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A recent scientific study (Craigie M, Loader B, Burrows R, Muncer S. Reliability of Health Information on the Internet: An Examination of Experts' Ratings. Journal of Medical Internet Research. 2002 Jan-Mar;4(1):e2) measured how consistent are experts when analyzi

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

ng qualitative data. The data included the text from 18 threads (series of connected messages) posted on a message board by individuals suffering from a chronic disease. Each thread consisted of a start message, or question, and a number of responses, or answers.

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

Examples of combination products may in

The experts processing the data were five doctors who worked together in the same specialist unit, and who had at least five years experience in treating the chosen disease. To process the data, the doctors devised the following two scales. The start message or qu

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

stion was coded according to a 6-part scale: A = excellent; B = less good but with some details; C = poor with little detail; D = vague; E = misleading or irrelevant; F = incomprehensible. The responses or answers were coded according to another 6-part scale: A =

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

evidence based, excellent; B = accepted wisdom; C = personal opinion; D = misleading, irrelevant; E = false; F = possibly dangerous.

After processing the data, the codes assigned by all five experts were compared using three statistical tests: kappa, gamma, and K

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

Combination pro

ndall's W. The results showed poor agreement between the codes of all five experts in both the starting question and the responses. Moreover, two of the five experts showed a statistical significant dis-agreement between the codes they assigned to th

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

e question, and different pairing of experts showed contradictions between the codes they assigned to the responses. In simple terms, when one doctor labeled an answer with A = evidence based, excellent, another doctor labeled the same answer with E = false

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

, or even F = possibly dangerous.

Points to consider:

1. The first stage of most 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 survey

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

to ask customers for their opinion. 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 articles, press releases, a

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

nd reports about their target companies. In all these cases, and many others, the data is presented in the form of words. In light of this study, how confident should you be in the "professional" analysis of these words?

2. How worried should you be when a market

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

researcher is presenting the analysis of focus groups, in-depth interviews, or answers to open-ended questions in a survey? A typical focus group holds about 12,000 words. The data in this study included 18 threads. An average thread consists of about 5 postings w

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

Following aspects would a

ith about 120 words each. These numbers suggest that the data in this study included 10,800 words; less than a single focus group. In contrast, a typical market research study consists of 4-8 focus groups, or 4 to 8 times more text. So, if the experts in this stud

dd to the challenges in developing combination products:

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

y failed to show consistency with a volume of data equivalent to a single focus group, what are the chances that a market researcher will show consistency with a much larger dataset?

3. In this study, the analysts were doctors with at least five years of experien

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

e in treating the specific chronic disease. These analysts possess 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 m

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

anagers analyzing candidate data, or the most schooled investment analyst. So, if these highly trained experts failed to show consistent processing of qualitative data, what are the chances that the less trained professionals (and layman) will show consistent anal

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

ysis of their data?

4. The criterion in this study was whether an answer is "evidence based" (see code A) or not. This is an objective criterion. Unlike this study, the great majority of qualitative studies involve subjective criteria such as tastes, morals, valu

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, or preferences. If the doctors failed to consistently apply a single objective criterion when coding the text, how can the less trained professionals (and layman) be trusted to consistently apply a large set of subjective criteria when evaluating qualitative da

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

ta?

5. In this study pairs of doctors assigned different codes to the same question or answer. For instance, one doctor labeled an answer with A = evidence based, excellent; while another doctor labeled the same answer with E = false, or even F = possibly dangero

.

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

s. Who is right? After all this is medicine and both cannot be right. Who should you believe? And what should you do as decision maker? If you believe that the first doctor is right, you should regard the response as great advice and follow its directives. If you

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

Companies that provide selfless information through particip

believe that the second doctor is right, you should run for you life. Now, if such great experts failed to convince us that they can process a small 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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