GxP Perspectives: Summer Reading

July 25, 2011

GxP Summer Reading

Summer Reading for GxP Professionals

GxP Perspectives firmly believes that summertime means more vacations, less work, and some different recommendations for your reading list. I am actually going to NOT be traveling for the entire month of August. I have weeds to pull, a fence to paint (can Tom Sawyer give me a call), Some hiking to do, and a blog to keep up (to a certain degree). Like most of you, I also enjoy reading. So here are some of my favorite sites for your perusal. Some are industry, some are not. All of them are good. I have really been enjoying the Harvard Business Review “Management Tip of the Day.” If you have other suggestions, please let us know.

UPDATE: Dr. Hamburg’s Op/Ed article printed in the Wall Street Journal.

7 August Update: Not to be missed is the Essex IRB Warning Letter. Earlier this year FDA warned of a fictitious submission to central IRBs. Essex took the bait and approved the fictitious submission.

Harvard Business Review Management Tips is a daily, very brief, “tip of the day.” I find them useful, well-written, and usually making sense. They have many products that they would like to sell you.

What I watched Last Night is a periodic, non-commercial blog about movies. No, not current Hollywood fare, but movies that this acclaimed video maker and film critic actually enjoys. It’s summertime and what better season to watch a movie.

MedCity News A weekly compilation of articles on this commercial website.

AbsoluteArts Because we all need some art in our life.

GCP works The twitter account of GCP Professional Tina Avanzato Chiodo.

NYRblog The blog of the NY Review of Books. If I could only subscribe to one print journal it would be the New York Review of Books.

PharmTech Talk is the blog of Pharmaceutical Technology. All play and no work…

Guardian.co.uk from London. The Guardian provides a different news perspective for readers from the U.S. who can see what others think of us. I like the column from Hadley Freeman on the ratings downgrade. The Guardian has a lot of very good writers.

Science 2.0 Now featuring “Decapitation and the Wave of Death” (now how cool is that?)

Value Added Connects: This blog from India discusses the inspections of CROs by the DCGI (Drugs Controller General of India). A good way to learn more about clinical trials in India.

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Please leave your comments on summertime reading


FDA & OHRP Hold Regulatory Forum at ACRP Meeting in Seattle

May 1, 2011

FDA OHRP regulatory forum

Jerry Menikoff of OHRP & Jean Toth-Allen of FDA

FDA and OHRP both presented at a Regulatory Affairs Public Forum at the ACRP Global Conference on Sunday, May 1st.Speaking for FDA were Leslie Ball, MD, Director of the Division of Scientific Investigations (DSI) which initiates the majority of Bioresearch Monitoring inspections at FDA. Also from FDA was Jean Toth-Allen, PhD, Biophysicist, Office of Special Medical Programs. Jerry Menikoff, MD, JD, spoke on the panel as the Director of the US Office for Human Research Protection. The Association of Clinical Research Professionals hosted the forum in a setting more reminiscent of a TV game show than a professional panel that was complete with theme music and multi-colored columns highlighting the stage. However the questions posed were the ones on everyone’s minds and the speakers gave some good answers.

Please note that the Plenary Session on the Regulatory Affairs Public Forum was recorded and is available on the ACRP website for free.

One question brought up the issue of sponsor oversight of outsourced clinical trial responsibilities. Toth-Allen said that the sponsor is ultimately responsible for all of the clinical trial responsibilities and only CROs are specifically mentioned in the regulations. She emphasized the need to have SOPs in place covering how they are going to oversee contracts of vendors and what the contracts should cover. Leslie Ball said that DSI had an increased focus on sponsor and CRO inspections.

Dr. Ball said that she thinks sponsors should look at three qualities when selecting vendors:

1. The overall capability of the organization and staff.

2. That contracts clearly point out who is responsible for specific responsibilities.

3. That the sponsor oversees the vendor’s activities while the trial is ongoing.

OHRP FDA regulatory forum in Seattle

When Does FDA Inspect?

Another area of interest was when and where FDA would inspect. Both Leslie Ball and Jean Toth-Allen said that FDA was focusing more on inspections during the actual conduct of the study and not just when a sponsor makes an application to the agency.

Dr. Ball said that with the shift to more sponsor/CRO inspections that FDA inspections were looking at sponsor oversight of ongoing trials. She also said that DSI was developing a risk-based site selection tool that looked at three different levels. First, at the application level, did the application pose certain risks that FDA needed to consider. Then at the trial level, tending to focus on pivotal trials. Then at the site level, were there complaints or a history of non-compliance. She also said that they were looking at data from the application such as the rate of subjects dropping out or very high or very low rates of adverse events.

FDA OHRP regulatory forum

Dr. Leslie Ball, FDA

Dr. Ball also emphasized that FDA looked at what they considered important, specifically data integrity for primary efficacy endpoints or key safety indicators, and oversight by the sponsor. She noted that many things that are routinely listed on a Form FDA 483, Inspectional Observations, such as study drug accountability sometimes didn’t find their way to a Warning Letter that focused on items of significance to the approval of the application.

