The Prevention and Treatment of Missing Data in Clinical Trials (2010) / Chapter Skim
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3 Trial Strategies to Reduce the Frequency of Missing Data
3 Trial Strategies to Reduce the Frequency of Missing Data
Pages 39-46
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From page 39... ...
REASONS FOR DROPOUTS The literature on the factors associated with and the effectiveness of various measures to reduce the occurrence of missing outcome values is relatively diffuse, possibly dependent on the medical condition, the intervention under study, and the population of interest. Thus, the literature is difficult to summarize and often not a great deal is known for particular situations.
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From page 40... ...
As discussed in Chapter 2, many trial sponsors and investigators mistakenly assume that there is little reason for additional data collection when participants discontinue study treatment. But as we emphasize, the continued collection of data is important in many trials.
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From page 41... ...
First, in the informed consent process, they can emphasize to participants the importance of continued participation for the full duration of the trial. Similarly, they can ensure that the trial procedures allow for an informed withdrawal of consent so that participants recognize the importance of continued follow-up for data collection if they discontinue study treatment: see Box 3-1 for an example of language for withdrawal.
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From page 42... ...
Most IRBs allow cash payments to be slightly backloaded (retaining a small proportion as an incentive for completion) , but, generally, payments accrue as a study progresses in payment for participation activities that are completed.
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From page 43... ...
The provision of transportation and child care costs can also improve retention. For participants who want to discontinue treatment, it is important for site personnel to determine the reasons and to make sure that the participants understand the importance of continuing on the study for the purpose of data collection.
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From page 44... ...
Nevertheless, it is important to set high standards for the participating investigators and monitor the amount of missing data for key outcomes in real time. We note that one cannot be specific as to how to set target and maximally acceptable rates for missing data in all clinical trials.
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From page 45... ...
However, primary responsibility for ensuring that missing data are kept to a minimum should reside with the investigators, the protocol team, and the sponsor.
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