What are the best practices in patient recruitment, budgets and contracts, and FDA audit readiness?

Investigative Site Boot Camp: Innovative Solutions to your OperationalChallenges
June 23 from 1:00PM – 6:00PM in Boston

This boot camp was designed for site personnel to address the state of the industry, trends impacting sites and highlight ways to overcome these recent challenges. Industry leaders will share insight to help sites position for future work. Moderators will facilitate this communication to allow sites an open exchange of best practices and innovative solutions to patient recruitment, budgets and contracts, and FDA audit readiness.

Instructor(s):
Christopher J. Hoyle, MBA
Executive Director
Elite Research Network, United States

Deena E. Bernstein,
Director of Clinical Research
Sheridan Clinical Research, United States

Representative Invited
Head of Site and Patient Networks; Site Optimization
Genzyme Corporation, A Sanofi Company, United States

Representative Invited
Principal Attorney
The Kulkarni Law Firm, United States

Alison Duhamel, MA
Senior Manager, Site Contracting, Clinical Site Services
Vertex Pharmaceuticals, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Clinical Operations Track at DIA's 49th Annual Meeting

 

• What are the emerging challenges with patient registries? 
• What do you need to know about statistics?  Variability~confidence intervals~hypothesis testing~p-values
• What are the best practices in patient recruitment, budgets and contracts, and FDA audit readiness?
• How do you ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV?
• How do different enrollment metrics/analyses benefit different stakeholders (site/sponsor/recruiter)? 
• Do you know how to shape your cost with hard and soft coverage analysis trends?
• How can investigator sites pave the way for running successful Clinical Trials?
• Is this trial worth it? Finding answers for Site and Project Managers.
• How should you tailor existing patient recruitment programs to engage parents for Pediatric Trials?  
• How do you establish metrics for Optimal Patient Recruitment and Retention?  
• What global requirements are needed in the Informed Consent Process? 
• What are the Domestic and Global trends in Clinical Trial budgeting?  
• How can we use Big Data to design smarter clinical studies? 
• Can a mathematical algorithm used in point-of-care risk assessment id and screen Clinical Trial subjects?  
• How do you build Patient engagement to make Clinical Research better for everyone?  
• Learn to apply innovation, avoid controversy and implement best practices in Clinical Trials 
• How can site metrics be used to improve enrollment timelines?
• Can you identify Pharmacy-directed outreach and Patient  Recruitment strategies for your Clinical Trial? 
• What do you need to maintain regulatory compliance with continuously evolving import/export processes? 
• How do you solve key challenges to running efficient investigator meetings during Clinical Study startup? 
• What impact will FDASIA have on your need to recruit diverse clinical subjects?  
• What 4 pillars support comprehensive operational feasibility assessment for Clinical Trial planning?  
• Fed Up with tracking pointless Metrics? Learn how to select and use Metrics that work.  
• What are the challenges and requirements of implementing Central Statistical Monitoring? 
• What unique challenges are associated with pediatric trial recruitment, retention and blood sample collection?  
• What are the Diverse Operational Approaches to generating evidence in the Late-phase Environment? 
• What are the areas of potential risks when undertaking Global Clinical Trials in Emerging Markets? 

Pfizer Ends Social Media Bid For Trial Recruitment - from Pharmalot

Pfizer Ends Social Media Bid For Trial Recruitment
A closely watched effort to use social media almost exclusively to recruit patients for a clinical trial has come to a disappointing end. One year after launching its so-called clinical-trial-in-a-box, Pfizer is discontinuing enrollment in the first such study that was designed to allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office for medicine and check-ups.

The drugmaker hoped to create a model for saving money that would rely on personal technology to more easily recruit patients and monitor their progress. But while the gambit generated substantive traffic to the web site that offered information about the trial, the drugmaker was unable to convert that interest into significant numbers of people who were willing to participate in the study, which was testing the Detrol overactive bladder drug.

“Recruitment has been very challenging,” says Craig Lipset, who heads clinical innovation at Pfizer. “We used a lot of social media for reaching patients… Online patient communities and forums where people gather to share data and information. And there were more typical web-based advertising channels… We found some might have been incrementally better than others, but none were going to provide the true yield we wanted to see to make this project sustainable.”

The decision is not entirely surprising, given that Pfizer earlier this year acknowledged that patient recruitment was lagging for the trial, which received FDA blessing. At the time, Pfizer officials called the effort a learning experience and noted that some people remain reluctant about using social media to sign up to particpiate in trials, even though they use the Internet to gather information about needed medications and research into diseases (back story).

