Today we have a special guest blog from Steve Ehrhard, our Quality Assurance Director.
We all know about quality control. We experience the results of it in most everything we encounter. Did I get a good haircut? Are the apples fresh? Did the car get fixed correctly? Will the software actually do what I think it will do? Is the car going to get good gas mileage? There is a lot of activity going on behind the scenes to answer these questions.
When we think of quality, we think of it most often in two ways. First, is the service delivered to us error free or do the goods that we buy come to us without defects or problems? Second, does the product (goods or services) have the necessary design features to meet our needs? These two ideas, quality in the sense of design and quality in the sense of deficiencies, generalized by Dr. Joseph Juran and others, provides a means to both understand how to think about quality, and how to achieve it. That is, a business of providing goods or services must design the offering to meet needs and deliver it defect free.
Clinical trials have quality considerations. The drug or medical device that is being tested must be provided without defects or, in regulatory terms, adulterated or misbranded. It would be ethically wrong to subject a person to a drug or device that we knew was adulterated or misbranded. In a clinical trial, the drug or device has been designed to achieve a particular diagnostic, therapeutic or disease treating objective. That's, of course, what the trial is designed to confirm. International regulatory bodies have created rules to make sure drug and device manufacturers ensure a quality of design and flaws in the study are prevented.
Clinical trials also have "people" considerations. Are patients subjected to the safest protocols we can design? Is privacy protected (HIPPA)? Did the patient consent to participate? Regulations also require a number of actions and rules that a drug or device clinical trial sponsor must follow to ensure there are no exposures in the design of the trial and no problems with how it is conducted.
Certus International, as a Contract Research Organization, is in the business of managing clinical trials. Our product is information, and we have an extensive set of procedures and activities to ensure that our clinical trials are properly designed and executed. Clinical study protocols and plans undergo extensive analysis ensuring that objectives are clear, achievable and logical for drug or device testing. The design of data collection and analysis is carefully considered to make sure that the diagnostic or therapeutic effect of the drug or device can be discerned. Procedures at the clinical sites are designed to address how study subjects are treated and protected. During the trial, we review data extensively, as it is collected (called source data) verifying that it is accurate and precise (defect free) so that it is analyzed correctly.
Our quality objective provides a clinical trial sponsor with information about the drug or device that is trustworthy and reliable and can be the basis for ultimately approving for use in diagnosing or treating disease. The data we collect, and make sure is sound, through quality assurance, is eventually used to establish a drug or device's safety. In other words, quality assurance means helping people by making sure their drugs and devices are as safe as possible.
Friday, December 18, 2009
Tuesday, November 17, 2009
Self- Breast Examinations
Personally and professionally, the new recommendations issued by the AHRQ at http://www.ahrq.gov/CLINIC/uspstf/uspsbrca.htm cause me concern.
Approximately eight years ago, I was attending the Society of Nuclear Medicine meeting in Toronto. While there, the headlines in the Toronto paper extolled the government's new policy of dissuading women from doing self-breast exams.
It seemed to me, at the time, that the only reason for this decision was to reduce healthcare costs by reducing costs for mammograms and biopsies, while sacrificing the possibility of early detection of breast cancer.
It now appears the US Government has taken this a step further by not only dissuading self-breast examinations but also by recommending the end to mammography screening in women under 50 years old. Having been indoctrinated with the importance of self-breast examinations in medical school, and dealt with patients who found breast lumps that eventually turned out to be malignant; I believe self-breast exams are critically important for every woman, no matter how old. You can find some important, and easy to understand statistics on breast cancer rates here. Thank you to Imaginis for providing this information to the public.
I have never seen any medical argument against self-examination as not being one valid way for early detection of breast cancer unless it was ultimately driven by cost saving. In fact, if women do their own examinations, it is likely they will detect a change much earlier than a doctor might at a yearly physical.
As a researcher in breast cancer detection and imaging, I worry that this recommendation is only the tip of the iceberg as the US government takes control of our healthcare.
Approximately eight years ago, I was attending the Society of Nuclear Medicine meeting in Toronto. While there, the headlines in the Toronto paper extolled the government's new policy of dissuading women from doing self-breast exams.
It seemed to me, at the time, that the only reason for this decision was to reduce healthcare costs by reducing costs for mammograms and biopsies, while sacrificing the possibility of early detection of breast cancer.
It now appears the US Government has taken this a step further by not only dissuading self-breast examinations but also by recommending the end to mammography screening in women under 50 years old. Having been indoctrinated with the importance of self-breast examinations in medical school, and dealt with patients who found breast lumps that eventually turned out to be malignant; I believe self-breast exams are critically important for every woman, no matter how old. You can find some important, and easy to understand statistics on breast cancer rates here. Thank you to Imaginis for providing this information to the public.
I have never seen any medical argument against self-examination as not being one valid way for early detection of breast cancer unless it was ultimately driven by cost saving. In fact, if women do their own examinations, it is likely they will detect a change much earlier than a doctor might at a yearly physical.
As a researcher in breast cancer detection and imaging, I worry that this recommendation is only the tip of the iceberg as the US government takes control of our healthcare.
Friday, November 6, 2009
Sunday, November 1, 2009
The Beginning
Social media is growing in popularity. I have been thinking of joining the craze for some time now, but due to perceived restrictions and general negativity about the Pharmaceutical industry, I have been hesitant. I now believe, however, that many of the Social Media restrictions placed on the industry have been self-imposed, and have decided to embark on a social media journey.
The hesitancy by our industry to dip our toes into the frigid waters of social media is understandable; especially because there have been little to no guidelines issued by the FDA in regards to what can or cannot be said. In addition, it can be a cold, crazy ocean out there with sharks waiting to eat you up at the slightest wrong move. Not to mention the millions of little fish that could be lead astray should the information you put out there be misinformed or worse- wrong all together. If the responsibility to the rest of the world, less informed about the industry of drug development, were not enough to keep you out of the water, the sharks definitely are.
Our industry is so used to strong guidance that the idea of embarking on unmarked, vastness of water that is social media is, in a way, scary. Granted, the FDA is now beginning to consider anchoring some buoys in some of the bays and coves with their hearing planned for mid-November, but with social media, even today, at the beginning of the same month, that is a long span of time. Social media does not have "hours" or reside only in one time zone. It is constant, practically omnipresent, in the modern world.
The hearing is scheduled to take place about 17,280 minutes from posting this blog. With 1,668,870,408 people with access to the internet, that is 28,838,080,650,240 people-minutes for someone to say something bad about your company or report an "Adverse Event." Those numbers can be really scary for a CEO like me, who just wants to protect his company and its reputation; ensure that the people that work for me can stay employed; and uphold social and personal values.
I have come to the realization that the conversation that I and other people in this industry have been avoiding is taking place, whether we are present or not. By not participating in the conversation we are being seen by those in the conversation as stuck up and unwilling to take part, or worse, secretive, greedy and dishonest. That is not what I am, nor my company.
Those with understanding in the industry need to be available to those without. In this way, we can ensure that the information out there is indeed valid and relevant. When the H1N1 virus first became the media firestorm that it now is, many misinformed individuals posted that you could get the "swine" flu from pigs (and other misnomers,) causing a great deal of confusion and a huge hit for the pig farmers. The greater travesty is that many still believe this. If more qualified individuals were present in the social media scene, perhaps many of these kinds of misunderstandings could be avoided.
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