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Health Information Technology
Published in Kelly H. Zou, Lobna A. Salem, Amrit Ray, Real-World Evidence in a Patient-Centric Digital Era, 2023
Joseph P. Cook, Gabriel Jipa, Claudia Zavala, Lobna A. Salem
Randomized controlled trials (RCTs) are a key part of the process of getting medicines safely from the lab to the market. As important as they are, traditional RCTs have some gaps to improve upon; in particular, patient recruitment and accrual speed. Studies show that it takes an average of 15 years to bring a drug to market, and one third of this time is spent on patient recruitment since the cohort composition needs to representatively reflect the larger population (Harrer et al., 2019). This results in a lengthy process with only a 10% success rate. Turning to the financial aspect, patient recruitment is necessary to ensure trial efficacy but takes up 32% of economic resources in the clinical trial process. This results in a significant burden since it is often challenging to recruit suitable patients and an average of 18% drop out after enrollment. These could be the two main causes of clinical trial failure are patient recruitment and monitoring (Harrer et al., 2019). Therefore, identifying the ideal patients via precision medicine can improve the speed, efficiency, and cost-effectiveness of clinical trials overall.
Clinical Trials, Patient Recruitment and Advertising
Published in Rebecca A. Krimins, Learning from Disease in Pets, 2020
The next solid step in recruitment is to create a recruitment plan. Some funding opportunities that the National Institutes of Health (NIH) presently offers require a recruitment plan as part of a grant package and also as an operational document requirement after an investigator receives funding. A recruitment plan not only helps an investigator to map out his/her approach to recruiting participants for the trial, it will also help identify barriers that might be faced along the journey to last patient in. Or, in some cases, the barriers that seem to block any patient recruitment at all. Later on in this chapter, we will break down the creation of a recruitment plan. The recruitment plan model that we will discuss in this chapter is adaptable to different types of funding, i.e., different types of advertising budgets and regulatory requirements. It is possible to recruit patients with little to no budget at all, but if an investigator has the opportunity to work advertising into their budget while working with a funder, more is better.
Harnessing Real-World Data to Inform Platform Trial Design
Published in Zoran Antonijevic, Robert A. Beckman, Platform Trial Designs in Drug Development, 2018
Daphne Guinn, Subha Madhavan, Robert A. Beckman
Often, drug development in rare diseases or biomarker defined subsets of a disease, where recruiting sufficient patients can be a costly challenge.4 Identifying eligible patients through EHRs or registries could streamline patient recruitment. Moreover, while the randomized controlled trial is the standard for clinical trial evidence, a control arm may not be ethical for severe diseases if there is no current standard of care. In such a case, RWD may be used to construct a historical control arm in selected instances, and with attention to additional confounding factors, which affect the use of historical controls. It is clear that diverse sources of RWD could be used to answer questions that cannot be addressed through traditional methods.
Development and validation of a combined model based on dual-sequence MRI radiomics for predicting the efficacy of high-intensity focused ultrasound ablation for hysteromyoma
Published in International Journal of Hyperthermia, 2023
Shize Qin, Yu Jiang, Fang Wang, Lingling Tang, Xiaohua Huang
This retrospective study was approved by the Institutional Review Board, and the requirement for informed consent was waived (IRB no. 2022ER101-1). From November 2019 to August 2021, 258 patients underwent hysteromyoma ablation at the HIFU center. The inclusion criteria were as follows: (I) premenopausal or perimenopausal women above 18 years old diagnosed with hysteromyoma by clinical and radiological examination; (II) patients undergoing their first HIFU ablation of hysteromyoma and having 10 or fewer hysteromyomas; (III) MRI examination within three days before and after ablation treatment; and (IV) no previous history of surgery or drug treatment. The exclusion criteria were as follows: (I) other uterine or accessory diseases; (II) lack of some MRI sequences or images; (III) poor MR image quality; and (IV) hysteromyomas with diameter ≤3 cm or diameter ≥10 cm [20]. According to the inclusion and exclusion criteria, 142 eligible patients (with 172 hysteromyomas; 45 (42–48) years) were enrolled in the study cohort. From January 2020 to July 2022, 40 patients (with 40 hysteromyomas; 43 (34–46) years) in another group were screened according to the same criteria. The patient recruitment process is shown in Figure 1.
Implementation of a municipality-based rehabilitation program for patients with neuritis vestibularis: lessons learned and derived snowball effects
Published in Physiotherapy Theory and Practice, 2023
Morten Villumsen, Anna Emilie Livbjerg, Bo Grarup, Christine Kjeldal Skram, Uffe Laessoe
A member of the research team (AEL) conducted the individual semi-structured interview at the end of the intervention period and transcribed it. The interview was conducted at the therapy department in the municipality and lasted approximately 45 minutes. Subsequently, members from the research team (BG and AEL) read the transcripts of the interviews and conducted a deductive content analysis to assess the acceptability. The seven components of the theoretical framework of acceptability by Sekhon, Cartwright, and Francis (2017) were used as guiding themes in the deductive analysis. Opportunity costs were not referred to in the interview. Instead, an additional theme emerged, covering aspects of patient recruitment, representing the barriers and possibilities of the recruitment process and the number of participants. The content of the themes will be described in the result section. The transcription and analysis were validated by the interviewee.
Increased risk of end-stage renal disease in patients with systemic sclerosis
Published in Scandinavian Journal of Rheumatology, 2022
C-Y Lin, Y-J Su, T-T Cheng, C-H Wu, J-F Chen, S-F Yu, Y-C Chen, C-Y Hsu
We developed a cohort consisting of an SSc group and a non-SSc control group. We identified patients with SSc based on International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code 710.1 and a catastrophic illness certificate (CIC) between 1 January 2000 and 31 December 2013. SSc is classified as a catastrophic disease by the Ministry of Health and Welfare of Taiwan. After diagnosing a patient with SSc, the specialist can submit a CIC application on behalf of the patient. NHI authorities will assign another senior rheumatologist to conduct an anonymous and rigorous review based on one of the two classifications most commonly used to identify SSc: the 1980 American College of Rheumatology (ACR) criteria (13) and the 2013 revised ACR/European League Against Rheumatism (EULAR) criteria (14). Methods of patient recruitment in the current study have been described in previous studies (2, 15).