ASSIGNMENT 1

Article Review-SLR

Management
Mr Abhishek M Wandakar
Research Methods
 IFIM School of Management

MBA-II SEMESTER
MANAGEMENT RESEARCH METHODS

Assignment on
ARTICLE REVIEW- SLR

PREPARED BY
Mr Abhishek M Wandakar

SUBMITTED TO
Dr Syed Ahamed S
Faculty- Management Research Methods

Submission Date: 01.08.2024

IFIM COLLEGE, ELECTRONIC CITY, BANGALORE

 1. DiMasi, J.A., Grabowski, H.G., Hansen, R.W. (2016). "Innovation in the
pharmaceutical industry: New estimates of R&D costs
Parameters Details
Record No 1
Authors DiMasi, J.A., Grabowski, H.G., Hansen, R.W.
Innovation in the pharmaceutical industry: New
Title
estimates of R&D costs
Year 2016
Volume No 47
Issue No 2
Journal Name Journal of Health Economics
Paper Type Empirical
Author
Tufts Center for the Study of Drug Development
Affiliations
Pharmaceutical R&D, Drug development costs,
Author keywords
Innovation
To provide updated estimates of the costs of drug
Focus/Objectives
development, including the cost of failures.
Previous estimates are outdated and may not
Research Gap
reflect current costs.
Research
What are the current costs of drug development?
Questions
Type of
Quantitative
Research
Research
Deductive
Approach
Secondary,(source -Tufts Center for the Study of
Data
Drug Development (CSDD)database)
Research
Cost analysis, Statistical modeling
Methods
Sampling
Stratified random sample
Techniques
Sample size 1442 compounds
Cost components, Success rates, Development
Factors
time
Data Analysis Statistical analysis, Cost adjustment
Finding Updated estimates show increased R&D costs.
Future Agenda Further research on reducing R&D costs.
 2. Wouters, O.J., McKee, M., Luyten, J. (2020). "Estimated Research and
Development Investment Needed to Bring a New Medicine to Market,
2009-2018."

Parameters Details
Record No 2
Authors Wouters, O.J., McKee, M., Luyten, J.
Estimated Research and Development Investment
Title Needed to Bring a New Medicine to Market, 2009-
2018
Year 2020
Volume No 323
Issue No 10
Journal Name JAMA
Paper Type Empirical

Author Affiliations London School of Economics and Political Science

Author keywords R&D investment, New medicine, Systematic review

To systematically review and analyze the
Focus/Objectives investment needed to bring a new medicine to
market.
Lack of comprehensive, updated analysis of R&D
Research Gap
investments.
How much investment is needed to bring a new
Research Questions
medicine to market?
Type of Research Quantitative

Research Approach Deductive

Data Secondary, (FDA approved compounds)

Research Methods Meta-analysis, Systematic review

Sampling
Whole population
Techniques
Sample size 63 Compounds
Investment amounts, Success rates, Development
Factors
time
Data Analysis Meta-analysis, Cost estimation
Finding Significant investment needed for new medicines.
Future Agenda Improving accuracy of cost estimations.
 3. (Årdal et al., 2018). " Insights into early stage of antibiotic development in
small- and medium-sized enterprises: a survey of targets, costs, and
durations."
Parameters Details
Record No 1
Christine Årdal, Enrico Baraldi, Ursula Theuretzbacher, Kevin
Authors
Outterson, Jens Plahte, Francesco Ciabuschi, John-Arne Røttingen

Insights into early stage of antibiotic development in small- and

Title
medium-sized enterprises: a survey of targets, costs, and durations
Year 2018
Volume No 11
Issue No 1
Journal Name Journal of Pharmaceutical Policy and Practice
Paper Type Research Article

Norwegian Institute of Public Health, Uppsala University, Center for

Author Affiliations Anti-Infective Agents, Boston University, Norwegian Institute of Public
Health, Uppsala University, Norwegian Institute of Public Health

Antimicrobial innovation, Antibacterial innovation, DRIVE-AB,

Author keywords
Pharmaceutical research and development
To gather a better understanding of SMEs’ targets, costs, and
Focus/Objectives durations related to discovery and early phase development of
antibacterial therapies
Lack of understanding of actual antibiotic discovery and development
Research Gap
costs and timelines in SMEs

