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Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

Davies BM, Rikabi S, French A, Pinedo-Villanueva R, Morrey ME, Wartolowska K, Judge A, MacLaren RE, Mathur A, Williams DJ, Wall I, Birchall M, Reeve B, Atala A, Barker RW, Cui Z, Furniss D, Bure K, Snyder EY, Karp JM, Price A, Carr A, Brindley DA - J Tissue Eng (2014)

Bottom Line: We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products.To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption.Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation.

View Article: PubMed Central - PubMed

Affiliation: Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

ABSTRACT
There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

No MeSH data available.


Perceived barriers to clinical development and adoption as identified through pilot questionnaire. Responses are presented as the mean for the whole group and then variation in each speciality’s mean response from the group mean. A higher score represents a greater perceived barrier.
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fig2-2041731414551764: Perceived barriers to clinical development and adoption as identified through pilot questionnaire. Responses are presented as the mean for the whole group and then variation in each speciality’s mean response from the group mean. A higher score represents a greater perceived barrier.

Mentions: Figure 2 shows the mean level for perceived barrier for all respondents and the variation in the mean response for each speciality from the group mean. Higher numbers represent a larger perceived barrier to adoption. The data show that the most concerning barriers to clinicians were cost-effectiveness and efficacy, followed by regulation, reimbursement, and safety. Infrastructure also frequently occurred in the top three responses.


Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

Davies BM, Rikabi S, French A, Pinedo-Villanueva R, Morrey ME, Wartolowska K, Judge A, MacLaren RE, Mathur A, Williams DJ, Wall I, Birchall M, Reeve B, Atala A, Barker RW, Cui Z, Furniss D, Bure K, Snyder EY, Karp JM, Price A, Carr A, Brindley DA - J Tissue Eng (2014)

Perceived barriers to clinical development and adoption as identified through pilot questionnaire. Responses are presented as the mean for the whole group and then variation in each speciality’s mean response from the group mean. A higher score represents a greater perceived barrier.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License 1 - License 2 - License 3
Show All Figures
getmorefigures.php?uid=PMC4221931&req=5

fig2-2041731414551764: Perceived barriers to clinical development and adoption as identified through pilot questionnaire. Responses are presented as the mean for the whole group and then variation in each speciality’s mean response from the group mean. A higher score represents a greater perceived barrier.
Mentions: Figure 2 shows the mean level for perceived barrier for all respondents and the variation in the mean response for each speciality from the group mean. Higher numbers represent a larger perceived barrier to adoption. The data show that the most concerning barriers to clinicians were cost-effectiveness and efficacy, followed by regulation, reimbursement, and safety. Infrastructure also frequently occurred in the top three responses.

Bottom Line: We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products.To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption.Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation.

View Article: PubMed Central - PubMed

Affiliation: Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

ABSTRACT
There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

No MeSH data available.