Tag: clinical trials

Blog Posts (28)

March 2, 2015

In Drug Trial, Parents Weigh Life and Loss

[WSJ/MSN] —While waiting for an infusion of a drug that might save his life, 15-year-old Andrew Marella gripped the controls of an NFL videogame, the hand-held version of a sport he played when he could still run without fear. Andrew is in a clinical drug trial of cyclodextrin, a sugar-based substance that scientists hope will […]
August 18, 2014

When unapproved drugs are the only help: A case for compassionate use

[CNBC] wo years ago, Nathalie Traller spent her days like any seventh-grader might. She played soccer and swam and studied for classes. Then Nathalie started getting bad headaches, the kind that made it hard for her to concentrate. A trip to the doctor revealed the unthinkable: a mass the size of a baseball in her […]
July 10, 2014

Hensinki Declaration revisions weaken protections for developing country trial participants

The latest revisions to the Declaration of Helsinki may weaken human research subject protections, particularly for participants in low and middle income countries, according to a recent analysis in BMJ.  See the article here:  http://www.bmj.com/content/349/bmj.g4254
July 8, 2014

Merck Says It Regrets Strong-Arming Italian Researcher

[Forbes] Merck says that it “regrets” using legal threats to push a leading Italian researcher to muffle his public critiques of one of the company’s cholesterol drugs. Merck spokesman Steve Cragle writes: Merck is committed to the open and transparent exchange of scientific information. We believe this exchange should take place in medical meetings and […]
June 24, 2014

Pharmaceutical firms find it hard to exit essential drugs market

[TheEconomicTimes] Pharmaceutical companies having more than a 1% market share for any essential drugs may find it difficult to stop manufacturing those products. Since May, when the government brought into force a new drug-pricing system after a gap of 18 years, the National Pharmaceutical Pricing Authority has denied such requests whenever the market share of […]
June 16, 2014

For cancer specialists, disease can make them better doctors

[San Francisco Chronicle] Dr. Pamela Munster‘s colleagues viewed the mammogram results and then played out a scene she knows well: the furrowed brow, the intense look of concern, followed by the composed, reassuring face for the patient’s benefit. They weren’t looking at her patient’s mammogram. These were Munster’s results. They were acting the same way she did […]
June 13, 2014

Outsmarting Breast Cancer With Evolving Therapies

[The New York Times]   Over the past few decades, changes in the treatment of breast cancer amount to a revolution in patient care. And it’s not over yet. There was a time when the standard approach was a radicalmastectomy, which involved removal of not just the breast, but all the lymph nodes in the armpit and […]
May 22, 2014

A Study on Prostate Cancer Relapses Suggests That Hormone Therapy Can Wait

[The New York Times]Many men with an early sign of a prostate cancer relapse can safely wait before starting hormone therapy, avoiding side effects without shortening their lives, according to the results of a study released on Wednesday. Dr. Clifford A. Hudis, president of the American Society of Clinical Oncology, said the study “certainly does […]
May 8, 2014

Nobel laureate Yamanaka denies image manipulation in 2000 paper

Original commentary by BEI Young Professionals Olivette Burton MBe MSW Asking for forgiveness rather than permission is, unfortunately, becoming a recurring international theme in the world of biomedical research.  Questions surrounding trust and integrity in science inevitably become more difficult for honest champions of research to answer convincingly.  Some of my previous work has been dedicated […]
November 22, 2012

Ethical Design for Cluster Randomized Trials

A team led by our friend and colleague Charles Weijer at the University of Western Ontario has just issued guideliens for what are known as “cluster randomized trials” (CRTs). See the story here: Western-led team delivers world-first ethics guidelines. CRTs are clinical trials in which randomization occurs across groups of participants, or across institutions, rather […]

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Published Articles (9)

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

The SUPPORT Controversy and the Debate Over Research Within the Standard of Care David Magnus

