Useful Advices - Business

A recent study (Rothwell, P.M. and Martyn, C.N. Reproducibility of peer review in clinical neuroscience: Is agreement between reviewers any greater than would be expected by chance alone? Brain 2000 123:1964–1969) me

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

asured the level of agreement between reviewers of manuscripts submitted for publication in a scientific journal. These reviewers are usually professors in universities with extensive expertise in the subject of the

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

reviewed manuscript.

The editor of the journal asked the professors two questions: 1. should the manuscript be accepted, revised, or rejected, and 2. is the priority for publication low, medium, or high. Every man

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

script was evaluated by two professors. The study was repeated with manuscripts submitted to two journals. In journal A the study compared the evaluations of 179 papers and in journal B the evaluations of 116 manus

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

cripts. The agreement between the professors was calculated using the k statistic.

The results showed no agreement between the reviewers regarding both the recommendation and priority for publication. In f

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ct, the level of agreement was no greater than which would produced by flipping a coin. Moreover, when a larger number of independent reviewers evaluated the same manuscript, the results were the same, no

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

agreement. As the author of the study write "if peer review is an attempt to measure the overall quality of research in terms of originality, the appropriateness of the methods used, analysis of data, and justif

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ication of the conclusions, then a complete lack of reproducibility is a problem.

These specific assessments should be relatively objective and hence reproducible." The assessments should be reproducible, but they

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

re not. When one professor said "accept for publication," the other said "reject," when one reviewer said "high priority for publication," the other said "low priority."

Points to consider:

1. The first stage of m

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ost decisions is gathering data. For instance, prior to making a marketing decision, researchers conduct focus groups, perform in-depth interviews, or use open-ended questions in surveys to ask customers for their o

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

inion. Before hiring a new employee, human resource managers conduct interviews with candidates to gather information about their background and proficiencies. Before making an investment, investors collect data ab

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

out their target companies. In all these cases, and many others, the information is captured in the form of words. In this study the professors analyzed the words in the manuscripts. In light of the professors fai

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

led analysis, should you believe your analysts' interpretation of their data?

2. In this study, the analysts were professors who were selected for their expertise in the subject of the manuscript. These professors p

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ssess a much higher level of expertise in the research subject relative to even the most experienced moderators and interviewers analyzing qualitative customer data, the most experienced human resource managers analy

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

zing candidate data, or the most schooled investment analysts. So, if these highly trained experts failed to show consistent processing of qualitative data, what are the chances that the less trained professionals (

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

nd layman) will show consistent analysis of their data?

3. The criteria in this study were whether the research reported in the manuscript is original, uses appropriate methods, correctly analyzes the data, and prop

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

erly justifies the conclusions. As the authors of the study say, these criteria are regarded relatively objective. Unlike this study, the great majority of qualitative studies involve subjective crite

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ria such as tastes, morals, values, or preferences. If the professors failed to consistently apply objective criteria when evaluating the manuscripts, how can the less trained professionals (and layman) be trusted t

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

consistently apply subjective criteria when evaluating qualitative data?

4. In this study, pairs of professors assigned different values to the same manuscript. Who is right? After all this is science and both ca

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

nnot be right. Now, if such great experts failed to convince us that they can process a qualitative dataset correctly, or at least consistently, how can we trust professionals (or layman) when they say that they can

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Useful Advices - Fire Your Analyst (Part II)

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