Wednesday, February 1, 2017

How to Coordinate a Successful Clinical Trial Collaboration

A lot of work goes into planning and running a clinical study. Sponsors have found that collaboration with a Clinical Research Organization (CRO) is needed to achieve the ultimate goal. A CRO is an organization that help sponsors conduct clinical studies. CROs use web-based collaboration to set up project managers and electronic document control systems to ensure the sponsor has up to date information on study progress. Based on 2005 statistics, biotechnology and pharmaceutical companies paid an estimated $14 billion to CROs for out sourced services. It is estimated that by 2010, approximately $20 billion will have been paid out to CROs for their services. This is a good sign that CROs are here to stay and sponsors, investigators, and CROs must learn to function cohesively to run successful clinical studies. Here are some tips to keep in mind.

The Hierarchy

First, a successful collaboration is very dependent on having a clearly defined relationship. Each person must know to whom to report certain aspects of the clinical trial. Once the relationship is defined, managers should ensure everyone adheres to the reporting structure. In an ideal situation, the sponsor hires the CRO and delegates all or select responsibilities to the CRO. Once hired, the CRO typically hires the clinical investigator staff (In the resource section, see the article on choosing good investigators for specifics). Therefore, the reporting structure should be that the CRO reports to the sponsor and the investigator reports to the CRO. If the sponsor interacts with the investigator site, it should only be due to communication breakdown between the CRO and the investigator site personnel.

During audits, I noticed the biggest complaint from the investigator site is that the CRO and the sponsor both contacts them at different times for the same information. This disrupts the site, causing them to stop their routine work to copy and fax the same record more than once. The sponsor should have contacted the CRO for the information and let the CRO get the information they needed. If the CRO is not performing up to expected standards, replace them, but don’t do their jobs for them.

Communication is the Key

Communication is always the core of the issue when people aren’t getting along. All three entities must learn to respect each others needs. The sponsors main concern is getting specific data from the protocol within a certain time frame. The CRO’s concern is meeting the sponsor’s predetermined time line. The investigator’s concern is conducting the clinical trial with as little as possible interruption to his or her routine. The three need to discuss how they prioritize certain elements related to their general routine, how clinical research can be integrated effectively in that routine and how good, honest and accurate data can be obtained in a timely manner. Respect for each other will go a long way in accomplishing a mutual goal.

Listen, truly LISTEN and understand how each person operate

In the Center Watch 2007 Survey on clinical trials, the CRO Kendle was rated number one by 522 US clinical investigator sites. According to the investigators, Kendle stood out over their competitor because they listened to what the investigator and staff had to say. Additionally, they were quick to respond to the investigator’s questions and provide feedback to ensure the clinical study progressed. The other fact that was impressive was their realistic time-lines. Sponsors and CROs tend to forget that they are not the investigator’s only client. Investigator site personnel do not always know or understand the significance of certain protocol requests and therefore do not follow through. For example, transcription errors occur a lot. I suggest that a few minutes of proofreading could reduce errors by more than 75%. Since investigator personnel do not have to analyze the data, they do not understand the significant setback caused by transcription errors.

The sponsor, CRO and clinical investigator’s site can be extremely productive when working together to achieve the common goal. To work well together, each one only need to implement these three ethical principles: 1) respect for persons, 2) beneficence and justice.

Labels: How to Coordinate a Successful Clinical Trial Collaboration



So many times through the years

I had so much I needed to say

Instead I lived with all the fears

And simply went the other way.

It never occurred to me

That my brother could be a friend

It was something I couldn’t see

And only something I could pretend.

It took the passing of our dad

And my journey into hell

To show me what I always had

To break me out of my shell.

Now these two brothers

Can finally share

We can show each other

How much we really care.

We can make up for time lost

And rediscover our past

No matter what the cost

Our special bond will always last.

And in the end

When all is said and done

My brother is my best friend

He is the chosen one.


