Should Researchers Share Their Results with Study Volunteers?

The News Review:

- Should Researchers Share Their Results with Study Volunteers?
- Daily Times – Leading News Resource of Pakistan
- Goldman opens annual health care conference Monday
- Nabbing suspicious SNPs
- Semafore reports positive interim results from Phase I cancer trial

Should Researchers Share Their Results with Study Volunteers?
Newswise – Newswise (press release) – Jun 6, 2008
A new review of the issue published recently in the journal Public Library of Science Medicine suggests that participants? desire to know the results of studies outweighs concerns by some bioethicists about the potential negative psychological consequences of sharing some results. Even when it?s bad news most study volunteers want to know. So should all medical researchers make an effort to communicate about their results with the volunteers who are so vital to their research? If they try to do so what hurdles ? ethical privacy-related financial or logistical ? might complicate their efforts? Could sharing clinical research results with some volunteers actually upset them? Such questions are addressed in the new paper which was written by University of Michigan medical student and Bioethics Program member David Shalowitz and Franklin Miller Ph. of the Department of Bioethics at the National Institutes of Health. The research was funded by a grant from the U-M President?s Initiative for Ethics in Public Life. The paper reviews the landscape of knowledge on this issue including commentaries on the potential positive and negative impacts of sharing results and data from studies that evaluated the desires and reactions of research volunteers in specific clinical trials… ?We also need better evaluations of the best ways to communicate data to research participants. We need to change the current situation in which claims are being made about the benefits and risks of sharing results without data to back them up. ?For more information on participating in clinical research trials at the University of Michigan visit the U-M Engage web site www. Reference: PLoS Medicine May 13 2008.

Daily Times – Leading News Resource of Pakistan
Daily Times – Jun 6, 2008
trial news with Wyeth losing $32 billion in market value though its HRT franchise is worth only $2 billion a year. Professor David Archer head of clinical research at the Jones Institute for Reproductive Medicine in Norfolk Virginia said the latest UK study findings on endometrial cancer were encouraging. But he added in a BMJ editorial: “These data should be taken in context with the formulation.

Goldman opens annual health care conference Monday
Motley Fool – Jun 6, 2008
Wall Street has since been watching CVS Caremark’s performance closely to see if similar deals are likely to follow. Though none have yet been proposed Wal-Mart earlier this year said it may enter the pharmacy-benefits fray working with certain employers to help them manage their employee prescription claims and processing. Stanicky also is looking for updates on the increasing focus of clinical research organizations drug suppliers and drug developers on international opportunities to both speed growth and lower costs. Lab and clinical services companies like Wilmington Mass. -based Charles River Laboratories Inc.

Nabbing suspicious SNPs
Science News – Jun 6, 2008
Ignoring these issues might cause scientists to wastevaluable time investigating innocent suspects while the truly significantgenes slip away unnoticed. As results from huge new studies roll in these challengesare attracting more attention. The National Institutes of Health held a specialmeeting in March to discuss how to translate genome-wide association data intoclinical research and practice. And scientific journals are publishing specialpapers instructing researchers in the art of interpreting genome-wideassociation studies. ?First you have to go through a sifting process filteringthe true signals from the false signals and making sure you don?t miss any?says epidemiologist Muin Khoury of the Centers for Disease Control andPrevention in Atlanta. ?I think this is as much of an art as a science rightnow. ? Deluge of dataFor all the apparent variation among people the humangenetic code is actually 99.

Semafore reports positive interim results from Phase I cancer trial
Pharmaceutical Business Review – Jun 6, 2008
In the current trial patients are dosed twice-weekly for four weeks as part of a 28-day SF1126 treatment cycle. Investigators are assessing the safety activity and pharmacokinetics of SF1126 as measured by standard response evaluation criteria in solid tumors. To date 17 patients with a wide range of solid tumors have been enrolled in this multicenter dose-cohort escalating trial which is being conducted at T-Gen Clinical Research Services in Scottsdale Arizona; the Arizona Cancer Center in Tucson Arizona; and the IU Simon Cancer Center in Indianapolis. Stable disease has been observed in three of 12 patients who have completed at least one cycle of treatment including a prostate endometrial and ovarian cancer patient. Adverse events noted so far were limited to nausea vomiting diarrhea and rash. All adverse events have been non-cumulative and reversible. With these encouraging results patient enrollment has accelerated and full enrollment of the trial is anticipated by the end of the third quarter.

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