scholarly journals Using Computable Phenotypes in Point-of-Care Clinical Trial Recruitment

Author(s):  
Martin Chapman ◽  
Jesús Domínguez ◽  
Elliot Fairweather ◽  
Brendan C. Delaney ◽  
Vasa Curcin

A key challenge in point-of-care clinical trial recruitment is to autonomously identify eligible patients on presentation. Similarly, the aim of computable phenotyping is to identify those individuals within a population that exhibit a certain condition. This synergy creates an opportunity to leverage phenotypes in identifying eligible patients for clinical trials. To investigate the feasibility of this approach, we use the Transform clinical trial platform and replace its archetype-based eligibility criteria mechanism with a computable phenotype execution microservice. Utilising a phenotype for acute otitis media with discharge (AOMd) created with the Phenoflow platform, we compare the performance of Transform with and without the use of phenotype-based eligibility criteria when recruiting AOMd patients. The parameters of the trial simulated are based on those of the REST clinical trial, conducted in UK primary care.

2015 ◽  
Vol 33 (2) ◽  
pp. 186-191 ◽  
Author(s):  
Nikolaos Mastellos ◽  
Grzegorz Bliźniuk ◽  
Dorota Czopnik ◽  
Mark McGilchrist ◽  
Andrzej Misiaszek ◽  
...  

2021 ◽  
Author(s):  
Jarett Anderson ◽  
Austin Hamp ◽  
Michelle Militello ◽  
Ryan Geist ◽  
Jaclyn Anderson ◽  
...  

BACKGROUND Clinical trials are an essential process in discovering new biomedical or behavioral outcomes in disease processes. There are several steps involved in creating a clinical trial. One step, patient recruitment, is often touted as the largest contributor to trial delays, which has financial, scientific, and ethical ramifications. Approximately 1.2 billion dollars in the United States is spent each year on this process and as many as 86% of clinical trials do not meet recruitment targets within their perspective timeframes, and 19% of trials had to be terminated early due to insufficient recruitment and/or patient retention1. Social media is a viable, inexpensive tool that can be utilized to improve both recruitment and retention rates2. To date, platforms such as Facebook, Twitter and others have been widely utilized in recruitment for clinical trials, communication among stakeholders, and educational tools. Social media also has the advantage of reaching populations that otherwise would be more difficult to reach3. A list of these platforms and each of their distinct advantages for clinical trial recruitment can be found in Table 1. This review aims to highlight the unique characteristics of several social media platforms and their advantageous properties in increasing recruitment and retention during clinical trials. OBJECTIVE This narrative review analyzes the current use of several social media sites in clinical trial recruitment and retention. It also offers insight concerning potential uses of these sites that are not currently utilized. METHODS A literature search was performed using PubMed, Google Scholar, and ResearchGate to access and review relevant articles published in peer-reviewed journals concerning social media and its use in clinical trials. Two independent researchers with education and experience in dermatology screened publications to select studies featuring quantitative results concerning social media and clinical trial recruitment. RESULTS 13 social media applications were studied and reviewed. 7 of these social media sites or applications have currently been studied, and their use in complementing traditional recruiting methods such as advertisements in newspapers, health fairs, and direct mailing, has been analyzed and reported. 6 additional social media applications have further been studied, and their potential use within clinical trial research has been additionally analyzed. CONCLUSIONS A large number and variety of social media platforms exist to aid in the recruitment and retention process for clinical trials, many of which can utilize niche features and reach a targeted demographic. Although recruitment remains a barrier for researchers involved in clinical trials, the potential to recruit through social media may be underutilized. Many avenues that exist to improve recruitment have not been leveraged. For example, partnering to create collaborative videos with social media influencers on platforms such as Instagram and Youtube may help to broaden the audience and increase clinical trial enrollments. Creating biomedical educational profiles or channels that discuss details of clinical trials with descriptions of these trials could also be employed to increase the scope of the audience. Reddit, Smart Patients, and Patients Like Me can target difficult-to-reach patient populations due to their use of subgroups, allowing researchers to reach their target audience. Additionally, many of these platforms provide user engagement features that allow users to respond directly to videos or posts and could be used to encourage enrollment by allowing users to react directly to clinical trial advertisements.


Author(s):  
Saliha Akhtar

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.


Author(s):  
Saliha Akhtar

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.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4055-4055
Author(s):  
Pelin Cinar ◽  
Anitra W. Talley ◽  
Jimmy Hwang ◽  
Daniel Paul Dohan ◽  
Margaret A. Tempero

4055 Background: Recruitment of oncology patients into clinical trials continues to be a challenge as <5% of patients are accrued. Low accrual rates may be due to reduced awareness of trial availability and eligibility by physicians/patients. Our objective was to study the attitudes of patients with pancreatic cancer (PC) regarding clinical trial participation and to identify possible barriers to recruitment. Methods: In this cross-sectional study, we collaborated with Pancreatic Cancer Action Network (PanCAN) and invited patients with PC or their caregivers to complete a survey. The survey that was developed consisted of 22 questions and inquired about patients’ previous clinical trial enrollment experiences and their views on participation. The surveys were collected over a 6-month period via the PanCAN website and regional meetings. Comparison analyses between groups were done by Chi-square and Fisher’s test using STATA software. Results: Of the390 surveys received, 149 were included in the final analyses. 30% of the patients were offered to participate in a trial by their physicians. When asked to participate, 62% of the patients agreed. Of the patients who were not enrolled in a clinical trial, 61% were offered to participate in a trial but did not agree. This suggests that these patients were eligible to participate but declined. Conclusions: Majority of the patients with pancreatic cancer were not offered to participate in clinical trials by their physicians but would have agreed if asked. While low clinical trial recruitment rates for PC may be multifactorial, further research may focus on the important role of physicians in clinical trial recruitment efforts. [Table: see text]


Author(s):  
Saliha Akhtar

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.