Decision for Prophylactic Double Mastectomy After Breast Cancer Diagnosis May Not Be Necessary

It is the rising trend to today that once a woman is diagnosed with breast cancer in one of her breasts, she will have a prophylactic removal of the unaffected breast for fear of recurrence of cancer in that breast.

Maybe this practice can be reduced by counseling and educating woman on the actual risk of recurrence. Many cancer survivors erroneously believe that the risk is 5-10% higher of also getting cancer in the unaffected breast at the time of diagnosis than it actually is. There is actually no evidence that the removal of the unaffected breast will positively affect the chances of survival for woman who have a risk for cancer recurrence.

A breast surgeon in Bristol, England, noticed this trend in his patients and wondered why. He also wanted to know if there was a period of time where the woman could regain her balance after the fright of the diagnosis and a chance to get counseling as to the actual facts, that she might change her mind about the removal of her perfectly good breast.

They did. In this physicians practice there were 23 of 27 women that changed their mind about having a bilateral mastectomy when only one breast was affected. These 23 women had a mastectomy of the affected breast and radiation and/or chemotherapy. They also received counseling and support for a year. And of course it is the woman’s choice so after one year if any woman still wanted the unaffected breast removed this was done for her.

It is obvious that when the diagnosis first occurs it is a time of stress and fear. This is certainly no time to make this emotional decision. All these women were counseled that no survival benefit was ever suggested by this drastic of a surgery. They had yearly mammography as a method for monitoring recurrence.

It is interesting as to the reasons these woman gave as to why they wanted their non cancerous breast also removed at the time the cancerous breast was operated. In twelve of the woman there was a family history of breast cancer. A few of the woman (four) had a family member or friend that didn’t fare well after a single mastectomy. One woman simply wanted to avoid radiation. And three wanted it due to their young age for fear of the cancer coming back.

It is never a good idea to make a hasty decision. It is always recommended to have a second opinion and to research the diagnosis and know all you can BEFORE you make any decisions.



Labels: Decision for Prophylactic Double Mastectomy After Breast Cancer Diagnosis May Not Be Necessary

Dog Training: Depersonalized Punishment

Punishment and Reinforcement are very powerful tools in dog training. The correct use of them can make your dog respond to any command in dog training. In the article Dog Training: The Command Sit,” I showed one simple use of Punishment and Reinforcement in dog training, but those can be used in any daily activities, if you do it correctly.

First of all, before any misunderstanding: punishing the dog doesn’t mean to beat the hell out of the dog. That’s only stupidity. The key to the correct punishment is to find out what is the best cost-benefit punishment. In most of the dogs, the worst punishment is the lack of your attention, and that’s what you should use in dog training. Dogs are very sociable animals, and your attention and approval are the best gifts you can give him, so, the opposite works. If you ignore the dog, he will feel punished already. One of the ways to do it is turning his back to him and refusing to play or talk to him.

Of course, ignoring the dog will work only when you are near him, but how to punish the dog when he does something you don’t want when you are not home, for example? That’s also dog training, and there is a very efficient method to teach your dog not to do something. Let’s take an example: suppose your dog pulls the towel of the dinner table every time you leave home (in fact, that was a real situation between me and my dog). That’s when you will use a very interesting dog training concept: the depersonalized punishment. That happens when the dog thinks he is being punished by the mere will of God.

In the towel case, I had to train the dog to believe that pulling the towel would bring nasty consequences to him, so, I had to think what would be unpleasant. Dogs have hearing much more accurate than humans, and they hate loud noises as bells or fireworks, so, I had to produce a loud noise when he pulled the towel. I took a can, filled it with coins and left it on the corner of the table. I left home and waited a few seconds outside before hearing the noise of the can hitting the floor. I came back him and the dog was scared in the corner. I did it for more two days in a row, and he never pulled the towel again. The dog was trained not to pull the towel.

There are gadgets that work as depersonalized punishment and train the dog for you, for example, a collar that pulverizes water on the dog when he barks too loud. For stronger dogs, as pit bulls, there are radio controlled electroshock collars that are used by the trainer to inhibit certain behaviors during dog training, but I’m not fond of that one; it’s kind of cruel.

