I strongly believe in keeping yourself in a continuous learning mode to make sure your business skills are always sharp and up to date. In this current tough job market, we all need to do everything we can to make ourselves more valuable to our employers (if you are fortunate enough to have a job) or attractive to a new employer (if you are looking for a job.) Therefore, I am bringing you another resource that I highly recommend.
A couple weeks ago, I came across a great website www.valuebasedmanagement.net that provides explanations for hundreds of business tools, business models, and business theories. Another great thing about this is that not only is it a treasure trove of business information, it is totally free, which is a terrific price that everyone can afford in these tough times.
The main business categories are:
• Strategy
• Valuation and Decision Making
• Organization, Change, and Culture
• Communication and Marketing
• Leadership and Management
I have found this webpage to be great for quick introductions to business models that I hear about in seminars/podcasts/white papers, as well as a quick way to find alternative business tools, theories, or models that I was not familiar with. I also use it for presentations where I want a nice, quick way to introduce a tool, theory, or model that I am referring to in my talk.
So whether you want to learn more about your favorite business strategy analysis tool (e.g., Porter’s 5 forces, the Balanced Scorecard), management theory (e.g., the Deming cycle, Management by objectives), or leadership styles, I think you’ll find this website a nice one to bookmark as a quick reference guide.
As always, I welcome you to let me know how you like the site and what other sites you use and recommend.
Blogs related to the business and management of biotechnology and pharmaceutical projects.
Sunday, August 2, 2009
Wednesday, July 15, 2009
Free Project Management training webinars
As I said in my previous blog 5 Best Podcasts for Business Managers, I am always on the lookout for useful free management training tools. I just recently came across a nice website with free Project Management training webinars.
PM Centers USA holds free monthly webinars for Project Management topics. Attendees can earn 0.5 Professional Development Units (PDUs) for each webinar that can be used for maintaining your PMP accreditation. You can register for their upcoming webinars at their website.
They also offer free access to many previously recorded webinars. You will need to register your name and contact information with the website, but it is completely free and well worth it. I highly recommend the following 2 Project Management webinars:
Common Scheduling Mistakes and How to Avoid Them
Joe Lukas, an outstanding presenter, takes you through his top 10 scheduling mistakes that he's seen people make. He gives some best practice tips including a nice Microsoft Project instruction document that will allow you to better track task float by visualizing early and late start/stops for your activities.
Essential Business Case Skills
Joe Lukas does another masterful job of providing useful training and tips in a short amount of time (about 25 minutes). Joe gives a very good introduction to Net Present Value (NPV), Internal Rate of Return (IRR), and other business finance calculations that all project managers should be familiar with. The webcast introduces an excel file document that can be freely downloaded from the PM Centers USA website that will automatically calculate NPV, IRR, and other project financial information. It's a very nice tool to play with, whether you're discounting future cash flows on your project or calculating your monthly car payments needed to pay back your loan in 3 years.
So there you go. More free management training tools for you to look at and learn from. As I continue to find others, I'll keep you posted on what I think are the best ones. Please feel free to contact me or comment to this post if you have other sources of good information that you know about.
PM Centers USA holds free monthly webinars for Project Management topics. Attendees can earn 0.5 Professional Development Units (PDUs) for each webinar that can be used for maintaining your PMP accreditation. You can register for their upcoming webinars at their website.
They also offer free access to many previously recorded webinars. You will need to register your name and contact information with the website, but it is completely free and well worth it. I highly recommend the following 2 Project Management webinars:
Common Scheduling Mistakes and How to Avoid Them
Joe Lukas, an outstanding presenter, takes you through his top 10 scheduling mistakes that he's seen people make. He gives some best practice tips including a nice Microsoft Project instruction document that will allow you to better track task float by visualizing early and late start/stops for your activities.
Essential Business Case Skills
Joe Lukas does another masterful job of providing useful training and tips in a short amount of time (about 25 minutes). Joe gives a very good introduction to Net Present Value (NPV), Internal Rate of Return (IRR), and other business finance calculations that all project managers should be familiar with. The webcast introduces an excel file document that can be freely downloaded from the PM Centers USA website that will automatically calculate NPV, IRR, and other project financial information. It's a very nice tool to play with, whether you're discounting future cash flows on your project or calculating your monthly car payments needed to pay back your loan in 3 years.
So there you go. More free management training tools for you to look at and learn from. As I continue to find others, I'll keep you posted on what I think are the best ones. Please feel free to contact me or comment to this post if you have other sources of good information that you know about.
