Best practices in social and behavioral research: report from the
                    Enhancing Clinical Research Professional’s Training and Qualifications
                    project

IntroductionThis article discusses the process of defining competencies and development of a best practices training course for investigators and clinical research coordinators who conduct social and behavioral research.MethodsThe first project phase established recommendations for training in Good Clinical Practice (GCP) and was done in conjunction with representatives from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in behavioral clinical trials and differences in regulation of behavioral trials compared with clinical trials involving drugs, devices, or biologics necessitated a separate Social and Behavioral Work Group. This group worked with CTSA representatives to tailor competencies and fundamental GCP principles into best practices for social and behavioral research.ResultsAlthough concepts underlying GCP were deemed similar across all clinical trials, not all areas were equally applicable and the ways in which GCP would be enacted differ for behavioral trials. It was determined that suitable training in best practices for social and behavioral research was lacking.DiscussionBased on the training need, an e-learning course for best practices is available to all CTSA sites. Each institution is able to track outcomes for its employees to help achieve standardized competency-based best practices for social and behavioral investigators and staff.

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Best Practices in Social and Behavioral Research: A multisite pilot evaluation of the good clinical practice online training course

Journal of Clinical and Translational Science ◽

10.1017/cts.2018.27 ◽

2018 ◽

Vol 2 (2) ◽

pp. 95-102 ◽

Cited By ~ 2

Author(s):

Susan L. Murphy ◽

Elias M. Samuels ◽

H. Robert Kolb ◽

Linda S. Behar-Horenstein ◽

Ellen Champagne ◽

...

Keyword(s):

Clinical Practice ◽

Best Practices ◽

Course Completion ◽

Online Training ◽

Good Clinical Practice ◽

Behavioral Research ◽

Future Studies ◽

Training Course ◽

Behavioral Trials ◽

Larger Sample

IntroductionThe Best Practices in Social and Behavioral Research Course was developed to provide instruction on good clinical practice for social and behavioral trials. This study evaluated the new course.MethodsParticipants across 4 universities took the course (n=294) and were sent surveys following course completion and 2 months later. Outcomes included relevance, how engaging the course was, and working differently because of the course. Open-ended questions were posed to understand how work was impacted.ResultsParticipants rated the course as relevant and engaging (6.4 and 5.8/7 points) and reported working differently (4.7/7 points). Participants with less experience in social and behavioral trials were most likely to report working differently 2 months later.DiscussionThe course was perceived as relevant and engaging. Participants described actions taken to improve rigor in implementing trials. Future studies with a larger sample and additional participating sites are recommended.

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The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

10.2196/preprints.17630 ◽

2019 ◽

Author(s):

Allison Hirsch ◽

Mahip Grewal ◽

Anthony James Martorell ◽

Brian Michael Iacoviello

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Scoping Review ◽

Digital Technologies ◽

Good Clinical Practice ◽

The United States ◽

Clinical Trial Research ◽

Digital Methods ◽

Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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Obstacles in conducting clinical trials in the Saudi Arabia

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20174864 ◽

2017 ◽

Vol 4 (4) ◽

pp. 166

Author(s):

Salem D. Al Suwaidan ◽

Aseel S. Alsuwaidan

Keyword(s):

Clinical Trials ◽

Saudi Arabia ◽

Clinical Practice ◽

Clinical Research ◽

Strategic Plan ◽

Good Clinical Practice ◽

European Countries ◽

Regulatory Authorities ◽

Research Institution

Background: Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern. It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.Methods: Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.Conclusions: To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.

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All nurses need to be research nurses

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.294 ◽

2017 ◽

Vol 1 (5) ◽

pp. 269-270 ◽

Cited By ~ 1

Author(s):

Patricia Eckardt ◽

Marilyn J. Hammer ◽

Margaret Barton-Burke ◽

Margaret McCabe ◽

Christine T. Kovner ◽

...

Keyword(s):

Clinical Practice ◽

Clinical Research ◽

Quality Care ◽

Good Clinical Practice ◽

Education And Training ◽

Validity And Reliability ◽

Test Items ◽

Research Nurses ◽

Training Need ◽

And Training

IntroductionNurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.MethodsA collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.ResultsA pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.ConclusionsAs the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.

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Abstract W P306: Identifying Stroke Researcher Challenges to Minority Inclusion in Clinical Research

Stroke ◽

10.1161/str.45.suppl_1.wp306 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Heather Carman ◽

Leigh Quarles ◽

Lauren Southwick ◽

Emma K Benn ◽

Salina P Waddy ◽

...

