 |
|
Upcoming Events
September 9th 2010 07:30 AM
- Successful Office Kaizen Events
September 9th 2010 08:00 AM
- Sup 1: Fundamentals of Leadership for Manufacturers - St Paul
September 9th 2010 09:00 AM
- Sup 2: The Next Stage for Improving Performance for Manufacturers-Plymouth
September 9th 2010 01:00 PM
- Sup 1: Fundamentals of Leadership for Manufacturing - Plymouth
September 14th 2010 08:00 AM
- Results-Driven Sales Incentives
September 14th 2010 08:00 AM
- Fraud and Misconduct at Investigator Sites
September 14th 2010 01:00 PM
- Failure Mode and Effects Analysis (FMEA)
September 21st 2010 08:00 AM
- Project Monitoring- The Earned Value Method
September 21st 2010 08:00 AM
- Project Monitoring: The Earned Value Method & Project Management
September 21st 2010 01:00 PM
- Project Management for Product Development
Article Index
Subgroup Analyses: Good Science, Data Mining and the FDAArticle by: Scott Brown The typical objective of a clinical trial is to demonstrate the beneficial effect of a medical therapy in a particular study population - the key being "in a particular study population." Deciding which patients to include in a clinical trial, especially one that involves a novel therapy, is one of the most important choices of the design stage. |
||
|
The Nimble Workforce Article by: Paula Norbom The past twenty years have seen a dramatic shift away from an employee-based workforce to a more nimble and focused workforce. Contract staff can now provide 'just in time', 'just what is needed' skills for virtually every aspect of a company's business, from data entry to experienced high-level management. Independent contractors work in companies across the country in almost every industry, including the medical device industry. |
||
Companies in the News: St. Jude Medical and Torax MedicalArticle by: Medical Device Alliance Torax Medical Inc. a firm that's developed a medical device used to treat acid reflux, has launched a key clinical trial. The Maple Grove company will test its device at 15 medical and academic facilities throughout the U.S. and Europe. |
||
ADVERTISEMENT
|
||
|
Subgroup Analyses: Good Science, Data Mining and the FDA |
||
|
The typical objective of a clinical trial is to demonstrate the beneficial effect of a medical therapy in a particular study population - the key being "in a particular study population." Deciding which patients to include in a clinical trial, especially one that involves a novel therapy, is one of the most important choices of the design stage. To put it simply, the patterns of disease are complicated, and patients who are candidates for investigational therapies are often the most complicated of all. These are typically people for whom established therapies have not worked, and who have few or no other choices. They often have widely different disease states and assorted comorbidities, and knowing in advance how a new therapy will work for each of them is impossible. Obviously, then, a great deal of effort is invested in figuring out the "right" patients for a study. Sometimes that effort is rewarded with a successful trial: good results from the statistical analysis, a compelling clinical justification and in regulatory situations, a thumbs-up from FDA. Other times -- well, you know what they say about the best-laid plans. When a trial fails to meet its clinical or statistical objectives, an attempt to understand what went wrong is the next step. For the sponsor, this is the right thing to do. When a great deal of time and money have been invested in a trial, it makes little sense to look at unappealing results, shrug one's shoulders and start from scratch. The obvious first question: what if we studied the wrong patient group? Specifically, what if there is a smaller group of patients in the trial who benefited, even if the overall population didn't show it? Welcome, then, to subgroup analysis. It's a natural thing to do from a practical standpoint, but fraught with difficulties both in a regulatory and a statistical sense. FDA tends to regard subgroup analyses as "hypothesis-generating," not as standalone evidence. That's partly because many subgroup analyses result from post hoc findings - analyses developed after the data were observed, as opposed to those prespecified in a study protocol. For instance, a recent paper by Hernandez et al. (Am Heart J. 2006 Feb; 151(2):257-64, "Subgroup analyses in therapeutic cardiovascular clinical trials: are most of them misleading?") found that among a selection of 63 randomized controlled trials, 39 reported subgroup analyses with 26 of those reporting on more than five subgroups, but only 14 - less than a quarter of all studies examined -- involved "fully prespecified" subgroups. This is probably unavoidable. Few sponsors can afford to make a trial large enough to permit powering of subgroup analyses. And if it were believed that therapeutic benefit would only be present in a subgroup, why include anyone else in the study in the first place? Rather, subgroup analyses are often motivated by the unexpected - we see something interesting in the data and react accordingly. From FDA's standpoint, though, the problem is bias - the increased chance of finding a false positive result by sifting through many possible analyses. This is why it is typical to prespecify study cohorts, primary endpoints and statistical methods - to prevent too much data mining, derisively called "data dredging." While data mining can produce findings of merit, it can be difficult to tell the difference between a real effect and spurious one under such circumstances. FDA isn't alone in its concerns. The New England Journal of Medicine recently published guidelines for reporting subgroup analyses in its pages (http://content.nejm.org/cgi/content/full/357/21/2189); the acknowledgements in that article include many well-respected statisticians, reflecting the interest in the issue and the importance of extracting the most scientific value from a clinical trial without stepping over into the murk. What to do? Despite potential misgivings, subgroup analyses are often important to interpreting the results of a clinical trial. Though a subgroup analysis may not carry the day by itself, it can provide valuable insight for future trials. For that matter, subgroup analysis may be useful in a pooled analysis across multiple studies, such as with a Bayesian trial design. As always, when in doubt contact your friendly neighborhood statistician for suggestions on how to proceed.