Sunday, July 5, 2009
Who owns your genes?
In May of this year, the American Civil Liberties Union (ACLU) filed a lawsuit against Myriad Genetics claiming that the company's patents on two breast cancer genes should be voided. Anyone working in the biotechnology industry should be aware of this pending case because it's outcome will have a huge impact on the future of biotechnology.
Myriad Genetics owns the patent rights to 2 genes known as BRCA1 and BRCA2. Mutations in these two genes have been strongly linked to developing breast and ovarian cancer. The link is so strong that some women testing positive for mutations in these genes have been having both breasts surgically removed (double mastectomy) and often their ovaries removed as a preventative measure to avoid the very likely chance of developing cancer. This medical scenario was even a story line on the popular Gray's Anatomy television show.
Myriad Genetics owns the only available and approved medical test for the BRCA mutations. The ACLU is leading the fight against Myriad Genetics. The lawsuit claims that Myriad Genetics' patents restrict research scientists at universities and other companies from studying and learning more about these genes. From a patient advocacy standpoint, the lawsuit claims that since the only BRCA tests available are developed and sold by Myriad Genetics, it prevents patients from obtaining a truly independent second opinion.
What's at stake is much more than whether or not Myriad Genetics can own a patent on the BRCA genes. The big issue, which the ACLU is going after, is whether anyone can own a patent on any gene or biological entity. It is estimated that about 20 percent of all the human genes now have some sort of patent rights placed upon them.
Biotechnology companies will claim that it is these patent rights that allow them the confidence and incentives to risk many millions, sometimes billions, of dollars needed to develop new drugs, treatments, and medical tests to improve patient safety and efficacy in treating our most challenging diseases. If these patents all become in danger of being voided and future patents on biological entities are prohibited, the public may be the biggest loser because biotechnology companies will no longer be willing to develop new or better treatments.
Let me know which side you are on. Whichever side you stand with in this battle, the outcome will have an important impact into not only the biotechnology industry, but the practice of medicine for you and those you love.
Myriad Genetics owns the patent rights to 2 genes known as BRCA1 and BRCA2. Mutations in these two genes have been strongly linked to developing breast and ovarian cancer. The link is so strong that some women testing positive for mutations in these genes have been having both breasts surgically removed (double mastectomy) and often their ovaries removed as a preventative measure to avoid the very likely chance of developing cancer. This medical scenario was even a story line on the popular Gray's Anatomy television show.
Myriad Genetics owns the only available and approved medical test for the BRCA mutations. The ACLU is leading the fight against Myriad Genetics. The lawsuit claims that Myriad Genetics' patents restrict research scientists at universities and other companies from studying and learning more about these genes. From a patient advocacy standpoint, the lawsuit claims that since the only BRCA tests available are developed and sold by Myriad Genetics, it prevents patients from obtaining a truly independent second opinion.
What's at stake is much more than whether or not Myriad Genetics can own a patent on the BRCA genes. The big issue, which the ACLU is going after, is whether anyone can own a patent on any gene or biological entity. It is estimated that about 20 percent of all the human genes now have some sort of patent rights placed upon them.
Biotechnology companies will claim that it is these patent rights that allow them the confidence and incentives to risk many millions, sometimes billions, of dollars needed to develop new drugs, treatments, and medical tests to improve patient safety and efficacy in treating our most challenging diseases. If these patents all become in danger of being voided and future patents on biological entities are prohibited, the public may be the biggest loser because biotechnology companies will no longer be willing to develop new or better treatments.
Let me know which side you are on. Whichever side you stand with in this battle, the outcome will have an important impact into not only the biotechnology industry, but the practice of medicine for you and those you love.
Wednesday, May 27, 2009
Managing Layoffs
Layoffs are the common theme these days in the economy, and the biotech/pharma industry has not been spared from the pain. My last post 5 Best Podcasts for Business Managers was focused on managers polishing their skills and knowledge. Enhancing your management skills is especially important for keeping your current job or quickly finding your next one. This podcast is geared towards managers one the other side of the table, namely, those responsible for giving the bad news of impending layoffs.
