Clinical Trial Recruitment Research Articles

Recruiting and retaining participants in three randomised controlled trials of psychological interventions conducted on acute psychiatric wards: top ten tips for success.

It is essential to conduct randomised controlled trials of psychological interventions on acute psychiatric wards to build a robust evidence base for clinical practice. This paper aims to share strategies from three different in-patient trials that successfully recruited and retained participants, to disseminate good practice for the conduct of future trials in this challenging and complex clinical setting. We present strategies from three in-patient trials of psychological interventions: TULIPS (Talk, Understand, Listen for Inpatient Settings), amBITION (Brief Talking Therapies on Wards) and INSITE (Inpatient Suicide Intervention and Therapy Evaluation). All studies recruited participants from acute in-patient wards, initiated therapy within the in-patient setting and followed up on participants post-discharge. We summarise our recommendations for good practice in the form of ten top tips for success, based on our collective experience of conducting trials on psychiatric wards. Key themes relate to the importance of relationships between the research team and clinical staff; good stakeholder involvement and getting early buy-in from the team; and adapting to the particular demands of the clinical setting. Sharing good practice recommendations can help reduce research waste arising from poor recruitment and/or retention in future in-patient clinical trials.

Community Detection in Medicine: Preserved Ejection Fraction Heart Failure (HFpEF)

The COVID-19 pandemic raised awareness of the complexities of the patient, the disease, and the practice of medicine. The impact of these reaches beyond healthcare (e.g., supply chains, politics, socioeconomic factors) to include nations, individuals, and molecules. In personalized medicine, “accurate diagnosis” is critical as it affects patient management, clinical trial recruitment, regulatory approval, and reimbursement policies for payers. Conventional statistics evaluate hypothesis-driven reductionist practices in medicine, e.g., the use of “scores” combining individual measurements, and are often limited by the data:variables ratio. True personalization (N of 1) is not practical but better stratification of diseases and patients can improve diagnoses. This work describes our approach and tests its ability to identify patient complexity and clinical markers in the trial of a candidate HFpEF drug better than prior methods.

Unmet Needs in Oncology Clinical Research and Treatment in Africa: Focus on Ghana.

Cancer incidence is increasing worldwide and is a major cause of mortality. The relative magnitude of the increase is remarkably high in low human development index (HDI; 95%) and medium HDI (64%) countries. On the African continent, a corresponding increase in cancer burden is predicted, particularly for sub-Saharan Africa. Current epidemiologic data indicate that mortality rates of certain cancers, such as breast and cervical cancers, in sub-Saharan Africa are the highest in the world, and the cancer risks are broadly comparable to the risks in high-income countries, such as the United States and Europe. Although emerging data alludes to the unique genetic profile of cancer in African populations, most cancer therapies are introduced to Africa without confirmatory clinical trials. Therefore, there is an increasing need for clinical trials directed toward prevention, screening, diagnosis, and identification of innovative treatments in the African context. This review will discuss the increasing cancer burden in Africa, with a particular focus on Ghana, unmet clinical needs in cancer, current medical systems, clinical trial regulatory systems, and challenges to clinical trial recruitment.

Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials

Background Trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research. Methods In November 2020, registered SWATs in the SWAT repository store were extracted and categorised into ‘recruitment’, ‘retention’ or ‘other’ based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings. Results 125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants ( n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process ( n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks ( n = 24, 67%), how incentives should be implemented ( n = 10, 28%) and strategies to make participants feel valued ( n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them. Conclusions This study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work.

Brief Report: Implementation of a Universal Prescreening Protocol to Increase Recruitment to Lung Cancer Studies at a Veterans Affairs Cancer Center

