“You Need to Be a Good Listener”: Recruiters’ Use of Relational Communication Behaviors to Enhance Clinical Trial and Research Study Accrual

This is a summary of a research study (known as a clinical trial) called CROWN. The study tested two medicines called lorlatinib and crizotinib in participants with untreated non-small cell lung cancer that had spread to other parts of their body. All those who took part had changes in a gene called ALK, which is involved in cell growth. In total, 296 participants from 23 countries took part. Half the participants took lorlatinib and half took crizotinib. After participants started taking lorlatinib or crizotinib, they were checked regularly to see if their tumors had grown or spread to other parts of their body (known as tumor progression) and to monitor any side effects. After 1 year of treatment, the participants who took lorlatinib were twice as likely to be alive with no tumor growth as the participants who took crizotinib. More participants who took lorlatinib had cancer that shrank (76%) compared with the participants who took crizotinib (58%). This was also true of the participants whose cancer had spread to their brain. The most common side effects in participants who took lorlatinib were increases in the amount of cholesterol and triglycerides (a type of fat) in their blood, swelling, weight gain, nerve damage, unclear thoughts, and diarrhea. Among the participants who took crizotinib, the most common side effects were diarrhea, feeling like you want to throw up, sight problems, swelling, vomiting, changes in liver function, and feeling tired. Overall, the CROWN study showed that fewer participants with advanced ALK+ non-small cell lung cancer died or had tumor growth with lorlatinib compared with crizotinib treatment. ClinicalTrials.gov NCT number: NCT03052608 .

Download Full-text

Participation in a research study related to acute myocardial infarction is not a guarantee to live more longer: results from the FAST-MI registries

European Heart Journal ◽

10.1093/ehjci/ehaa946.1617 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

E Puymirat ◽

F Schiele ◽

F Roubille ◽

V Tea ◽

J Ferrieres ◽

...

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Clinical Trial ◽

Clinical Outcome ◽

Clinical Characteristics ◽

Research Study ◽

St Elevation Myocardial Infarction ◽

Lower Mortality ◽

St Elevation ◽

One Year

Abstract Background The main potential benefits of participating in a clinical trial is to have access to a treatment that is not available yet and to have a regular and careful attention from physicians. Several data have suggested that inclusion in a research study was associated with better clinical outcome. Aims The aim of this study is to describe the prevalence of inclusions in a research study (i.e., device or medication), clinical characteristics, management and clinical outcome in patients admitted for acute myocardial infarction (AMI) according to participation in a research study (versus not) using data from the French registries of Acute ST-or non-ST-elevation Myocardial infarction (FAST-MI) 2010 and 2015. Methods We used data from 2 one-month French registries, conducted 5 years apart, including 9,414 AMI admitted to coronary or intensive care units. We analyzed baseline characteristics, management and one-year survival according to participation in a research study. Results From 2010 to 2015, the prevalence of patients included in a research study decreased from 6.8% to 3.6% (P<0.001). Inclusions were performed mainly in university hospitals (8%). Clinical characteristics according to participation in a research study were strongly different. Overall, patients included in a research study were younger (61.2±12.7 vs 65.7±14.1; P<0.001) with less previous medical history and co-morbidities. Clinical presentation was preferentially a ST-elevation myocardial infarction (STEMI: 70% vs 52%; P<0.001) in these patients who had a lower GRACE score (133±32 vs. 141±35; P<0.001). The use of invasive strategies was more used in patients included in a research study (coronary angiogram: 99% vs 95%, P<0.001) as prescriptions of recommended medications (i.e., antiplatelet agents, beta-blockers, angiotensin-converting-enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) and statins) at discharge (72% vs 63%; P<0.001). In a cox multivariate analysis, participation in a research study was not associated with lower mortality at one-year (HR= 0.68, 95% CI, 0.39–1.18, P=0.17). Similar results were observed in patients discharge alive (HR= 0.81, 95% CI, 0.44–1.48, P=0.49). Recommended medications were however more used in patients included in a clinical trial (OR=1.34; 95% CI, 1.09–1.65; P=0.007). Conclusions The number of inclusions in a research study related to AMI in France is low. Our data suggest that patients included in a research study are selected and received more recommended medications and invasive strategies. However, this management is not associated with a lower mortality at one-year. Funding Acknowledgement Type of funding source: None

