Increasing Cross-Referral and Recruitment to Clinical Trials: A New Approach

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 636-636 ◽  
Author(s):  
Roslyn Ristuccia ◽  
Xavier C Badoux ◽  
Melinda Gibson ◽  
Admir Huseincehajic ◽  
Judith Trotman
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Conflicts Of Interest ◽  
Smart Phone ◽  
Basic Structure ◽  
Smartphone Application ◽  
Research Network ◽  
Research Staff ◽  
Mutational Status

Abstract Background/Aims The Haematology Clinical Research Network of New South Wales & the Australian Capital Territory (HCRN NSW/ACT) comprises public hospital clinical trial unit managers committed to collaboration in the clinical research endeavour. In June 2013 we launched the ClinTrial Refer Application (App) on iTunes and Google play. This smart-phone and iPAD/Tablet tool provided clinicians, research staff and patients with instant knowledge of currently recruiting local haematology trials. It was associated with an immediate increase in inter-hospital cross referrals of patients to trials. Following this, the HCRN aimed to sustain and measure this increased referral and trials recruitment and to create a not-for-profit 'template App' that could be transferrable to other clinical trial portfolios. Methods Patient cross-referral patterns, recruitment and staffing data were obtained from each of the 18 contributing hospitals in the HCRN from June 2013 to June 2015 and compared with prior to June 2013. Google analytics for the App were downloaded. We worked with research staff of other cancer networks to create modified versions of the App, establishing search functions unique to each network's geography and/or tumour stream. Newly derived Apps had to conform to the specifications of ClinTrial Refer, namely being publically available and free to download, simple to use and hosting only publically listed data of currently recruiting trials. Results Within the HCRN there has been a sustained increase in cross referrals for clinical trials (median 1/month (range 0-6) to 9/month (0-18)) (Figure 1) and a state-wide >50% increase in recruitment from 300 to 460 from 2012 to 2014 and a 20% increase in unit staffing from 2013 to 2014. Google analytics usage metrics identify 3362 App users, over 24,703 sessions lasting an average 56 seconds. 19,907 of these sessions are in NSW where 91% of users are repeat users. Ten other state and national haematology or other tumour stream ClinTrial Refer Apps have been derived from the original App, from Sept 2013 to July 2015 (Figure 2). While maintaining the basic structure of an easy-to-navigate listing of currently recruiting trials, each new App has been re-designed to ensure relevance for the needs of each network. This ranged from a simple re-configuration of the logo, splash screen and recruiting locations for other Australian haematology Apps, to providing mutational status options for melanoma trials or age criteria for paediatric and adolescent- young adult Networks. The back-end database of listed trials, selection criteria and recruiting sites can be rapidly easily updated by local trial unit managers ensuring currency of trial information (est. 30 minutes/month in total). The "early adopters" within other cancer research networks have reported a similar upswing in trials recruitment and Google analytics for these newer Apps are similarly impressive. Recognising ClinTrial Refer as an effective tool for patients to identify recruiting trials close to home, cancer consumer groups have posted the Apps on their websites. Conclusions An instantly accessible, simple smartphone Application has provided better knowledge management of local clinical trials across the spectrum of rare haematologic malignancies. A tool to facilitate collaboration in clinical research, it has significantly enhanced cross-referral and recruitment rates, increasing patient access to emerging therapies and supporting the viability of haematology clinical trial units across Australia. ClinTrial Refer has been rapidly adapted to suit the trials portfolios of other clinical trial networks, both within and beyond cancer. Figure 1. Figure 1. Figure 2. Figure 2. Disclosures No relevant conflicts of interest to declare.