Another interesting discussion was on the topic of online informed consent forms, which are beginning to appear. Jerry Menikoff said it depended on the nature of the study when an online consent might be appropriate. Jean Toth-Allen spoke of the need for a verification process, that the online consent was given by a real person.

FDA regulatory forum Seattle

Discussion on Electronic Medical Records in
Clinical Trials

Finally the panel discussed electronic medical records (EMRs). All three panelists supported the use of EMRs. Toth-Allen said that if an EMR is used in a clinical trial then the institution needs to provide access to verify the record, that it was not acceptable to for monitors to be told that you can’t see it, which elicited a hearty round of applause from the many monitors in attendance. Dr. Ball noted that there were a lot of advantages to EMRS. “You can actually read them,” she said. She also emphasized that EMRs should have the same criteria for clinical trials, that they should be ALCOA– Attributable, Legible, Contemporaneous, Original and Accurate. She also said that although they may not need to be Part 11 compliant, they did need to have an audit trail so that all changes to the record could be traced.

To view the Regulatory Forum visit the
ACRP Website on the Plenary Sessions

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On the Blogroll: RegBlog on all things regulatory from the University of Pennsylvania Law School. Covers much more than FDA

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On The Blogroll: Applied Clinical Trials Blog discusses,
“It Takes a Village: Recruiting Latino and Hispanic Patients.”


ACRP Meets in Seattle for 2011 Global Conference

April 29, 2011

ACRP Seattle

ACRP Meets in Seattle for 2011 Global Conference

Seattle, WA plays host to the Association of Clinical Research Professionals’ (ACRP) annual Global Conference. ACRP is one of the larger professional organizations focusing on clinical trials and expects 2,000 participants. It will be the first time I have attended their Global Conference and I am looking forward to it. There will be sessions on “Introduction to Imaging in Clinical Trials” and on “Distance-Based Learning for Foreign Study Coordinators.” GxP Perspectives will be there for the entire conference (the pre-conference workshops have already begun) and among the sessions I look forward to is “Comparative Effectiveness Trials.” I am going to try to blog at least twice during the conference on issues I think are of concern to GxP Perspectives readers. If I am super industrious maybe I will blog from the ACRP Global Conference every day.

Here is a new feature that ACRP is offering:ACRP is pleased to announce that for the first time ever, two live-feed Plenary Sessions from the ACRP Global Conference & Exhibition will be broadcast FREE of charge. Join us May 1 for the Regulatory Affairs Public Forum featuring representatives from global regulatory agencies addressing issues facing clinical trials. Join us May 2 for Innovation & Global Health, a discussion by Tachi Yamada, MD, President, Global Health Program, Bill and Melinda Gates Foundation.

For more information visit the ACRP Website on the Plenary Sessions

ACRP clinical trials

Do You Have a Guest Commentary for
GxP Perspectives?

Another highlight will be the May 1st session on “Your Site Doesn’t Need 60 SOPs, But How Many Does It Need?” The speakers are Christine Pierre, RN and Steven Steinbreuck, MPH and the author of a Guest Commentary on GxP Perspectives on Informed Consent Requirements. Remember, I am always looking for a good Guest Commentary. Send me a note and ask me how-

Leave a Comment to Submit a Guest Commentary!

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On the Blogroll: Top 40 Websites (and Tweeters) on the FDA, by FDAZilla (Yes, we made the list.)

Moriah Consultant’s Blog – Commentary by Michael Hamrell, one of the conference speakers
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Conferences: Pharma/Bio Boot Camp on the eTMF on 20-21 May 2011 in Philadelphia


Top FDA, Health, and Science Blogs

September 8, 2010

FDA health science blogs

Hamlet and Yorick Discuss FDA Compliance, Health,
& Science Blogs

Here are some interesting blogs on the topics of FDA regulated industry, FDA regulations, health and science that regular readers of GxP Perspectives might enjoy while I am on vacation. Everyone should have a vacation now and then and I am going off for almost two weeks!

Acronym Required states they follow science and industry but don’t tell a lot about themselves. Interesting reading.

Applied Clinical Trials: Their blog is one of the best. Take their salary survey.

Chemistry Explained: A good site on a dry topic. Not an actual blog.

Compliance Zen: “Practical FDA compliance insights and intelligence.”

Diabetes Self Management Well organized and informative

Drug Health Supersite An eclectic mix.

Endocrine Today: “Clinical news on diabetes and endocrine disorders.”

Eye on FDA: Not my favorite but an important blog on FDA stuff.

FDA Law Blog: As described

FDA Matters: Feisty blog on FDA from Steven Grossman

GxP Lifeline: A Master Control Newsletter (commercial content and GxP news)

Medical Devices Today: From Elsevier (not feisty)

Partners in Health Blog: News about the health organization’s work in Haiti.

PharmaGossip: We all need a little gossip in our lives. This blog has the longest blogroll I have ever seen (almost). Blogs that everyone has heard of and that no one has heard of.

