A community-centered approach to sickle cell disease and clinical trial participation: an evaluation of perceptions, facilitators, and barriers.

Sickle cell disease (SCD) is the most common inherited red blood cell disorder in the United States, affecting 70 000 to 100 000 Americans and causing a range of serious medical complications. Although the cause of SCD was established decades ago, existing therapies have varied effectiveness and side effects, and development of novel therapies has been slow. The limitations of existing treatment options highlight the need for new therapies that are aligned with the desires of the community.

Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications.

Background: As clinical trial protocol designs become more complex and eligible patient populations narrow, it is becoming increasingly difficult to recruit participants and retain them for the duration of the trial. This study surveyed clinical trial participants to learn about the prevalence and impact of new technologies and other supportive solutions designed to improve patient engagement and retention. Patient perceptions of these convenience-enhancing solutions and how they have changed since our last study in 2017 were examined.

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.

Establishing Consensus Understanding of the Barriers to Drug Development in Lupus.

Objective: Due to the extreme heterogeneity of lupus and the lack of consensus among stakeholders, pharmaceutical and biotechnology companies have had limited success in developing treatments for lupus. For this reason, the Lupus Foundation of America (LFA), researchers at the Center for the Study of Drug Development at Tufts University School of Medicine (Tufts CSDD) and an advisory committee of 13 international lupus experts collaborated to launch the Addressing Lupus Pillars for Health Advancement (ALPHA) project.

Methods: To inform the ALPHA project, 17 in-depth interviews among lupus experts and a global survey among lupus drug development and clinical care professionals was conducted to identify, characterize, and prioritize fundamental barriers and validate findings.

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.

Using Patient Advisory Boards to Solicit Input Into Clinical Trial Design and Execution.

Academic institutions, pharmaceutical and biotechnology companies, foundations, and associations are routinely implementing patient advisory boards (PABs) to solicit patients' voices and perspectives on a variety of clinical research-related areas, including protocol design, clinical trial execution, informed-consent form design, clinical trial medicine kit design, wearable devices and mobile technologies, and patient-communication materials. Based on experience conducting >50 PABs during the past several years, the authors provide insights into how to best plan and execute PABs and their value in informing improvement in patient engagement.

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.

Global Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials.

Importance: Effective, continuous improvement in patient engagement depends on an intimate understanding of public and patient perceptions and experiences in clinical research.

Objectives: To identify the views of clinical trial participants and nonparticipants and characterize trends in these views over time.

Design, Setting, And Participants: In this survey study, a questionnaire was administered online from May 8 to July 24, 2017, by the Center for Information and Study on Clinical Research Participation (CISCRP), and findings were compared with previous studies conducted in 2013 and 2015.

Insights and Best Practices for Planning and Implementing Patient Advisory Boards.

A growing number of organizations-including pharmaceutical and biotechnology companies, foundations and associations-are routinely implementing patient advisory boards (PAB) given their high reported value for minimal relative investment. Organizations are typically implementing PABs to solicit patient voices and perspectives on a variety of areas such as protocol designs, clinical trial medicine kit designs, informed consent form designs, technology solutions, and patient communication materials. The Center for Information and Study on Clinical Research Participation (CISCRP) has planned, executed, and facilitated more than 30 PABs.

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.

Impact of In-Pharmacy Education on Patients' Knowledge and Attitudes About Clinical Trials.

The lack of public awareness and understanding about clinical research has long hindered the efficiency and speed in recruiting patients to participate in clinical trials. Earlier research conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) examined whether pharmacists might be a viable channel to educate and engage the public about clinical research, and the results suggested that pharmacy-directed outreach and education are feasible. This study measured the impact of in-pharmacy education on patient comprehension and willingness to participate in clinical research.