Clintrial Refer- a Mobile App To Connect Patients With Local Clinical Trials

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5600-5600
Author(s):  
Judith Trotman ◽  
Xavier Badoux ◽  
Admir Huseincehajic ◽  
Michele Gambrill ◽  
Anais LeGall ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Entry ◽  
Smart Phone ◽  
Mobile App ◽  
Research Network ◽  
Trial Participation ◽  
Time Data ◽  
App Development

Abstract Background Readily accessible, smart-phone applications (Apps) have the potential to revolutionise and improve the delivery of patient care. Significant challenges associated with recruiting patients to haematology clinical trials include the rarity of diseases, complexity of trials, limited site locations, and maintaining knowledge of current trials in the context of rapid therapeutic developments. The Haematology Clinical Research Network, of New South Wales and the Australian Capital Territory (NSW/ACT) aimed to develop an App to facilitate clinician and patient access to current information on local clinical trials and improve trial participation by increasing referrals. Methods Key objectives were to develop an App that was free to download, simple to use and effective. Only publically listed data was to be included. Endpoints were rates of App usage, and cross-site and internal clinical trial referrals. Through liaison between the end-users (clinicians, trial managers and patients), and the contracted software developer, App specifications were refined through successive iterations. With the key search filters of Disease, Location, Sponsor and Study Status, the App has an easy to navigate listing of currently recruiting haematology trials. Useful features include: listing of inclusion and exclusion criteria; direct links to ClinTrials.gov; a lay summary; and direct contacts from the mobile device to participating study sites. Real-time data entry into the database app manager ensures currency of trial information. Results ClinTrial Refer went live in May 2013, on both iOS and Android platforms. As at 10th August, ClinTrial Refer has 654 users, over 4358 sessions and 13924 screen views.91% of current users are repeat users. Despite its local application the App has been accessed in 46 countries. Among the target audience in NSW 290 repeat users returned for an average 11 sessions each indicating a high user acceptance. It is being endorsed on the websites of Australian blood cancer consumer groups. A survey has confirmed that since its launch, through having readily accessible data on their smart-phones, ClinTrial Refer has increased clinician awareness of the NSW trial portfolio. In just twelve weeks it has resulted in the cross-referral of an additional 30+ patients for clinical trials, representing a >300% increase over previous referral patterns. This improvement in trials knowledge management has also increased within-site recruitment; however it is harder to quantify the exact short-term impact of ClinTrial Refer within hospitals. The App has already been duplicated for other Australian state-wide haematology networks and the Adolescent & Young Adult Research Network, NSW. Conclusion ClinTrial Refer is an innovative but simple, readily accessible mobile Application. Its widespread adoption across 18 Haematology Clinical Research sites in NSW Australia is facilitating increased patient recruitment to trials. Only recently available on iTunes and Google Play, it has attracted national and international attention as a template for any clinical trial network portfolio. Disclosures: Trotman: Celgene: Grant for App development Other. Huseincehajic:Celgene: Grant for App development Other.

scholarly journals Discordant attitudes and beliefs about cancer clinical trial participation between physicians, research staff, and cancer patients

2020 ◽  
Vol 17 (2) ◽  
pp. 184-194 ◽  
Author(s):  
Grace C Hillyer ◽  
Melissa Beauchemin ◽  
Dawn L Hershman ◽  
Moshe Kelsen ◽  
Frances L Brogan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Cancer Patients ◽  
Cancer Clinical Trial ◽  
Comprehensive Cancer Center ◽  
Attitudes And Beliefs ◽  
Research Staff ◽  
Hispanic Patients ◽  
Clinical Trial Enrollment

