4. Kretser A, Murphy D, Bertuzzi S, Abraham T, Allison DB, Boor KJ, et
al. Scientific Integrity Principles and Best Practices: Recommendations
from a Scientific Integrity Consortium. Sci Eng Ethics. 2019 Apr
15;25(2):327–55.
5. Di Renzo G C, Tosto V T V. The island of research (one rule): do not
block the path of enquiry. In: Di Renzo G C Ed, editor. Essential
Writing, Communication and Narrative Skills for Medical Scientists
Before and After the COVID Era. Springer Nature, Basel; 2022. p. 1–17.
6. Departmental policy to guide integrity of science and scientific
products.
7. European Network of Research Integrity Offices (ENRIO)
[Internet]. [cited 2022 Jan 17]. Available from:
http://www.enrio.eu/
8. World Conferences on Research Integrity Foundation (WCRIF)
[Internet]. [cited 2022 Jan 17]. Available from:
https://wcrif.org/
9. COPE: Committee on Publication Ethics | Promoting integrity
in scholarly research and its publication [Internet]. [cited 2022
Jan 17]. Available from: https://publicationethics.org/
10. Bauchner H, Golub RM, Fontanarosa PB. Reporting and Interpretation
of Randomized Clinical Trials. JAMA. 2019 Aug 27;322(8):732–5.
11. Hariton E, Locascio JJ. Randomised controlled trials – the gold
standard for effectiveness research: Study design: randomised controlled
trials. Vol. 125, BJOG: An International Journal of Obstetrics and
Gynaecology. NIH Public Access; 2018. p. 1716.
12. de Vrieze J. Large survey finds questionable research practices are
common. Science (80- ). 2021;373(6552):265.
13. Gopalakrishna G, ter Riet G, Vink G, Stoop I, Wicherts JM, Bouter
LM. Prevalence of questionable research practices, research misconduct
and their potential explanatory factors: A survey among academic
researchers in the Netherlands. PLoS One. 2022;17(2 February).
14. Steen RG, Casadevall A, Fang FC. Why Has the Number of Scientific
Retractions Increased? PLoS One. 2013 Jul 8;8(7).
15. Resnik DB, Stewart CN. Misconduct versus honest error and scientific
disagreement. Account Res. 2012 Jan;19(1):56–63.
16. Bolland MJ, Avenell A, Gamble GD, Grey A. Systematic review and
statistical analysis of the integrity of 33 randomized controlled
trials. Neurology. 2016;87(23):2391–402.
17. Guraya SY, Norman RI, Khoshhal KI, Guraya SS, Forgione A. Publish or
perish mantra in the medical field: A systematic review of the reasons,
consequences and remedies. Pakistan J Med Sci. 2016;32(6):1562–7.
18. Djurisic S, Rath A, Gaber S, Garattini S, Bertele V, Ngwabyt SN, et
al. Barriers to the conduct of randomised clinical trials within all
disease areas. Trials. 2017 Aug 1;18(1).
19. International Council for Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use (ICH): Official web site
[Internet]. [cited 2022 Jan 17]. Available from:
https://www.ich.org/
20. Núñez-Núñez M, Maes-Carballo M, Mignini LE, Chien PF, Khalaf Y,
Fawzy M, Zamora J, Khan KS B-CA. Research integrity in clinical trials:
an umbrella review. BJOG. 2022;
21. Jandhyala R. Delphi, non-RAND modified Delphi, RAND/UCLA
appropriateness method and a novel group awareness and consensus
methodology for consensus measurement: a systematic literature review.
Curr Med Res Opin. 2020;36(11):1873–87.
22. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi
survey technique. J Adv Nurs. 2000;32(4):1008–15.
23. Fitch K, Bernstein SJ, Mcdonnell J, Kahan JP. The RAND / UCLA
Appropriateness Method User ’ s Manual Appropriateness Method User ’ s
Manual Approved for Public Release Approved for Public Release.
Transformation. 2001. 109 p.
24. Gracht HA Von Der. Technological Forecasting & Social Change
Consensus measurement in Delphi studies Review and implications for
future quality assurance. Technol Forecast Soc Chang.
2012;79(8):1525–36.
25. Cottam H-R, Roe M, Challacombe J, Roe M. Outsourcing of trucking
activities by relief organisations. 2004;(January):1–26.
26. Shea BJ, Reeves BC, Wells G, Thuku1 M, Hamel C, Moran J, et al.
AMSTAR 2: a critical appraisal tool for systematic reviews that include
randomised or non-randomised studies of healthcare interventions, or
both. BMJ. 2017;358:4008.
27. Houghton C, Dowling M, Meskell P, Hunter A, Gardner H, Conway A, et
al. Factors that impact on recruitment to randomised trials in health
care: a qualitative evidence synthesis. 2020;
28. Natale P, Saglimbene V, Ruospo M, Gonzalez AM, Strippoli GF,
Scholes-Robertson N, et al. Transparency, trust and minimizing burden to
increase recruitment and recruitment in trials: A systematic review. J
Clin Epidemiol. 2021;134:35–51.
29. Paramasivan S, Davies P, Richards A, Wade J, Rooshenas L, Mills N,
et al. What empirical research has been undertaken on the ethics of
clinical research in India? A systematic scoping review and narrative
synthesis. BMJ Glob Heal. 2021;6(5):1–19.
30. Staniszewska S, Brett J, Simera I, Seers K, Mockford C, Goodlad S,
et al. GRIPP2 reporting checklists: Tools to improve reporting of
patient and public involvement in research. Res Involv Engagem.
2017;3(1).
31. Marusic A, Wager E, Utrobicic A, Sambunjak D, Anderson MS, Rothstein
HR. Interventions to prevent misconduct and promote integrity in
research and publication. Cochrane Database Syst Rev. 2013;2013(2).