The dog training trick for depersonalized punishment is to use the dog’s bad behavior as a lever to his punishment and training. Gadgets are good, but there are simpler things. When the dog likes to eat your furniture, for example, you can spray some bitter substance on it, and he won’t like to eat the furniture anymore. After some time, he won’t even try it.

Regular punishment as yelling to the dog, or even beating him, can make the dog believe that he can do anything as long as you are not home. Depersonalized punishment, however, won’t associate the punishment to you, but to the environment, what will train the dog to behave when you are home or not.

Labels: Dog Training: Depersonalized Punishment

Credit Card Data Breaches Cost Big Bucks

Javelin Strategy & Research estimates that credit and debit card issuers spent $252.7 million in 2009 replacing more than 70 million cards compromised by data breaches.

In 2009, an estimated 39 million debit cards and 33.3 million credit cards were reissued due to data breaches, for a total of 72.2 million. An estimated 20% of those affected by the breaches had more than one card replaced. I had my MasterCard replaced twice.

Javelin’s survey shows that 26%, or one out of four U.S. consumers received a data breach notification last year from a company or agency holding their personal data, including credit and debit card or checking account information.

What is very interesting is of those notified (which is required by law in most states), 11.5% were victims of identity fraud compared with only 2.4% who weren’t notified.

I’ll say this again and then explain what I think this means. They say a consumer who has been notified that his credit or debit card number was compromised is five times more likely to become a victim of identity fraud than a person who doesn’t get such a notice.

The report’s reasoning behind this is that data breaches lead to fraud. Okay, yes, I’ll agree that data breaches do lead to fraud, and my belief is that the people who were notified simply took a closer look at their statements and recognized unauthorized charges. If they weren’t notified they are no less susceptible to fraud, they are just blissfully unaware they are paying for an identity thief’s Las Vegas bender, and the fraud goes undetected.

DigitalTransactions explains, “Data breaches are one obvious pathway to fraud, but a breach alone doesn’t mean an affected consumer will become an identity-fraud victim. Banks often give free credit-report monitoring services to customers whose data may have been compromised.”

The flaw here is that credit monitoring only makes the consumer aware of new account fraud, when a Social Security number is used to open a new account. Credit monitoring has nothing to do with credit card fraud in which an existing account is compromised. Furthermore, in my experience credit monitoring is hardly ever provided when a credit card number has been compromised. Credit monitoring doesn’t help when an existing account is taken over.

“There’s a disconnect,” Javelin tells Digital Transactions News. Consumers “should pay attention to your credit reports after you’re notified, because you’re more vulnerable.”

Yes, it’s true that if you are notified that your Social Security number has been compromised, you are more vulnerable to fraud, but not more vulnerable to fraudulent charges on an existing credit card, since the bank will replace a card that is known to have been compromised. And monitoring a credit report does nothing to prevent credit card takeover fraud.

The only way to combat credit card account takeover fraud is to pay close attention to credit card statements, while credit reports and credit monitoring are essential to prevent or detect new account fraud.

I recommend checking your credit card and bank statements every day, or at least once a week, from a secure PC.

Robert Siciliano, personal security and identity theft expert adviser to Just Ask Gemalto, discusses credit and debit card fraud on MSNBC. (Disclosures)

Labels: Credit Card Data Breaches Cost Big Bucks

Early Breast Cancer Detection Begins with the Candelis ImageGrid

Breast cancer is a serious matter. It is quickly becoming one of the most widespread types of cancers for women in the western world. Detection is the best weapon against it. Unfortunately, the old standard form of mammography is no longer cutting it, since it is one of the most difficult exams to read due to lesions being disguised by normal tissue. pacs radiology combined with a mammography viewer is filling in that void and becoming widely accepted as the best method for early diagnosis of breast tumors.

A woman’s annual mammography examination requires the comparison of images from previous years. Digital images stored on mammography workstations provide your doctor or radiologist the easiest way to find these past images which they can then compare to newer ones. Digital mammography implementing an affordable PACS provides images which can be tweaked by your doctor to better contrast or improve an image, a capability simply not possible with film.

