Planning for closeout — From Day One

Shepherd, Rodger M.; Macer, Judith L.; Grady, Deborah

doi:10.1016/j.cct.2007.06.001

Cited by 5 publications

(5 citation statements)

References 18 publications

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“…The penultimate visit questions pertaining to unblinding and study results should occur during the informed consent process of the study with a default of providing this information to participants at the end of the study and only if they opt out would their data not be provided to them. Shepherd et al[3] has suggested the study protocol stipulate planning for closeout before or just after the first participants are randomized with the goal of final plans prior to the first interim analysis. If investigators can plan closeout earlier, they can fully budget to support regular study activities, training, drug supplies and storage, and closeout activities.…”

Section: Discussionmentioning

confidence: 99%

“…With all the DCC transitions, operational details regarding closeout had not been addressed as the investigators had focused on recruiting, follow-up, and day to day operations. [3] Using the framework for the Hypertension Detection and Follow-up Program (HDFP),[7] the Closeout Committee was formed with just over 2 years before the end of patient follow up. This major effort was undertaken by two clinical investigators and a coordinator from each site (Participating Clinical Center, PCC) under the direction of the DCC’s Principal Investigator, lead statistician and research coordinator.…”

Section: Closeout Issues To Be Resolvedmentioning

confidence: 99%

“…[15] We agreed with others in the literature that participants should receive their study allocation and individual study results as there was no justification for nondisclosure. [3, 14] There was some concern about protecting the wishes of participants who wished to remain blinded. [15] Treatment allocation could not be provided at the final visits due to the structure of these visits occurring over a 6-month period (January 2014 through June 2014) prior to the release of study results to investigators.…”

Section: Closeout Of Participantsmentioning

confidence: 99%

“…Open communication and coordination with the journal staff was critical. [3] Our trials’ results were published online[12, 13] and presented at the national meeting within 4 months of the last in-person patient visit. Our decision to begin statistical programming months prior to study end, to use a small writing team who received unblinded results for drafting the papers, then disseminate to the entire group of investigators was critical to staying on time with delivery of the papers to the journal.…”

Section: Closeout Activities Of the Data Coordinating Centermentioning

confidence: 99%

“…[1–3] Authors have made recommendations on designing closeouts to ensure patient safety, follow-up, and timely publications for trials reaching their expected end[1–4] while others have described the aspects of shutting down studies earlier than planned. [5–7] Specific recommendations entail having a common closing date[1] and post-treatment follow-up[1, 4], preparing patients psychologically for trial end[1], updating patient contact information[1, 2], getting staff input about operational details and feasibility of closeout plans[3], including plans for early termination[3, 6], ensuring adequate training for data collection and entry[2], allowing for adaptable strategies[2] and flexibility in staff roles[6], keeping communication flowing with sites[2, 6], and allowing time and personnel for closeout[6]. However, when closeout has not been planned early, minimal guidance exists to help investigators prioritize design and conduct issues during the end of a long-term trial.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Closeout of the HALT-PKD trials

Moore

Spillane

Simon

et al. 2015

Contemporary Clinical Trials

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Background The HALT Polycystic Kidney Disease Trials Network consisted of two randomized, double blind, placebo-controlled trials among patients with autosomal dominant polycystic kidney disease. The trials involved 5–8 years of participant follow-up with interventions in blood pressure and antihypertensive therapy. We provide a framework for designing and implementing closeout near the end of a trial while ensuring patient safety and maintaining scientific rigor and study morale. Methods We discuss issues and resolutions for determining the last visit, tapering medications, and unblinding of participants to study allocation and results. We also discuss closure of clinical sites and Data Coordinating Center responsibilities to ensure timely release of study results and meeting the requirements of regulatory and funding authorities. Results Just over 90% of full participants had a 6-month study visit prior to their last visit preparing them for trial closeout. Nearly all patients wanted notification of study results (99%) and treatment allocation (99%). All participants were safely tapered off study and open label blood pressure medications. Within 6 months, the trials were closed, primary papers published, and 805 letters distributed to participants with results and allocation. DCC obligations for data repository and clinicaltrials.gov reporting were completed within 12 months of the last study visit. Conclusions Closeout of our trials involved years of planning and significant human and financial resources. We provide questions for investigators to consider when planning closeout of their trials with focus on (1) patient safety (2) dissemination of study results and (3) compliance with regulatory and funding responsibilities.

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Section: Discussionmentioning

confidence: 99%

Section: Closeout Issues To Be Resolvedmentioning

confidence: 99%