IntroductionThe oncology clinical trial recruitment process is time, labor, and resource intensive, and poor accrual rates are common. We describe the VA Connecticut Cancer Center experience of implementing a standardized, universal prescreening protocol and its impact on thoracic oncology research recruitment. MethodsResearch coordinators prescreened potentially eligible patients with confirmed or suspected cancer from multiple clinical sources and entered relevant patient and research study information into a centralized electronic database. The database provided real-time lists of potential studies for each patient. This enabled the research team to alert the patient's oncologist in advance of clinic visits and to prepare documents needed for enrollment. Clinicians could ensure sufficient time and attention in clinic to the informed consent process, therefore maximizing enrollment opportunities. Patients were also monitored on waitlists for future studies. ResultsFrom March 2017 to December 2020, a total of 1518 patients with lung nodules and suspected or confirmed lung cancers were prescreened. Of these, 379 patients were enrolled to a study, 103 patients declined participation, and 639 were monitored for future studies. Our prescreening protocol identified all new patients with lung cancer who were ultimately added to the cancer registry. We found a substantial increase in study enrollment after prescreening implementation. ConclusionsUniversal prescreening was associated with improved patient enrollment to thoracic oncology studies. The protocol was integral in our VA becoming the top accruing VA site for National Cancer Institute’s National Clinical Trials Network studies for 2019 to 2021.

A Scoping Review of Strategies to Increase Black Enrollment and Retention in Cancer Clinical Trials.

To address health disparities faced by Black patients with cancer, it is critical that researchers conducting cancer clinical trials (CCTs) equitably recruit and retain Black participants, develop strategies toward this aim, and document associated outcomes. This narrative scoping literature review, as part of a larger study, aimed to identify, describe, and categorize strategies and interventions intended to improve the recruitment and retention of Black participants with breast, lung, prostate, colorectal, or multiple myeloma cancer into CCTs. We conducted comprehensive searches in PubMed, Embase, Cochrane Library, PsycInfo, CINAHL, Scopus, and Web of Science with three main concepts: Black persons, neoplasms, and clinical trial recruitment. The search resulted in 1,506 articles, of which 15 met inclusion criteria. Five main categories of recruitment and retention strategies and interventions were identified based on their specific population focus and type of approach: (1) participant identification, (2) provider awareness/resources, (3) focused research staff interventions, (4) patient and community-focused awareness strategies, and (5) participant-directed resources. Thirteen studies had recruitment acceptance rates of over 30%. Eight studies with acceptance rates of ≥ 50% reported implementing ≥ 5 strategies, with an average use of seven strategies across multiple categories. Five studies with acceptance rates ≥ 50% implemented strategies in ≥ 3 categories. Four studies reported retention rates ≥ 74%. Three studies with reported retention rates ≥ 74% used strategies in ≥ 3 categories, and all included strategies aimed at meeting participant needs beyond the study. Our results show that many efforts that aim to increase the recruitment and retention of Black participants into CCTs have great potential, but the most promising strategies use a multiprong approach.

Availability of Structured Data Elements in Electronic Health Records for Supporting Patient Recruitment in Clinical Trials.

Automated identification of eligible patients for clinical trials is an evident secondary use for electronic health records (EHR) data accumulated during routine care. This task requires relevant data elements to be both available in the EHR and in a structured form. This work analyzes these data quality dimensions of EHR data elements corresponding to a selection of frequent eligibility criteria over a total of 436 patient records at 10 university hospitals within the MIRACUM consortium. Data elements from demographics, diagnosis and laboratory findings are typically structured with a completeness of 73 % to 88 % while medication as well as procedures are rather untructured with a completeness of only 44 %. The results can be used to derive suggestions for data quality improvement measures with respect to patient recruitment as well as to serve as a baseline to quantify future developments.

Participatory Action for Access to Clinical Trials (PAACT): Increasing participation of blacks in Southeastern Michigan in cancer clinical trails.