It is very hard to manage layoffs well. It is unfortunately very easy and common to handle them poorly. Some key points on what to do are:
Transparency: Trying to keep your employees in the dark until the last minute often fails and results in low morale, rumor mongering, and fear. Everyone feels vulnerable when they see the top management in "secret" meetings and no one is providing factual information. In the absence of facts, rumors will fill the void of information that people are searching for and sharing. If your company is going through a rough time, do not sugar coat or attempt to give the "everything's fine" speech. Let the employees know what problems the company is facing and what the options are. Layoffs should not be the first choice, but if they are announced, people will better accept the decision if they see what led to the problem, why layoffs had to occur, and what the rationale is for who is being laid off.
Fairness A sense of fairness is extremely important when layoffs occur, both for those losing their job and especially for those remaining. For those remaining after a layoff, their is a lot of survivor guilt and anger. People feel bad for their friends who lost their job. If they feel that the layoffs were not fair and that good people were let go and bad people were kept, they will harbor resentment for upper management. If they do not see a rationale for who was laid off and who was not, they will think the layoffs are happening at random and that they are vulnerable for a future layoff. Those who were not involuntarily asked to leave, will likely start looking for opportunities to leave voluntarily.
Planning When laying off people, it is essential to do so according to a well defined and communicated plan. Make sure you, as upper management, have a plan for who is being laid off, what responsibilities will need to be transferred to the remaining personnel, and how the company will move forward with the new organizational structure. This plan should be clearly communicated to all personnel at the time of the layoff. If possible, it is always best to have all the layoffs at once. This will put the bad news behind you as quickly as possible and get things moving forward in the right direction. The worse thing to do is to have multiple layoffs announced randomly during an extended period of time. This will devastate morale and strongly inhibit productivity as people focus their time and energy on guessing who is next and preparing themselves in case they are in the next round.
McKinsey Quarterly just released a nice short video interview with Robert Sutton entitled Good Boss, Bad Times. Dr. Sutton gives some nice advice for managers dealing with layoffs. As he mentions, troubling times and uncertainty in companies can lead to a Toxic Tandem, where managers become blinded to the needs of their employees at the same time that their employees, who are working in a state of heightened anxiety, are scrutinizing their manager's every move. This is a vicious cycle as employees' increased sensitivity to their boss's attitude and signals progressively worsens as their boss's interactions with them become less and less open and responsive.
As with most things in life, it's easy to be good at what you do when things are going well. The test of the good manager is how they act and manage their people when things are bad. How you handle your team and employees during these tough times will determine your reputation as a manager. Hopefully, while the times are bad, your managing will be good.
It is very hard to manage layoffs well. It is unfortunately very easy and common to handle them poorly. Some key points on what to do are:
Transparency: Trying to keep your employees in the dark until the last minute often fails and results in low morale, rumor mongering, and fear. Everyone feels vulnerable when they see the top management in "secret" meetings and no one is providing factual information. In the absence of facts, rumors will fill the void of information that people are searching for and sharing. If your company is going through a rough time, do not sugar coat or attempt to give the "everything's fine" speech. Let the employees know what problems the company is facing and what the options are. Layoffs should not be the first choice, but if they are announced, people will better accept the decision if they see what led to the problem, why layoffs had to occur, and what the rationale is for who is being laid off.
Fairness A sense of fairness is extremely important when layoffs occur, both for those losing their job and especially for those remaining. For those remaining after a layoff, their is a lot of survivor guilt and anger. People feel bad for their friends who lost their job. If they feel that the layoffs were not fair and that good people were let go and bad people were kept, they will harbor resentment for upper management. If they do not see a rationale for who was laid off and who was not, they will think the layoffs are happening at random and that they are vulnerable for a future layoff. Those who were not involuntarily asked to leave, will likely start looking for opportunities to leave voluntarily.
Planning When laying off people, it is essential to do so according to a well defined and communicated plan. Make sure you, as upper management, have a plan for who is being laid off, what responsibilities will need to be transferred to the remaining personnel, and how the company will move forward with the new organizational structure. This plan should be clearly communicated to all personnel at the time of the layoff. If possible, it is always best to have all the layoffs at once. This will put the bad news behind you as quickly as possible and get things moving forward in the right direction. The worse thing to do is to have multiple layoffs announced randomly during an extended period of time. This will devastate morale and strongly inhibit productivity as people focus their time and energy on guessing who is next and preparing themselves in case they are in the next round.
McKinsey Quarterly just released a nice short video interview with Robert Sutton entitled Good Boss, Bad Times. Dr. Sutton gives some nice advice for managers dealing with layoffs. As he mentions, troubling times and uncertainty in companies can lead to a Toxic Tandem, where managers become blinded to the needs of their employees at the same time that their employees, who are working in a state of heightened anxiety, are scrutinizing their manager's every move. This is a vicious cycle as employees' increased sensitivity to their boss's attitude and signals progressively worsens as their boss's interactions with them become less and less open and responsive.
