Sites should follow, get involved in industry initiatives
Never has it been more apparent than today that the views and issues facing research sites are important to sponsors, CROs and suppliers that support the clinical trial business system.
There currently are more than 20 initiatives, both private and industry supported, addressing the concerns related to the unstable environment in which clinical research is conducted. I believe it is critical for site leaders to take an active role not only in understanding these entities and their missions, but in participating as much as possible. Many of these efforts will shape the future of the world in which we perform clinical research.
The changes in delivery of clinical research across the globe, principal investigator turnover, quality management and the ability of sites to sustain themselves all are of major importance not only to sites, but to the overall ecosystem. The cost of research continues to escalate, and it appears the time has come when serious evaluation of the process is taking place all around us. Being a bystander to this activity will not be in the best interest of sites.
The following are just a few of what I consider the most prominent organizations serving the industry. I recommend all sites follow their progress and/or join or volunteer to be involved.
- TransCelerate Biopharma’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and implement solutions to drive the efficient, effective and high-quality delivery of new medicines. TransCelerate has chosen these areas of emphasis: risk-based monitoring, site qualification and training, clinical data standards, comparator drugs and shared investigator portals. Membership is open to pharma and biotech companies with R&D operations.
- The Society for Clinical Research Sites (SCRS), a trade association established to represent global clinical research sites, aims to unify and amplify the voice of the site community for site sustainability. Companies that sponsor or support the work conducted at sites also can benefit from membership.
- Alliance for Clinical Research Excellence and Safety (ACRES) has a vision of a global system for clinical trials responsibly conducted according to the highest standards of safety, quality and efficiency, to collaboratively reshape global clinical research. It sees the industry patterned after the international air transport system and leveraging the expertise of stakeholders worldwide. ACRES is a nonprofit, non-governmental organization working collaboratively to build a robust global network for clinical research.
- The Clinical Trials Transformation Initiative (CTTI) is working toward a high-quality clinical trial system that is patient-centered and efficient, enabling reliable and timely access to evidence-based prevention and treatment options. CTTI members, from more than 60 member organizations, serve on a steering committee and represent diverse stakeholders from across the clinical trials enterprise. This collaborative approach makes CTTI uniquely positioned to affect change.
Research Across America has followed the actions of these groups carefully over the last year. We have joined SCRS and our staff participates in its listserv daily; we also participate in its webinars and its annual Site Solutions Summit. We attend other industry conferences to keep abreast of topics that will impact our future. In addition, we are considering volunteering for appropriate opportunities with groups such as ACRES and TransCelerate.
Although our time is valuable and often stretched by our day-to-day research activities, we believe we must respond to the industry efforts going on around us. We want to participate in the decisions being made that will impact our growth and future. These are exciting ventures that are supported by many of the big pharma companies and CROs we work with daily. It is our time to be recognized and heard, so I encourage all sites to get out there and get involved!
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization.
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