May 12th, 2009 by kpennert
“I know”, said A. “Let’s do a parallel group design”. “No, no, no. Not a subject consuming parallel group design!” B cried out in a high voice “This is obviously a text book example of when a cross-over design should be used”. C looked at them both in disbelief. Did they not follow the latest developments? Did they not receive the weekly e-issue of “Stats for You and Me”? “Well”, he said feeling quite pleased with himself, “I suggest an adaptive design”. He did not really know what it meant, but he knew it was the new in-word. “You what?” said A and B in chorus. “What do you mean?” C did not feel quite as comfortable any longer and wished his friend and statistician, Ritch Monde was there. “Well”, he said again and took a deep breath.
“We can start with a parallel group design, and then we may cross over to a factorial design if the first 30 subjects included show a lower between subject variability than the next 20 subjects we may or may not include. That of course depends on the 92.5% confidence interval which we will adjust according to the Brown-Darling method, and how many p-values we want to present”. “To be absolutely certain we should carry out a couple of regression models analyses, and perhaps top up with an analysis of variance. Just in case.” “What do you reckon?” “Hello, where is everybody gone?”
Do you feel confused and not certain how to design and analyse your clinical trial? Our senior statisticians have many years of experience from a wide range of therapeutic areas, statistical designs and models. Nothing is too simple or too complex.
Challenge us!
Posted in RPL Clinical Data Management, Statistical Methods, analysis | No Comments »
April 7th, 2009 by kpennert
What is a blog, and how common are they?
Wikipedia defines blogs as:
• A blog (a contraction of the term weblog) is a type of website, usually maintained by an individual with regular entries of commentary, descriptions of events, or other material such as graphics or video. Entries are commonly displayed in reverse chronological order. “Blog” can also be used as a verb, meaning to maintain or add content to a blog.
The Blogosphere is the collective community of all blogs. There have been a number of studies aimed at understanding the size of the Blogosphere. As of August 2008, blog search engine Technirati was tracking more than 188.9 million blogs! As the Blogosphere grows in size and influence, the lines between what is a blog and what is a mainstream media site becomes less clear. Larger blogs are taking on more characteristics of mainstream sites and mainstream sites are incorporating styles and formats from the Blogosphere. In fact, 95% of the top 100 US newspapers have reporter blogs.
The size of the Blogosphere may be uncertain, however it is clear that blogs are a global phenomenon that are here to stay!
We at RPL Data Management would like to hear from you, so join the Blogosphere and enter a comment, start a discussion or challenge us!
Tags: blog, Clinical Data Management Services, RPL Data Management
Posted in RPL Clinical Data Management, blogs | No Comments »
March 31st, 2009 by kpennert
We all probably use the word “quality” several times a day. Using expressions such as “With high quality”, “providing the highest quality”, we are giving the message we are professionals with skills and knowledge in what we are doing.
So what is quality? Well, the simple answer is “it depends”. Quality can be very subjective, as in quality of life. What to one person is good quality of life may be perceived as poor quality of life to another.
More scientifically, it depends on the area of interest.
As an example, in thermodynamics, the quality of a fluid is the percentage of mass that is vapor; i.e. saturated vapor has a “quality” of 100%, and saturated liquid has a “quality” of 0%.
In music theory, quality is the number of harmonics of a fundamental frequency of an instrument (the higher the quality, the richer the sound).
The quality of clinical data can be defined as the reflection of a subject’s true health status at a given point in time. In order to ensure that the data that are included in the study report are of “highest quality”, it is common practice to apply a number of quality check steps from data collection to study report. However, the chain is only as good as its weakest link. The motto for anyone involved in clinical trials must be Get It Right First Time! This is achieved by implementing robust processes at the beginning of the data flow to ensure a smooth running of the study with little or no opportunities to go wrong.
In clinical trials, all the instruments need to be playing to the same tune in order to achieve a rich sound. At Richmond, all the instruments are playing in perfect harmony – challenge us!
Tags: quality data management
Posted in RPL Clinical Data Management, opinion | No Comments »
March 23rd, 2009 by kpennert
The pharmaceutical industry is spending twice as much on R&D we did a decade ago to produce 40% new medicines of what it did then?
There may be many reasons for this, but it raises the question if the huge advances in technology we have seen, have not led to any significant increase in the quality of data? This was one of many interesting topics discussed at this year’s ACDM Annual Conference. After a lively discussion all delegates took a vote and the majority did not believe the advances in technology have led to a significant increase in quality. The consensus was that technology allows a quicker access to data, but that the end product will be of the same quality, even though we have to make a bigger effort to get there with less technology.
The theme of the conference dinner was “James Bond – 007”, and we all enjoyed a bit of gambling at the tables. However, do not gamble with your study – put your bet on RPL Data Management to take care of your data.
Tags: ACDM Conference, Clinical Data Management technology, Pharmaceutical R&D
Posted in ACDM, events | No Comments »
March 2nd, 2009 by kpennert
… and I am very excited to officially launch the RPL data management website.
If we have not had the pleasure of working with you before, I certainly hope that will change soon. Surfing our website, you will see that we provide a full range of data management and statistical services, and our experienced and enthusiastic team here at Richmond Pharmacology, are ready to take care of your data from study start to study report.
Our motto is “everything is possible” and we treat every project, small or big, with the same level of attention, accuracy and affection in order to always deliver to your requirements,
Watch this space!
Tags: Clinical Data Management Services, RPL Data Management
Posted in RPL Clinical Data Management, opinion | No Comments »