human," "Medicines," "Withdrawn application," "refused." We will search all EPARs published from the 17th of July 2000 (date of publication of the first EPAR) up to April 2024.
Identification of GCP inspections:
For each identified assessment, we will search the available documents on the EMA website for mentions of a GCP inspection conducted by the EMA by searching the terms "Good clinical practice" or "GCP" used in these reports. We will preferably use the document "EPAR - Public assessment report." We will also look, when available, in the paragraph: "Steps taken for the assessment of the product." In the absence of this document, the other documents present on the EMA website (withdrawal letter, or Question-Answer) will also be screened.
If a GCP inspection was conducted, we will look in the document to see if this inspection is described and if the deviations eventually observed mentioned. We will look at the conclusions issued by the CHMP concerning the impact of deviations eventually observed on the results presented. We will note for each application if the inspection impacts the efficacy criterion or the safety/tolerance profile of the drug. The deviations observed by the EMA are classified as "critical," "major," or "minor." We will use this classification by the EMA, using the terms employed in the report. Besides the qualitative nature of the deviations observed, the EPARs sometimes describe the number of deviations observed by category. The number of “critical” deviations per inspection will also be searched.
Finally, in rare cases, the EPAR describes in detail the verbatim elements of the GCP inspection influencing its decision. In these cases, the elements of this description will be collected in free text. In the absence of detail, we will not include anything.
Published studies:
For each identified assessment mentioning a GCP inspection, we will search if one or more studies have been published in a peer-reviewed medical journal. For this, we will search in the EPARs in the sections: "Clinical efficacy" and "Main studies" for any EU Clinical Trials Register or ClinicalTrials.gov trial identification number or study number used by the sponsor. If only a sponsor's study number is available, we will search for its match with a Clinical trial number. Then, we will search in Google Scholar and study registries for the clinical studies published in medical journals using the identification number. We will differentiate studies published as articles from results posted as abstracts or conference presentations. In the absence of an identification number, we will search in free text the descriptive elements of the study using the drug's name (commercial or international nonproprietary name), study design regarding randomization, comparator, the presence of blinding (single or double), and the medical indication (disease name with stage if specified) in the Google search engine. We will use the number of patients and the inclusion dates to confirm that the studies found correspond to those mentioned in the EPAR. IN case of doubt about the trial, we will contact the author or the sponsor. We will collect all publications even if a study has resulted in different publications.
Dissemination in meta-analyses, reviews, and citation count:
For each EPAR concerning a withdrawn or rejected drug where a GCP inspection revealed a critical deviation and resulted in a scientific publication, we will use the Web of Science search engine to identify the citation count of each study and specifically study the number of reviews and meta-analyses citing them.
Request for inspection reports from the EMA:
For each EPAR concerning a withdrawn or rejected drug where a GCP inspection revealed a critical deviation and resulted in a scientific publication, we will request the complete GCP inspection report from the EMA. Indeed, the EPARs describe the presence of deviations but do not detail them. In accordance with Article 7 of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council, and Commission documents (the Regulation) and Section 3 of the Annex to the “European Medicines Agency policy on access to documents - POLICY/0043” (the Agency policy), all documents of the EU Institutions and European decentralized Bodies such as the European Agencies are deemed accessible to the public. Thus, we will ask the EMA for access to GCP inspection reports.
Data collected:
For each identified assessment, we will record the opinion date, the commercial name of the drug, the international nonproprietary name, whether the application was refused or withdrawn, and whether a GCP inspection conducted by the EMA is mentioned. For each assessment involving an inspection, we will collect the clinical trial identification numbers associated with the application. We will record if one or more publications are associated. We will note how many publications mention the GCP inspection and its conclusions. We will note if deviations are reported and if so, their classification as "critical," "major," or "minor," according to the EMA's classification. We will look in each article if the author mentioned the GCP inspection, or its conclusion only. We will also report if the inspection report impact the efficacy of the drug, or its safety using the wording of the EPAR. We will also note if the GCP inspection mention deviation to ethic rules. The extraction will be carried out independently by two researchers. Any discrepancies will be resolved by a third author.
Criteria and method of analysis
Our study is descriptive. It is a descriptive analysis. For quantitative variables we will report means, standard deviations and numbers or medians (interquatrile range) if the distribution is not normal; for qualitative variables we will report numbers and percentages.
The primary outcome criterion will be:
- The mention of the deviation in the publication or the mention of the EMA GCP inspection.
The secondary outcomes will be
- Description of the deviations in the EPAR, both qualitatively and quantitatively.
- Discordance between the deviations described in the EPAR and the publication.
- Description of publications in terms of journal and date
- Dissemination of the discordant study in journals and meta-analyses.
We will describe in free text the differences observed between the clinical studies and the EPARs when the conclusions of the GCP inspections are described.
For each request for an inspection report made to the EMA, we will note the date on which the request was made. We will note how long it takes the EMA to respond to our request, and the answers we receive. If there is no response after one year, we will consider that the EMA has not responded to our request for access to documents.
References:
1. Carlisle JB. False individual patient data and zombie randomised controlled trials submitted to Anaesthesia. Anaesthesia. avr 2021;76(4):472‑9.
2. Carlisle JB. The analysis of 168 randomised controlled trials to test data integrity. Anaesthesia. mai 2012;67(5):521‑37.
3. Doshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility. BMJ. 16 sept 2015;351:h4629.
4. Hardwicke TE, Thibault RT, Kosie JE, Tzavella L, Bendixen T, Handcock SA, et al. Post-publication critique at top-ranked journals across scientific disciplines: a cross-sectional assessment of policies and practice. R Soc Open Sci. août 2022;9(8):220139.
5. COPE: Committee on Publication Ethics [Internet]. [cité 17 oct 2023]. COPE: Committee on Publication Ethics. Disponible sur: https://publicationethics.org/
6. Besançon L, Bik E, Heathers J, Meyerowitz-Katz G. Correction of scientific literature: Too little, too late! PLoS Biol. 3 mars 2022;20(3):e3001572.
7. Goldacre B, Drysdale H, Dale A, Milosevic I, Slade E, Hartley P, et al. COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time. Trials. 14 févr 2019;20(1):118.
8. Seife C. Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature. JAMA Intern Med. 1 avr 2015;175(4):567‑77.
9. What we publish on medicines and when | European Medicines Agency [Internet]. [cité 2 juill 2024]. Disponible sur: https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when
10. Transparency | European Medicines Agency [Internet]. [cité 2 juill 2024]. Disponible sur: https://www.ema.europa.eu/en/about-us/how-we-work/transparency
11. Committee for Medicinal Products for Human Use (CHMP) | European Medicines Agency [Internet]. [cité 2 juill 2024]. Disponible sur: https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chm
