Principles for the production and dissemination of recruitment material for three clinical trials of an online intervention.
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ABSTRACT:
SUBMITTER: Rennick-Egglestone S
PROVIDER: S-EPMC8268340 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundRecruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies.ObjectiveThis study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods.MethodsData on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant.ResultsIn total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02).ConclusionsTargeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.
| S-EPMC7673977 | biostudies-literature
Project description:Lack of trust and rapport with health care providers has been identified in the under-representation of racial/ethnic minorities within clinical trials. Our study used a coach to promote trust among minority patients with advanced cancer.Minority patients with advanced breast, colorectal, lung, or prostate carcinoma were randomly assigned to receive a coach Intervention (CI) or usual care (UC). All patients completed baseline and 6-month telephone interviews to assess demographics, trust in health care providers, attitudes toward clinical trials, and quality of life. Patients randomly assigned to CI were assigned a coach, who made biweekly contacts for 6 months to address general issues, progress or development in cancer care, and available resources. Patients randomly assigned to UC received the standard of care, without this intervention. Clinical trial enrollment was assessed.Over 21 months, we screened 268 patients and enrolled 73 African Americans and two Asian Americans. Patients were randomly assigned to CI (n = 38) or to UC (n = 37). Longitudinal analyses were conducted on 69 patients who completed the 6-month follow-up assessment. Trial enrollment was 16 and 13 patients for the CI and UC groups, respectively. This difference was not significant (P = .351). Higher quality of life (1-point odds ratio on Functional Assessment of Cancer Treatment-General = 1.033, P = .036) and positive attitudes toward trials predicted enrollment. There was no significant difference between these groups in quality of life, attitudes toward clinical trials, perceptions of racism, trust in doctors, or depression.Quality of life and positive attitude toward trials predicted trial enrollment, regardless of assignment to CI or UC.
| S-EPMC3825290 | biostudies-other
Project description:BackgroundRecruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research.MethodsMEDLINE (Ovid), Scopus, Cochrane Database of Systematic Reviews and Cochrane Methodology Register, Science Citation Index Expanded and Social Sciences Citation Index within the ISI Web of Science and Education Resources Information Center were searched in January 2015. Search strategy results were screened by title and abstract, and full text obtained for potentially eligible articles. Studies reporting or evaluating strategies, interventions or methods used to recruit patients were included along with case reports and studies exploring reasons for patient participation or non-participation. Eligible articles were categorised as systematic reviews, nested randomised controlled trials and other designs evaluating the effects of recruitment strategies (Level 1); studies that report the use of recruitment strategies without an evaluation of impact (Level 2); or articles reporting factors affecting recruitment without presenting a particular recruitment strategy (Level 3). Articles were also assigned to 1, or more, of 42 predefined recruitment domains grouped under 6 categories.ResultsMore than 60,000 records were retrieved by the search, resulting in 56,030 unique titles and abstracts for screening, with a further 23 found through hand searches. A total of 4570 full text articles were checked; 2804 were eligible. Six percent of the included articles evaluated the effectiveness of a recruitment strategy (Level 1), with most of these assessing aspects of participant information, either its method of delivery (33%) or its content and format (28%).DiscussionRecruitment to clinical trials remains a common challenge and an important area for future research. The online resource for Recruitment Research in Clinical triAls project provides a searchable, online database of research relevant to recruitment. The project has identified the need for researchers to evaluate their recruitment strategies to improve the evidence base and broaden the narrow focus of existing research to help meet the complex challenges faced by those recruiting to clinical trials.
| S-EPMC6236587 | biostudies-literature
Project description:There are multiple available treatments to enhance stroke rehabilitation, although few interventions have confirmed significant clinical improvements on motor function in pivotal Randomized Clinical Trials. Development of large Randomized Clinical Trials is limited by several barriers and low enrollment rate is considered an important factor. Consequently, most of the evidence comes from small sample size studies, often leading to limited conclusions. According to the National Institute of Health (NIH), about 80% of clinical trials in the United States do not achieve their timelines, increasing research costs and postponing regulatory approval of new therapies. Given that the success of a Randomized Clinical Trial is dependent on enrolling an adequate number of subjects, effective strategies to enhance recruitment rates are highly desirable. In addition, given the resources and time limitations, it is important to understand which strategies are most cost-effective. In this manuscript, we summarize and discuss nine recruitment strategies used in an NIH R21 sponsored clinical trial, including medical records review and online advertising, among others. In addition, we developed an index to compare the time spent benefit of each approach and guide the allocation of the recruitment efforts. For this trial, online advertising and referral from health care professionals other than physicians were the strategies with greater time-benefit, leading to the largest number of stroke subjects enrolled.
