Have you seen this special article in the NEJM entitled: A Randomized Study of How Physicians Interpret Research Funding Disclosures. It is disturbing reading for all of us in the industry, including MA.
In the study, researchers presented 503 board-certified internists with three random studies with a high, medium and low level of methodological rigor. And then randomly assigned each study one of three funding sources: NIH, Biopharma Industry, Not Disclosed.
The good news is that respondents generally assigned stronger credibility to studies with stronger methodologies.
The difficult news is that the internists believed the results of industry-sponsored were less credible than those that were NIH funded and with no funding disclosed. And that results remained the same whether the study was of high rigor or low rigor. Since the funding source was randomly assigned its clear that simply associating industry funding reduced credibility.
And the kicker – over 75% of the respondents accept support from industry in some manner, so these are not a bunch of ivory tower purists throwing stones. These are exactly the people that MA needs to educate and these are exactly the kinds of studies that we use for that education. Clearly we have a problem.
In an editorial that accompanies the study entitled Believe the Data, Dr. Jeffery Drazen suggests that physicians need to focus on the data and the rigor of developing that data. As an industry, we need to echo that exact point.
We know where this skepticism comes from - too many newspaper stories of incomplete study disclosures, too many studies that seemed to lack rigor, too much willingness to spin results.
We cannot ignore this issue. We need to hit it head on – discussing this now proven bias and why it should not impact the interpretation of results for a given study due to its rigor, etc.
Something that many of us have suspected for awhile, that industry science was being discounted simply because of funding, is now shown to be true. We must address it openly because like any bias when it is pointed out to people they are less likely to be prey to it.
What do you think we can do to address anti-industry bias? Leave your thoughts in the comments section.
Focus on MA Ops Issues
Tuesday, September 25, 2012
Monday, September 17, 2012
Topic14: SOPs in MA
Now for a topic no one wants to talk about but everyone should become more familiar with – Standard Operating Procedures. The hard truth of today’s world is that SOPs are no longer optional for MA. In fact, SOPs are critical for success in today’s global MA. In this post, I will discuss SOPs in general as well as share some do’s and don’ts for developing effective MA SOPs.
Our brethren in Clinical Development have been living in a world of SOPs for much longer than MA because their work was more explicitly regulated. When you are regularly audited by agencies looking for an excuse to delay the marketing of your next blockbuster, you are highly motivated to have whatever documentation they are looking for. And, in CD, that means SOPs that clearly demonstrate that all clinical trials are conducted following GCP and other related standards.
In MA we used to be less concerned about regulation enforcement, but those days are over. So, what is the state of MA’s SOPs? If your environment is like those in my experience, the answer is a mixed bag. Many organizations have some good SOPs but few organizations would claim their SOPs are simultaneously:
Most MA leaders will tell you it’s important and on the organizational To Do list but it rarely seems to rise up to the top of that list and almost nothing below number 3 on that list can get addressed in any given year.
Yet SOPs represent one of the very best defenses any organization has to arguments that it is operating contra to regulations. By having clearly defined processes that are compliant, a training program to show that people learned and understood those processes and a program to ensure that those SOPs remain updated, the organization has a very strong argument in its favor, even if a single actor is caught performing incorrectly, the argument can be made that it is a single bad actor not an institutional problem.
But SOPs are not just defensive in nature. When well done, SOPs represent an opportunity to capture best practice and apply that best practice on a global level. Every country, every region does not need to re-invent the wheel. What we do in MA is standard enough that we should be able to build a single optimized approach that we can apply on a global basis.
When building SOPs there are some definite Do’s and Don’ts.
DO’S
DON’T
SOPs in MA – not a topic anyone gets excited about tackling. Yet, SOPs are going to grow increasingly important as the regulatory burden on MA grows.
What is your experience with MA SOPs? Leave a comment and let me know!
Our brethren in Clinical Development have been living in a world of SOPs for much longer than MA because their work was more explicitly regulated. When you are regularly audited by agencies looking for an excuse to delay the marketing of your next blockbuster, you are highly motivated to have whatever documentation they are looking for. And, in CD, that means SOPs that clearly demonstrate that all clinical trials are conducted following GCP and other related standards.
In MA we used to be less concerned about regulation enforcement, but those days are over. So, what is the state of MA’s SOPs? If your environment is like those in my experience, the answer is a mixed bag. Many organizations have some good SOPs but few organizations would claim their SOPs are simultaneously:
- Complete
- Accurate
- Trained and understood by the relevant staff
- Consistently updated
Most MA leaders will tell you it’s important and on the organizational To Do list but it rarely seems to rise up to the top of that list and almost nothing below number 3 on that list can get addressed in any given year.