Keyword(s):

Clinical Trials ◽

Mixed Methods ◽

Best Practices ◽

Clinical Research ◽

Focus Groups ◽

Minority Recruitment ◽

Mixed Methods Approach ◽

Recruitment And Retention ◽

Patient Reported ◽

Key Informant

Background: Race-ethnic disparities exist in stroke incidence, recurrence and mortality. Minority participation in stroke clinical trials is staggeringly low. A significant literature describes patient-reported barriers to recruitment, but researcher barriers are not well documented. Aim: To assess stroke researcher best practices and challenges to minority inclusion in stroke trials. Methods: The National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT) uses a mixed methods approach including surveys, focus groups and key informant interviews to expand on understanding of minority recruitment and retention in stroke clinical trials. We designed and tested a 40-item survey based on literature review and used the results to inform semi-structured focus groups and key informant interviews among stroke clinical trial investigators (N=110). Results: Key stroke investigators, identified through the Princeton Conference, were invited via email to participate in the survey. Over 70% (n=93) responded: 68% White. Less than half (N=43) reported actively setting recruitment goals for minority inclusion. Only 37% (N=29) required cultural sensitivity training for recruitment staff. Over 80% reported treating adults unable to consent and were concerned about acute stroke time constraints negatively impacting patient/family participation decisions. Key themes from focus groups (N=17) included: 1) Role of government in defining valid minority sub analyses and enforcing existing inclusion guidelines; 2) Challenges unique to acute setting including consent in conditions of prognostic uncertainty; 3) Lack of scientific/research literacy in the lay population; 4) Lack of community engagement including Primary Care Physicians; 5) Lack of cost data to adequately budget for inclusion efforts. Best practices included health literate consent forms, cultural competency, and motivational interview training for coordinators. Conclusion: NIMICT’s mixed methods approach contributes new perspectives on unique challenges in stroke clinical research. These findings will inform strategies to improve minority recruitment and retention among neurological clinical trials.

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Managing clinical trials during COVID-19: experience from a clinical research facility

Trials ◽

10.1186/s13063-020-05004-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Frances Shiely ◽

Jean Foley ◽

Amy Stone ◽

Emma Cobbe ◽

Shaunagh Browne ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Best Practices ◽

Clinical Research ◽

Research Facility ◽

Clinical Research Facility ◽

Key Issues ◽

Practical Guidance ◽

Trial Manager

AbstractThere is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.

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The Investigational Clinical Center: a clinical-supportive and patient-centered trial unit model. Ten years of experience through normal and pandemic times of a large pediatric Trial Center in Italy.

10.21203/rs.3.rs-110604/v2 ◽

2021 ◽

Author(s):

Giuseppe Pontrelli ◽

Marco Ciabattini ◽

Franco De Crescenzo ◽

Isabella Biondi ◽

Rossana Cocchiola ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Good Clinical Practice ◽

Legal Framework ◽

Patient Centered ◽

Unit Model ◽

Clinical Center ◽

High Workload ◽

Pediatric Trial

Abstract Evidence-based medicine relies on appropriately designed, conducted and reported clinical trials (CTs) to provide the best proofs of efficacy and safety for pharmacological and non-pharmacological treatments. Modern clinical research features high complexity and requires a high workload for the management of trials-related activities, often hampering physicians’ participation to clinical trials. Dealing with children in clinical research adds complexity: rare diseases, parents or legal guardian reluctance to engage and recruitment difficulties are major reasons of pediatric trials failure. However, because in pediatrics many treatments are prescribed off-label or are lacking, well-designed clinical trials are particularly needed. Clinical Trial Units (CTUs) are indeed an important asset in the implementation of clinical trials, but their support to investigators is limited to administrative and non-clinical tasks. In this paper we present the model of the Investigational Clinical Center (ICC) of the Bambino Gesù Children’s Hospital in Rome. The ICC includes clinicians supporting the Principal Investigators for clinical management of enrolled patients in compliance of Good Clinical Practice, the legal framework of Clinical Trials. Furthermore, we present ten years’ experience in pediatric clinical trials and how it has been affected in 2020 by the COVID-19 pandemic. The activity of the ICC has been evaluated according to specific metrics of performance. The ICC model offers a complete support, helping investigators, patients and their families to overcome majority of barriers linked to clinical research, even in time of pandemic. We propose this organization as an innovative model for total-supportive and patient-centered clinical trial implementation.

