The transitioning from trials to extended follow-up studies

Lea T Drye; Anne S Casper; Alice L Sternberg; Janet T Holbrook; Gabrielle Jenkins; Curtis L Meinert

doi:10.1177/1740774514547396

The transitioning from trials to extended follow-up studies

Clin Trials. 2014 Dec;11(6):635-47. doi: 10.1177/1740774514547396. Epub 2014 Aug 12.

Authors

Lea T Drye¹, Anne S Casper², Alice L Sternberg², Janet T Holbrook², Gabrielle Jenkins², Curtis L Meinert²

Affiliations

¹ Department of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA ldrye@jhu.edu.
² Department of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA.

Abstract

Background: Investigators may elect to extend follow-up of participants enrolled in a randomized clinical trial after the trial comes to its planned end. The additional follow-up may be initiated to learn about longer term effects of treatments, including adverse events, costs related to treatment, or for reasons unrelated to treatment such as to observe the natural course of the disease using the established cohort from the trial.

Purpose: We examine transitioning from trials to extended follow-up studies when the goal of additional follow-up is to observe longer term treatment effects.

Methods: We conducted a literature search in selected journals from 2000 to 2012 to identify trials that extended follow-up for the purpose of studying longer term treatment effects and extracted information on the operational and logistical issues in the transition. We also draw experience from three trials coordinated by the Johns Hopkins Coordinating Centers that made transitions to extended follow-up: the Alzheimer's Disease Anti-inflammatory Prevention Trial, Multicenter Uveitis Steroid Treatment trial, and Childhood Asthma Management Program.

Results: Transitions are not uncommon in multicenter clinical trials, even in trials that continued to the planned end of the trial. Transitioning usually necessitates new participant consents. If study infrastructure is not maintained during the transition, participants will be lost and re-establishing the staff and facilities will be costly. Merging data from the trial and follow-up study can be complicated by changes in data collection measures and schedules.

Limitations: Our discussion and recommendations are limited to issues that we have experienced in transitions from trials to follow-up studies.

Discussion: We discuss issues such as maintaining funding, institutional review board and consent requirements, contacting participants, and combining data from the trial and follow-up phases. We conclude with a list of recommendations to facilitate transitions from a trial to an extended follow-up study.

Trial registration: ClinicalTrials.gov NCT00000575 NCT00007189 NCT00132691.

Keywords: Clinical trial; extended follow-up; morphing; transitioning.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Follow-Up Studies*
Humans
Multicenter Studies as Topic
Outcome Assessment, Health Care
Randomized Controlled Trials as Topic*

Associated data

ClinicalTrials.gov/NCT00000575
ClinicalTrials.gov/NCT00007189
ClinicalTrials.gov/NCT00132691

Abstract

Publication types

MeSH terms

Associated data

Grants and funding