|
||
ADVERTISEMENT
|
||
|
The Nimble Workforce |
||
|
The past twenty years have seen a dramatic shift away from an employee-based workforce to a more nimble and focused workforce. Contract staff can now provide 'just in time', 'just what is needed' skills for virtually every aspect of a company's business, from data entry to experienced high-level management. Independent contractors work in companies across the country in almost every industry, including the medical device industry. According to the U.S. Bureau of Labor Statistics, independent contractors increased 10% between 1995 and 2005, and made up 7.4% of total employment, with 81% over age 35. 82% of these independent contractors preferred their work arrangement to a traditional job and indicated that increased independence was a significant component of their satisfaction. In the current economy, contract staffing is a critical element in the strategic planning of any company and perhaps even more important for small or midsize businesses. A company that cannot quickly and effectively re-direct resources in response to changing business and market needs will fall behind and may ultimately fail. Risk Management There is no doubt that the largest single operating expense for any company is payroll and related costs. The effective use of human resources goes right to the bottom line. Companies with too many, too few or the wrong people may pay a high price. Overstaffing Change in business demands creates the risk of having excess employees. An independent contractor workforce can easily and cost effectively adapt to changing needs. For example, a local medical device firm increased permanent staff during three proposal processes, but ultimately did not "win" any of the proposals. An employee of only four months was laid off, resulting in a loss of recruitment and training costs associated with that employee, not to mention the effect on the morale of remaining employees. Hiring an independent contractor would have provided much more flexibility. Understaffing For staffing gaps due to illness, resignations, or extended vacations, independent contractors with a like skill set may be able to fill in seamlessly. A local emerging medical device company requested a Sr. Clinical Research Associate when a current employee resigned. An independent contractor with a complementary medical device technology background was sourced and placed in the interim position within a week, and was able to cross train with the employee who was leaving. Right staffing One of the greatest benefits of contract staffing is the ability to tap into a world of talent and experience when you need it, but only for as long as you need it. For opportunities outside normal business or process improvement initiatives, the best decision may be to hire a skilled and experienced independent contractor instead of incurring delays and costs involved in recruiting, hiring and training a new employee or re-training an existing employee. A local medical device start-up needed to develop a quality system. Rather than hire a full-time resource, they looked to an independent contractor with over 20 years of experience. He developed a quality system the company could utilize as they proceeded through their product development process. Another company implementing a new ERP system hired independent contractors to help with integration and documentation of new process flows. For these companies, tapping into the right talent at the right time was critical to their ability to grow. Perry Parendo of Perry's Solutions, LLC says it can be a slow process for organizations to understand "right staffing". An organization first contracted with him when their product development project had their "back against the wall". After years of development, and well into the test cycle, product performance was not satisfactory. To compound the problem, a large amount of custom manufacturing equipment was purchased to prepare for production, and process development was well underway. Perry created a series of tests using Design of Experiments that determined with confidence that a design change was needed. From these DOE test results, the product was redesigned, and Perry continued his involvement with testing. Using strategic testing without the prior constraints, the project came together quickly and objectives were achieved in 3 months. Due to this success, the organization asked for early development assistance from Perry for the next project. The working dynamic was very different, with the focus on answering the following questions:
A strategy and project plan was created to address those questions so that another crisis situation could be avoided. "While I can help when they hit the wall," Perry says, "it is much easier and smoother for the company when they involve me early to expose the potential gaps to reduce risk". Productivity With the right talent in the right job, productivity will increase. It is common for a company to focus staff on the core mission and outsource non-core activities. When a local urology medical device company needed reimbursement expertise, a staffing agency helped them quickly find a senior reimbursement expert to efficiently answer their questions. Companies can gain productivity by offloading job posting and candidate screening to meet their staffing needs, while freeing up existing staff to work on income producing activities. With a ready reserve of qualified talent, an agency can speed up the placement process and provide a candidate pool carefully selected to meet a company's specific, current needs. Capital Efficiency Companies must be fluid in the size of their workforce. Hiring experienced full-time employees is a commitment. Recruiting fees, vacation, sick leave, unemployment insurance, workers compensation, and payroll taxes typically represent approximately 20% of an employee's base pay. And this doesn't include bonuses! If the hire doesn't perform as planned or business needs change, costs of terminating an employee include severance, vacation pay out, effect on unemployment insurance ratings, and possible negative impact on morale. Hiring contract talent can lead to significant cost avoidance, as illustrated in Perry's Design of Experiments testing, but there are other cost savings. Contracting eases the administrative burden by spreading out costs and creating a sort of assured performance period, helping ensure a mutual match. If eventual permanent placement is the end goal, contracting is an affordable way for both sides to "try before you buy." For short term engagements, there are few cost effective solutions as easy to employ. The trend toward a workforce as adaptable as the world is changeable will continue. CareerBuilder's "2009 U.S. Hiring Forecast" published on December 30, 2008 states that "28 percent of employers anticipate hiring freelancers or contractors to support their business as they wait for the economy to bounce back." The companies that thrive will be those who consider all workforce options, including contract staffing through an ongoing relationship with an experienced agency.
|
||
ADVERTISEMENT
|
||
|
Companies in the News: St. Jude Medical and Torax Medical |
||
|
Torax Medical Inc. a firm that's developed a medical device used to treat acid reflux, has launched a key clinical trial. The Maple Grove company will test its device at 15 medical and academic facilities throughout the U.S. and Europe. Torax's device supports a muscle that, when weakened, allows acid to seep out of the stomach. The firm is targeting patients who haven't been helped by drugs, which can relieve pain but don't necessarily prevent acid from damaging the body. Torax estimates that about 19 million people in the U.S. suffer from acid reflux disease. The company has raised more than $10 million in venture capital from venture firms including Minneapolis-based Thomas, McNerney & Partners. Medical-device consultancy opens in Bloomington Emergo Group Inc. announced it has opened an office in Bloomington. The Austin, Texas-based medical-device regulatory consulting firm opened the office Friday. Mike Johnson is the office's director of business development. The company decided to locate an office in the Twin Cities because of the concentration of medical-device companies here, said Chris Schorre, a spokesman. Johnson is the only employee in the Bloomington office now, but the company plans to hire more people when the economy improves, Schorre said. St. Jude Medical wins FDA approval for defibrillator lines St. Jude Medical Inc. on Monday said federal regulators have approved a pair of cardiac defibrillator product lines. The Promote Plus and Current Plus defibrillators, approved by the U.S. Food and Drug Administration, include features that allow doctors to customize therapy for patients with heart arrhythmias and heart failure. St. Jude (NYSE:STJ) said the new products also have a smoother header configuration to make the defibrillators more comfortable for patients, as well as provide more visibility at the connector site, where the thin wire that delivers electricity to the heart is connected. Cardiac devices such as defibrillators are big business for Little Canada-based St. Jude, which reported a 14 percent jump in earnings in its first quarter. The increased profit was partly fueled by strong sales gains in St. Jude's cardiac device business units. Sales of cardiac-rhythm management products, such as pacemakers, rose 7 percent to $676 million in the first quarter. Implantable cardiac defibrillator sales increased 9 percent to $394 million, while pacemaker sales climbed 4 percent to $282 million.
|
||