Collaboration from industry leaders has led to many steps in the evolution of clinical trials and it is becoming significantly apparent that common goals to streamline many of the processes involved in conducting clinical research studies are critical. Simplifying the experience for investigators to allow more time for clinical activities is an important step toward achieving this goal.
TransCelerate BioPharma, a nonprofit, is a prime example of an organization developed from interest and commitment among industry leaders and is dedicated to making clinical studies more efficient. The group is committed to the development of innovation in research and development, improvement of patient well-being, and the identification and solving of today’s common research-and-development problems. The organization is led by Dalvir Gill, who was appointed CEO in 2012.
When the company was first established, clinical trial execution was considered to have incredibly outdated methods that could be quite costly and were in need of a revamp. Multiple projects were deliberated and narrowed down as initial priorities to target, including risk-based monitoring, site qualification and training, clinical data standards, comparator drugs, and the shared-investigator portal. It was agreed that there was a need for standardization in many of those areas across the industry, which is particularly necessary in site conduct. So far, actionable information has been delivered on all but one of those initial projects, the shared-investigator portal, which currently is being implemented.
The organization has identified those multiple initiatives and draws from the expertise of members and collaborators on developing practical solutions to overcome various inefficiencies affecting clinical studies. Many of the initiatives are advantageous to clinical research sites, and have resulted in a plethora of resources and systems aimed at helping investigators. For example, as part of its Clinical Trial Diversification Initiative, TransCelerate has developed training materials for sites and sponsors to improve patient engagement and enrollment of minority populations; content developed from the initiative ranges from webinars to patient letter templates and is available at no cost to sites on the TransCelerate website.
As part of the Site Qualification and Training Initiative, TransCelerate has developed a GCP Training Mutual Recognition Program, which is targeted to site employees. The member companies have established minimum criteria and created guidelines to facilitate GCP training. When a GCP training certificate is issued upon completion of a course, it will be recognized by other member companies, eliminating the need to train separately for each participating company; this could be a massive timesaver for site personnel, specifically when they are conducting studies for multiple member companies. Those companies include well-known organizations such as Roche, Pfizer, Abbvie, Johnson & Johnson and many others (see Table 1).
More recently, the organization has collaborated with DrugDev and announced an initiative to develop an investigator registry that will utilize cloud-based technology to allow member companies to pool investigator data into a centralized database. The registry will give sponsors the ability to access data needed to make informed decisions about site selection, and ensure investigators have direct access to clinical studies appropriate for their site. Additionally, the group is developing a shared investigator platform, which allows sites to join with one login and receive access to multiple sponsors. Rather than juggling multiple accounts for several different platforms, it will work among member companies and allow sites to maintain their data centrally, complete GCP training, interact with a study team, exchange documents and complete feasibility surveys in one location.
While bringing leaders of competing companies together, TransCelerate also works closely with multiple trade organizations, including the Association of Clinical Research Organizations (ACRO) and the Society for Clinical Research Sites (SCRS). While the purpose is not necessarily to create networking opportunities among industry leaders, it is certainly an added benefit that could really make a difference in collaboration on meaningful projects. Such cooperation not only provides a forum for industry leaders to meet but also creates a surplus of opportunities to advance the development of drugs beyond TransCelerate’s own initiatives.
By continuously postulating what technological, process or regulatory changes will occur and evaluating the current state of clinical trials, the future initiatives team at TransCelerate is developing a road map specifying how to achieve the ideal clinical trial state of the future. From a site’s perspective, it is clearly beneficial to take advantage of resources provided by these new organizations, which seek to improve the process of clinical trials all across the industry by reducing the administrative burden and establishing clearly defined processes and guidelines for sites to follow.
Jeffrey Adelglass, M.D., F.A.C.S., is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multidiscipline CRO. Email comments and questions to firstname.lastname@example.org.
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