If your radiologist needs to spend an extra minute or two accessing mammography images, it may not seem like a huge deal. However, multiply that by the tens of thousands of mammograms taken annually, and you have yourself a problem. It is a waste of time for the radiology department while being a large financial burden to that institution.

candelis pacs enable medical professionals to access PACS workstations in real time over the web. No other device can increase productivity while also being an effective form communication. It also adds a more streamlined record-keeping and storage service, as well for viewing medical images.
It’s no wonder why an increasing number of breast centers are choosing to integrate full-field digital mammography workstations with their preexisting PACS workstations, archive, network, and Web distribution system. It acts as a means of enhancing radiologist efficiency and improving administrative efficiency.
Some its benefits are:

 PACS radiology allows for ease of access to all radiologic studies off only one database.
 An affordable PACS works to leverage the balance between the facilities Web server, network, and archive, working to save on huge costs.
 A mammography viewer eases comparing exams from different modalities off of one database. This would include digital mammography, PACS workstations, MRI, ultrasound, and PET.
 A mammography workstation functions far beyond that of a standard mammo viewer and forms of radiology medical imaging. They are fully capable of storing virtually any type of digital file.

A mammography workstation combined with Candelis PACS allows radiologists along with referring physicians the ability to view any radiologic examination, reporting off of one database and with one user interface. It’s no wonder health facilities are beginning to see benefits for both the patient and themselves.

Labels: Early Breast Cancer Detection Begins with the Candelis ImageGrid

. . . Continuation of Florida Snowbird

Likes and dislikes to consider for a vacation home are abundant

What it boils down to is the individuals. Choices range from embracing a party atmosphere, to a quieter lifestyle.

More glamorous places like the Florida Keys come with a price. Usually visitors go to the mainstream shops and party places.

A visit to the neighborhoods reveals houses with tennis court type fences to guard the place. Warm weather attracts indigents, because living outdoors is so easy. Hence, the excessive backyard fencing.

The Keys offer excitement. A backyard fence keeps the druggies away because they don’t have the vitality to climb.

Living close to the water clusters a diverse array of people.

Diverse equals diversity. An example of one neighborhood in South Florida is a prime example of why I don’t want to live near the water.

In this neighborhood middle class folks remained from a by gone day. As this beautiful area was discovered by new comers, the battles began. Construction of two new homes led to a petition to shut off access to a long standing public beach.

The ramifications for preexisting residents was glaringly apparent. First, they would lose convenient access to the water. Second, without being able to offer the access, resale value would plummet.

Yet,the petition hearing got scheduled. Folks in the neighborhood had to stop their lives so they could rally against the closure of the neighborhood beach.

Homeless people gravitate toward beaches. Again, many of these are addicts, or victims of mental illness. They could be and are wandering around the neighborhood while residents sleep.

Down a ways from this neighborhood, are cardboard mansions.

Let me correct that. They are cardboard condos. The building materials for these were so cheap, that hurricane damage turned out to be permanent. With only a shabby foundation to work with, repairs couldn’t return the original, crisp looking facade.

All of the lust and avarice surrounding waterside living is universal. Be it ocean or lake, the zeal that people have for being there is fodder for antagonism.

I’ve met people living in the high rise buildings along the oceanside that are happy there. All they have to do is walk out the door and onto the beach.

It was a different story when the hurricanes hit. Some of these literally got filled with sand on the first floor.

I like to feel as if I’m sort of a part of community. I love meeting people, and it seems easier to do this in a less glamorous setting. All the same, this is a personal preference. I can get to the beach in tens minutes. Beautiful beaches are found almost everywhere in Florida.

Labels: . . . Continuation of Florida Snowbird

Bogner Outerwear for Women

Stay warm in luxury this fall and winter season with jackets from the collection of Bogner Outerwear for women, Known as one of the most well made coats Bogner Outerwear for women offers lightweight and heavyweight coats and jackets designed for cold weather and regions prone to severe weather while being stylish and fashionable.

