Published papers and peer reviewed journals

by our active R&D department

BLOGS AND FUTURE PAPERS

Efficient analysis of Dose-Time-Response Assays

This paper describes the use of survival analysis techniques. Significant increase in precision, or reduction in test subjects (usually animals) is possible by using this mathematically efficient analysis.

Yellowlees A, LeButt CS, Hirst KJ, Fusco PC, Fleetwood KJ. Efficient Analysis of Dose—Time—Response Assays. BioScience. 2013 Jun 1;63(6):490-8.

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Bioassay

Parallelism in Practice

This paper examines the common methods used for evaluation of parallelism, and provides a guide to choosing the optimal method taking into account factors such as data available, regulatory environment and expected data variability. A flow chart guide is included.

Fleetwood K, Bursa F, Yellowlees A. Parallelism in Practice: Approaches to Parallelism in Bioassays. PDA Journal of Pharmaceutical Science and Technology. 2015 Mar 1;69(2):248-63.

PRE PUBLICATIONPUBLICATION

Statistical approaches for reporting potency of Biosimilars

This poster reports on research work examining the particular problem of the non-parallel dose response curves that may be seen in biosimilars.

Fleetwood K, Bursa F, Yellowlees A, Upsall A. Statistical approaches for reporting potency of Biosimilars. BioPharmaceutical Emerging Best Practices Association Conference Presented 2015 Sep

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Increasing the potency of an alhydrogel-formulated anthrax vaccine by minimizing antigen-adjuvant interactions

This paper examines the role of a phosphate buffer in the potency of an anthrax vaccine. 

Watkinson, A., Soliakov, A., Ganesan, A., Hirst, K., Lebutt, C., Fleetwood, K., Fusco, P. C., Fuerst, T. R., Lakey, J. H. Increasing the Potency of an Alhydrogel-formulated Anthrax Vaccine by Minimizing Antigen-adjuvant Interactions. Clinical and Vaccine Immunology . 2013 NOV;20(11):1659-1668.

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Health Technology Assessment

Systematic review and meta-analysis: the effects of fermented milk with Bifidobacterium lactis CNCM I-2494 and lactic acid bacteria on gastrointestinal discomfort in the general adult population

This paper uses a systematic review and meta-analysis to identify and use existing medical data to compare outcomes of gastrointestinal discomfort in healthy adult populations between those who consumed probiotic fermented milk products containing B. lactis and those who did not.

 

Gibson P, Whorwell P, Kellow J, Yellowlees A, Perry R H J, Edwards M, King S, Wood H, Glanville J. Systematic review and meta-analysis: the effects of fermented milk with Bifidobacterium lactis CNCM I-2494 and lactic acid bacteria on gastrointestinal discomfort in the general adult population.  Thereputic Advances in Gastroenterology. 2017 10(1)74-88. DOI:10.1177/1756283X16670075.

View at PubMed Central

A Review of the Use of Network Meta-Analysis in NICE Single Technology Appraisals

A podium presentation at the ISPOR 19th Annual European Congress, 2016.

Fleetwood K , Glanville J , McCool R , Wood H , Wilson K , Marshall C , Yellowlees A , James D, Toupin S , McCabe R ,

A Review of the Use of Network Meta-Analysis in Nice Single Technology Appraisals. A podium presentation at the ISPOR 19th Annual European Congress, 2016. (Vienna)

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Comparative assessment of onabotulinumtoxinA and mirabegron for overactive bladder: an indirect treatment comparison

In the absence of head-to-head data, network meta-analysis provides the best available evidence to allow for informed decisions between different treatments. The objective of this study was to evaluate the relative clinical efficacy of the licensed dose of onabotulinumtoxinA (100 U) compared with mirabegron (25 and 50 mg) in adults with overactive bladder via a network meta-analysis.

Freemantle N, Ginsberg DA, McCool R, Fleetwood K, Arber M, Khalaf K, Loveman C, Ni Q and Glanville J. Comparative assessment of onabotulinumtoxinA and mirabegron for overactive bladder: an indirect treatment comparison. BMJ Open 2016; 6:e009122. doi: 10.1136/bmjopen-2015- 009122.

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The principles of indirect and mixed treatment comparisons

Presentation given on YHEC training event.

A, Fleetwood. The principles of indirect and mixed treatment comparisons. A  presentation given on the YHEC Indirect and Mixed Treatment Comparisons training events, 2015. 

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Systematic Review and Network Meta-analysis of Tedizolid for the Treatment of Acute Bacterial Skin And Skin Structure Infections (ABSSSI) due to Methicillin-Resistant Staphylococcus aureus (MRSA)

This network analysis was conducted to compare the effectiveness of tedizolid with other antibacterials approved for treating MRSA-associated ABSSSI. 