| S-EPMC6639562 | biostudies-literature
Project description:Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55-2.58, P=0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P=0.0072). The change in anxiety score between the arms was also statistically significant (P=0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.
| S-EPMC2360384 | biostudies-other
Project description:Study hypothesis: The addition of a patient information video/CD-ROM/DVD to supplement written information in the informed consent process for patients considering participation in clinical trials will increase knowledge and reduce rates of patient refusal
Primary outcome(s): Percentage of patients consenting to enter the therapeutic trial
| 2417619 | ecrin-mdr-crc
Project description:BackgroundRacial and ethnic minorities are often underrepresented in clinical trials, threatening the generalizability of trial results. Several factors may contribute to underrepresentation of minorities in clinical trials, including lack of training for researchers and staff on the importance of diversity in clinical trials and effective strategies for recruiting and retaining minority populations.MethodsApplying community engaged research principles, we developed a massive open online course (MOOC) to help research team members develop knowledge and skills to enhance the recruitment of minorities in clinical trials. A transdisciplinary working group, consisting of clinical researchers, community engagement specialists, minority clinical trial recruitment and retention educators and specialists, and knowledge management information scientists, was formed to develop an evidence-based curriculum. Feedback from the Recruitment Innovation Center Community Advisory Board was incorporated to help finalize the curriculum. The course was implemented in Coursera, an online learning platform offering MOOCs. A bootstrap paired sample t-test was used to compare pre- and post-assessments of knowledge, attitudes, and intentions as it relates to minority recruitment.ResultsThe final course, entitled Faster Together, was divided into eight 1-h modules. Each module included video presentations, reading assignments, and quizzes. After 10 months, 382 individuals enrolled in the course, 105 participants completed the pre-test, and 14 participants completed the post-test. Participants' knowledge scores were higher with an increase in the mean number of correct answers from 15.4 (95% CI:12.1-18.7) on the pre-test to 18.7 (95% CI:17.42-20.2) on the post-test. All post-test respondents (n = 14) indicated that the course improved their professional knowledge, and 71.4% of respondents indicated that they were very likely to make changes to their recruitment practices.ConclusionsFaster Together, a massive open online course, is an acceptable, accessible approach to educating research teams on minority recruitment in clinical trials. Preliminary evidence indicates the course increased knowledge on how to recruit minorities into clinical trials and could promote change in their recruitment practices.
| S-EPMC7936494 | biostudies-literature
Project description:Transformational research frameworks provide understanding and guidance for fostering change towards sustainability. They comprise stages of system understanding, visioning and co-designing intervention strategies to foster change. Guidance and empirical examples for how to facilitate the process of co-designing intervention strategies in real-world contexts remain scarce, especially with regard to integrating local initiatives. We suggest three principles to facilitate the process of co-designing intervention strategies that integrate local initiatives: (1) Explore existing and envisioned initiatives fostering change towards the desired future; (2) Frame the intervention strategy to bridge the gap between the present state and desired future state(s), building on, strengthening and complementing existing initiatives; (3) Identify drivers, barriers and potential leverage points for how to accelerate progress towards sustainability. We illustrate our approach via a case study on sustainable development in Southern Transylvania. We conclude that our principles were useful in the case study, especially with regards to integrating initiatives, and could also be applied in other real-world contexts.
| S-EPMC7320093 | biostudies-literature
Project description:PurposePalliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study.Patients and methodsThe PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications.ResultsFrom an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%).ConclusionChallenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.
| S-EPMC3825289 | biostudies-literature
Project description:BackgroundAll clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials.Methods/resultsAppropriate monitoring of clinical trials typically includes assessing rate of recruitment or enrollment; monitoring safe and effective delivery of study treatments; assuring that study staff act to minimize risks; monitoring quality and timeliness of study data; and considering interim analyses for early detection of benefit, harm, or futility. Each of these responsibilities applies to pragmatic clinical trials. Just as design of pragmatic trials typically involves specific and necessary departures from methods of explanatory clinical trials, appropriate monitoring of pragmatic trials typically requires specific departures from monitoring procedures used in explanatory clinical trials. We discuss how specific aspects of pragmatic trial design and operations influence selection of monitoring procedures and illustrate those choices using examples from three ongoing pragmatic trials conducted by the Mental Health Research Network.ConclusionsPragmatic trial investigators should not routinely adopt monitoring procedures used in explanatory clinical trials. Instead, investigators should consider core principles of trial monitoring and design monitoring procedures appropriate for each pragmatic trial.
| S-EPMC6902512 | biostudies-literature