Yet SOPs represent one of the very best defenses any organization has to arguments that it is operating contra to regulations. By having clearly defined processes that are compliant, a training program to show that people learned and understood those processes and a program to ensure that those SOPs remain updated, the organization has a very strong argument in its favor, even if a single actor is caught performing incorrectly, the argument can be made that it is a single bad actor not an institutional problem.
But SOPs are not just defensive in nature. When well done, SOPs represent an opportunity to capture best practice and apply that best practice on a global level. Every country, every region does not need to re-invent the wheel. What we do in MA is standard enough that we should be able to build a single optimized approach that we can apply on a global basis.
When building SOPs there are some definite Do’s and Don’ts.
DO’S
- Leverage major disruptive changes to implement or enhance SOPs
- SOPs are a major effort and often difficult to justify on their own (see To Do comment above)
- Instead, leverage a new system implementation, new regulatory regime or other major change that seems to hit every year or two as the vehicle for investing in SOPs
- Be inclusive
- Ensure to involve every function and every region that is affected by the SOPs, even those that are outside MA
- Make sure the SOPs remain valuable throughout the globe if possible
- Develop MA-specific SOP templates and development processes
- Trying to take the CD SOP development templates and processes can result in over engineered MA SOPs
- MA SOPs don’t need to be as detailed or structured as CD SOPs because the goals are different in terms of regulatory support – CD SOPs need to comply with GCP at a minimum which drives a certain level of depth that is not necessarily required in MA
- Remember the Training
- Training is the link between SOP development and real world value, yet many organizations fall down on this important step
- SOP development efforts seem to lose steam after the creation effort and often result in training programs that fail to ensure that everyone who should learn does learn
DON’T
- Pave the Cow Path
- Don’t just document the current process (cow path), instead take the opportunity of SOP development to do some process improvement work capturing best practices and defining new approaches
- This may take a bit longer but the results are significantly more valuable
- Get Overly Complex
- SOPs are guidelines not computer programs – the more detail the LESS valuable the SOPs can become as more and more real world situations don’t fit into the very specific processes
- Forget Certification
- Its great to train, but in the future someone will question whether the training was effective – without some type of certification to prove understanding on the part of the trainees this is very difficult to prove
- Certification does not, and should not, be onerous – just enough to prove that the key points are understood
SOPs in MA – not a topic anyone gets excited about tackling. Yet, SOPs are going to grow increasingly important as the regulatory burden on MA grows.
What is your experience with MA SOPs? Leave a comment and let me know!
Thursday, September 6, 2012
OffTopic: JAMA Article on Accelerated Review
I was reading about the JAMA article on accelerated review and it really bugged me. Just as I was about to write a post about why, Derek Lowe over at In the Pipeline read my mind and wrote the perfect post on this subject. Take a look. I could not agree more.
What are your thoughts on the topic? Have we both drunk the industry kool-aid?
What are your thoughts on the topic? Have we both drunk the industry kool-aid?
Topic13: Medical Information Groups
I was talking with a friend the other day who is charged with running the medical information (MI) function for their small pharma company. Currently they outsource the MI function and she was wondering if it made sense to bring the function in-house of keep the current arrangement. We discussed how effectively the outsourced MI function works with the current MA group, including the MSL field force, and the answer is that they have some formal links but rarely talk. We talked some more and reached some conclusions, but I thought this might be a good topic for a post.
MI is both a regulatory mandated function, and a critical component in achieving MA’s educational and public outreach goals. It is possible to structure and run the MI function merely to meet the regulatory requirements but that would represent a significant waste of an opportunity.
From a regulatory perspective, the MI function needs to be structured to answer calls from both patients and healthcare professionals (HCPs), differentiate between inquires and pharmacovigilance calls and route the calls appropriately, answer questions directly when appropriate, distribute accurate and approved materials to appropriate audiences, and develop outgoing medical communications on important issues (Dear Doctor letters). It needs to be staffed by people with appropriate qualifications to answer medical and technical questions about the use of company’s products.
But, some organizations gain much more benefit from their investment in MI. For one thing, MI is often the first sign that a problem is occurring relating to our products or issues are being raised concerning the scientific underpinnings of our products. Spikes in the type and content of questions help provide a Zeitgeist view of the needs for education in the HCP community. But, this only works if MA listens. There must be processes and systems in place to ensure that MI is coding their contacts in a manner that allows for analysis and reporting in place to ensure that the information is summarized on a timely basis. Finally, clear responsibilities need to be established for who will review and respond to this information.
Other organizations utilize the MI resources to more effectively partner with the MSL field force. MI and MSL groups tend to talk with related but mutually exclusive audiences. Given the limitations on MSL time, they need to focus that time on those HCPs that can offer the greatest impact on the medical community, the so-called Key Opinion Leaders (KOLs). Based on research I have seen in the past, it is very rare for a KOL to call MI. They tend to expect the answers to come to them through MSLs or research on the internet. Non-KOL HCPs tend to call MI. Given that, the opportunities for MSLs and MI to interact is not in terms of serving the same HCPs but instead in terms of “having each other’s backs.” Often when MSLs are interacting with HCPs, they need to provide those HCPs with additional information and support. MI is well suited to provide that information and support. And, when MI is answering questions for HCPs they encounter situations that require more in-depth support, and MSLs are well positioned to provide it.