e18527 Background: The underrepresentation of minority populations in research violates principles of distributive justice, slows scientific progress, and exacerbates health disparities. Henry Ford Cancer Institute (HFCI) is one of 20 sites offering clinical trials in Michigan and currently participates in 1300 trials. The rate of cancer cases at HFCI is 78% in whites and 21.9% in Blacks/African Americans (B/AA). However, analysis of cancer clinical trials conducted at HFCI showed participation rates to be 2.66% in B/AA and 90.28% in whites. Diverse attempts by HFCI to improve participation of B/AA in clinical trials have yielded limited success. The Participatory Action for Access to Clinical Trials (PAACT) project is using a community-based participatory research (CBPR) approach to design/adapt, pilot, and evaluate interventions which address cancer clinical trial participation barriers among B/AA. Methods: PAACT uses a 5-step approach: 1. Establish a steering committee (SC) in partnership with the Detroit Urban Research Center, which has a strong history of implementing CBPR programs in Detroit. 2. Conduct a scoping review to evaluate evidence-based strategies and interventions used to engage B/AA communities in clinical trials. 3. Conduct qualitative and quantitative research with members of B/AA community, cancer survivors/patients, and HFCI providers. 4. Engage stakeholders in the interpretation and translation of data to inform intervention strategies. 5. Pilot the intervention(s) to assess B/AA individuals’ behavioral intentions to enroll and participate in cancer clinical trials, and health care providers’ intentions to engage in change processes. Results: We have conducted 13 SC meetings, co-facilitated by a community, academic and health system partner. The SC has been actively engaged in all aspects of the project. Through the scoping review, we identified five categories of recruitment and retention strategies. We have conducted 13 focus groups with 100 participants, 7 provider interviews, and administered 1 survey to HFCI staff. Data from the focus groups has provided information on respondents’ clinical trial knowledge and systemic, socio-cultural, and economic barriers to trial participation. Data from the provider interviews has provided information on experience with clinical trial recruitment and recommendations for improving participation among B/AA community members. Conclusions: Through CBPR, PAACT actively engages B/AA community members, survivors/patients, healthcare providers, and researchers in the process to develop/adapt, implement, and evaluate strategies to better inform communities and patients about cancer clinical trials. The long-term goal of this project is to implement changes in both the community and the health care system thereby increase levels of participation in clinical trials among B/AA.

Assessing baseline cancer demographics versus those that participate in cancer clinical trials over one year in Louisiana.

e18546 Background: To determine which barriers exist for cancer clinical trial participation in Louisiana and define areas for improvement, we report cancer demographics of all new cancer diagnoses in Louisiana in 2019 and compare those to the baseline demographics of cancer patients that enrolled on a cancer treatment trial. Methods: A retrospective study evaluating baseline cancer demographics over 2019 was performed. Our baseline population included all new cancer diagnoses in patients 18+ registered with the Louisiana Tumor Registry (LTR) between January-December 2019. Baseline demographics were compared between all patients enrolled in a cancer treatment clinical trial in 2019 through the Gulf South Clinical Trials Network (GSCTN) versus those who were not. Summary statistics were performed with regards to basic cancer and patient demographics. Results: Although patients of the highest socioeconomic group made up, n = 5,444, (21.9%) of total cancers, a larger proportion, n = 35 (32.4%), p = 0.01 ultimately enrolled in a trial. Similarly, of those living in an urban area, n = 22,258 (84.5%), a larger proportion, n = 103 (92.8%), enrolled in a trial when compared to those that were not, p = 0.02. There was a significant positive correlation (p = 0.01) between clinical trial enrollment and residency in geographic areas with higher rate of high-school graduation. Our data also demonstrated that a smaller proportion, n = 7 (6.3%), of clinical trial participants died compared to those who did not participate, n = 5176 (19.6%), p < 0.01. Urologic cancer, including both prostate and bladder cancer, was the second most-diagnosed cancer primary site in Louisiana in 2019 with, n = 5481, patients diagnosed. Although black men made up, n = 1767 (32.2%) of diagnosed urologic cancer, only, n = 9 (14.1%), were accrued to participate in a urologic cancer clinical trial, p < 0.01. White men, who made up, n = 3661 (66.8%), of diagnosed urologic cancer, had a larger proportion, n = 55 (85%), of trial participation, p < 0.01. Conclusions: Overall, lack of geographic access proves to be a barrier for recruitment in clinical cancer trials. Patients of higher SES that live in urban areas make up a larger proportion of clinical trial participants and have better survival rates than those who do not participate. For specific cancers such as urologic cancer, further investigation on the cancer-specific inclusion and exclusion criteria must be investigated to determine the effect on equitable trial entry for populations in need. In conclusion, Louisiana offers a diverse cancer population, however, further efforts must be made to improve clinical trial access to our diverse and underserved populations.

