A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward.

Background: (1) A growing number of pharmaceutical and biotechnology organizations are engaging patients, their support networks, and clinical trial site staff at various touchpoints along the clinical research development spectrum to solicit feedback on how to reduce the burden of clinical trial participation and administration. (2) However, many organizations are still evaluating how to best implement such engagement initiatives in a manner that will evoke meaningful, sustainable results and change.

Methods: In an effort to support meaningful engagement in a novel way, Janssen organized a 2-day innovative workshop designed to promote collaboration and foster mutual understanding among a cross-functional group of clinical research stakeholders.

Why scientific societies should involve more early-career researchers.

Early-career researchers (ECRs) make up a large portion of the academic workforce. Yet, most leadership positions in scientific societies are held by senior scientists, and ECRs have little to no say over the decisions that will shape the future of research. This article looks at the level of influence ECRs have in 20 scientific societies based in the US and UK, and provides guidelines on how societies can successfully include ECRs in leadership roles.

Differences in Clinical Research Perceptions and Experiences by Age Subgroup.

Background: (1) To assess the differing viewpoints of actual and potential adult clinical trial participants in 5 age cohorts, (2) identify misperceptions and opportunities to reduce unnecessary burdens on volunteers, and (3) provide age-specific feedback to study sponsors on their current engagement efforts.

Methods: Based on 12,427 responses to a global online survey collected between May and July 2017, we conducted a subgroup analysis by age of general clinical research impressions, the participation decision-making process, and experiences of study participants.

Results: Overall, younger people were the most misinformed and experienced the most difficulties, while older people had the most misgivings about studies and sponsoring pharmaceutical companies.

Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials.

Background: It is widely acknowledged that patient recruitment is a significant challenge and represents one of the primary reasons for drug development delays. Data from the Center for Information and Study on Clinical Research Participation (CISCRP) "Perceptions & Insights" study indicate that the 18- to 34-year-old Generation Y subgroup was the least willing to participate in a clinical trial.

Methods: The willingness of Generation Y to participate in clinical studies was compared to that of older groups in the CISCRP study.

Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.

Background: Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed.

Methods: The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change.