American Journal of Bioethics: Volume 10 Issue 8 - Aug 2010

Translational Research Beyond Approval: A Two-Stage Ethics Review

American Journal of Bioethics: Volume 10 Issue 8 - Aug 2010

The Diverse Ethics of Translational Research

American Journal of Bioethics: Volume 7 Issue 2 - Feb 2007

Money and Distorted Ethical Judgments about Research: Ethical Assessment of the TeGenero TGN1412 Trial

American Journal of Bioethics: Volume 6 Issue 4 - Jul 2006

The Real Problem with Equipoise

American Journal of Bioethics: Volume 6 Issue 5 - Sep 2006

Innovation in Human Research Protection: The AbioCor Artificial Heart Trial

American Journal of Bioethics: Volume 6 Issue 3 - May 2006

Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects

American Journal of Bioethics: Volume 5 Issue 3 - May 2005

U.S. Military Sponsored Vaccine Trials and La Resistance in Nepal

American Journal of Bioethics: Volume 4 Issue 2 - Jun 2004

When ?Minimal Risk? Research Yields Clinically-Significant Data, Maybe the Risks Aren?t So Minimal

News (27)

October 25, 2016 8:00 am

Can Ecstasy Help Relieve Social Anxiety Epidemic Among Autistic People? (NPR)

For a long time, Daniel Au Valencia got the message that she was wrong, wrong, wrong. She stood wrong. She talked wrong. She looked at people wrong. “There’s a lot of shame around autism,” she says. “There’s a lot of being told you look weird.”

October 11, 2016 8:00 am

80% of China’s clinical trial data are fraudulent, investigation finds (BMJ)

Just over 80% of clinical trial data submitted to support new drug registrations in China have been revealed as fraudulent or substandard by the country’s drug regulator.  An investigation of data for 1622 new drugs submitted to China’s State Food and Drug Administration (CFDA) for registration said that 1308 of the applications should be withdrawn because they contained fabricated, flawed, or inadequate data from clinical trials.

August 14, 2013 6:27 pm

Safety First? How the Current Drug Approval System Lets Some Patients Down

Licensed drugs have to go through rigorous trials. Even if an unlicensed drug works in some way, it might kill you in another way or cause problems.

February 22, 2013 12:41 pm

Families Push for New Ways to Research Rare Diseases (WSJ)

Parents with children who have rare and debilitating diseases are pushing to change how researchers develop medicines to treat the conditions.  The parents want different scientists researching the diseases to share data about the patients so the children won’t need to participate in so many studies.

January 28, 2013 1:33 pm

Lumpectomy Saves Lives in Early Breast Cancer (MedPage Today)

In real-world practice, women with early-stage breast cancer were more likely to survive if they had a lumpectomy rather than mastectomy, a population-based registry study found.

January 23, 2013 4:32 pm

Bird Flu Research to Resume After Safety Debate (New York Times)

Experiments with a deadly flu virus, suspended last year after a fierce global debate over safety, will start up again in some laboratories, probably within the next few weeks, scientists say.

December 12, 2012 2:02 pm

Coffee May Lower Risk of Dying From Oral Cancers (WebMD)

Heavy coffee drinkers — those who drink more than four cups a day — may cut their risk of dying from cancers of the mouth and throat by nearly half, according to new research.

December 11, 2012 2:04 pm

Obesity, diabetes are robbing people of sight (USA Today)

The nation’s twin epidemics of obesity and diabetes are robbing more Americans of their sight.  The percentage of American adults suffering from uncorrectable vision loss spiked 21% in only about six years, rising to nearly 1.7% of the population.

December 7, 2012 4:33 pm

Beer May Have Anti-Virus Properties According to a New Study (Huffington Post)

According to a new study funded by Japanese beer company Sapporo Breweries, a “key ingredient” found in the world’s most popular alcoholic beverage may very well help stave off winter sniffles.

December 5, 2012 7:13 pm

Bigger Role Seen for Breast Cancer Drug (NYT)

The widely prescribed drug tamoxifen already plays a major role in reducing the risk of death from breast cancer. But a new study suggests that women should be taking the drug for twice as long could upend the standard that has been in place for about 15 years.

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