Leveraging patient engagement to optimize a phase 3 clinical trial design, study participation and recruitment for women diagnosed with triple-negative breast cancer (TNBC).

1073 Background: The importance of Patient Engagement (PE) on clinical trial design is well established. PE in oncology medicines development can serve many purposes including obtaining input on trial design/procedures, identifying recruitment challenges and barriers to participation, and understanding retention strategies. Designing a clinical trial with procedures that have been confirmed as acceptable to participants is also likely to improve patient adherence to treatments. Triple-Negative Breast Cancer (TNBC) is a virulent subtype associated with early onset and increased risk of early recurrence and accounts for 15% to 20% of breast cancers. In addition, a higher risk exists in premenopausal and Black women. Chemotherapy is the mainstay of curative therapy recommended by guidelines. The aim was to obtain insights from patients to inform key aspects of a clinical study design including choice of chemotherapy regimen, study feasibility and recruitment strategies. Methods: Two groups of US women (N = 20) ages 28-54; (race 55% Caucasian, 30% African American, 10% Hispanic, 5% Native American) diagnosed with Stage IIb-IV TNBC and in active or completed treatment were recruited to participate in two in person IRB approved sessions. Trained 3rd party facilitators used qualitative methods to elicit patient feedback. Preliminary research included interviews with key stakeholders, including TNBC advocacy group leaders and a review of online patient communities. Patients reviewed a study design with an investigational agent every 3 weeks plus chemotherapy (nab-paclitaxel; paclitaxel) or placebo plus chemotherapy. Results: Patient reaction to the choice of taxane chemotherapy in the standard of care arm was neutral to negative. Approximately 50% of the patients identified taxane treatment as a barrier to participation. All patients requested flexibility in treatment choices, clear information about required tests and visits, and more diversity in recruitment materials. Black and Hispanic women impacted by TNBC did not feel they had equal access to clinical trials due to race, rural location, and other factors. Patient insights reinforced the decision to add another standard-of-care option (carboplatin plus gemcitabine) as a treatment arm to the trial design and was confirmed with investigators. Patient feedback was incorporated into the trial along with additional strategies to support recruitment of diverse patients in the clinical study. Conclusions: On November 13, 2020 the FDA approved this regimen in the label for pembrolizumab in combination with chemotherapy, as the 1st line treatment in women with locally recurrent or metastatic TNBC. Both patients and physicians perceived that a flexible chemotherapy backbone was a benefit.

At-risk patient and healthcare provider perspectives on clinical trial participation for ductal carcinoma in situ.

10539 Background: Significant challenges exist in recruiting newly diagnosed ductal carcinoma in situ (DCIS) patients to participate in presurgical intervention trials. Perceived motivators and barriers to participation have not been formally studied from the patient or healthcare provider (HCP) perspective. Based on our experience in the Promise Study (NCT02694809), we hypothesized that delaying surgery and concern for side effects are barriers to trial participation and that access to new treatments and financial benefits are motivators. To improve recruitment, we conducted focus groups to better understand barriers and motivators for trial participation in our patient population. Methods: Three focus groups with post-menopausal women (PMW) without history of DCIS, one focus group with patients previously treated for DCIS, and two HCP focus groups were conducted. Due to COVID-19, the focus groups took place online via videoconferencing and included participants from across the United States. A third-party facilitator generated discussion on predetermined topics including knowledge of DCIS, clinical trial recruitment materials, hormone replacement therapy, healthcare delivery and clinical trials during COVID-19, and perceived motivators and barriers to trial participation in general and specifically for women with DCIS. Here, we focus on comparing perceived influential factors for patient participation in DCIS clinical trials in PMW and HCP focus groups. Qualitative thematic analysis was completed on focus group transcripts in NVivo. Results: PMW had no knowledge of DCIS prior to the focus groups and believed DCIS should be removed promptly. PMW believed barriers to DCIS clinical trial participation included the potential for the study drug to cause harm, distrust of medicine, and the fact that DCIS is not life-threatening. PMW identified helping future DCIS patients, accessing better treatment, and easing anxiety as motivators for DCIS trial participation. HCPs believed patients were motivated by increased monitoring by the medical team, financial incentive, and access to newer treatment. HCPs believed that delays in DCIS surgery, the potential for the intervention to be harmful or ineffective, and the trial causing patient anxiety were barriers. Neither group emphasized time commitment as a barrier to DCIS trial participation. PMW were not motivated by financial incentives. Conclusions: Knowledge about DCIS is lacking in PMW. PMW and HCPs agreed that the risk of harm caused by study interventions is a deterrent to trial participation and that access to superior treatment is a motivator. However, PMW and HCPs did not agree on other motivators and barriers which could lead to missed recruitment opportunities. Providing educational materials on DCIS and addressing motivators and barriers to clinical trial participation may increase recruitment to presurgical DCIS trials. Clinical trial information: NCT02694809.

