Monday, April 22, 2013

#PCTUS Summit Day: How to connect with your clinical trial community

To continue Summit Day at Partnerships, Elsie Matthews, Brystol Myers Squibb presented  Improve Patient Data Collection with Electronic Patient Reported Health Outcomes.  She pointed out that the best used patient reported outcomes come in the form of good protocol development.

2013 Partnerships Exhibit Hall
What are some of the ePRO Benefits?  For the sites, it provides clean, in-range and legible responses, eliminates need to transcribe data, produces little to no data queries, simplifies administration of site assessments. For sponsors, the benefits lie in the reduction in incomplete/missing data, reduced on-site monitoring time, reduce printing/shipping costs, possible reduction in clinical grants and real-time access to data.  This decision will be
based on who your target audience is.

Data management is critical for ePRO. You can’t go back and query like you would with a clinical database. But because the 3rd party vendor is involved, there’s a long chain of commands that make it difficult go back and clarify the data.

When doing clinical trials, we need to focus on the ultimate stakeholder. The patient. They are now ePatients. They are informed. Approximately 61% go online for health information. Of that, 37% access user generated content and 42% believe that information online has helped someone they know. How can we get patients to use this information? It reduces their burden, the data is collected in a non-clinical setting and the data collection platform must be comfortable to use for the patients.

Your ePRO platform interface should be easy for the patient. Training to successfully use the platform should be minimal. Good instructions must be passed down the line from the vendor to the sponsor to the site to the patient.

Sponsors need to have a better understanding of the value and the power of the patient. By using electronic methodologies, we’ll get better information from the patient.

Peter Coe, Executive Director & Co-Foundor Tudor Reilly then took the main stage to kick off the conference.  He focused on the changing role of clinical trial patients and how we can reach the new generation today. is very difficult to navigate and even more difficult to navigate for potential trial participants. Clinical trials are critical to developing new drugs. As many as half of all clinical trial sites enroll one patient. The costs of delays in getting drugs to market is $600,000 to $8,000,000. However, things are changing. Individuals are going to the internet to find out about their health.
Deborah W. Brooks
Michael J Fox Foundation

What is an ePatient? 32% of the videos watched on YouTube are about health. Tudor Reilly has been working on creating online communities of their own, independent of any specific company. They’re focusing on creating communities that need information and hte audience. They’ve just launched the Practical Alzheimer’s.

Finally, to close our day, Deborah W. Brooks of the Michael J. Fox Foundation For Parkinson’s Research presented Patient-Centered Drug Development: The Key Role That Only Patients Can Play

Countless people are living with unmet needs created by disease. There are over one million living with Parksinson's living in the United States. They use their platform boldly to cultivate the patients to both fund and participate in research. All of their efforts go into research, including 60 clinical trials. The funding is provided by patients and families. They’ve realized that they can’t change biology but they are looking at biomarkers for clinical trial end points and they’re also looking at how they can work with the patient community to do testing. They’ve developed the Fox Trial Finder to match those with Parkinson’s Disease with clinical trials and seen huge success in getting traffic to their webpage through search, social media and relevant web pages. They know that the investment in this webpage is long term. They believe that the online tool will be successful. They are creating a long term engagement. Sharing stats and information with patients about clinical trials encourages them to join clinical trials. If you know what you’re doing a clinical trial for, then it means more than you.  If you want to hear more about the Michael J Fox Foundation and the Fox Trial Finder, check out this edition of the Inside Outsourcing Podcast Series.

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