32. Kretser A, Murphy D, Bertuzzi S, Abraham T, Allison DB, Boor KJ, et
al. Scientific Integrity Principles and Best Practices: Recommendations
from a Scientific Integrity Consortium. Sci Eng Ethics. 2019
Apr;25(2):327–55.
33. Khan KS. Integrity culture is underpinned by education, not
post-submission dishonesty assessments. Reprod Biomed Online.
2022;00(0):6483.
34. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of
health research reporting guidelines. PLoS Med. 2010;7(2).
35. FDA guidance: Multiple Endpoints in Clinical Trials. Guidance for
Industry. Jan 2017. FDA-2016-D-4460. Issued by the Center for Drug
Evaluation and Research.
36. EMA guidance: POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL
TRIALS, Sep 2002, CPMP/EWP/908/99, Issued by the Committee for
proprietary medicinal products (CMPM.
37. Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H,
Diéras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY,
Funke R, Husain A, Winer EP, Loi S ELImTI. Atezolizumab and
Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med.
2018;379(22):2108–21.
38. Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED,
Kopyltsov E, Park CH, Alekseev B, Montesa-Pino Á, Ye D, Parnis F, Cruz
F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Méndez-Vidal MJ,
Maughan BL, Joensuu H, Thiele S, Li R, Kuss I TBATI. Darolutamide and
Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med.
2022;386(12):1132–42.
39. Fizazi K, Foulon S, Carles J, Roubaud G, McDermott R, Fléchon A,
Tombal B, Supiot S, Berthold D, Ronchin P, Kacso G, Gravis G, Calabro F,
Berdah JF, Hasbini A, Silva M, Thiery-Vuillemin A, Latorzeff I, Mourey
L, Laguerre B, Abadie-Lacourtoisie S, Martin E BAP-1 investigators.
Abiraterone plus prednisone added to androgen deprivation therapy and
docetaxel in de novo metastatic castration-sensitive prostate cancer
(PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2
× 2 factorial design. Lancet (London, England).
2022;399(10336):1695–707.
40. Qaseem A, Forland F, Macbeth F, Ollenschläger G, Phillips S van der
WP. Guidelines International Network: toward international standards for
clinical practice guidelines. Ann Intern Med. 2012;156(7):525–31.
41. García-Martín M, Amezcua-Prieto C, H Al Wattar B, Jørgensen JS,
Bueno-Cavanillas A, Khan KS. Patient and public involvement in sexual
and reproductive health: Time to properly integrate citizen’s input into
science. Vol. 17, International Journal of Environmental Research and
Public Health. 2020. p. 1–12.
42. Moss N, Daru J, Lanz D, Thangaratinam S, Khan KS. Involving pregnant
women, mothers and members of the public to improve the quality of
women’s health research. Vol. 124, BJOG: An International Journal of
Obstetrics and Gynaecology. 2017. p. 362–5.
43. Macleod M. Want research integrity? Stop the blame game. Nature.
2021;599(7886):533.
44. Nolan TW. System changes to improve patient safety. Br Med J.
2000;320(7237):771–3.
45. Malički M, Jerončić A, Aalbersberg IjJ, Bouter L, ter Riet G.
Systematic review and meta-analyses of studies analysing instructions to
authors from 1987 to 2017. Vol. 12, Nature Communications. 2021.
46. Malički M, Jerončić A, Aalbersberg IjJ, Bouter L, ter Riet G.
Systematic review and meta-analyses of studies analysing instructions to
authors from 1987 to 2017. Vol. 12, Nature Communications. 2021.
47. Goldstein CE, Weijer C, Brehaut JC, Fergusson DA, Grimshaw JM, Horn
AR, et al. Ethical issues in pragmatic randomized controlled trials: A
review of the recent literature identifies gaps in ethical
argumentation. BMC Med Ethics. 2018;19(1):1–10.
48. Schellings R, Kessels AG, ter Riet G, Knottnerus JA, Sturmans F.
Randomized consent designs in randomized controlled trials: Systematic
literature search. Contemp Clin Trials. 2006;27(4):320–32.
49. Darmon M, Helms J, De Jong A, Hjortrup PB, Weiss E, Granholm A, et
al. Time trends in the reporting of conflicts of interest, funding and
affiliation with industry in intensive care research: a systematic
review. Intensive Care Med. 2018;44(10):1669–78.
50. Bekelman JE, Gross CP. Scope and impact of financial conflicts of
interest in biomedical research: A systematic review. JAMA - J Am Med
Assoc. 2003;289(4):454–65.
51. International Committee of Medical Journal Editors’ (ICMJE)
[Internet]. Available from:
http://www.icmje.org/disclosure-of-interest/
52. Fanelli D. Why Growing Retractions Are (Mostly) a Good Sign. PLOS
Med. 2013;10(12):e1001563.
53. Hartgerink C, Voelkel J WJ. Detection of data fabrication using
statistical tools. PsyArXiv. 2019;1–50.
54. Lewandowsky S, Bishop D. Research integrity: Don’t let transparency
damage science. Nature. 2016;529(7587):459–61.
55. Khan KS. ‘Flawed use of post publication data fabrication tests”.
Research misconduct tests: putting patients’ interests first”.’ J Clin
Epidemiol. 2021;138(xxxx):227.
56. Khan KS. Assessing Research Misconduct in Randomized. Obstet
Gynecol. 2021;138(6):944.
57. Allen L, O’Connell A K, V. How can we ensure visibility and
diversity in research contributions? How the Contributor Role Taxonomy
(CRediT) is helping the shift from authorship to contributorship. Learn
Publ. 2019;32(1):71–4.