Can clinical trials be reinvented?
Over the last few years, I have been involved in several initiatives related to strengthening the sustainability and reducing the burden of sites around the globe. This momentum is growing through associations working on behalf of sites such as the Alliance for Clinical Research Excellence and Safety (ACRES), the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Sites (SCRS), the Collaborative Institutional Training Initiative (CITI), TransCelerate and others.
2016 is the year of the site. Advisory groups of site personnel are forming worldwide, and sponsored by pharma, CROs and others. Special meetings designed to address the perceptions and issues facing sites are virtually everywhere. Research sites around the world have many faces, different scales and various models of delivery. It bears thinking about how any clinical research site, large or small, can stay informed of this activity and become involved and as knowledgeable as possible.
I would like to highlight some solutions being developed. In many cases, sites are either uninformed or misinformed. I believe it is critical for sites to better understand the unique attributes of organizations like TransCelerate undertake on behalf of sites and patients. Those who are making an effort to reinvent clinical trials cannot do so without representing the site perspective.
TransCelerate BioPharma is a nonprofit organization dedicated to improving the health of people around the world by accelerating and enhancing the R&D of innovative new therapies. The organizations’ mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate the implementation of solutions designed to drive efficient, effective and high-quality delivery of new medicines.
Two site-facing initiatives in particular that have been spearheaded by TransCelerate are:
- Investigator Registry, which enhances TransCelerate’s Shared Investigator Platform and accelerates identification and recruitment of qualified investigators in order to avoid duplication of standard sites.
- Shared Investigator Platform,which facilitates interaction between investigators and multiple clinical trial sponsors, enabling study planning, study startup and study conduct activities, while reducing the administrative burden on the site staff.
Christine Pierre, president of SCRS, has worked with TransCelerate on a number of programs. For example, TransCelerate has supported up to five SCRS Site Advisory Groups per year over the last two years. SCRS’ mission is to unify the voice of the global clinical research site community for greater site sustainability.
Other site advocacy initiatives are supported by ACRP. For over 30 years, they have provided global leadership to promote integrity and excellence for clinical researchers. ACRP is a nonprofit organization with over 13,000 members in 70 countries.
ACRES strives to align good business practices and good ethical practices to enhance safety, quality, efficiency and professionalism in clinical trials. Research sites can register to become an ACRES-affiliated site by registering online.
The CITI program promotes the public’s trust in the research enterprise and aims to provide high-quality, peer-reviewed, web-based, research education materials to enhance the integrity and professionalism of investigators and staff conducting research.
The growing demands on sites today are clearly being recognized by industry as untenable. It is with serious intent that I reinforce that 2016 truly can be the year that sites are on the map permanently. These organizations include site involvement to help the industry on new clinical trial delivery methods, and quality and structure for an industry that cannot function without the investigator site.
This growing portfolio of organizations may warrant your interest and follow-up.
Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to firstname.lastname@example.org.
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