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Welcome to the August issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
Articles in this issue include:
- SCRS Current: The global scope of SCRS programs is increasing.
- SCRS Connects: Al Pacino brings his passion to Blue Cloud.
- Listen Up: How are sites preparing for summer power outages and brown outs?
- Metrics to Monitor: Technology is helping minimize temperature excursion impacts.
- CTTI Update: Improving the process for qualifying investigators to conduct clinical trials.
We always love to hear from you, please let us know what you think or would like to hear profiled next month.
The SCRS Ambassador program is developing rapidly. After inaugural SCRS Ambassador Symposiums in The United Kingdom and Poland last month, the program traveled to Taipei, Taiwan. The symposium in Taiwan was organized by Professor Chung Y. Hsu of China Medical University Hospital and attended by more than 80 attendees from 30 key clinical research site stakeholders from Taiwan. Each attendee received a complimentary SCRS membership, sponsored by INC Research.
Heading toward the SCRS Global Site Solutions Summit, the finalists for Site Tank and Site Patient Recruitment Innovation Award (SPRIA) will be announced shortly. They will advance to present live at the Summit where a winner will be selected by a panel of judges.
The sponsor and CRO finalists for the 2017 SCRS Eagle Award were just announced. Congratulations to the Sponsor finalists: AbbVie, AstraZeneca, Eli Lilly &Co., GlaxoSmithKline, Merck, Novo Nordisk, Purdue Pharma, and Sanofi. Also congratulations to the CRO finalists: ICON, INC Research/inventive Health, PRA Health Sciences.
Voting for the winners of the Eagle Award is open to all site personnel, whether or not you are an SCRS member. Go here to vote.
Attend the SCRS Global Site Solutions Summit in person and find out which companies receive the SCRS Eagle Award! Go here to reserve your seat now.
BlueCloud founder Al O. Pacino has an unforgettable name, and an unforgettable brush with cancer. He served as a medic in the US Army and worked in a Phase I unit in Austin where he also participated as a subject in multiple clinical trials. “I became involved with patients who worked in the healthcare system and, as patients, were passionate about leaving a better system for future generations. Some of those patients are no longer with us, but those of us who are still here truly wanted to make a difference,” he remembers. “We were frustrated with the inefficiencies in healthcare and clinical research and we wanted to do something.”
That something became a system which is now known as the BlueCloud Network. Mr. Pacino was in a hot bed of technological innovation, Austin, at just the right time 15 years ago. He and four other patient partners developed a system where health information as well as healthcare professional and stakeholder information could be privately shared between stakeholders who opt-in to the private network. “Think of BlueCloud as being like a cell phone,” he explains. “We provide Blue Cloud systems to every stakeholder in the healthcare and clinical research industry so that we can all be connected while empowering compliance at no cost to industry stakeholders. This enables all healthcare and clinical research organizations to become involved in the ecosystem using their own technologies- just like our cell phones allow all of us to be connected today.”
Today, more than 1.4 million healthcare professionals from more than 60,000 organizations use BlueCloud, with more than 10,000 users becoming members each month. “Directories are a powerful way to enable connectivity between organizations in healthcare. For example, EMRs are directories containing our health history which we own, LinkedIn is a directory of our business connections, etc.; however, these and thousands of other directories are usually siloed, they don’t talk to each other,” explains Mr. Pacino. “BlueCloud becomes powerful because it organizes directories using a common global collaborative system where unlimited directories are connected at the same time for immediate gratification, compliance and a common real-time healthcare and clinical research purpose.” For example, a study coordinator can access standardized training modules, link their training record to a study regulatory file, and also share that connectivity with a sponsor for site selection.
Looking forward, Mr. Pacino envisions additional functionality for BlueCloud. A feature in development will provide real-time information including but not limited to regional patient pools and how they intersect with available clinical research sites. This and dozens of other real-time functionalities are steps toward the original goal of serving the needs of patients – leaving no patient behind.
Mr. Pacino thinks back to his early days in research when he had volunteered as a healthy Phase I patient before January 2006 when he became a part of the current healthcare and clinical research patient system. “You don’t really know what a clinical trial is until you’re a participant,” he said. “And then when your life depends on being provided with the best opportunity to survive – that’s when I found my purpose – to leave a better and more efficient healthcare and clinical research system for our future generations.”
