Voice of Experience.

This Voice of Experience column marks the second corporate "voice;" actually a "chorus" of voices of experience, sometimes singing in tune, but always singing lustily. However, we note with sadness the passing of our colleague, Herbert "Chuck" Chermside, the original "solo" voice of experience for several prior issues. Chuck was a role model for many and a source of information for all. We will miss Chuck and his contribution to research administration.

1. Dealing with Multi-Center Study Publication Clauses

Question: One of our clinical investigators is preparing to participate in a multi-center clinical trial. The sponsor is proposing an agreement that limits individual investigators' publication rights prior to publication of a joint report on the trial. Is this common? What do other institutions do when they receive agreements with these provisions in them?

Answer: Most of multi-center clinical trial agreements prepared by pharmaceutical companies use the same clause. Apparently many of academic institutions accept a clause that restricts individual publication until a joint publication is prepared. Most participating investigators consider this reasonable, assuming that the joint report will be prepared and released promptly. Such clauses go on to say something like the following:

If such a multi-center publication is not submitted within twelve (12) months after conclusion of the study at all sites, or after the Sponsor confirms there will be no joint, multi-center publication, but not longer than twelve (12) months after conclusion of the study at all sites, University and Principal Investigator may publish individually in accordance with this Section. (Emphasis added). www.ohsu.edu/research/rda/rgc/docs/cttemplate.doc

Some of us have a problem with provisions like this. We recently reviewed a presentation given by Susan Carney, Yale University; Theresa Colecchia, University of Pittsburgh; and BethLynn Maxwell; The University of Texas System; at the Association of American Cancer Institutions Annual Meeting in Washington, D.C. October 17-18, 2005. One of their slides says it all:

Multi-site/center clinical trial studies

--Preserve Institution/PI's right to publish separately from multi-site joint publication after reasonable delay

--Reasonable delays permitted until joint publication is published OR 12-18 months after our study is over (whichever is shorter) (emphasis in the original).

http://www.aaci-cancer.org/pdf/2005_ameeting/Oct 17-1355-Colecchia.pdf

It may seem like a small thing, but it is important to stand firm on the last point made by Colecchia, et al. Institutions need to have a firm deadline after which the lack of a multi-center publication is no longer a bar to publication at the individual institution. If the companies' standard language is accepted, then the company can effectively prohibit publication, simply by not completing the study at one single site.

The University of Louisville model agreement, and the University of Texas sample agreement with Merck; both excerpted below, delete the "at all sites" language.

The U of L provision states:

Notwithstanding the foregoing, U of L agrees that if the Research is part of a multi-center study, the first publication of the results of the Research shall be made in conjunction with the results from the Investigators at the other study centers. However, if a multi-center publication is not forthcoming within one year following completion of this Agreement study, U of L will be free to publish. research.louisville.edu/p-and-p/clinical-trialagree-ULRF.doc

I am not completely convinced that the UT language is explicit enough in asserting the Institution's right to publish at a firm point after completion of the UT study.

The UT provision states:

It is understood that this study is part of a multi-center trial and INSTITUTION will be free to publish the results of its part of the study in collaboration with the other investigators in this trial, but with due regard to MERCK's confidential information and materials. Subsequent to the multi-center publication or twenty-four (24) months after completion of the study, whichever occurs first, INSTITUTION may itself publish the results of the study, with due regard to MERCK's confidential information.

www.utsystem.edu/ogc/Intellectualproperty/ contract/merck.htm

I also noted that the University of Texas is not consistent with the requirement that it be allowed to publish at a time based on completion at UT. The AstraZeneca Master agreement provides:

In no event will the Institution or the Principal Investigator be so restricted after 18 months have elapsed since the completion of the Study at all centers. (emphasis added).

www.utsystem.edu/OGC/Intellectualproperty/ Contract/AZMASTER.doc

The secret to getting companies in a single industry to accept the position of academia is to present a united front on a reasonable approach to a matter where reasonable parties can disagree. If every academic medical center and every clinical research thought leader takes the same position, then the pharma companies will eventually come around. I have discussed this issue with two large pharma companies that have made it company policy to accept firm deadlines. I have also had extended negotiations with other pharma companies which are still fighting the battle to control the publication process. In each case, where negotiation was necessary, I heard the same refrain: "But XYZ institution accepts this language." Perhaps academic institutions that perform clinical trials need to agree on a reasonable practice, and communicate that practice among themselves and with the pharma companies that support clinical trials. It seems that it is reasonable to academic medical centers to insist on the right to publish, absent a joint publication, either 12 or 18 months after the study ends at the institution. This seems like a reasonable standard of practice; much as assuring the fight to publish after a reasonable period for review became standardized in all university-industry research agreements in the 1980s.

2. Benchmarks for the Size Research Management Staff

Question: I am trying to find out if anyone has done any work on best practice or assessment of optimum dedicated admin support for academic researchers--e.g. in research centers or institutes. An academic colleague indicated optimum level of one administrative/support staff member per 4-5 academic staff in an active and externally focused research center but I am not aware of any modeling or best practice assessment or benchmarking that has been done--have you heard of anything either for number of admin staff or levels of support?

Answer: This is an oft-asked question!

William Kirby and Paul Waugaman tried to deal with this issue in their national benchmarking work from 1998 through 2003, and developed some ratios which speak to the questions of practice and norms current at the time, but do not give a complete answer.

In a series of surveys, their studies showed participating institutions how their sponsored programs administration staffing and workload compared with the other institutions. Each participant had the opportunity to do comparisons and prepare their own studies using a flexible web-based data system (Fig. 1). Aggregate data was presented as ratios and showing median values for four groups of institutions, grouped by size of research expenditure. Here are some results from the 2000 survey that point to possible answers to the question (Figs. 2.1-2.4):

Each graph portrays the median value for the number of institutions in each size group, and the median value for the entire survey population (all participants). The bar on the left represents the value for all participants. The other bars represent a size group (measured size of sponsored program expenditures) with the largest on the left and the smallest on the right.

These graphs portray a pattern of results showing that research management at smaller institutions generally costs more and requires more people per units of business (investigators, awards, proposals, and active projects). These results are consistent for the other measures developed in these surveys. There are confounding factors, however. The data do not consider the cost and effort of decentralized research administrators, which may be greater at the larger institutions.

There are a number of other reasons why the data alone do not fully answer the question.

First, the numerators and denominators for these ratios may not comparable from institution to institution beyond the study. For example the definition of "faculty member" or "principal investigator" shifts widely, so it is very difficult to identify a comparable researcher base across a number of institutions. Likewise, it is hard to identify administrative staffing when staffing is spread across the institution; and at many levels, people have mixed responsibilities including research management. Support staff are often hidden is accounting or purchasing offices and miss being counted. The participants in these surveys worked very hard to standardize definitions, so comparisons within the population could be valid. Comparisons outside the study population may be difficult.