Background/Aims Essential to bringing innovative cancer treatments to patients is voluntary participation in clinical trials but approximately 8% of American cancer patients are enrolled onto a trial. We used a domain-oriented framework to assess barriers to cancer clinical trial enrollment. Methods Physicians (MD, DO, fellows, residents) and research staff (physician assistants, nurse practitioners, staff and research nurses, clinical assistants, and program coordinators) involved in clinical research at a comprehensive cancer center completed an online survey in 2017; adult cancer patients not currently enrolled in a trial were interviewed in 2018. To inform the construct of our physician/staff and patient surveys and to assess barriers to clinical trial enrollment, we first conducted in-depth interviews among 14 key informants representing medical, hematologic, gynecologic, neurologic, radiation oncology, as well as members of the clinical research team (one clinical research coordinator, one research nurse practitioner). Perceived structural, provider- and patient-level barriers to clinical trial enrollment were assessed. Differences in perceptions, attitudes, and beliefs toward clinical trial enrollment between (1) physicians and staff, (2) patients by ethnicity, and (3) physicians/staff and patients were examined. Results In total, 120 physicians/staff involved in clinical research (39.2% physicians, 60.8% staff; 48.0% overall response rate) and 150 cancer patients completed surveys. Nearly three-quarters of physician/staff respondents reported difficulty in keeping track of the eligibility criteria for open studies but was more often cited by physicians than staff (84.4% vs 64.3%, p = 0.02). Physicians more often reported lack of time to present clinical trial information than did staff( p < 0.001); 44.0% of staff versus 18.2% of physicians reported patient family interaction as a clinical trial enrollment barrier ( p = 0.007). Hispanic patients more often stated they would join a trial, even if standard therapy was an option compared to non-Hispanic patients (47.7% vs 20.8%, p = 0.002). Comparing the beliefs and perceptions of physicians/staff to those of patients, patients more often reported negative beliefs about clinical trial enrollment (e.g. being in a trial does not help patients personally, 32.9% vs 1.8%, p < 0.001) but less often felt they had no other options when agreeing to join (38.1% vs 85.6%, p < 0.001), and less often refused clinical trial enrollment due to lack of understanding (9.1% vs 63.3%, p = 0.001) than reported by physicians/staff. Conclusion Our findings indicate a wide gap between physician/staff and patient attitudes and beliefs about clinical trial enrollment and highlight the importance of focusing future initiatives to raise awareness of this incongruency. Reconciling these differences will require tailored education to reduce implicit biases and dispel misperceptions. Strategies to improve the quality of patient–provider communication and address infrastructure and resource issues are also needed to improve patient enrollment onto cancer clinical trials.

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

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.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals Estimands: bringing clarity and focus to research questions in clinical trials

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e052953
Author(s):  
Timothy Peter Clark ◽  
Brennan C Kahan ◽  
Alan Phillips ◽  
Ian White ◽  
James R Carpenter
Keyword(s):  
Clinical Trial ◽  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recent Work ◽  
Treatment Effect ◽  
Research Question ◽  
Probability Of Success ◽  
Research Questions

Precise specification of the research question and associated treatment effect of interest is essential in clinical research, yet recent work shows that they are often incompletely specified. The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials introduces a framework that supports researchers in precisely and transparently specifying the treatment effect they aim to estimate in their clinical trial. In this paper, we present practical examples to demonstrate to all researchers involved in clinical trials how estimands can help them to specify the research question, lead to a better understanding of the treatment effect to be estimated and hence increase the probability of success of the trial.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Using Social Media to Increase the Recruitment of Clinical Research Participants

2018 ◽  
pp. 7181-7189
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recruitment Strategies ◽  
Primary Role ◽  
Trial Recruitment ◽  
Recruitment Methods ◽  
Pros And Cons ◽  
Clinical Trial Recruitment

Research has shown that clinical research continues to have difficulty recruiting participants. This problem is expected to increase as the number of clinical trials increases and as there continues to be more focus on complex diseases and treatments. Researchers have typically relied on traditional recruitment methods to recruit participants, which revolve around the physicians and their support staff having the primary role to locate and recruit these participants. However, with individuals using online platforms such as social media to retrieve information, this creates an opportunity for research site personnel to use it as a way to relay information on clinical trial opportunities. Studies that have used social media as a way to recruit participants are discussed. Furthermore, pros and cons of social media for recruitment, along with recommendations that future researchers should consider when deciding whether to implement this type of strategy in their clinical trials will be shared. In general, clinical trial recruitment strategies need to shift to an approach that is not only more targeted, but also has a larger reach. By evaluating the success of studies that have used social recruitment strategies so far, it is evident that future researchers can also achieve recruitment success through social media. Moreover, social media could be a promising new avenue for clinical trial recruitment that allows for a more positive experience for both investigative site personnel and potential participants.

