Drivers of Start-Up Delays in Global Randomized Clinical Trials
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ORIGINAL RESEARCH
Drivers of Start‑Up Delays in Global Randomized Clinical Trials Jennifer Lai, DHA, MBA, CCRA1 · Leila Forney, DNP, CCRP1 · Daniel L. Brinton, PhD1 · Kit N. Simpson, DrPH1 Received: 12 May 2020 / Accepted: 19 August 2020 © The Drug Information Association, Inc 2020
Abstract Background Global, randomized clinical trials are extremely complex. Trial start-up is a critical phase and has many opportunities for delay which adversely impact the study timelines and budget. Understanding factors that contribute to delay may help clinical trial managers and other stakeholders to work more efficiently, hastening patient access to potential new therapies. Methods We reviewed the available literature related to start-up of global, Phase III clinical trials and then created a fishbone diagram detailing drivers contributing to start-up delays. The issues identified were used to craft a checklist to assist clinical trial managers in more efficient trial start-up. Results We identified key drivers for start-up delays in the following categories: regulatory, contracts and budgets, insurance, clinical supplies, site identification and selection, site activation, and inefficient processes/pitfalls. Conclusion Initiating global randomized clinical trials is a complex endeavor, and reasons for delay are well documented in the literature. By using a checklist, clinical trial managers may mitigate some delays and get clinical studies initiated as soon as possible. Keywords Global clinical trials · Study start-up · Best practices · Performance · Process optimization · Trial efficiency
Introduction/Background This study was conducted prior to the outbreak of the COVID-19 pandemic. After the onset of the pandemic, many planned clinical trials were delayed due to widespread lockdowns and to conserve resources for front-line healthcare workers. Trials in many indications including life-threatening illnesses like cancer and cystic fibrosis have been delayed by the pandemic [1]. Once initiation of delayed studies does resume, it will be essential to conduct start-up activities as efficiently as possible to expeditiously start clinical trials for the benefits of the clinical trial participants. Randomized, controlled trials (RCT) are considered the gold-standard to assess the safety and efficacy of potential medications/therapies [2, 3]. FDA-regulated trials increasingly engage sites outside the United States, including sites in developing nations, in order to hasten patient enrollment, reduce costs and achieve market expansion by including participants for various geographies [4]. These studies are * Jennifer Lai [email protected]; [email protected] 1
complex to start-up, especially when they include multinational sites subject to different laws, regulations governing the conduct of research, infrastructure (or lack of infrastructure) and local standards of care [5]. Clinical study startup is a key determinant of success in a clinical trial, and the time required to activate a trial may be inversely relat
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