Trends in early phase clinical trials: A tale of exponential economic growth and access.

e18504 Background: There has been exponential economic growth in the BRIC (Brazil, Russia, India and China) nations in recent years, and outsourcing of clinical trials to these countries has occurred in tandem. Our study aimed to assess the current status of early phase oncology clinical trial recruitment in the BRIC countries, to assess the impact of these emerging economies and global markets in health care. Methods: We reviewed the open-access clinical trial registry, clinicaltrials.gov, for registered interventional recruiting early phase trials (Phase I/II) in the BRIC countries in adults and analyzed each country separately and collectively. We extracted descriptive data and established a database and proceeded to perform literature review and examine trends in early phase clinical trials. Results: We identified 888 recruiting early phase clinical trials in BRIC countries; China had 95% (842/888) of the trials, Brazil 1.5% (13/888), Russia 3.4% (30/888) and India 0.34% (3/888). For tumor specific studies, gastrointestinal (17%, 148/888), lung 11% (94/888) and breast (17%, 53/888) cancers were the most studied. Most trials were industry-sponsored (76%, 675/888); and most conducted in a single country (95%, 846). Industry-sponsored studies comprised 96% in China (635/842), 87% in Russia (26/30), 92% in Brazil (12/13), 67% (2/3) in India. Overall, immunotherapy agents in single and combination treatment strategies were the most common agent under investigation, with novel therapies such as CAR T-cell therapy (eg. CAR-T/TCR NK-CAR CAR-T/TCR-T Cell) being increasingly used in China (168 single agent trials, 30 trials in combination: 24% of trials in China). In contrast, CAR T-cell therapy trials were not yet in BRIC nations outside of China. Combination studies were frequent (33%, 293/888), and included a variety of combination strategies utilizing targeted therapies, immunotherapies, chemotherapies, antibody drug conjugates and novel biologics. Conclusions: Despite the economic explosion and shift of non-oncology clinical trials to BRIC nations, US and Europe continue to dominate in the design and conduct of early phase clinical trials in hematology and oncology. However, there has been exponential growth in early phase trial testing in China, which now accounts for 18.5% of the world’s population and has the majority (95%) of trials in BRIC nations. Contrastingly, India, which accounts for 17.7% of world’s population, has < 1% of BRIC nation trials. In keeping with trends in the US and Europe, there is a dominance of industry-sponsored studies in BRIC countries. Globally, early phase trials are increasing in their complexity with ongoing interest in immune modulation as a treatment strategy.

Evaluating the feasibility of using an electronic patient-reported outcome (ePRO) smartphone application (app) and biosensor by patients with cancer undergoing systemic treatments.

