Assessing knowledge, attitude, and practice of adaptive designs in clinical trials among Indian stakeholders
DOI:
https://doi.org/10.18203/2320-6012.ijrms20250688Keywords:
Adaptive clinical trials, Perspective, Questionnaire, SurveyAbstract
Background: This study attempted to evaluate the knowledge, attitude and practices of various stakeholders addressing adaptive clinical trials (ACT), as no analogous studies have been published in India.
Methods: Ethics committee (EC) approval was sought before circulating an online pre-validated questionnaire (28 questions in three domains) among 200 stakeholders involving the clinicians, clinical trial unit personnel, and medical advisors from various pharmaceutical industries. The responses collected were analysed using appropriate statistical tests. A p value <0.05 was considered significant.
Results: Out of the 200 participants surveyed, 169 responded, yielding a response rate of 84.5%. When the three distinct stakeholders’ median knowledge scores were evaluated, there was no statistically significant difference. The median knowledge score of stakeholders with more than five years of experience did not vary statistically from those with less than five years. In the attitude domain, 21.8% and 17.1% of participants agreed that the validity and integrity of research in ACT are hampered respectively. However, 73.9% felt that ACT has potential benefits while 79.2% believed they were underutilized. In the practice domain, only 4.7% of stakeholders have been a part of adaptive clinical trials.
Conclusions: The study found that fewer stakeholders participated in studies utilizing adaptive designs, which resulted in a decrease in knowledge, perception, and practices among the various stakeholders. This emphasizes the necessity for further educational initiatives in the future, such as planning conferences or training sessions, to raise the understanding of adaptable designs in clinical trials.
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References
Chow SC, Chang M, Pong A. Statistical consideration of adaptive methods in clinical development. J Biopharm Stat. 2005;15:575-91. DOI: https://doi.org/10.1081/BIP-200062277
Meurer WJ, Lewis RJ, Tagle D, Fetters MD, Legocki L. An overview of the adaptive designs accelerating promising trials into treatments (ADAPT-IT) project. Ann Emerg Med. 2012;60:451-7. DOI: https://doi.org/10.1016/j.annemergmed.2012.01.020
Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, et al. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med. 2018;16(1):29. DOI: https://doi.org/10.1186/s12916-018-1017-7
Mahajan R, Gupta K. Adaptive design clinical trials: Methodology, challenges, and prospect. Indian J Pharmacol. 2010;42(4):201. DOI: https://doi.org/10.4103/0253-7613.68417
Van Norman GA. Phase II trials in drug development and adaptive trial design. JACC Basic Translat Sci. 2019;4(3):428-37. DOI: https://doi.org/10.1016/j.jacbts.2019.02.005
Dimairo M, Boote J, Julious SA, Nicholl JP, Todd S. Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials. Trials. 2015;16(1):430. DOI: https://doi.org/10.1186/s13063-015-0958-9
Dimairo M, Julious SA, Todd S, Nicholl JP, Boote J. Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns, and facilitators to the appropriate use of adaptive designs in confirmatory trials. Trials. 2015;16(1):1-3. DOI: https://doi.org/10.1186/s13063-015-1119-x
Morgan CC, Huyck S, Jenkins M, Chen L, Bedding A, Coffey CS, et al. Adaptive design: results of 2012 survey on perception and use. Ther Innov Regulat Sci. 2014;48(4):473-81 DOI: https://doi.org/10.1177/2168479014522468
Hatfield I, Allison A, Flight L, Julious SA, Dimairo M. Adaptive designs undertaken in clinical research: a review of registered clinical trials. Trials. 2016;17(1):150. DOI: https://doi.org/10.1186/s13063-016-1273-9
Legocki L, Meurer W, Frederiksen S, Lewis R, Durkalski V, Berry D, et al. Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis. BMC Med Ethics. 2015;16(1):27. DOI: https://doi.org/10.1186/s12910-015-0022-z
Lorch U, Berelowitz K, Ozen C, Naseem A, Akuffo E, Taubel J. The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings. Eur J Clin Pharmacol. 2012;68:543-51. DOI: https://doi.org/10.1007/s00228-011-1176-3
Hartford A, Thomann M, Chen X, Miller E, Bedding A, Jorgens S, et al. Adaptive designs: Results of 2016 survey on perception and use. Ther Innov Regulat Sci. 2020;54(1):42-54. DOI: https://doi.org/10.1007/s43441-019-00028-y
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