Therapeutics
Delivery Technology Paves Way for RNAi Therapies

Neuroscience
Gene Clue to Brain Asymmetry Revealed on Right Side

Social Medicine
Gun Violence May Be Viewed as Contagious

Neurology
Fetal-cell Transplants Reverse Parkinson’s in Two Patients

Clinical Research
Discord Found in Clinical-trial Contracts

Health Care Policy
National Mental Health Survey Shows Mixed Results on Progress

Genetics
Disease Mutation Tracked Down, Ending ‘Curse’ for Colombian Families

New Books
The Spring Bookshelf

Education
HMS Teaching Awards Presented for 2005

Accolades
Students Laud Gardner as Champion of Humanism in Medicine

Medical Ethics
Debate at HMS Frames Ethics of Online Organ Donation

Brain Chemical Serotonin Linked to Left–Right Patterning of Embryo

Rising Leaders in Minority Health Research Turn Data into New Directions

New Chairs Honor Federman and Egan Family

Honors and Advances

In Memoriam

Let Consumers Drive Progress in Health Care Quality

Front Page

Discord Found in Clinical-trial Contracts

Greater Harmony in Agreements Might Strengthen Academic Freedom

Photo by Steve Gilbert Michelle Mello believes that greater openness about contractual relationships with sponsors could lead to more standardization in clinical-trial agreements.

Though industry provides about 70 percent of the funding for clinical trials conducted by academic researchers across the country, the contracts between sponsors and academic medical centers that govern the trials show little standardization. In a study of contract provisions that restrict researchers’ control over clinical trials, Michelle Mello and colleagues show that centers are divided on key issues of data ownership and dissemination and of confidentiality. Their findings, which address ways to bolster academic freedom, appear in the May 26 New England Journal of Medicine.

Using a mail survey of research administrators who negotiate clinical-trial agreements with industry sponsors, Mello, an HSPH associate professor of health policy and law; David Studdert, an HSPH associate professor of law and public health; and Brian Clarridge, of the Center for Survey Research at the University of Massachusetts, gathered detailed information from 107 administrators out of the 122 they contacted. The researchers found a weighty consensus on many of the policies they queried regarding multicenter clinical trials: 96 percent of administrators said their office would allow a sponsor to review a research manuscript for an agreed-upon period prior to publication; 87 percent said their office would allow a sponsor to delay publication beyond the set time while a patent application was filed; and 93 percent said their office would not allow a sponsor to decide that the results should not be published.

But some of the finer contractual points drew more disagreement among respondents. Addressing data ownership, Mello and her colleagues asked if research administration offices would allow a sponsor to store study data and release portions to the investigators: 35 percent of administrators said yes; 30 percent said no; and 36 percent were not sure. Would research offices allow a sponsor to write up study results for publication if the investigators could review the manuscript and suggest revisions? Yes, said 50 percent of administrators; no, said 40 percent; not sure, said 11 percent. Would research offices allow a sponsor to prohibit investigators from sharing raw data with third parties after the trial was over? Yes, said 41 percent; no, said 34 percent; not sure, said 24 percent.

One further area of disagreement among research administrators is an issue on which the current study hinges, according to Mello and her collaborators. When asked if their offices would allow a sponsor to stipulate that the terms of a clinical-trial agreement remain confidential, 62 percent of administrators said yes and 37 percent said no. During their analysis, in fact, the researchers found that most centers would not let them look at contracts directly. The scientists back the minority response on this question, arguing that greater openness and more agreement on the sharing of information about contractual relationships with sponsors would help build consensus about appropriate standards across all academic medical centers.

“The clinical-trial agreement is the critical regulator of threats to academic freedom,” they write, “with the potential to induce researchers’ compliance with a sponsor’s demands or to protect researchers from them.”

—Robert Neal

top