PharmTech Talk: Pharmaceutical Technology’s excellent blog.

Two Decades and Counting: A GxP professional’s blog that is well worth checking out.

WSJ Health Blog: A good blog from a newspaper that I don’t read.

FDA blog health science

Hamlet Should Have Taken More Vacations

On my return I hope to have a post on the new FDA Guidance: FAQ for IVDs. I also have several Guest Commentaries lined up on the TMF reference model, informed consent, and more! And as for Hamlet and Yorick, Hamlet never said that he knew him well. He did say that Yorick was, “a fellow of infinite jest, of most excellent fancy.” Sounds like a “to be” kind of guy. Unfortunately, the Hamlet of Ashland 2010 left a little to be desired. Oh well.

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Announcement: The 18th and 19th of January 2011 I will be at the conference for Developing CAPAs in the GCP Environment, Arlington, VA.


Ethics and the debate on health care

August 15, 2009

The media coverage on debate regarding health care reform has been a non-stop display of people protesting “death panels” and “socialized medicine.” What hasn’t happened has been a discussion of the ethics of not providing health care to millions of people and bioethics in general. This hasn’t always been the case. Bioethics were very much the focus when the country discussed “The Tuskegee Syphilis Study” and the U.S. government issued the Belmont Report in 1978. This was the basis for the protection of human participants in research in the United States and very much should be a part of the health care policy debate. The Belmont Report’s core principles are:

(1) respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent;

(2) beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and

(3) justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits to potential research participants.)

The “Tuskegee Study” was actually sponsored by the U.S. Public Health Service and studied syphilis in poor African American men in the South during the Jim Crow era of segregation. The men were not treated even after the discovery that penicillin could effectively treat syphilis in the 1940s. The study was carried out from 1932 until 1972. President Clinton officially apologized to the survivors and family members for the government’s participation in the study.

All of the bioethical principals for medical research are applicable to the debate on the reform of health care and bioethics is entering the debate. Justice, which hasn’t received enough attention to say the least, is also being discussed. According to an article in today’s NY Times (attached as “11: Debate over health policy” on Blogroll” The “dramatic advances in health care pose questions for bioethicists.” The article discusses the fact that the debate has centered on the organizational management of healthcare and ideological debates and not How do we think about the ultimate goals of te health care system and even about health itself.” (Daniel Callahan)

Most importantly to me is that the bioethics concerned in health care is not being discussed. What does it mean when there are multi-tiered levels of health care? What role is the pharmaceutical and medical device industries playing? What does end of life counseling really mean? There should be a number of questions regarding ethics for the nation as a whole including, how do we work “Justice” back into the discussion.


New FDA Commissioner wants to “enforce the Act.”

June 17, 2009

Update 3: The government columnist for Applied Clinical Trials, Jill Wechsler, writes about the increased enforcement of good clinical practice regulations for clinical trials. See the link in interesting articles, Applied Clinical Trials…

In her first discussion of her goals and priorities for FDA with the media, new FDA Commissioner Dr. Margaret Hamburg made it clear that she would place an increased emphasis on enforcement. When I conducted FDA inspections (1993-2005) we used to call this, “enforcing the Act.” We saw our primary job as enforcement of the US Food Drug & Cosmetic Act, which we modestly referred to as the “foremost consumer protection law in the world.” I am attaching a NY Times article (1: New FDA chief says she’ll toughen enforcement standards) that describes Hamburg’s new emphasis on enforcement activities (see Blogroll on the right). The Times also reports that FDA warns against using Zicam, a popular cold remedy that evidently can destroy your sense of smell (see NY Times website).

Update: Matrixx defends Zicam, read their views under Interesting Articles on the right (scroll down).

Update 2: Time seems to think that FDA is getting tougher. See: 2 Is FDA Getting Tougher on the blogroll

Update 3: Take a look at Dr. Hamburg’s speech to FDLI in the latest 2 posts. This post has been confirmed!

Read the NY Times Article:

http://www.nytimes.com/2009/06/17/us/17fda.html?_r=1


Tobacco heads to the House

June 12, 2009

Ted Kennedy’s bill to allow FDA to regulate tobacco passed by a wide margin in the US Senate and now moves to the House of Representatives. For the first time the tobacco companies will have to list ingredients in cigarettes. That sounds pretty good to me. However, I have serious concerns regarding FDA taking over an addictive product (see post below). However, as usual, they forgot to ask me. I am attaching the Washington Post’s take on it all under Interesting Articles “Bill Heads to House.”

Update: Under blogroll NY Times on Tobacco Bedfellows you can read the interesting story of how three unlikely partners worked together on behalf of FDA regulating tobacco.

UPDATE: See this interesting analysis for Seattle under Interesting articles on the right, scroll down until Bill on Tobacco spurs debate. Soon I will return to views on clinical trials.

Update: Wouldn’t you know it. WordPress has changed how to add links and I just don’t understand it. When up against a bureaucracy, WordPress is pretty fierce. Look at the blogroll under DC Freedom. WordPress isn’t letting me post links elsewhere.


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