What are the targets, costs, and durations related to discovery and
Research Questions
early phase development of antibacterial therapies in SMEs?
Type of Research Empirical
Research Approach Quantitative and Qualitative
Research Methods Survey
Sampling
Convenience sampling
Techniques
Sample size 25
Factors Targets, Costs, Durations
Data Analysis Descriptive statistics
SMEs have variable costs and durations for antibiotic R&D; costs are
Finding
generally less than large pharmaceutical companies

Design incentives to stimulate antibacterial innovation considering the

Future Agenda
unique characteristics of each antibiotic project
Data type Quantitative and Qualitative
Data source Survey responses from SMEs
Data collection type Survey
Primary/Secondary
Primary
Data
 4. Morgan, S., Grootendorst, P., Lexchin, J., Cunningham, C., Greyson,
D. (2011). "The cost of drug development: A systematic review."
Parameters Details
Record No 4
Morgan, S., Grootendorst, P., Lexchin, J.,
Authors
Cunningham, C., Greyson, D.
The cost of drug development: A systematic
Title
review
Year 2011
Volume No 22
Issue No 2
Journal Name PharmacoEconomics
Paper Type Systematic Review
Author
University of British Columbia
Affiliations
Drug development costs, Systematic review,
Author keywords
Meta-analysis
To compile data from multiple studies to provide
Focus/Objectives
an overview of drug development costs.
Variability and inconsistency in existing cost
Research Gap
estimates.
Research
What are the true costs of drug development?
Questions
Type of
Mixed-method
Research
Research
Inductive
Approach
Research
Systematic review, Meta-analysis
Methods
Data Secondary, (FDA approved compounds)
Sampling
Systematic sampling
Techniques
Sample size 22 studies
Factors Cost estimates, Methodologies, Success rates
Data Analysis Meta-analysis, Cost comparison
Finding Wide variability in cost estimates.
Future Agenda Standardizing cost estimation methodologies.
 5. Kavisha Jayasundara, Aidan Hollis, Murray Krahn, Muhammad
Mamdani, Jeffrey S. Hoch, Paul Grootendorst (2019). "Estimating the
clinical cost of drug development for orphan versus non-orphan drugs."
Parameters Details
Record No 5
Kavisha Jayasundara, Aidan Hollis, Murray Krahn,
Authors Muhammad Mamdani, Jeffrey S. Hoch, Paul
Grootendorst
Estimating the clinical cost of drug development for
Title
orphan versus non-orphan drugs
Year 2019
Volume No 14
Issue No 12
Journal Name Orphanet Journal of Rare Diseases
Paper Type Research Open Access
Author Leslie Dan Faculty of Pharmacy, University of Toronto,
Affiliations others
Author
Cost of drug development, Orphan drugs, Rare diseases
Keywords
To estimate the differences in trial characteristics and
Focus/Objectives clinical development costs for orphan and non-orphan
drugs using publicly available data
Research Gap Sparse estimates of orphan drug development costs
Research What are the differences in clinical development costs
Questions between orphan and non-orphan drugs?
Type of
Quantitative Research
Research
Research
Comparative analysis
Approach
Research Data collection from public databases, statistical
Methods analysis
Sampling
Simple Random
Techniques
Sample Size if
200 orphan and non-orphan drugs
any
Factors Costs, trial characteristics
Data Analysis Statistical analysis
The out-of-pocket clinical costs per approved orphan
Findings drug were found to be lower than those for non-orphan
drugs
Discussion on aligning cost components in R&D costs
Future Agenda
for pharmaceuticals
Data Type Quantitative
Source of Data Public databases
Data collection
Secondary
type
 References

1. (DiMasi, Grabowski and Hansen, 2016) Innovation in the pharmaceutical

industry: New estimates of R&D costs
2. (Wouters, McKee and Luyten, 2020) Estimated Research and
Development Investment Needed to Bring a New Medicine to Market,
2009-2018.
3. (Årdal et al., 2018). " Insights into early stage of antibiotic development in
small- and medium-sized enterprises: a survey of targets, costs, and
durations."
4. (Morgan et al., 2011) "The cost of drug development: A systematic review."
By Morgan, S., Grootendorst, P., Lexchin, J., Cunningham, C., Greyson,
D.
5. (Jayasundara et al., 2019)Estimating the clinical cost of drug development
for orphan versus non-orphan drugs.

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