As with most things in life, it's easy to be good at what you do when things are going well. The test of the good manager is how they act and manage their people when things are bad. How you handle your team and employees during these tough times will determine your reputation as a manager. Hopefully, while the times are bad, your managing will be good.
Tuesday, May 26, 2009
5 Best Podcasts for Business Managers
I have been attending a lot of management seminars lately for business development. The current trend seems to be less business development talks and discussions and a lot of job seeking advice and counseling. In this economic downturn, lots of people are out of work and looking for advice on how to get their next job.
I highly recommend polishing your interview and management skills to make sure that when that next job opportunity arises, you'll be ready for that elevator pitch, job interview, and next new job.
I strongly recommend listening to the many free podcasts that are available for business managers. My top 5 podcasts for business managers are listed below. They can all be downloaded from iTunes for free. If you don't have an MP3 player or iPOD, you can still listen to these by going directly to their websites.
1. ManagerTools Mike and Mark have been providing outstanding advice for several years now. They cover everything from how to give a strong handshake, how to run meetings, how to interview people and prepare for being interviewed, and how to manage people. This is a terrific podcast series and has won podcasts awards for the best business podcast.
2. The Cranky Middle Manager Wayne Turmel provides terrific interviews with management and business experts, authors, and gurus. He always provides terrific content mixed with his own humor and history lesson. Great show.
3. Project Management Podcast Cornelius Fichtner provides interviews, tips, and tools for project managers. Whether you’re a beginning project manager studying for the PMP exam or an experienced manager looking to extend your project management knowledge, this podcast provides a lot of valuable information.
4. PMLessonsLearned Henry Will set up this series of podcasts for project managers. They are divided into 3 types of podcasts each month: (i) project management education, (ii) PMP exam preparation, and (iii) project management job search podcasts.
5. StartupBizCast If you own or work for a small start up company, this podcast provides lots of excellent advice. It has a particular focus on small business marketing, with lots of good advice that any business manager can use.
Once you've listened to these (which can take a long time given the thousands of free podcasts available from these 5 alone) and you're ready for more: I recommend Negotiation Tip of the Week, The Public Speaker Quick and DIrty Tips, and Ethan Becker Speech Coach for more great tips to prepare you for getting and keeping your next job.
Good luck with your job searches. Let me know what websites, podcasts, books, and other tools you recommend.
I highly recommend polishing your interview and management skills to make sure that when that next job opportunity arises, you'll be ready for that elevator pitch, job interview, and next new job.
I strongly recommend listening to the many free podcasts that are available for business managers. My top 5 podcasts for business managers are listed below. They can all be downloaded from iTunes for free. If you don't have an MP3 player or iPOD, you can still listen to these by going directly to their websites.
1. ManagerTools Mike and Mark have been providing outstanding advice for several years now. They cover everything from how to give a strong handshake, how to run meetings, how to interview people and prepare for being interviewed, and how to manage people. This is a terrific podcast series and has won podcasts awards for the best business podcast.
2. The Cranky Middle Manager Wayne Turmel provides terrific interviews with management and business experts, authors, and gurus. He always provides terrific content mixed with his own humor and history lesson. Great show.
3. Project Management Podcast Cornelius Fichtner provides interviews, tips, and tools for project managers. Whether you’re a beginning project manager studying for the PMP exam or an experienced manager looking to extend your project management knowledge, this podcast provides a lot of valuable information.
4. PMLessonsLearned Henry Will set up this series of podcasts for project managers. They are divided into 3 types of podcasts each month: (i) project management education, (ii) PMP exam preparation, and (iii) project management job search podcasts.
5. StartupBizCast If you own or work for a small start up company, this podcast provides lots of excellent advice. It has a particular focus on small business marketing, with lots of good advice that any business manager can use.
Once you've listened to these (which can take a long time given the thousands of free podcasts available from these 5 alone) and you're ready for more: I recommend Negotiation Tip of the Week, The Public Speaker Quick and DIrty Tips, and Ethan Becker Speech Coach for more great tips to prepare you for getting and keeping your next job.
Good luck with your job searches. Let me know what websites, podcasts, books, and other tools you recommend.
Friday, April 3, 2009
How to Innovate? Get lots of ideas and keep the best ones
"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?
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?
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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