Download Full-text

Discussion of a well-designed clinical trial which did not demonstrate effectiveness: UIC center for botanical dietary supplements research study of black cohosh and red clover

Fitoterapia ◽

10.1016/j.fitote.2010.10.013 ◽

2011 ◽

Vol 82 (1) ◽

pp. 88-91 ◽

Cited By ~ 6

Author(s):

Lee P. Shulman ◽

Suzanne Banuvar ◽

Harry H.S. Fong ◽

Norman R. Farnsworth

Keyword(s):

Clinical Trial ◽

Dietary Supplements ◽

Research Study ◽

Red Clover ◽

Black Cohosh ◽

Botanical Dietary Supplements

Download Full-text

Research Clinical Trial- A Review

International Journal Of Medical Science And Clinical Research Studies ◽

10.47191/ijmscrs/v1-i9-08 ◽

2021 ◽

Vol 01 (09) ◽

Author(s):

Dr. Ishita Attri ◽

Keyword(s):

Clinical Trial ◽

Healthcare Professionals ◽

Research Study ◽

Research Protocol ◽

Team Members ◽

Roles And Responsibilities ◽

Post Marketing Surveillance ◽

Post Marketing

Majority of healthcare professionals are struggling with conducting and writing a protocol for a research study. Thus, the purpose of this article is to summarize significant steps and necessary guidelines for producing a standard research protocol, roles and responsibilities of various team members involved in the study, and conduction of actual clinical trial including its initiation, phases (I-III), termination or post-marketing surveillance phase. It is important to note that the quality of a clinical trial largely depends on the protocol to achieve success in the research study.

Download Full-text

Recommendations for Supporting Prospective Study Registration in the Basic Experimental Studies in Humans And Alternative Procedures for Results Dissemination

10.31219/osf.io/j4a2s ◽

2021 ◽

Author(s):

David Thomas Mellor ◽

Nicole Pfeiffer

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Research Study ◽

Human Subjects ◽

Behavioral Outcomes ◽

Experimental Studies ◽

Basic Research ◽

Health Related ◽

Alternative Procedures ◽

Definition Of

Recently, the NIH has modified the definition of clinical trial so that it applies to a much broader range of studies that previously were classified as clinical research but not specifically as trials. This definition, below, specifically includes research where behavioral outcomes are a focus of the study: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”With the addition of behavioral outcomes, many studies that previously would not have been “clinical trials” are now so classified. Research studies that meet both criteria for “clinical trial” and “basic research” are now referred to as basic experimental studies in humans (BESH). The purpose of this whitepaper is to analyze and investigate ways that existing infrastructure could be improved to support these new requirements in ways that benefit all stakeholders.

Download Full-text

Defining Research: The Effect of Linguistic Choices on the Intentions to Participate in Clinical Research

Clinical Nursing Research ◽

10.1177/1054773817713179 ◽

2017 ◽

Vol 27 (7) ◽

pp. 790-799 ◽

Cited By ~ 1

Author(s):

Yulia A. Strekalova

Keyword(s):

Clinical Trial ◽

Clinical Research ◽

Online Survey ◽

Research Study ◽

Related Research ◽

Ethical Implications ◽

Health Related Research ◽

Health Related ◽

Knowledge Brokers ◽

Intentions To Participate

Significant barriers to participant recruitment for clinical research (CR) are related to effective communication, and nurse coordinators are entrusted with being knowledge brokers between investigators and prospective participants. This prospective cohort study sought to identify linguistic choices that could inform and facilitate recruitment efforts. Healthy adults ( N = 204) were invited to join an online survey to assess the likelihood of participation in CR based on short and extended definitions of CR. Five short definitions included clinical trial, clinical study, health-related research study, community participatory study, and quality improvement study. The likelihood of participation in CR was the lowest for clinical trial and the highest for health-related research study. However, when only an extended definition was provided, those differences were not observed. A linguistic change from trial to study could lead to positive attitude toward CR and improvements in recruitment. However, ethical implications of linguistic choices should be considered.

