The transitioning from trials to extended follow-up studies

Lea T. Drye, Anne S. Casper, Alice L Sternberg, Janet Teresa Holbrook, Gabrielle Jenkins, Curtis L Meinert

Research output: Contribution to journalArticle

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.

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.

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.

Original languageEnglish (US)
Pages (from-to)635-647
Number of pages13
JournalClinical Trials
Volume11
Issue number6
DOIs
StatePublished - Dec 20 2014

Fingerprint

Multicenter Studies
Research Ethics Committees
Uveitis
Appointments and Schedules
Alzheimer Disease
Anti-Inflammatory Agents
Asthma
Randomized Controlled Trials
Steroids
Research Personnel
Clinical Trials
Costs and Cost Analysis

Keywords

  • Clinical trial
  • Extended follow-up
  • Morphing
  • Transitioning

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

Cite this

The transitioning from trials to extended follow-up studies. / Drye, Lea T.; Casper, Anne S.; Sternberg, Alice L; Holbrook, Janet Teresa; Jenkins, Gabrielle; Meinert, Curtis L.

In: Clinical Trials, Vol. 11, No. 6, 20.12.2014, p. 635-647.

Research output: Contribution to journalArticle

Drye, Lea T. ; Casper, Anne S. ; Sternberg, Alice L ; Holbrook, Janet Teresa ; Jenkins, Gabrielle ; Meinert, Curtis L. / The transitioning from trials to extended follow-up studies. In: Clinical Trials. 2014 ; Vol. 11, No. 6. pp. 635-647.
@article{6a2205c7f2114907a6086f06a1d2d419,
title = "The transitioning from trials to extended follow-up studies",
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.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.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.",
keywords = "Clinical trial, Extended follow-up, Morphing, Transitioning",
author = "Drye, {Lea T.} and Casper, {Anne S.} and Sternberg, {Alice L} and Holbrook, {Janet Teresa} and Gabrielle Jenkins and Meinert, {Curtis L}",
year = "2014",
month = "12",
day = "20",
doi = "10.1177/1740774514547396",
language = "English (US)",
volume = "11",
pages = "635--647",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "6",

}

TY - JOUR

T1 - The transitioning from trials to extended follow-up studies

AU - Drye, Lea T.

AU - Casper, Anne S.

AU - Sternberg, Alice L

AU - Holbrook, Janet Teresa

AU - Jenkins, Gabrielle

AU - Meinert, Curtis L

PY - 2014/12/20

Y1 - 2014/12/20

N2 - 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.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.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.

AB - 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.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.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.

KW - Clinical trial

KW - Extended follow-up

KW - Morphing

KW - Transitioning

UR - http://www.scopus.com/inward/record.url?scp=84911435255&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84911435255&partnerID=8YFLogxK

U2 - 10.1177/1740774514547396

DO - 10.1177/1740774514547396

M3 - Article

C2 - 25115882

AN - SCOPUS:84911435255

VL - 11

SP - 635

EP - 647

JO - Clinical Trials

JF - Clinical Trials

SN - 1740-7745

IS - 6

ER -