As energy loads lead to increased power outages and brownouts in some parts of the world, sponsors and CROs seem to be asking about backup generators more now than in the past. Sites are thinking about power outages more too, and the impact on the conduct of the clinical study if these events jeopardize frozen biological samples and stored investigational product (IP).
Some sites have Standard Operating Procedures (SOPs) detailing power outage procedures including when to ship samples. Sites expressed frustration with their experiences of cases in which SOPs were reviewed by sponsor or CRO personnel at the site selection visit and collected and submitted to the study team; however, those same SOPs were later questioned when a power outage event occurred that required the site to follow that SOP.
Sites also expressed frustration regarding the slow response from many sponsors while waiting for approval to use IP after an out-of-range temperature event. Site managers prefer detailed operational instructions in the study manual allowing the site to manage brief out-of-range events, such as a brownout, at the site level. This is another area in which some sites created SOPs they have trained their staff to fllow if the study manual does not address a procedure to follow.
For more on what site leaders had to say about procedures for power outages, Global Impact Partners can join mySCRSsolutions online community (link to join) and members can join the online forum created for them – mySCRScommunity for investigators, owners, directors, and managers or mySCRShuddle for site staff.
We asked sites about the impact of temperature excursions during shipment and during storage at the site. Sites responded that temperature excursions have little to no impact on their operations. Technology seems to be a major reason for this: sites reported that more than 75% of their studies use real-time temperature reporting during shipping. Like sites on the SCRS discussion forum, sites responding to the survey commented on review times for out-of-range events. These sites would prefer drug be released from quarantine sooner.
The discussion continues on the SCRS LinkedIn Group: How have temperature excursions affected your studies?
At the Clinical Trials Transformation Initiative (CTTI), we recognize the need to ensure investigators and their staff are trained in best practices for trial conduct. However, we have also heard concerns about such training from across the clinical trials industry: “Some trainings are redundant; I didn’t learn anything new; that was a waste of time.”
In response, CTTI has launched a new Investigator Qualification Project to evaluate current approaches to investigator qualification—including good clinical practice (GCP) training—and issue recommendations on effective and efficient methods for investigators to become qualified to conduct clinical trials.
We are collecting evidence to identify both gaps and redundancies in training, as well as exploring other ways of ensuring that investigators are qualified for the quality conduct of clinical trials. For example, mentoring and experience may substitute for, or complement, formal training to optimally prepare investigators and their staff for quality trial conduct.
Although GCP training is currently the industry standard, to date, little evidence has been collected to determine whether this training is providing the necessary knowledge and skills for investigators and other clinical trial professionals. Our evidence-based approach will identify areas of improvement for increasing the efficiency and effectiveness of the investigator qualification process. This information is expected to benefit sites, sponsors, and, ultimately, trial participants.
CTTI previously released recommendations to address the issue of the requirement for investigators being required to take GCP training before each clinical trial, often multiple times each year. Our new Investigator Qualification Project is an extension of this work and will hone in on the question of what are the best practices for investigators to become qualified to conduct clinical trials.
We look forward to sharing the results of this work with you and collaborating to improve the start-up and conduct of clinical trials.
Go here to find out more: https://www.ctti-clinicaltrials.org/projects/investigator-qualification
Pamela Tenaerts, MD, MBA, Executive Director of CTTI
Don’t Miss SCRS at these Upcoming Events
2017 Global Site Solutions Summit – October 5-8, 2017
Boca Raton, FL
2018 EU Site Solutions Summit – March 26-27, 2018
2018 Asia-Pac Site Solutions Summit – July 17-18, 2018
2018 Global Site Solutions Summit – October 11-14, 2018
Boca Raton, FL
SCRS is a global trade organization founded in 2012 which represents almost 9,000 research sites in over 45 countries. SCRS’ mission is to unify the voice of the global clinical research site community for greater site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites, as well as companies that sponsor or support clinical research sites, benefit from membership and partnership. Our Voice. Our Community. Your Success. Join the community and collaborate with the Global Experts in Site sustainability.