Chicago, Illinois is home to the Willis (Sears) Tower, Blues Brothers, hot dogs, and deep dish pizza, but most importantly this year’s 47th DIA Annual Meeting. The Annual Meeting has always been and will continue to be an important conference for ERT. Exhibiting at this conference has allowed us to consistently provide clients easy access to our subject matter experts, as well as an opportunity for our staff and project managers to attend informational sessions and learn about the major trends and issues affecting the global pharmaceutical industry. Many of ERT’s experts came to answer questions and say hello to customers, including Jeffrey Litwin M.D. (CEO), Keith Schneck (CFO), John Sory (Chief Development Officer and ePRO business leader), Robert Brown (Senior Vice President of Strategic Partnerships), as well as several of our other Cardiac, Respiratory and ePRO product and service specialists.
Traffic to the ERT booth was steady throughout the conference. Our booth featured a new design with comfortable seating areas to hold meetings, as well as our popular (you could even say ‘famous’) coffee bar. The coffee bar was once again a huge success, serving close to 3,500 cups of coffee. That’s over 50 pounds of coffee beans! Our baristas, Warren and Madge, greatly appreciate all of the fine compliments you so graciously gave throughout the conference. It appears the “DIA runs on ERT” after all, with comments such as “Your coffee has been my life saver all week” and “This is best espresso that I have ever had from anywhere” radiating from every corner.
Visitors to the booth completed a brief survey, given on one of three iPads, regarding industry information. With over 250 responses, the survey results are as follows:
Do you collect trial data in a centralized manner? (Using some form of technology at site where data is collected and stored centrally for analysis and reporting)
81% of respondents claim to collect clinical trial data in a centralized manner. This supports the overall message of centralization and indicates that sponsors and supporting CROs strongly recognize the benefits of collecting and storing data centrally for analysis and reporting as the adoption rate continues to grow.
What type of data do you collect centralized? (Select all that apply)
Participants were asked to select which types of data they centralize and were able to select more than one from the included options of imaging, cardiac safety, respiratory, ePRO, EDC and CTMS. This graph depicts that industry colleagues are supporting the message of centralization and recognize its importance in terms of high quality results with better science, lower costs and most convenience. With imaging, cardiac safety, ePRO, EDC and CTMS spanning all therapeutic areas, it is not surprising that centralized respiratory services came in at a lower percentage given the lower number of attendees who are directly related to this area of drug development.
What benefits has your company realized as a result of collecting data in a consistent manner and storing centrally for analysis and reporting? (Select all that apply)
Participants were asked to select what benefits they have witnessed from central data collection including regulatory compliance, time to database lock, query reductions, data quality, data integrity, trial efficiency, internal decision-making, site performance and cost reduction. Again, they were able to select more than one option. While it is apparent many sponsors and CROs have experienced all of these advantages, data quality was the most recognized benefit, followed by time to database lock and regulatory compliance.
What’s most important when selecting a vendor?
Among six other choices including cost, relationships, financial stability, response timeliness, previous experience/habit and other, over 60% of respondents cited quality as the number one reason to choose a vendor.
To show our appreciation for participating, those who completed the survey were automatically entered into a drawing to win a brand new Apple iPad2, compliments of ERT. We were pleased to announce the winner, Rachell Chiao, from Roche.
As well as paying homage to our clients with great coffee, an iPad giveaway, and having our own subject matter experts on hand, we were also there to reap the educational benefits the DIA has to offer. You can read a brief recap of some of the interesting sessions our staff attended below.
Blurring the Boundaries Between Technologies: Examples of Next Generation Clinical Trial Technology Integration: This session discussed the importance of integrating various databases used in clinical trials by using single sign-on for multiple databases and trying to use data from one to populate another (i.e. data entered from IVRS directly loads into case report form for single data entry). While this might be feasible for a sole provider of IVRS, case report forms and RTSM, it seems a long way off for vendor integration. However, it was interesting to see that as company, ERT has been taking these same steps internally to increase efficiency, including single sign-on, system integration with My Study Portal and EXPERT, as well as integrating all product and data service lines into EXPERT v3.
An Innovative Strategic Partnering Relationship: Can this Approach Revolutionize Drug Development?: This session discussed the increasing prevalence of preferred partnerships in clinical trials and how it has led to increased satisfaction between drug companies and CROs/vendors. It was shown that there is a direct correlation to the size of the drug company and the size of the preferred CRO/vendor. You can read more about ERT’s Strategic Alliance and Partnership Program here.
Using Patient-reported Outcomes to Assess Comparative Safety and Tolerability: Methodological and Regulatory Issues: This session started by stressing the importance of PROs being completed by patients. Data was presented in various forms showing that patient symptoms are often underestimated by clinicians. There has been recent guidance from the FDA corroborating this information and stating that whenever possible, PROs should be completed by the patient. The session then moved into discussing the need to proactively collect safety PROs for patients throughout studies. This would be a change to the current model in which information is only collected after an adverse event is reported. By having subjects provide safety PROs throughout the trial, especially in a Comparative trial (active control arm of an approved drug in the same indication), drugs may be able to be brought to market due to a better safety profile even if the efficacy has increased from other drugs in the market. This topic is especially relevant in cancer studies, as quality of life is a primary endpoint and treatments often have great side effects. The concern from pharmaceutical companies is that if you collect more safety endpoints you will also need to report those end-points to the FDA and they will be included in drug labeling. Therefore, a drug which did not include safety PRO throughout the drug development process may have fewer side effects on the label.
Electronic Patient Reported Outcomes (ePRO) How to Maximize Patient-reported Information for your Studies: This session focused on how the choice of technology and close engagement with the patient is crucial to overall trial success. More and more, regulators are looking to ensure that Patient Reported Outcomes are collected directly from the patient, away from the clinic. To do this successfully, sponsors and their technology partners must choose solutions that are right for the study, the site and, most importantly, the patient. However, simply having a technology solution in place is not enough to ensure a successful trial. It is important that the patient also feel engaged in order to increase compliance and retain them within the study. Many different technologies were discussed both during the presentations and via the Q&A at the end of the session, which reinforced the choice now available to sponsors and their CRO partners in deciding on the right solution for the specific therapy area, study demographics and patient population. The underlying message appeared to be, “look after the patient and the data will look after itself”.
A Special Thank You:
We thank everyone who came out to see us last week and hope you enjoyed the coffee. We can’t imagine after 3,500 cups that you didn’t! ERT enjoyed meeting each of you and if you have any further questions regarding our products and services please leave a comment below or send an email to firstname.lastname@example.org and a representative will get back to you right away. See you next year in ERT’s home town – Philadelphia!