Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.     

Researchers’ Views of the Acceptability of Restrictive Provisions in Clinical Trial Agreements with Industry Sponsors

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators’ academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.     

Negative Dependence in Sampling

Abstract. The strong Rayleigh property is a new and robust negative dependence property that implies negative association; in fact it implies conditional negative association closed under external fields (CNA+). Suppose that and are two families of 0‐1 random variables that satisfy the strong Rayleigh property and let . We show that {Z_i} conditioned on is also strongly Rayleigh; this turns out to be an easy consequence of the results on preservation of stability of polynomials of Borcea & Brändén (Invent. Math., 177, 2009, 521–569). This entails that a number of important π ps sampling algorithms, including Sampford sampling and Pareto sampling, are CNA+. As a consequence, statistics based on such samples automatically satisfy a version of the Central Limit Theorem for triangular arrays.