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October 08, 2013; 81 (15) Article

Analysis of start-up, retention, and adherence in ALS clinical trials

Nazem Atassi, Padmaja Yerramilli-Rao, Jackie Szymonifka, Hong Yu, Marianne Kearney, Daniela Grasso, Jing Deng, Mark Levine-Weinberg, Jordan Shapiro, Alexandra Lee, Lucia Joseph, Eric A. Macklin, Merit E. Cudkowicz
First published September 4, 2013, DOI: https://doi.org/10.1212/WNL.0b013e3182a823e0
Nazem Atassi
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Padmaja Yerramilli-Rao
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Jackie Szymonifka
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Hong Yu
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Marianne Kearney
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Daniela Grasso
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Jing Deng
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Mark Levine-Weinberg
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Jordan Shapiro
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Alexandra Lee
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Lucia Joseph
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Eric A. Macklin
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Merit E. Cudkowicz
From the Neurological Clinical Research Institute, Department of Neurology (N.A., P.Y.-R., H.Y., M.K., D.G., J.D., M.L.-W., J.S., A.L., L.J., M.E.C.), and Biostatistics Center (J.S., E.A.M.), Massachusetts General Hospital, Boston; and Harvard Medical School (N.A., P.Y.-R., E.A.M., M.E.C.), Boston, MA.
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Citation
Analysis of start-up, retention, and adherence in ALS clinical trials
Nazem Atassi, Padmaja Yerramilli-Rao, Jackie Szymonifka, Hong Yu, Marianne Kearney, Daniela Grasso, Jing Deng, Mark Levine-Weinberg, Jordan Shapiro, Alexandra Lee, Lucia Joseph, Eric A. Macklin, Merit E. Cudkowicz
Neurology Oct 2013, 81 (15) 1350-1355; DOI: 10.1212/WNL.0b013e3182a823e0

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Abstract

Objective: To investigate predictors of trial start-up times, high attrition, and poor protocol adherence in amyotrophic lateral sclerosis (ALS) trials.

Methods: Retrospective analysis of start-up times, retention, and protocol adherence was performed on 5 clinical studies conducted by the Northeast ALS Consortium and 50 ALS clinical trials identified by PubMed search. Predictors of start-up times were estimated by accelerated failure time models with random effects. Predictors of retention and protocol deviations were estimated by mixed-model logistic regression.

Results: Median times for contract execution and institutional review board (IRB) approval were 105 days and 125 days, respectively. Contract execution was faster at sites with more ongoing trials (p = 0.005), and more full-time (p = 0.006) and experienced (p < 0.001) coordinators. IRB approval was faster at sites with more ongoing trials (p = 0.010) and larger ALS clinics (p = 0.038). Site activation after IRB approval was faster at sites with more full-time (p = 0.038) and experienced (p < 0.001) coordinators. Twenty-two percent of surviving participants withdrew before completing the trial. Better participant functional score at baseline was an independent predictor of trial completion (odds ratio 1.29, p = 0.002) and fewer protocol deviations (odds ratio 0.86, p = 0.030).

Conclusion: Delays in IRB review contribute the most to prolonged trial start-up times, and these timelines are faster in sites with more experienced staff. Strategies to improve protocol adherence and participants' retention may include enrolling people at early disease stages.

GLOSSARY

ALS=
amyotrophic lateral sclerosis;
CI=
confidence interval;
CIRB=
central institutional review board;
IRB=
institutional review board;
NEALS=
Northeast Amyotrophic Lateral Sclerosis;
NeuroNEXT=
Network for Excellence in Neuroscience Clinical Trials;
OR=
odds ratio

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Supplemental data at www.neurology.org

  • Received March 13, 2013.
  • Accepted in final form July 8, 2013.
  • © 2013 American Academy of Neurology
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