Posted by Keith ward on Fri, Jun 25, 2010 @ 08:24 AM
Here's a question we were asked regarding clinical trial coding that involved SAS programming.
Question? Can you code a software for covariate adaptive randomization? We are conducting a parallel double blind, placebo-controlled, 5-arm (1 control, 4 intervention) randomized study. We have a list of 225 subjects. For each subject we want the SAS program to put the subject in one of the five arms considering two covariates. The two covariates are: The Center where the patients are recruited (VA, UHS, and Center3), and the other is the Severity of Kidney Disease (Moderate, Severe). The random assignments using this method should prevent a skew of how the subjects get distributed in the arms (that is for example there should not be a large number of VA patients in one arm instead of being evenly distributed in all arms).
This can be done with covariate randomization models with normal distribution using Proc Lifetest, Proc GLM or Proc PHREG etc.
**Suppose there are 100 patients in 3 centers
classified by sever 1 or 2.**;
data orig;
do i=1 to 100;
patNo=i;
if i<33 then center=1;
else if i>32 and i<65 then center=2;
else center=3;
if i<5 or (i>17 and i<22) or (i>77 and i<92) then sever=1;
else sever=2;
output;
end;
drop i;
run;
proc sort data=orig; by patNo;
**Randomly Assigning Subjects to Treatments we can use the PLAN procedureto design a completely randomized design to assign one of two treatments to each patients.**;
**Permuted-block randomization**;
ods listing close;
proc plan seed=54321;
factors patNo=100 cell=1;
treatments trt=2 random;
output out=rand;
run;
ods listing;
proc sort data=rand(drop=cell); by patNo;
data randomized; merge orig(in=a) rand(in=b); by patNo;
if a;
run;
You can find good articles and further explanations at the SAS support website when typing 'randomization' in the search field. But basically PROC PLAN and PROC FATEX SAS procedures can do it all.
http://www.clinplus.com/report-landing-clinplus-report-tables-listings?utm_campaign=blog
Hope this was helpful! DZS Software Solutions
DZS/ClinPlus can also give you a hand producing the Statistical Analysis Tables of the trial results in the course of the trial. (Safety and Efficacy reports etc.).
Posted by Keith ward on Mon, Jan 18, 2010 @ 10:07 AM
In 1897, after reading his obituary in the New York Journal, author and humorist Mark Twain famously quipped, “The reports of my death are greatly exaggerated.” Similarly, for life sciences organizations, the clinical-trials stalwart that are SAS solutions, remain as viable, relevant, industry-leading, and cost-effective as ever.
The economic forecast for 2010 continues to look challenging to say the least; global competition grows more intense; the regulatory compliance climate index only moves in one direction: more complex; and the case for collaborating on research endeavors grows more compelling every day; all the more reason to rely on SAS, the only end-to-end solution that can drive efficiencies throughout a drug’s lifecycle.
SAS enables businesses, big, small, and in-between to leverage enterprise-scale solutions to develop, execute, and manage the collection, sharing, transformation, analysis, and submission of clinical research data, while driving down costs and ratcheting up time-to-market and profitability.
Is SAS still the hands-down leader in managing clinical trial data? Consider these facts:
• The FDA and most global regulatory bodies review clinical data summaries for NDA, eCTD, and NeeS submissions using SAS analytics
• Taking data out of SAS and putting it back into SAS datasets creates unwarranted and unpredictable liabilities
• SAS’s proven track record is decades long
• SAS has a deep bench of experienced professionals ensuring faster programming and quicker time to market
• When it comes to clinical trials analysis, SAS is the de facto industry standard
Posted by Keith ward on Tue, Jan 05, 2010 @ 10:32 AM
Introduction:
While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company. We've made a genuine, good will effort to compile the most important factors that should be considered before buying. Some questions are fairly basic, but most are insightful and thought provoking. If you think of additional questions that should be asked by others in the decision mode, please pass them on to us and we'll include in updated editions.
Is your software 21CRF Part 11 compliant?
Reason for asking: 21 CRF Part 11 are FDA regulations to which all clinical trials software must adhere.
DZS Answer: Yes, DZS continues to strive to meet all applicable FDA regulations.
How long does it take to install your system?
Reason for asking: It stands to reason that the longer it takes to install a system, the longer it takes for you to be up and running. Furthermore, a long and complex installation process may indicate an excessive future maintenance requirement.
DZS Answer: Our Data Management software is installed in about 15 minutes using Wise Installer®, an intuitive installation utility. Installation qualification and system configuration may take a few hours. User acceptance validation may take 1-2 weeks using the available ClinPlus Validation Package.
How long does it take to be trained on your system?
Reason for asking: As in the above question, the longer it takes to learn a software system, the longer it takes to become operational. Furthermore, the longer the training period, more complex the system and the more likely mistakes are to occur. Lastly, users are less likely to retain information from drawn out sessions.
DZS Answer: Training is conducted over a two day period. All users need not attend all sections if topics are not related to their job functions.
What aspects of the clinical trial process does your software address?
Reason for asking: Most clinical trials software programs are quite specific in their application. Be sure to determine exactly what applications are supplied as well as what other integrated modules are available. Although you many not recognize a current need for a specific capability, it is advisable that the software you choose be able to smoothly integrate with the full scope of clinical trials software requirements.
DZS Answer: The ClinPlus Data Management product supports CRF tracking, data entry and data review with additional features that support EDC capabilities, import/export and a customizable report writer. Also available are ClinPlus Coding that supports auto and manual coding of adverse events and drugs, ClinPlus CTMS for your clinical trial management needs and ClinPlus Report for the production of NDA quality tables and listings.DZS Software Solutions provides the broadest suite of software available for clinical trial support.
Does your software support EDC studies via the Internet, Intranet or VPN?
Reason for asking: This should allow real-time access to data, summary reports and query information and should support telecommuting and is a must if you plan to implement EDC studies. Remote capability is a valuable attribute when you realize the advantages of expediting data entry from the site and then being able to access it from wherever you may be.
DZS Answer: Remote access is supported via Citrix. Features such as role-based menus, site-based security, electronic signatures and monitoring functions are included to support EDC. Since the same software is used for paper and EDC, studies may be entered remotely at some sites while paper CRFs are collected at other sites.
For a more extensive list of the questions you should consider before selecting a Clinical Data Management System please go to our website http://www.clinplus.com/products/clinical-data-management-0/
You can also contact a ClinPlus sales representative toll free at 1-866-CLINPLUS or email us at salesandmarketing@clinplus.com to discuss your requirements and options.