The Business of Clinical Research

2018 ◽  
pp. 417-433
Author(s):  
Lívia Caroline Mariano Compte ◽  
Jorge Leite ◽  
Andre Brunoni ◽  
Felipe Fregni
Keyword(s):  
Clinical Trial ◽  
Intellectual Property ◽  
Clinical Research ◽  
Conflict Of Interest ◽  
Clinical Case ◽  
Conflicts Of Interest

This chapter presents a series of important topics that should be considered and evaluated before conducting a clinical trial in which there is a collaboration between industry and academia. It discusses important topics such as the project budget and sources of funding. Additionally, this chapter highlights the advantages of the academia-industry partnership, potential conflicts of interest, and, in the advent of a conflict of interest, strategies to minimize its effects. Intellectual property, indemnifications, publication, and other specific issues are also presented as key elements in a clinical trial agreement. A clinical case is used to exemplify and discuss the practical aspects of this challenging negotiation.

scholarly journals OC 8526 THE RWANDA CLINICAL RESEARCH NETWORK (RWANDA-CRN): A MODEL FOR MIXED SOUTH-SOUTH AND NORTH-SOUTH COLLABORATIONS FOR CLINICAL RESEARCH CAPACITY DEVELOPMENT

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A11.2-A12
Author(s):  
Jean Pierre Musabyiman ◽  
Clarisse Musanabaganwa ◽  
Valentine Dushimiyimana ◽  
Jean Pierre Namabajimana ◽  
Prosper Karame ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Burden Of Disease ◽  
Resource Sharing ◽  
Research Capacity ◽  
Research Network ◽  
Grant Writing ◽  
Clinical Research Network ◽  
Funding Model ◽  
Local Funding

BackgroundPoor countries carry 90% of the global burden of disease, with access to only 10% of globally available health research funding and technical capacity. Fragile south–south collaborations hinder effective use of limited resources, career opportunities and funding to retain the insufficiently available quality scientists. The Rwanda Health System established a clinical research network involving academia, non-governmental organisations and private sector to accelerate generation of talented scientists, create enabling environment and incentives to retain scientists by establishing a local funding model.MethodsBased on a baseline assessment, potential clinical trial units were mapped and developed through adoption of a Clinical trial management training model from European Universities. The Rwandan law on Public Private Partnership was leveraged to attract and engage local and international private players in a win-win approach. So far, countries such as Kenya and Sweden were engaged in the roadmap.ResultsFrom 2014 to date, a total of 285 scientists are trained on various clinical research components: Good Clinical Practice (28%), Research Grant writing (14%), systematic review and meta-analysis (9%) and scientific communication (8.7%). Ten Clinical Research Units and one centre for evidence-based healthcare were established. So far 13 health investigator-initiated projects in malaria, metabolic disorders and maternal health were funded through the local funding model. A process to empower six malaria sentinel sites into fully functioning clinical research sites is underway.ConclusionThe creation of strong networks of excellence for’clinical research among southern academic, research institutions and pharmaceutical and non-pharmaceutical industry is a promising strategic approach to promote sustainable clinical research capacity. The government vision is that beyond national boundaries, resource sharing and involvement of private players are key factors to mitigate the high burden of disease, nationally and regionally.

Research with Minors in Germany

2008 ◽  
Vol 15 (2) ◽  
pp. 127-134 ◽  
Author(s):  
Dieter Hart ◽  
Benedikt Buchner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
German Law ◽  
European Level ◽  
Direct Benefit ◽  
Individual Participant ◽  
Long Time ◽  
The Individual

AbstractThe European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called “group benefit”. Particularly the latter possibility of conducting clinical trials on minors even if no individual benefit can be expected is not a matter of course in Germany since due to historical experiences a sceptical attitude towards clinical research on humans prevailed for a long time. German legislature has availed itself of the option granted by Article 3 of the GCP Directive to establish a higher level of protection of clinical trial subjects than the European level.

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