KAI Research Focus

January 2013

REMOTE: The Revolution in Clinical Trials

In 2011, Pfizer pharmaceuticals launched the Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) study, the first direct-to-patient clinical trial. The trial was a pilot study to confirm data from a previous phase IV of the drug Detrol LA to treat overactive bladder symptoms. What made this trial revolutionary was the design of the study. Instead of having the patients work with a clinic or hospital, the patients received the drug directly and recorded the data using Smartphones and Web-based technology. More..

Pharmaceutical Industry Alliance to Streamline Clinical Research

It was announced on September 19, 2012, that 10 major pharmaceutical companies will support the creation of a new, nonprofit organization called TransCelerate. This new organization’s mission is to accelerate the development of new drugs. The initial goals are to improve the efficiency of clinical trials. Clinical trials, particularly phase III trials, are the most costly in terms of time, effort, and finances of any component of drug development. More..

June 2012

Changes to FDA’s Prescription Drug User Fee Act (PDUFA)

Every 5 years since its inception in 1992, PDUFA under goes a review by Congress. It allows the Food and Drug Administration (FDA) to collect fees from drug manufacturers when a New Drug Application (NDA) is submitted to fund the new drug approval process. The money is designated for use by the Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research drug approval activities and related staff. More..

PACeR, a Statewide Electronic Health Records System Supports Clinical Research

The Partnership to Advance Clinical electronic Research (PACeR) is a New York state organization made up of medical centers, health systems, community hospitals, patient representatives, pharmaceutical companies, and health technology companies to create an economically sustainable electronic clinical research network (PACeR Phase I and II, 2011). More..

February 2012

KAI White Paper - Risk Based Monitoring: Maximizing Efficiency While Maintaining Quality

Generic Drugs: Why the Controversy?

If generic drugs are just as effective and just as safe as their brand counterparts, but don’t cost as much, why is there any concern amongst some practitioners and patients? More..

Upcoming Meetings

• Meetings and Events
  
  Society of Clinical Data Management Annual Meeting – Sept 22-25th, 2012 Los Angeles, CA.
  • Scott Brand will be chairing a session on Risk-based Approach to Monitoring: The Way of the Future, September 24th 10:30 AM

• Previous Meetings
  
  Drug Information Association DIA 48th Annual Meeting– June 24–28, Philadelphia, Pennsylvania
  • Scott Brand, Presentation, Electronic Data Capture (EDC): How Much Quality Is Enough, June 26, 3:30 p.m..
  • Susan Li, Poster, Systematic MedDRA Upgrade in Clinical and Post-marketing Safety Databases, June 26, 11:30 a.m.
  
  
  
  MAGI's Clinical Research Conference - 2012 East – May 20-23, 2012, Washington DC
  • Patti Shugarts will be giving a presentation titled, Introduction to Clinical Data Management (session F266 at 3:45 on May 21).
  
  
  
  Society for Clinical Trials 2012 33rd Annual Meeting – May 20-23, 2012, Miami FL
  • Patti Shugarts will be giving a presentation titled, Challenges of Creating and Managing Standards (Common Data Elements) for Use in Clinical Trials.
  • Tibor Szentendrei, PhD will be presenting a poster titled, Aging In Numbers – National Health Care Trends And The National Institute On Aging Funded Clinical Trials.
  • Selma Kunitz, PhD will be giving a presentation titled, Risk-based Approach to Monitoring: The Way of the Future.
  
  
  
  Drug Information Association (DIA) Clinical Data Quality Summit – April 24-25, 2012, Philadelphia PA
  • Scott Brand, PhD will be giving a presentation titled, Multiple Levels of Database Quality Auditing.
  
  
  
  Drug Information Association (DIA) Medical Communications Workshop 2012 – March 5-7, 2012, Orlando FL
  • Miriam Fogelson, MS will be presenting a poster titled, Crisis Management-Involvement of Medical Communications Department.
  
  
  
  American Society at the Experimental NeuroTherapeutics Meeting (ASENT) 14th Annual Meeting– February 22-25, 2012, Washington DC
  • Alex Stout and Lisa Hunegs will be presenting a poster titled, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Common Data Element (CDE) Project: Using the NINDS CDEs in Research Projects.
  