Download Full-text

A Post Hoc Analysis of Research Study Staffing: Budgetary Effects of the Health Insurance Portability and Accountability Act on Research Staff Work Hours during a Prospective, Randomized Clinical Trial

Anesthesiology ◽

10.1097/01.anes.0000287212.90397.6b ◽

2007 ◽

Vol 107 (5) ◽

pp. 860-861 ◽

Cited By ~ 2

Author(s):

Brian A. Williams ◽

Matthew T. Bottegal ◽

Kimberly A. Francis ◽

James J. Irrgang ◽

Molly T. Vogt

Keyword(s):

Clinical Trial ◽

Health Insurance ◽

Randomized Clinical Trial ◽

Research Study ◽

Work Hours ◽

Research Staff ◽

Prospective Randomized Clinical Trial ◽

Post Hoc Analysis ◽

Health Insurance Portability ◽

Post Hoc

Download Full-text

Participation in a Clinical Trial Does Not Impact Outcome in Pediatric Acute Lymphoblastic Leukemia

Blood ◽

10.1182/blood.v112.11.1318.1318 ◽

2008 ◽

Vol 112 (11) ◽

pp. 1318-1318

Author(s):

Carl Koschmann ◽

Doug S Hawkins ◽

Blythe Thomson

Keyword(s):

Clinical Trial ◽

Acute Lymphoblastic Leukemia ◽

Research Study ◽

Risk Group ◽

Lymphoblastic Leukemia ◽

P Value ◽

Study Participation ◽

Single Institution ◽

Home State ◽

Pediatric All

Abstract Background: Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy. Over the past four decades, the outcome for pediatric ALL has rapidly improved secondary to the participation of children on clinical trials, resulting in standardization of the treatment. Some have argued that the best outcome results from participation in a pediatric clinical trial. To address the potential benefits and barriers to participation in a clinical trial, we analyzed clinical trial participation in pediatric ALL at a large single institution. Methods: We evaluated 322 ALL patients < 22 years old at diagnosis who receive their initial therapy at Seattle Children’s Hospital Regional Medical Center (S-CHRMC) between January 1997 and December 2005. Using a retrospective chart review, we analyzed the following variables: study participation (SP) or non-participation (NP) in an ALL therapeutic study, gender, race, patient immunophenotype, risk group (standard risk (SR), high risk (HR) or infant), home state, and distance of primary residence from S-CHRMC. S-CHRMC is the largest pediatric cancer center in the Pacific Northwest, with referrals from Washington, Alaska, Montana, Idaho and Wyoming. Events were defined as relapse or death from any cause. Results: The overall 5 year event free survival (EFS) was 78% (+/− 2.5%). 157 patients participated in a treatment research study (49%). Only risk group was associated with EFS. SP and NP had similar EFS. Gender, race, immunophenotype, home state, or distance from primary residence were not associated with outcome. There was no difference in study participation by gender, race, home state, or distance of primary residence. There were trends to increased participation in SR vs HR (54% vs 35%, p value 0.15) and B lineage vs T lineage (50% vs 35%, p value 0.11). Variable n 5 year EFS p value Study participation No 165 76 (+/− 3.9) 0.47 Yes 157 81 (+/− 3.3) Risk group SR 175 85 (+/− 3.0) HR 132 73 (+/− 4.2) (0.038 to SR) Infant 15 59 (+/−12.9) (0.011 to SR) Discussion: Participation in a research study for treatment of pediatric ALL was not associated with improved outcome in our large single institution series. Study participation was not different by clinical features, including distance to the primary residence. Strict standardization of treatment for all patients may contribute to the similar outcome for SP and NP.

Download Full-text