Patient safety reporting and drug label accuracy missing vital information

Mar 10, 2010

A Perspective piece in the New England Journal of Medicine calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration (FDA), and how the FDA represents this information on drug labels.

Ethan Basch, MD, outcomes researcher and medical oncologist at Memorial Sloan-Kettering Cancer Center, recommends that fundamental change is necessary in order to improve the process of evaluating the true toxicity of drugs. Dr. Basch has found that clinicians - the current responsible party for collecting and reporting symptoms in clinical trials - systematically miss important symptoms and often underestimate the severity of the symptoms they do notice. According to Basch, this leads to under-reporting of adverse events and, consequently to clinical trial results, publications, and drug labels that don't adequately represent the true toxicity of drugs.

To provide researchers, clinicians, and patients with more usable and valuable symptom information, Dr. Basch, who works closely with the FDA and National Cancer Institute on research issues, suggests that patients be given the tools to self-report adverse symptoms in clinical trials and online reporting between clinic visits, which can assist nurses and doctors with symptom management and improve communication.

According to Dr. Basch, "Patient self-reporting enhances the quality and comprehensiveness of symptom and adverse event data," and he notes that "patients must be given a voice in , research, and regulatory processes, as they are the most important stakeholders and deserve access to the impressions of their peers when trying to decide whether to start a new treatment."

Explore further: FDA approves new drug for rare genetic disease

Provided by Memorial Sloan-Kettering Cancer Center

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Half of trials supporting FDA applications go unpublished

Sep 23, 2008

Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine. The most important trials determining efficacy, and those with s ...

New paper from internists calls for increased role for FDA

Sep 24, 2009

A new policy paper that calls for broader authority and increased funding for the Food and Drug Administration (FDA) was released today by the American College of Physicians (ACP). Improving FDA Regulation of Prescription ...

Recommended for you

Boxed warnings are common in novel therapeutics

20 hours ago

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

AstraZeneca says DOJ closes probe into drug trial

22 hours ago

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.

Perampanel for epilepsy: Still no proof of added benefit

22 hours ago

The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment ...

User comments : 1

Adjust slider to filter visible comments by rank

Display comments: newest first

terrylwalker
not rated yet Mar 12, 2010
Back in July 2001 I went to St. Michael's Family Clinic in down town Toronto for a letter to take a leave of absense from my employer because of the age discrimination I was subjected to I was 50 at the time single metis/celtic white male. I was talked into taking a pill that was supposed to work like a vitamin pill which would keep me calm in dealing with the young female supervisors (age mid to late 20's). I took this once a day pill Paxil; I was fired from my job Sept 2001. The doctor increased the paxil to 50mg; 3 visits with these St. Mike's doctors where I reported severe head aches, night mares and falling out of bed were removed from my medical records. The doctor reported that she had not seen me for 6 months and only renewed paxil by the phone; (n.b. for a doctor to prescribe an atypical antidepressant/ antipsychotic for six months and not monitor them is malpractise).
1)medical professional s/b punished or fined for non disclosure of s/e
2) blood type s/b recorded