TPS1599 Background: Almost half of the nearly 370,000 patients with cancer who receive chemotherapy in the United States each year experience Emergency Department (ED) visits and unplanned hospital inpatient (IP) stays during treatment, largely due to poorly controlled symptoms. Recent studies have shown that utilizing PRO information in oncology practice can improve symptom management and patient outcomes. This study aims to examine the feasibility and usability of a PRO app paired with a biosensor to identify patients who are at high risk for ED and IP visits. Methods: This prospective, pragmatic, observational study will evaluate the feasibility and usability of a clinic-provided smartphone app and smartwatch biosensor for monitoring patients undergoing systemic cancer treatment. Eligible patients are 18–80 years old, ECOG PS 0–2, have a biopsy-proven solid tumor diagnosis of cancer (excluding non-melanoma skin cancer), and are scheduled to receive the first dose of intravenous (IV) or oral cancer therapy as an initial or new line of treatment. Patients should be able to provide informed consent, wear the biosensor daily, and complete the app ePRO survey and questionnaires in English. Study exclusion criteria include receiving radiation or hormone therapy only, residing in a skilled nursing facility, participating in another clinical trial, current pregnancy, and wearing pacemakers, implantable cardioverter defibrillators, cochlear implants, and/or neurostimulator devices. The app collects PROs (PRO-CTCAE), app usability and satisfaction (modified mHealth App Usability Questionnaire [mMAUQ]) and patient satisfaction with the biosensor (modified Quebec User Evaluation of Satisfaction with Assistive Technology [QUEST 2.0]). The study is divided into two phases: (1) vanguard (N = 30); (2) operational (N = 70). Patients will be asked to wear the biosensor and enter PROs into the app daily for a 2-week (vanguard) or 6-week period (operational). The vanguard sample size allows for the recruitment of ̃10 patients at each of the three participating oncology community clinics as is standard for initial device and software testing and development. Study endpoints for feasibility include: (1) vanguard – patient recruitment and protocol adherence, completeness of data capture, app usability, user satisfaction of biosensor; (2) operational – validity of self-reported hospital visits, feasibility of using electronic case report forms. Data collected from the vanguard will inform modifications to the app for the operational phase. The operational phase sample size is sufficient to assess data capture completion and clinical trial recruitment procedures in diverse practice settings (e.g., low volume vs. high volume, rural vs. urban). Clinical trial information: ISRCTN25569053.

Should informed consent and information related to patient recruitment in clinical trials be available to the reader of scientific articles? A case study in dentistry

ABSTRACT Ethical aspects in research should be transparently reported. This study aimed to investigate whether informed consent and information related to patient recruitment in clinical studies are well reported in the scientific literature. Randomized clinical trials (RCTs) on root coverage procedures published between November 2016 and November 2021 were selected from the PubMed database. Items/questions were used to guide the extraction of data related to patient recruitment, with a focus on the detailed report of informed consent used to clarify the research to the patient. Data were extracted from the published article and the respective research protocol published in a public registry. Information related to potential selective outcome reporting (SOR) was also extracted. In total, 187 documents were initially screened and 74 reports of RCTs were included. No informed consent was published in the article. Only one research protocol provided a link to the informed consent. Deviations from reporting in the research protocol and published article were found, suggesting SOR. Informed consent and information related to patient recruitment in RCTs on root covering procedures are severely underreported. The present findings may stimulate further discussion and debate on the need for making this information publicly available.

Implementation of a Clinical Trial Recruitment Support System Based on Fast Healthcare Interoperability Resources (FHIR) in a Cardiology Department.

Clinical Trial Recruitment Support Systems can booster patient inclusion of clinical trials by automatically analyzing eligibility criteria based on electronic health records. However, missing interoperability has hindered introduction of those systems on a broader scale. Therefore, our aim was to develop a recruitment support system based on FHIR R4 and evaluate its usage and features in a cardiology department. Clinical conditions, anamnesis, examinations, allergies, medication, laboratory data and echocardiography results were imported as FHIR resources. Clinical trial information, eligibility criteria and recruitment status were recorded using the appropriate FHIR resources without extensions. Eligibility criteria linked by the logical operation "OR" were represented by using multiple FHIR Group resources for enrollment. The system was able to identify 52 of 55 patients included in four clinical trials. In conclusion, use of FHIR for defining eligibility criteria of clinical trials may facilitate interoperability and allow automatic screening for eligible patients at multiple sites of different healthcare providers in the future. Upcoming changes in FHIR should allow easier description of "OR"-linked eligibility criteria.

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

Perceived Barriers to Pediatric Clinical Trials Implementation: A Survey of Health Care Staff.