Rachael McCool, Jacqui Eales, Teresa Barata, Mick Arber, Maria Cikalo, Kelly Fleetwood, Julie Glanville, Ian Gould, Teresa L. Kauf.  Systematic Review and Network   Meta-analysis of Tedizolid for the Treatment of Acute Bacterial Skin And Skin Structure Infections (ABSSSI) due to Methicillin-Resistant Staphylococcus aureus (MRSA).  Value in Health.  2015;18(3):A231

 Rachael McCool, Jacqui Eales, Teresa Barata, Mick Arber, Maria Cikalo, Kelly Fleetwood, Julie Glanville, Ian Gould, Teresa L. Kauf.  Systematic Review and Network Meta-analysis of Tedizolid for the Treatment of Acute Bacterial Skin And Skin Structure Infections (ABSSSI) due to Methicillin-Resistant Staphylococcus aureus (MRSA). Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 20th Annual International Meeting, 2015. Marriott Hotel, Philadelphia Pennsylvania. 

PAPERPOSTER

What is Indirect Comparison?

An overview of indirect comparisons written as part of the Health Technology Assessment’s ‘What is…?’ series. 

Kelly Fleetwood,  Ann Yellowlees.  What is Indirect Comparison?  Health Technology Assessment  2014

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The MAGEC System for Spinal Lengthening in Children with Scoliosis: A NICE Medical Technology Guidance

This analysis reviews clinical evidence of the efficacy of the MAGEC spinal rod implant for the treatment of scoliosis in children as a means of evaluating the system according to the NICE medical technologies guidance to establish comparative cost modelling.

 Jenks M, Willits I, Craig J, Barata T, Kimpton C, Higgins J, Wood H, Sims A.  The MAGEC system for spinal lengthening in children with scoliosis: A NICE Medical Technology Guidance.  Applied Health Economics and Health Policy. 2014 12(6):587-599. DOI 10.1007/s40258-014-0127-4

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Systematic review and meta-analysis of the additional benefit of local prophylactic antibiotic therapy for infection rates in open tibia fractures treated with intramedullary nailing

This analysis compared the rate of deep wound infections in patients with open tibia fractures, treated with intramedullary nails, receiving additional locally-delivered antibiotics to those receiving standard care

Craig J, Fuchs T, Jenks M, Fleetwood K, Franz D, Iff J, Raschke M. Systematic review and meta-analysis of the additional benefit of local prophylactic antibiotic therapy for infection rates in open tibia fractures treated with intramedullary nailing. International Orthopaedics. 2014 May 1; 38(5):1025-30. 

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Comparative efficacy of everolimus plus exemestane versus fulvestrant for hormone-receptor-positive advanced breast cancer following progression/recurrence after endocrine therapy: a network meta-analysis

This network analysis was conducted to compare the efficacy of everolimus plus exemestane versus fulvestrant in patients with advanced breast cancer who are eligible for further endocrine therapies.

Bachelot T, McCool R, Duffy S, Glanville J, Varley D, Fleetwood K, Zhang J, Jerusalem G. Comparative efficacy of everolimus plus exemestane versus fulvestrant for hormone-receptor-positive advanced breast cancer following progression/recurrence after endocrine therapy: a network meta-analysis. Breast Cancer Research and Treatment. 2014 Jan 1; 143(1):125-33.

Chandiwana D, Vieira J, Bains M, Heaton1, Jie Zhang J, Glanville J, McCool R, Fleetwood K. An indirect treatment comparison of the efficacy of Everolimus (Afinitor®) and Fulvestrant for the treatment of hormone receptor positive (HR+) HER2 negative (HER2–) advanced or metastatic breast cancer. Poster presented at the International Society For Pharmacoeconomics and Outcomes Research 16th Annual European Congress, 2013. The Convention Centre (Dublin)

PAPERPOSTER

Clinical

Multiple imputation presentation

One of the approaches to dealing with missing data is multiple-imputation. For a short introduction to what it is and how it works read our presentation.

Bursa F. Internal Quantics presentation. 2014 Mar

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A randomised trial of secondary prophylaxis using granulocyte colony-stimulating factor (‘SPROG’ trial) for maintaining dose intensity of standard adjuvant chemotherapy for breast cancer by the Anglo-Celtic Cooperative Group and NCRN

This paper describes a randomised clinical trial comparing dose intensity outcomes for two granulocyte colony-stimulating factor treatments used in breast cancer treatment.

Leonard R C, Mansi J L, Keerie C, Yellowlees A, Crawford S, Benstead K, Matthew R, Adamson D, Chan S, Grieve R,  Anglo-Celtic Collaborative Oncology Group.  A randomised trial of secondary prophylaxis using granulocyte colony-stimulating factor (‘SPROG’ trial) for maintaining dose intensity of standard adjuvant chemotherapy for breast cancer by the Anglo-Celtic Cooperative Group and NCRN.  Annals of Oncology. 1 December 2015; 26(12): 2437–2441.  DOI: 10.1093/annonc/mdv389

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A Prognostic Index for Operable, Node-negative Breast Cancer

This report uses clinical data and outcomes from breast cancer cases to create a predictive index. It then applies the index to an independent set of cases to test predictive abilities.

McCallum M, Baker C, Gillespie K, Cohen B, Stewart H, Leonard R, Cameron D, Leake R, Paxton J, Robertson A, Purdie C, Gould A, Steel M.  A prognostic index for operable, node-negative breast cancer. British Journal of Cancer. 2004 May 17. 90(10):1933-1941. DOI 10.1038/sj.bjc.6601826.

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