Establishing a strong partnership between MI and MSL groups brings value to both sides, yet it is not as common as you might expect. Sometimes it’s due to organization structure – the two groups have unrelated reporting relationships and thus lack incentive to interact. Other times it’s due to a difference in philosophy, where one of the two groups does not see value in interacting with the other. Regardless, there is value in establishing this relationship, but it needs to be clearly structured and actively managed to avoid either group “dumping” on the other.
This leads back to the discussion of outsourcing MI. To really gain value from MI, it needs to tie in easily with the rest of the MA organization. It may be possible to pull that off with an outsourcer, but its unlikely. For that reason, I suggest that insourcing MI brings more value to the organization.
My final thought on MI relates to technology. A call does not have to be a phone call. Web chats are significantly more efficient to manage and allow for careful scripting of responses. Providing this service on an after-hours basis may allow more of those KOLs discussed earlier to actually connect. And, I have yet to see a company develop an MI app, but I think we can’t be too far from having one – just tap the icon and link directly to an MI chat or other dialog.
What has been your experience with MI and how it relates to other function in MA? Please leave your comments below. And if this is your first time on the blog, please sign up on the right to receive email updates of the latest posts – don’t worry its spam free.
MI is both a regulatory mandated function, and a critical component in achieving MA’s educational and public outreach goals. It is possible to structure and run the MI function merely to meet the regulatory requirements but that would represent a significant waste of an opportunity.
From a regulatory perspective, the MI function needs to be structured to answer calls from both patients and healthcare professionals (HCPs), differentiate between inquires and pharmacovigilance calls and route the calls appropriately, answer questions directly when appropriate, distribute accurate and approved materials to appropriate audiences, and develop outgoing medical communications on important issues (Dear Doctor letters). It needs to be staffed by people with appropriate qualifications to answer medical and technical questions about the use of company’s products.
But, some organizations gain much more benefit from their investment in MI. For one thing, MI is often the first sign that a problem is occurring relating to our products or issues are being raised concerning the scientific underpinnings of our products. Spikes in the type and content of questions help provide a Zeitgeist view of the needs for education in the HCP community. But, this only works if MA listens. There must be processes and systems in place to ensure that MI is coding their contacts in a manner that allows for analysis and reporting in place to ensure that the information is summarized on a timely basis. Finally, clear responsibilities need to be established for who will review and respond to this information.
Other organizations utilize the MI resources to more effectively partner with the MSL field force. MI and MSL groups tend to talk with related but mutually exclusive audiences. Given the limitations on MSL time, they need to focus that time on those HCPs that can offer the greatest impact on the medical community, the so-called Key Opinion Leaders (KOLs). Based on research I have seen in the past, it is very rare for a KOL to call MI. They tend to expect the answers to come to them through MSLs or research on the internet. Non-KOL HCPs tend to call MI. Given that, the opportunities for MSLs and MI to interact is not in terms of serving the same HCPs but instead in terms of “having each other’s backs.” Often when MSLs are interacting with HCPs, they need to provide those HCPs with additional information and support. MI is well suited to provide that information and support. And, when MI is answering questions for HCPs they encounter situations that require more in-depth support, and MSLs are well positioned to provide it.
Establishing a strong partnership between MI and MSL groups brings value to both sides, yet it is not as common as you might expect. Sometimes it’s due to organization structure – the two groups have unrelated reporting relationships and thus lack incentive to interact. Other times it’s due to a difference in philosophy, where one of the two groups does not see value in interacting with the other. Regardless, there is value in establishing this relationship, but it needs to be clearly structured and actively managed to avoid either group “dumping” on the other.
This leads back to the discussion of outsourcing MI. To really gain value from MI, it needs to tie in easily with the rest of the MA organization. It may be possible to pull that off with an outsourcer, but its unlikely. For that reason, I suggest that insourcing MI brings more value to the organization.
My final thought on MI relates to technology. A call does not have to be a phone call. Web chats are significantly more efficient to manage and allow for careful scripting of responses. Providing this service on an after-hours basis may allow more of those KOLs discussed earlier to actually connect. And, I have yet to see a company develop an MI app, but I think we can’t be too far from having one – just tap the icon and link directly to an MI chat or other dialog.
What has been your experience with MI and how it relates to other function in MA? Please leave your comments below. And if this is your first time on the blog, please sign up on the right to receive email updates of the latest posts – don’t worry its spam free.
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