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Good Clinical Practice (GCP) – an alternative, unarticulated narrative

Indian Journal of Medical Ethics ◽

10.20529/ijme.2021.064 ◽

2021 ◽

pp. 01-04

Author(s):

Samir Malhotra

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Practice ◽

Clinical Research ◽

Gold Standard ◽

Scientific Community ◽

Good Clinical Practice ◽

Official Document ◽

Market Expansion ◽

New Drug Development

GCP has become the gold-standard for clinical research; initiated as a guideline pertaining to new drug development, it became a law in many countries, extending its scope to include all research. GCP is an excellent document that outlines the responsibilities of stakeholders involved in clinical research. Widely acclaimed, and deservedly so, it is considered as the “go-to” document whenever questions arise during the conduct of a clinical trial. This article presents another narrative, one that has not been articulated so far. Irrespective of whether we consider GCP as a law or a guideline, it is viewed as an “official” document, without the overt realisation that this was actually an initiative of the pharmaceutical industry, the “masters of mankind”. While the stress on documentation and monitoring in GCP was justified, its over-interpretation led to increased costs of clinical trials, with the result that smaller companies find it difficult to conduct the already expensive trials. GCP as an idea is now so entrenched within the scientific community that the real aims which led to its birth and that can be mined from the ICH website, like the need for market expansion, have remained largely unnoticed and undocumented, and are being expressed here.

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Impact of COVID-19 pandemic on design and conduct of clinical trials: developing best practices based on lessons learned for risk and change management

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20210148 ◽

2021 ◽

Vol 8 (1) ◽

pp. 79

Author(s):

Marina A. Malikova

Keyword(s):

Clinical Trials ◽

Best Practices ◽

Clinical Research ◽

Risk Mitigation ◽

Geographic Location ◽

Study Drug ◽

Lessons Learned ◽

Drug Mechanism ◽

Push Forward ◽

Study Teams

The coronavirus disease 2019 (COVID- 19) pandemic is disrupting clinical research in most of the world. We have seen an immediate impact on clinical trials due to challenges coming from the COVID-19 travel bans, hospitals/clinics’ visitation restrictions, social distancing precautions and shifting operations to work remotely on a short notice. These factors have translated into the issues challenging clinical trials such as operations, milestones, budgets, data integrity, etc. Given the complex risk/benefit considerations associated with each specific clinical trial, there is no single solution to manage the risks in clinical trials conduct due to COVID-19. Each trial is unique with respect to patient population, study drug mechanism of action, concomitant medications, and geographic location needs. It is important to continue to engage the networks and communities to push forward with creative risk mitigation and develop solutions during this challenging time. Risk assessment should be a continuous and living process as the situation evolves over the coming weeks to months. Routine and ongoing cross checks with study teams are already proving to maintain alignment on key timelines, critical risk points and other study specific challenges as we are moving towards de-centralized settings in the conduct of clinical trials. We have analyzed lessons learned and attempted to develop best practices to mitigate risks and adjust clinical research operations during this unprecedented time.

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2200

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.165 ◽

2017 ◽

Vol 1 (S1) ◽

pp. 45-45

Author(s):

Susan Lynn Murphy ◽

Christy Byks-Jazayeri ◽

Brenda Eakin ◽

Jordan Hahn ◽

Brandon Lynn ◽

...

Keyword(s):

Clinical Trials ◽

Good Clinical Practice ◽

Relevant Information ◽

Behavioral Research ◽

Preliminary Evaluation ◽

Pass Rates ◽

Job Aids ◽

Additional Information ◽

University Of Buffalo

OBJECTIVES/SPECIFIC AIMS: To conduct a preliminary evaluation of the Social and Behavioral Research Best Practices Course. METHODS/STUDY POPULATION: Learners are sampled from 5 institutions: University of Michigan, University of Rochester, University of Florida, Boston University, and University of Buffalo. Learners who take the course and consent to be in the study receive a web link to a survey immediately after course completion and at 2–3 months follow up. In addition to demographic information, learners will report their perceptions of usefulness and relevance of the course to their job, their satisfaction with the course and associated job aids, and at follow-up, if and how the course impacted their work. Additional information will be collected from the learning management systems which host the course at each institution. The data collected will include the number of participants who take the course, the number who complete, how many times the course was attempted, and pass rates. RESULTS/ANTICIPATED RESULTS: We anticipate that several hundred learners will take the course by the end of our project. Of learners who agree to participate in the survey, we anticipate that they will find the course useful and relevant to social and behavioral clinical trials and will be satisfied with the course. Information including suggestions about missing content, items or content that were not extremely clear, or any other comments will be collected to iterate and expand the course. DISCUSSION/SIGNIFICANCE OF IMPACT: This course was developed to fill a gap in training in good clinical practice for social and behavioral research. An evaluation of how the training provided in the course impacts the jobs of learners is needed both to ensure that the most relevant information is included in the course as well as to identify ways that the training may contribute to the quality and safety of social and behavioral clinical trials.

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