2021 ◽  
Author(s):  
Paris Baptiste ◽  
Angel YS Wong ◽  
Anna Schultze ◽  
Marianne Cunnington ◽  
Johannes FE Mann ◽  
...  

ABSTRACTIntroductionCardiovascular disease (CVD) is a leading cause of death globally, responsible for nearly 18 million deaths worldwide in 2017. Medications to reduce the risk of cardiovascular events are prescribed based upon evidence from clinical trials which explore treatment effects in an indicated sample of the general population. However, these results may not be fully generalisable because of trial eligibility criteria that generally restrict to younger patients with fewer comorbidities. Therefore, evidence of effectiveness of medications for groups underrepresented in clinical trials such as those over 75 years, from ethnic minority backgrounds or with low kidney function may be limited.The ONTARGET trial studied the effects of an angiotensin-converting-enzyme (ACE) inhibitor and an angiotensin II receptor blocker (ARB) separately and in combination on cardiovascular event reduction. Using individual anonymised data from this study, in collaboration with the original trial investigators, we aim to investigate clinical trial replicability within routinely-collected patient data. If the original trial results are replicable, we will assess treatment effects and risk in groups underrepresented and excluded from the original clinical trial.Methods and analysisWe will develop a cohort analogous to the ONTARGET trial within CPRD between 1 January 2001 to 31 July 2019 using the trial eligibility criteria and propensity score matching. The primary outcome, as in the trial, is a composite of cardiovascular death, non-fatal MI, non-fatal stroke and hospitalisation for congestive heart-failure, examined in a time-to-event analysis. If results from the cohort study fall within pre-specified limits, we will expand the cohort to include those with advanced kidney dysfunction and increase the proportion of elderly participants and those from ethnicity minority backgrounds.We will then compare the risk of adverse events and association with long-term outcomes in the clinical trial, with that seen in a directly comparable sample of those attending NHS primary care.STRENGTHS AND LIMITATIONSStrengthsLarge cohort study giving power to look at effects within subgroups underrepresented in the clinical trialAccess to individual patient level data from a landmark trial to support creation of a trial-analogous cohortNovelty of studying treatment effects of dual therapy in real-world settingsLimitationsThere may be differences between the trial population and the observational cohort due to the level of detail on inclusion/exclusion criteria provided by the trialDrug-specific effects are unlikely to be able to be investigated due to small numbers in the dual-therapy arm: class-specific effects will be studied insteadMisclassification by primary care coding may lead to inaccurate replication of trial inclusion and exclusion criteria.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18066-e18066
Author(s):  
Mina S. Sedrak ◽  
Arti Hurria ◽  
Virginia Sun ◽  
Daneng Li ◽  
Jennifer Liu ◽  
...  

e18066 Background: Social media may be an effective strategy to improve public awareness of oncology clinical trials and increase accrual. How oncologists perceive the role of social media in clinical trials now and in the future remains unknown. We explored oncologists’ attitudes and perceptions related to social media and clinical trial recruitment. Methods: Semi-structured interviews were conducted with 44 medical oncologists at City of Hope from March to June 2018. Primary measures were oncologists’ self-reported benefits, concerns, and future interventions to leverage social media for trial recruitment. Secondary measures were facilitators and barriers to social media use for professional purposes. Responses were recorded digitally, transcribed, and de-identified. Data was managed using NVivo v12. Two analysts coded interview data using thematic content analysis (kappa = 0.7). Results: Of the 44 participants, 55% were academic and 45% were community oncologists, 36% were women, and 68% had > 10 years of experience. The most commonly cited benefit was increased awareness and visibility (63%). The most commonly cited concerns were: lack of time or support (31%), misinformation or oversimplification (31%), and lack of guidance (regulatory/ethical oversight) (28%). Oncologists reported a desire for an institutional-level intervention (e.g., personnel support with social media expertise) to facilitate trial recruitment using social media (50%). Oncologists’ perceptions of the facilitators to social media use for professional purposes were centered on networking (40%) and staying up to date in the field (33%). Perceived barriers were clustered around lack of comfort, training, time (38%), and lack of evidence of benefit (25%). No differences were identified between academic and community oncologists. Conclusions: Oncologists are hopeful that social media can increase awareness and visibility of cancer clinical trials. However, they have numerous concerns about the application of social media in clinical trials due to lack of time, support, and risk of misinformation. Further research is needed to examine whether social media can facilitate recruitment to oncology clinical trials.


Sign in / Sign up

Export Citation Format

Share Document