  
  
  SCDM 2011 (9/11-9/14, 2011) and will present
  • The Balancing Act: Managing a Multi Vendor Trial (9/12/11, 10:30 a.m. - 12:00 p.m, Session IB: Tools and Techniques for vendor Management)
  • Re-focusing the Focus of Data Collection (9/12/11, 1:30 p.m. - 3:00 p.m, Session IIA: Data Capture - How much is enough?)
  SCT 2011 (May 15-18, 2011)
  • Complexities of Conducting Substance Abuse Trials (Poster)
  • Making Meeting Scheduling More Efficient, Simple, and Reliable: Using KAI’s Web-based Shared Calendar Application (Poster)
  • Challenges Of Reporting And Coding Adverse Events In Clinical Trials (Poster)
  • Challenges of Creating Data Standards (Presentation)

November 2011

Henry Jackson Foundation for the Advancement of Military Medicine

Recently, KAI was awarded contracts to serve as the data and statistical coordinating centers (DSCC) for two clinical trials funded by the Henry M. Jackson Foundation with Uniformed Services University of the Health Sciences (USUHS), the National Institutes of Health. More..

FDA’s Office of Combination Products

The Food and Drug Administration’s (FDA) Office of Combination Products (OCP) was established in 2002 as part of the Medical Device User Fee and Modernization Act of 2002. The Office was formed to accommodate the number of FDA submissions involving products that were part device, part drug, and part biologic. Expertise was needed in the areas of biotechnology, bioengineering, pharmacology, physiology. as well as medicine, to understand how these combination products were developed and how they worked. The OCP’s most important function is to assign primary jurisdiction to an FDA center for review of a combination product and to develop guidance and regulations to clarify the regulation of combination products. More..

September 2011

HHS releases notice of new Guidelines for Protection of Research Subjects

The U.S. Department of Health and Human Services (HHS) released an advanced notice of proposed rulemaking (ANPRM) on July 26th, 2011 which describes possible changes to the Federal Policy for the Protection of Human Subjects. Before making changes to the regulations, which are often referred to as the Common Rule, the government is seeking the public's input on an array of issues related to the ethics, safety, and oversight of human research. The goal of this ANPRM is to "request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective, while facilitating valuable research and reducing the burden, delay, and ambiguity for investigators." More..

The National Institute on Aging Clinical Research Toolbox for Investigators

The National Institute on Aging (NIA) of the National Institutes of Health (NIH) leads a national scientific effort to understand the nature of aging in order to promote the health and well-being of older adults. NIA sponsors numerous clinical trials as part of this effort and wants to make sure that these studies are in compliance with federal guidelines and regulations regarding human subjects’ protection and safety monitoring and that they provide results of the highest quality. More..

June 2011

Drug Companies Manufacturing Prescription Pain Medication Required to Provide Training of Health Care Providers

The Food and Drug Administration (FDA) has sent letters to 16 companies that manufacture transdermal patches and pills for pain requiring them to create a program to teach health care professionals when a pain medication is appropriate to prescribe and how abuse of the prescription medication can be recognized. Some of the companies that were notified were Pfizer’s King Pharmaceutical unit (Avinza and Embeda morphine capsules), Johnson and Johnson (pain patch Duragesic), Endo (Opana oxymorphone tablets), and Purdue (OxyContin, Covidien), whose Mallinckrodt brand makes six affected products including generic morphine and oxycodone. More..

The Food and Drug Administration Good Clinical Practices Audit

It is 8:00 a.m. and an FDA auditor is sitting in your reception area waiting for you. You do not panic because you have planned and prepared for this eventuality. It is now time for the Quality Assurance (QA) department to become the corporate hero by demonstrating your company is in compliance with all regulations and guidelines. The key word is prepared. Preparations for an audit should be part of your company’s ongoing activities and involve 1) the development of standard operating procedures (SOPs), 2) oversight of ongoing trials, and 3) maintenance of corporate and study documents. This article will focus on SOPs. More..

Rapid Scale Up of Call Center Capacity

The recall of a drug requires a team approach involving the pharmaceutical company experts in drug safety and a team of information technology (IT) professionals. The mechanism for handling the recall is a call center provided by the manufacturer. Drug safety specialists, knowledgeable about the product and the reason for the recall staff the call center. KAI assists the sponsor in identifying possible scenarios that could occur when a call is made to the call center and the proper response to each scenario. For example, if the product is still efficacious and the problem is due to a problem with packaging, the scenario would involve instructions for returning the product and being reimbursed for the returned purchase . However, if the problem involves a possible adverse event, the calls must be triaged by the safety staff with the appropriate clinical background. More..