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Main Subject - Fire Your Analyst (Part III)
A study (Baxt WG, Waeckerle JF, Berlin JA, Callaham ML. Who reviews the reviewers? Feasibility of using a fictitious manuscript to evaluate peer reviewer performance. Ann Emerg Med. 1998 Sep;32(3 Pt 1):310-7) introduced 10 major and 13 minor errors in a fictitious scientific manuscript. The manus
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
cript was sent to all reviewers of the Annals of Emergency Medicine, the official publication of the American College of Emergency Physicians. The Annals has been in print for more than 25 years, and is the most widely read journal in emergency medicine. The work described in the manuscript was
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
a standard double-blind, placebo control study of the effect of the propranolol drug on migraine headaches. The manuscript was reviewed by 203 reviewers. Eighty percent of the reviewers were professors at academic emergency medicine departments, and twenty percent were physicians in private prac
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tice.
The analysis of the reviewers' comments produced the following results. Fifteen reviewers recommended publication. The reviewers in this group missed 82.7% of the major errors and 88.2% of the minor errors. Sixty seven reviewers recommended revisions. The reviewers in this group mi
The analysis of the reviewers' comments produced the following results. Fifteen reviewers recommended publication. The reviewers in this group missed 82.7% of the major errors and 88.2% of the minor errors. Sixty seven reviewers recommended revisions. The reviewers in this group mi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ssed 70.4% of the major errors and 78.0% of the minor errors. One hundred and seventeen reviewers recommended rejection. The reviewers in this group missed 60.9% of the major errors and 74.8% of the minor errors.
According to these results, the 15 professors who recommended publication, on avera
According to these results, the 15 professors who recommended publication, on avera
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ge, missed 82.7% of the major errors, and 88.2% of the minor errors. In other words, the professors missed at least 4 out of 5 errors inserted in the manuscript. These errors were defined by the authors as "nonremediable errors that invalidated or markedly weakened the conclusions of the
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
study." It is interesting to note that one of the minor errors included in the manuscript was a misspelling of the drug's name. Out of the 203 reviewers, 30 were convinced in the correctness of the misspelled name and used it throughout their interview. The authors of the study said about the r
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
esults (with the usual scientific undertone): "the small number of errors identified by the reviewers in this study was surprising. The major errors placed in the manuscript invalidated or undermined each of the major methodologic steps of the study … The identification of even a fraction of t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hese errors should have indicated that the study was unsalvageable, yet the reviewers identified only 34% of these errors, and only 59% of the reviewers rejected the work."
Points to consider:
1. In this study, the reviewers were professors and private practice physicians with an average of
Points to consider:
1. In this study, the reviewers were professors and private practice physicians with an average of
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
3 years experience as reviewers for the Annals and additional years of experience reviewing scientific manuscripts for 2 other scientific journals, and with 10 years of experience practicing emergency medicine. These reviewers possess a much higher level of expertise in the subject of the tested
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
anuscript relative to even the most experienced market researchers analyzing qualitative customer data, the most experienced human resource managers analyzing candidate data, the lawyers analyzing patents, or the investment analysts and consultants analyzing business data. So, if professors and p
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
hysicians failed to recognize major errors in a standard scientific manuscript, what are the chances that the less trained professionals will identify gaps and inconsistencies in non-standard qualitative business data?
2. In this study, the professors were expected to identify the technical error
2. In this study, the professors were expected to identify the technical error
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
s found in the manuscript. The identification and elimination of this type of errors is the objective of the years of training undergone by every scientist. Unlike this study, the great majority of qualitative studies in business include psychological gaps and inconsistencies, and unlike scienti
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
sts, most other professionals receive little to no training in the identifying psychological errors. If the professors failed to identify most of the technical errors, what are the chances that the less trained professionals be successful in identifying the much more challenging psychological err
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ors?
3. How worried should you be when a market researcher is analyzing your focus groups? A typical focus group holds about 12,000 words. An average manuscript holds about 3,000 words, much less than a single focus group. A typical market research study consists of 4-8 focus groups, or 16 to
3. How worried should you be when a market researcher is analyzing your focus groups? A typical focus group holds about 12,000 words. An average manuscript holds about 3,000 words, much less than a single focus group. A typical market research study consists of 4-8 focus groups, or 16 to
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
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
32 times more text. So, if the experts in this study failed to identify most of the technical errors in a volume of data equivalent to one forth of a single focus group, what are the chances that a market researcher will identify the psychological inconsistencies (and intellectual inconsistencies
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
) with a much larger dataset?
4. How worried should you be when a human resource manager is analyzing a pool of candidates? A transcript of a one hour interview holds about 6,000 words (when hiring middle and top managers, the interviews might take a whole day with an order of magnitude more word
4. How worried should you be when a human resource manager is analyzing a pool of candidates? A transcript of a one hour interview holds about 6,000 words (when hiring middle and top managers, the interviews might take a whole day with an order of magnitude more word
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s). When interviewing a few candidates, the total data may include 30,000 or more words (for 5 candidates). So, if the experts in this study failed to identify the major inconsistencies in a volume of data equivalent one half of a single interview, what are the chances that a human resource mana
.
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
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
ger will identify the major inconsistencies with a much larger dataset?
5. How worried should you be when an investment analyst is analyzing some companies for you? An annual report might include tens of thousand of words. For instance, the IBM 2004 annual report is 100 pages long and includes m
5. How worried should you be when an investment analyst is analyzing some companies for you? An annual report might include tens of thousand of words. For instance, the IBM 2004 annual report is 100 pages long and includes m
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ore than 65,000 words. So, if the experts in this study failed to identify the major problems in a dataset that holds less than 5% of the data included in the IBM 2004 annual report, what are the chances that an investment analyst will identify the major problems hidden in the much larger dataset
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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