“I think it’s still a new way for patients to engage and there’s a healthy amount of trepidation from patients about participating,” says Lipset. “We know from data that, in terms of health information, many patients are not very aware of clinical research… And so, not having help online (from a physician, for example) for that decision-making process has been a barrier.”

Social Media and Pharmacovigilance, FDA, AE and Patient Recruitment at DIA2012

DIA 2012 Collaborate to Innovate

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA

Pennsylvania Convention Center

What questions are on your mind regarding Social Media? Feel free to post a comment on your concerns or successes below.-W

Title: The Impact of Social Media on Product Promotion and Pharmacovigilance

Social media creates challenges and opportunities for the promotion and safety of drugs and other medical products. FDA and industry are working to optimize truthful product information and ways to gather adverse event data utilizing this resource

Tracks: Advertising & Promotion|Regulatory Affairs|Medical Communications

Presentation(s) & Speaker(s):
FDA Perspective
Thomas W. Abrams, MBA,RPh, Director, Office of Prescription Drug Promotion, CDER
FDA

Panelist
Gerald J. Dal Pan, MD, Acting Director, Office of Surveillance and Epidemiology, CDER
FDA

Industry Perspective
Paul James Savidge, JD,MBA, Vice President and Associate General Counsel
Bristol-Myers Squibb Company

Elizabeth E. Garrard, PharmD,RPh, Chief Safety Officer
Drug Safety Alliance, Inc.

Title: AE Reporting in the Era of Web 2.0: The Challenges of Having a Two-Way Conversation

This session will focus on the specific types of social media currently being used by pharmaceutical companies with discussion on their successes and challenges. In addition, discussions on AE identification and collection while emphasizing the need for practices and guidance on the use of social media.

Tracks: Clinical Research|Medical Communications|Advertising & Promotion

Presentation(s) & Speaker(s): 

Embracing and Incorporating New Technology (eg. Social media, iPad) into a Modern Pharmacovigilance System
Gregory J. Fiore, MD, President
SSI Strategy

Safety and Social Media: Returning the Intention to Report: Adding the Human Factor Back to High Tech
Michael A. Ibara, PharmD, Head of Safety Innovation
Pfizer Inc

Title: Social Media: The Promise and Pitfalls for Patient Recruitment

Social media has huge potential as a new set of tools to drive patient recruitment. How do you use it and what happens when you do? In this symposium, we will offer both successes and lessons learned from trying social media as a recruitment strategy.
 

Tracks: Advertising & Promotion

Presentation(s) & Speaker(s):

 Is Social Media the New Technology for Helping Patients Find Clinical Trials?
Richard Mayewski, Global Trial Optimization Specialist
Merck & Co., Inc.

Finding the “ePatient” for Your Clinical Trial
Rodney William Butt, MBA,MSc,MT, Principal Consultant, Clinical Operations
Hamilton Medical Consultants Group, Canada

When Social Media Undermines Clinical Trial Performance
Elizabeth A Moench, President and Chief Executive Officer
MediciGlobal

Title: Communicating Drug Safety Information Using Social Media: FDA and Industry Perspectives
FDA relays the latest drug safety information through drug safety communications which are disseminated using social media tools. This session provides FDA and industry perspectives on the development, communication, dissemination, and impact of drug safety communications.

Tracks: Medical Communications|Clinical Safety/Pharmacovigilance|Regulatory Affairs

Presentation(s) & Speaker(s): 

Communicating Drug Safety Information: FDA Perspective
Catherine Yu Chew, PharmD, Acting Deputy Director, Division of Drug Information, CDER
FDA

Communicating Drug Safety Information :FDA Perspectives
Gregory Busse, PhD, Senior Writer/Editor, Team Lead for Drug Safety Communications, CDER
FDA

Communicating Drug Safety Information: Industry Perspective
Sue E. James, Vice President, Global Regulatory and Quality, Consumer Healthcare
GlaxoSmithKline

 
Title: Social Media 2.0: The Power of Online Rare Disease Communities to Connect and Engage ePatients
Relevant case studies will be presented to demonstrate how online patient communities and social media are revolutionizing how patients gain access to disease and treatment information.

Tracks: Advertising & Promotion|Clinical Research 

Presentation(s) & Speaker(s): 
RareConnect: A Global Social Network for Rare Disease Communities and Patients
Mary Dunkle, Vice President of Communications
National Organization For Rare Disorders (NORD)

The Power of Patient-driven Research and Rare Disease Online Communities: The SCAD Ladies and Beyond
Brian Loew, CEO
Inspire

Biopharma and Social Media: A Case Study
Eric Grinstead, Senior Vice President, Commercial Operations
Synageva Biopharma Corporation