The Bogner Lightweight Quilted Jacket is an excellent example of the style and quality expected by followers of the brand. Designed with military styling the quilted olive green jacket features long sleeves, snap cuffs, allover quilting, a snap and zip front, and a button-down collar. Pockets are plentiful on the Bogner Lightweight Quilted Jacket as the stylish coat features front slash pockets, a vertical zip pocket, hip pockets and a cargo pocket on the left sleeve. Made from durable polyamide and gilled with goose down feathers the Lightweight Quilted Jacket from Bogner Outwear for women retails for $1499.

Military styling is big this season in women’s wear and the Bogner Quilted Military Jacket in black is a must have for fall and winter. Made from woven nylon and filled with goose down feathers, the Bogner Quilted Military Jacket features allover quilted styling, a tabbed back, long sleeves and snap cuffs, and a standup collar with military inspired details. Perfect for pairing with skirts or luxury denims the Bogner Quilted Military Jacket was found for $1299 from Neiman Marcus.

A favorite choice for fall and winter from the collection of Bogner Outerwear for women is the Paisley Print Fur Trim Jacket in a pink multicolor paisley print. Made from woven nylon and filled with goose down feather insulation the Bogner Paisley Print Fur Trim Jacket features long sleeves with quilted arms, quilted sides and back and a detachable hood with a removable fur trim. Adorned with pockets on the left sleeves, hips and chest the Bogner Paisley Print Fur Trim Jacket retails for $1878 found at Neiman Marcus.

Labels: Bogner Outerwear for Women

Daddys Cap

My daddy was a small man
His stature five foot five,
But when he wore his cap
It was raised about a hight.

He wore his cap so manly
It built up his physique,
It made him look distinguished
He certainly looked unique.

But a hat don’t make a man
It’s what he Is Inside,
When I think of daddy
My heart swells with pride.

A father protects his children
makes them feel secure and safe,
A real dad Is Jesus like
God sent him to feel his place.

God instructed us to you dad
Be the hedge, fill In the gap,,
There’s more to being a dad
Than putting on a hat.

Labels: Daddys Cap

Should You Diet when You're Sick with Reduced Calories?

The idea of a reduced calorie diet to lose weight is not to place the immune system in the red zone while maintaining a negative calorie deficit in the body. The average dieter is expected to consume between 1200 and 1800 calories every day, depending on gender. When sickness strikes, it is common to ask if you should diet when you’re sick by continuing the same reduced calorie meal plans? The simple answer is yes.

Healthy Eating and Sickness

A healthy eating plan for weight loss should contain enough calories to suffice the body in times of sickness and health. Dieters can think of the menu plan as a marriage. When times get tough, most couples will work through the differences and come out better on the other side. The same goes for weight loss plans with reduced calories. If the immune system is kicked into overdrive to fight off illness, this is the best time to continue eating healthy.

Why Does Sickness Mean Eating Unhealthy?

Most often, dieters ask the question, “Should you diet when you’re sick?” because they “feel” better when they are eating unhealthy. Food addiction is a physical condition that affects mental status. When eating unhealthy foods, it may not be that the dieter physically feels better, but the mental state changes. That is why comfort foods are called such.

Comfort foods tend to be high in fat and cholesterol, which are both unhealthy for an ailing body. It is important to remember, however, that certain foods or dieting habits may need to be changed during times of sickness in order to best achieve wellness in a shorter amount of time.

When to Sacrifice Calories or Weight Loss for Better Health

If the menu plan you have chosen for dieting is lacking in vitamins and nutrients, food changes need to be made to better support the body’s natural defenses. Low carb diets, for instance, tend to be high in fat and protein. If followed correctly, there will also be a healthy supply of all necessary vitamins and nutrients. If the dieter has chosen to follow a strict meat-only plan, vitamin C levels could be lower than necessary to support better health. In this case, taking a vitamin C supplement may suffice, but natural sources of vitamin C are better absorbed by the body.

Labels: Should You Diet when You're Sick with Reduced Calories?

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