Digg It - Business

In a recent article [Testing – the most effective tool for database marketing], we have analysed the importance of

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

testing in marketing campaign management. Testing is done by promoting an offer to a smaller group of customers in order

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

Examples of combination products may in

o evaluate the effectiveness of the whole approach (value proposition, message used, timing, target group). This smaller

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

roup is a sample which is used to predict the behavior of a larger group. Sampling always introduces bias in any measurem

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

nt. The larger the sample is, the smaller the bias introduced. Assuming that:

an expected positive response rate

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

Combination pro

p is 2 % (the percent of customers accepting the offer - this estimate may be an average of previous similar tests),

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

an expected standard deviation S 0,05 % in response rates. This estimate may be derived from previous tests: S can be

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

calculated after executing a campaign on a group of given size (actually, the accurate term for this is ‘standard e

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

ror of a proportion’ in a binomial distribution which however resembles highly the normal distribution),

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

very simple formula to estimate the size of the needed test group is the following: Group size = p * (1-p) / square(S) ,

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

and yields a value of 78.400. Should a sensitivity analysis be carried out by changing the input values, the results do n

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

Following aspects would a

t provide a feeling of a stable estimation. For example if the expected positive response rate p is 1,5 % and the expecte

dd to the challenges in developing combination products:

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

standard deviation S 0,06 % then the group size should be 41.042. The sensitivity analysis helps recognise the importanc

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

of the estimations used. A relatively small change leads to a huge difference. Therefore, Campaign managers should analy

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

e the findings of previous campaigns, in order to have a good idea on the expected range of p and S values. Previous find

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

ngs contribute to the adjustment of future test group sizes. Though this may not be a highly safe approach in dynamically

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

Professional from academic institutions, pharmaceutical industries, health care indust

changing market conditions and offers, it is much better than using randomly selected group sizes, which may lead either

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

o inaccurate findings or wasted resources when the group size is much higher than needed. Concluding, in order to build c

.

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

mpaign management intelligence, a Business should capture and analyze the results of each campaign or test campaign. The

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

Companies that provide selfless information through particip

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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/30676/diggit-Test-Campaign-Result-Accuracy--Test-Group-Sizing--Part-I.html">Test Campaign Result Accuracy – Test Group Sizing - Part I</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/30676/diggit-Test-Campaign-Result-Accuracy--Test-Group-Sizing--Part-I.html]Test Campaign Result Accuracy – Test Group Sizing - Part I[/url]

Tips for you, the efficient office employee who finished all your job responsibilities early. You don't want to get handed a new stack of work by the boss, now, do you?

Do you collect your customers email addresses? I doubt it. This is a huge mistake! Building an email list of your customers is very valuable. By staying in contact with your customers by email, or mailing to them, you build loyalty and you never let them forget you!

People cannot refer others to you if they do not truly know who you are and what a good referral is for you. If you ignore the power of your circle of communication, you ignore the ability to grow your business.

Tags

Links

Digg It - Test Campaign Result Accuracy – Test Group Sizing - Part I

Related Articles: