"Innovation" has become one of the most over-used buzz words in business. Everyone wants to be innovative, but few companies do it well. While there are different definitions of what innovation looks like, I think there are a few key ingredients to successful innovation in any form. Fortunately, the past several years have created some useful Web 2.0 tools that companies can leverage to harvest these key innovation ingredients.
What is innovation?
People have different viewpoints and definitions of what innovation is. Some think of innovation as being the big game-changing ideas and technology that disrupt the status quo and make past processes, tools, or technologies obsolete. This is the classic disruptive technology scenario of big ideas leading to big changes. I think it is often a very romanticized idea of the genius innovator being able to see farther than those that came before and making the great leap forward. The trailblazing pioneer has always held an esteemed position in the public eye.
An alternative view is that innovation can be the slow, steady improvement of the status quo. The idea of continuous improvement is the core principle of the Japanese Kaizen strategy and philosophy. It certainly doesn't seem to have the romantic imagery of our trailblazer mentioned above. Instead, this definition conjures up the image of the tinkerer, making little adjustments here and there, ever trying to get a little more out of the technology at hand.
While I admit that for a long time I believed that the former scenario was the only true definition of innovation, I have begun to give way to the latter as the more common means of true innovation in its populace form. I will not say that either definition is wrong, but that they are both roles being played in how we, as a community/society/culture/whatever, move forward. The pioneering scout has gone ahead of us all and has come back to us to point the way forward to innovation, often bringing back with them some ideas and a rough map that they used in their reconnaissance of the new land, but it is the following masses that now trod ahead step by step through the thickets of the new territory that inevitably allow it to become navigable and inhabited.
At this point, I must give a plug for my favorite podcast Econtalk. If you are fascinated by the incentives that drive human behavior, I highly recommend this terrific series of podcasts to you. One recent episode related to the topic in this blog is the February 16 episode entitled Bhide on Outsourcing, Uncertainty, and the Venturesome Economy. In the conversation, they touch on Friedrich Hayek's view that progress (and innovation) often arises from the emergent property of many thousands of individuals trying to solve their own most pressing problems.
This idea that we all can contribute to innovation should not dim the luster of innovation, but quite the opposite, should make it shine brighter. For if innovation can come from the masses, not just from an elite group of thinkers, than it may be easier than many people think for a company to become innovative and foster a truly innovative culture.
The first key ingredient to innovation:
This now leads me to the first key ingredient for innovation: Ideas.
Innovation comes from ideas, and the more ideas, the better chance you have at innovating. As Linus Pauling said, "the way to get good ideas is to get lots of ideas and throw away the bad ones."
That one quote provides two of the most important components a company needs to become innovative:
1) have a mechanism for capturing lots of ideas, and
2) have a means to filter out the best ones (I prefer stating it this way rather than Linus' harsher labeling of "bad" to those ideas that are thrown away. An idea may be thrown away for now, not because it's bad, but because it isn't right for the company.)
Get lots of ideas:
So how does a company gather lots of ideas? The little wooden suggestion box in the break room or the "how am I doing?" solicitation with telephone number sign may get a few good ideas, but most likely won't generate the volume of ideas needed to be considered an innovative culture and are likely to be limited to complaints about the donuts in the break room or the driving habits of your transportation crew.
Fortunately, the past several years have generated several useful IT resources that companies can utilize to get the ideas that lead to true innovation. The Web 2.0 revolution and all of it's social networking resources can now be used internally inside corporations to gather the seeds of innovation. This includes blogs, wikis, prediction markets, and other tools that have become commonplace in the internet world, and can now be internalized into a company's intranet processes.
A nice little intro to some of the dos and don'ts of using Web 2.0 tools inside your company was published by the McKinsey Quarterly recently.
My next several blogs will focus on my first component of innovation, namely how can lots of ideas be captured using Web 2.0 tools. I will subsequently touch on the second component of how companies can filter out the best ideas that come their way.
If, like me, you are a continuous student of innovation, please leave a comment or suggestion on your ideas about what innovation means to you and how you think companies (and individuals) can do a better job at becoming more innovative. Maybe that will be a future blog topic...Innovation: Nature versus Nuture?
Blogs related to the business and management of biotechnology and pharmaceutical projects.
Friday, April 3, 2009
Thursday, April 2, 2009
Comparator Clinical Trials: What are they and what you need to consider
The point of a clinical trial is the see if a medical treatment (e.g., drug, device, biologic) is 1) safe, and 2) effective for treating the target medical condition. The way this has often been done is to randomly put subjects into 2 groups and give one group the treatment (I'll use the example of a drug for simplicity) and the other group a placebo. The placebo is commonly thought of in the public eye as "a sugar pill". This isn't really accurate, but the idea is close to reality, namely that the placebo is an inert treatment that has no active medical ingredient in it, but looks and feels indistinguishable from the drug. This way, the subjects (and often the doctors) do not know which group is getting the drug and which group is getting the placebo. This helps prevent any bias in the way people respond.
As an aside, note that I use the term "subjects" for clinical trial participants, not "patients". Clinical trial participants are not patients because the treatment being tested is experimental and should not be considered therapy. In fact, the treatment may even be harmful. The whole point of the trial is to determine this issue. Therefore, clinical trial participants, who have graciously and generously agreed voluntarily to put their health at risk for the sake of the trial, are "subjects", not "patients".
Ok, back to the topic at hand.
A recent trend in the clinical trial field is to do a comparator trial, rather than a placebo-controlled trial. This means that the experimental drug is not being compared to a placebo, but rather to a drug that is already being used to treat patients. There are several reasons for this trend.
One reason is because it may be unethical to put clinical trial subjects on a placebo when there is a proven drug already on the market that can help them. For example, if a company is testing a new high blood pressure medication, which is a medical problem that has proven effective drugs that people can use today, it would be unethical to give your control subjects a "sugar pill", rather than a drug that you know is beneficial. This is especially important if the medical indication that is being targeted is life-threatening.
Ethical issues aside, comparator trials are also being heavily promoted by the FDA regulators. Again, the idea is that if a drug is already approved on the market, the FDA wants a company to prove that their drug is just as good, if not better, than the available treatments. This protects patients, because a drug shouldn't be approved to give to patients if it has higher risks and less efficacy than a drug that patients are already taking.
So what does this mean for pharmaceutical companies? Well as you can imagine, a comparator trial is more expensive and considerably more complicated to manage than a placebo-controlled trial. This is because the company not only has to manage the manufacturing and supply of their experimental drug, but they have to manage the procurement and supply of the comparator drug.
If you have experience with this topic, let me know what your thoughts are on this issue.
As an aside, note that I use the term "subjects" for clinical trial participants, not "patients". Clinical trial participants are not patients because the treatment being tested is experimental and should not be considered therapy. In fact, the treatment may even be harmful. The whole point of the trial is to determine this issue. Therefore, clinical trial participants, who have graciously and generously agreed voluntarily to put their health at risk for the sake of the trial, are "subjects", not "patients".
Ok, back to the topic at hand.
A recent trend in the clinical trial field is to do a comparator trial, rather than a placebo-controlled trial. This means that the experimental drug is not being compared to a placebo, but rather to a drug that is already being used to treat patients. There are several reasons for this trend.
One reason is because it may be unethical to put clinical trial subjects on a placebo when there is a proven drug already on the market that can help them. For example, if a company is testing a new high blood pressure medication, which is a medical problem that has proven effective drugs that people can use today, it would be unethical to give your control subjects a "sugar pill", rather than a drug that you know is beneficial. This is especially important if the medical indication that is being targeted is life-threatening.
Ethical issues aside, comparator trials are also being heavily promoted by the FDA regulators. Again, the idea is that if a drug is already approved on the market, the FDA wants a company to prove that their drug is just as good, if not better, than the available treatments. This protects patients, because a drug shouldn't be approved to give to patients if it has higher risks and less efficacy than a drug that patients are already taking.
So what does this mean for pharmaceutical companies? Well as you can imagine, a comparator trial is more expensive and considerably more complicated to manage than a placebo-controlled trial. This is because the company not only has to manage the manufacturing and supply of their experimental drug, but they have to manage the procurement and supply of the comparator drug.
If you have experience with this topic, let me know what your thoughts are on this issue.
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