The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership to identify and promote practices that will increase the quality and efficiency of clinical trials.
CTTI comprises more than 60 organizations from across the clinical trial enterprise. Members include representatives of government agencies (the FDA, Centers for Medicare and Medicaid Services, Office of Human Research Protections, National Institutes of Health, and other national and international governmental bodies), industry representatives (pharmaceutical, biotech, device, and clinical research organizations), patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.
'Best Practices for Effective Engagement with Patient Groups around Clinical Trials' is one of CTTI's current research projects. Key sectors of the research community have identified a gap in knowledge and understanding about how and when to best interact with patient groups regarding clinical trials. This knowledge gap has the potential to delay the start of meaningful clinical trials or lead to the conduct of less efficient trials by not tapping into the patient resource. Complex legal, ethical and regulatory issues, and ill-defined expectations can lead to unproductive relationships and disparate or unanticipated outcomes. While key stakeholders have declared commitment to create a more effective model for engagement between research sponsors, investigators and patient groups, leading to better clinical trials, no guidelines for best practices currently exist. Actionable recommendations are needed, and CTTI’s diverse membership is well positioned to generate these recommendations through its collaborative problem-solving model.
By understanding best practices for effective engagement with patient groups around clinical trials and utilizing an actionable toolkit that aids in navigation of these relationships, more productive collaboration between patient groups and sponsors will lead to more efficient and quality-driven clinical trials. The stages of the project are:
Conduct a literature review and assessment of types of relevant patient groups, by querying a representative sample across disease states to assess and highlight distinctions among their missions, reach, infrastructures, governance models, and interest in/engagement with clinical trials
Identify and understand current research sponsor and investigator practices for engaging with patient groups, as well as practices used by patient groups to engage with research sponsors and investigators, around clinical trials
Explore both successes and failures in order to identify models of engagement with patient groups that have led to more quality-driven and efficient trials
Hold an expert meeting to gain a better understanding of what patient groups, research sponsors, and investigators are hoping to achieve through various interactions in different settings
Identify limitations, unrealistic expectations, best practices, and pitfalls, as well as create recommendations on best practices supporting more meaningful, efficient and high quality trials
Generate a manuscript for publication, and a longer, accompanying white paper, describing the current landscape, input of stakeholders, best practices, and benefits to CTE of adopting best practices
Create a document that summarizes recommendations for best practices and an accompanying toolkit for stakeholders
Hold an implementation meeting to gather input on the toolkit, develop a plan for its dissemination, and promote adoption of best practices
Ultimately if the project achieves all its outcomes and the resulting recommendations document and toolkit are disseminated widely, it stands to have a significant positive effect on both participant experience and the quality of the research outcomes of clinical trials.