IntroductionClinical trials are the gold standard for assessing the effectiveness and safety of treatments. The objective of this study was to assess provider opinions regarding implementing pediatric clinical trials in various practice settings across Kansas.MethodsThe study was completed within the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE), an affiliate of the IDeA States Pediatric Clinical Trials Network (ISPCTN). A cross-sectional, 36-item survey was administered to a state-wide convenience sample targeting health care providers and clinic staff.ResultsA total of 115 health care providers and clinic staff completed surveys; 31% were physicians. Physicians were more likely than other clinic staff to have experience with clinical trials (correlation coefficient [CC] = 0.270, p = 0.004). When compared to urban respondents, rural providers were less supportive of recruitment for clinical trials in their practices (CC = −0.251, p = 0.008) and more likely to feel comfortable referring patients for clinical trials involving treatments that their insurance did not cover (CC = 0.302, p = 0.001).ConclusionsA range of rural and urban health care professionals supported conducting pediatric clinical trials but identified several barriers as well. These results will support future pediatric clinical trials across the country including Kansas.

Applications of artificial intelligence and machine learning in heart failure.

Machine learning (ML) is a sub-field of artificial intelligence that uses computer algorithms to extract patterns from raw data, acquire knowledge without human input, and apply this knowledge for various tasks. Traditional statistical methods that classify or regress data have limited capacity to handle large datasets that have a low signal-to-noise ratio. In contrast to traditional models, ML relies on fewer assumptions, can handle larger and more complex datasets, and does not require predictors or interactions to be pre-specified, allowing for novel relationships to be detected. In this review, we discuss the rationale for the use and applications of ML in heart failure, including disease classification, early diagnosis, early detection of decompensation, risk stratification, optimal titration of medical therapy, effective patient selection for devices, and clinical trial recruitment. We discuss how ML can be used to expedite implementation and close healthcare gaps in learning healthcare systems. We review the limitations of ML, including opaque logic and unreliable model performance in the setting of data errors or data shift. Whilst ML has great potential to improve clinical care and research in HF, the applications must be externally validated in prospective studies for broad uptake to occur.

E-Consent—a guide to maintain recruitment in clinical trials during the COVID-19 pandemic

BackgroundThe COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomized clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate, and patients’ experience using e-Consent.MethodsA substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. Although e-Consent obviated the need for in-person meeting, there was nonetheless counselling sessions performed interactively online. This new pathway offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation.ResultsBefore the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation.ConclusionRemote e-Consent-based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues.Trial registrationNeuroSAFE PROOF trial NCT03317990. Registered on 23 October 2017. Regional Ethics Committee reference 17/LO/1978.

Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries

BackgroundPatient recruitment for clinical trials is challenging—only approximately one third of all trials recruit their participants as planned. The pharmaceutical industry’s views on recruitment success have not been comprehensively investigated, although the industry globally conducts almost one third of all clinical drug trials. This study explored patient recruitment success and failure factors and the role of electronic health records (EHR) in the recruitment of trial participants in the Nordic countries.MethodsA descriptive qualitative interview study was conducted with 21 representatives of the pharmaceutical industry or contract research organizations operating in Finland, Sweden, Denmark, and Norway. The interviews covered 34 clinical pre-market drug trials. Qualitative data were analyzed using inductive content analysis.ResultsFour main categories were derived to represent both success and failure factors, whereas a fifth category represented only failure factors: (1) sponsor-related (protocol and trial preparation and feasibility evaluations), (2) site/investigator-related (access to patients, motivation, commitment and resources), (3) patient-related recruitment factors (medical need, patients’ role in their care and attitudes towards trials), (4) Sponsor—sites—patients collaboration factors, and (5) start-up related factors. EHR was the most important source of recruitment, utilized in 29 out of 34 trials discussed. Revision of the legislation regulating the secondary use of EHR was highlighted as the most effective measure to facilitate the use of EHR in recruitment of trial participants.ConclusionsThe industry representatives recognized quite well their own role in contributing to the success or failure of the recruitment: to facilitate recruitment of trial participants, many obstacles can be avoided with better trial preparation and proper feasibility evaluations. As access to patients represents one of the key success or failure factors of recruitment, and as the EHR is regarded the main source of searching for and finding patients, the development of EHR utilization appears to represent a powerful tool to improve patient recruitment.