StATS: My second grant, part 3 (created 2006-10-02)

I just finished my second grant, which I gave the title "Estimating delays in completion of IRB approved and KBR supported research studies" The two acronyms, IRB and KBR should be familiar to the group I am applying to. IRB stands for Institutional Review Board and KBR represents an internal grant mechanism here at Children's Mercy Hospital to support initial research efforts. The initials KBR stand for Katherine Berry Richardson, who is one of the initial founders in Children's Mercy Hospital.

So I am applying for a KBR grant in order to study delays in completion of other KBR grants. If nothing else, it should be something that the KBR grant committee will have an interest in. It will also be interesting when I request IRB approval for a research study that reviews IRB approved studies.

The technical abstract for this grant submission is

As the research biostatistician at Children's Mercy, Dr. Simon has supported the development of literally hundreds of clinical trials across just about every branch of pediatric medicine. In his experience and in the experience of many of the people he works with, the greatest practical problem in conducting medical research is slow accrual of patients. It is not unusual to see a research project that has gone a full year past its completion date and yet the researcher still has less than half of the subjects originally planned for. Slow accrual causes serious difficulty for researchers, for groups that fund research, and for groups that review research, such as Institutional Review Boards (IRBs) and Data and Safety Monitoring Committees.

There is little appreciation, however, in the research community for the problem caused by slow patient accrual. This lack of concern is caused, in large part, by the lack of hard data on scope and magnitude of the problem with slow patient accrual. This research proposal asks for $15,000 for a pilot study to evaluate a random sample of 100 studies approved by the Children's Mercy IRB. This sample will produce an estimate of the proportion of studies that fall behind schedule, the proportion that end with fewer patients than originally planned, and the average shortfall in those studies. A qualitative analysis of the interim and final reports will help identify the major factors that cause slow patient accrual. The results of this research will serve as preliminary data for an R03 or R21 grant to produce quantitative tools for planning and monitoring accrual rates in clinical trials. These tools will help researchers plan appropriate and realistic accrual rates and monitor them regularly, so that corrective action can be taken early to get a study back on track.

and the layperson summary is

The greatest practical problem with clinical research studies is the inability to recruit patients in sufficient numbers in a limited time frame. Although this problem is widely recognized, there is little hard data on the extent of this problem. This research study will examine the research protocols, interim reports, and final reports of a random sample of IRB approved research study to estimate the proportion of studies that fall behind schedule and/or fail to recruit the originally planned number of patients. This data will help support an NIH grant to develop software for better planning and monitoring of patient accrual rates in clinical trials.

I have the full text of the grant (excluding some initial pages of budget and other information) in PDF format. I had discussed this proposal in two earlier weblog entries

and an earlier grant in these weblog entries

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Accrual problems in clinical trials.