Tuesday, 18 January 2011

Questionable research removed from record as Lancet retracts publication

The British Medical Journal (BMJ) this month (January 5th) has published an article (the first of a special series) in which it outlines how a link between the measles, mumps & rubella vaccine and autism was artificially manufactured. A startling recap of how 'bogus data' has had an impact in the global perspective on vaccines and autism.

The article, by Brian Deer, a journalist, is titled "How the case against the MMR vaccine was fixed."

In 1998, Dr. Andrew Wakefield in the Lancet published his findings, based upon data from 12 patients, that there was an apparent link between the measles, mumps & rubella vaccine and the onset of behavioral symptoms.

In the decade following this publication, many parents decided not to vaccinate their children. It doesn't stretch the imagination that as a result, probably a number of children attracted the diseases unnecessarily, with who knows what results.

Flawed data, fabricated conclusions, severe allegations made against Dr. Wakefield. His original article in the Lancet was retracted by the Lancet February 2010, 12 years after the publication.

Of course, this is not the first time that fixed data is published, and it's likely not the last time. This case is so remarkable though, as it impacts the lives of so many children. Both from the side of unnecessarily worried parents making the choice not to vaccinate, but let's certainly not forget the parents of children with autism, desperately looking for a cause, something to blame, as is only natural. In this case, their position was openly and loudly pleaded by celebrity parents like Jenny McCarthy, who incidentally still supports the findings of Dr. Wakefield. Although it is somewhat understandable that someone does not want to let go of something to blame for such an unfair ordeal, I'm afraid it does more harm than good.

Perhaps needless to say, Dr. Wakefield also denies all allegations and stands by his findings.

However, currently 10 of the 12 original authors of the 1998 publication have retracted their support of the original study and its interpretation, the Lancet partially retracted in 2004 and after The General Medical Council ruled he had acted “dishonestly and irresponsibly” in doing his research, the Lancet completely retracted the article.

And therewith, they removed this questionable research and its conclusions from the records. With public voices still defending the discredited research, I doubt it will be the last we hear from it though.wow gold

Monday, 10 January 2011

FDA Basics for Industry

Over the last week, the FDA launched a new section of their website, called 'FDA Basics for Industry'.

"The website includes basic information about the regulatory process, including information that is frequently requested by industry."

The intention of the FDA is to improve communication between FDA and industry. The website contains information about the regulatory process, about current guidelines, about registrations, etc. It also includes a frequently asked questions section.

It looks like a good initiative, and a site that hopefully will continue to grow. It of course still aims at all areas covered by the FDA, including cosmetics, food and tobacco products.

The FDA reports that the starting of this website is a part of the agency's transparency initiative, launched in 2009 in response to President Obama’s commitment to openness in government.

I'm curious to find out if you find it a useful site, please feel free to comment.wow gold

Monday, 3 January 2011

A True Investigator Meeting

Today I would like to draw your attention to a thought provoking column in the December issue of The Monitor, the publication of the Association of Clinical Research Professionals (ACRP). Dr. Joel S. Ross, MD, entitled his column "Investigating Investigator Meetings" (Page 84-85).

For members of the ACRP, you can read the article online here.

Dr. Ross in his column puts some critical notes to "practically invisible PIs" at investigator meetings. PIs who "blend into the furniture in the conference room", and asks out loud how they "reach the point of being so poorly prepared for the investigator meeting". He continues outlining how a "true PI" would prepare, versus the "practically invisible PI".

Rather than what his title suggests, the column is more about how a PI should prepare to be ready to start prescreening, screening and randomising eligible subjects than about investigator meetings. Although the link from this to investigator meetings is not made in so many words in his conclusion, Dr. Ross kind of makes the assertion that preparation for the one, should prepare a "true PI" for the other.

In this blog, I would like to add my perspective to his subtitle "With apologies to Shakespeare, 'To attend, or not to attend, meetings with the sponsor: That is the question'", addressing this from the angle of the sponsor.

Because indeed, the question 'to attend or not to attend' investigator meetings is a common question in clinical research. Where Dr. Ross makes the argument that if you attend, you should be well prepared to add benefit to the meeting, there is also a good argument to make for sponsors to make the investigator meetings more appealing to attend.

And here I don't mean by holding those meetings in exotic locations or providing an interesting evening (social) programme, though I can certainly appreciate the importance of providing opportunity for the participants to less formally discuss the trial other topics.

What I'm asserting is that sponsor companies often fail to cash in on the enormous potential that an investigator meeting has. Where the common purpose of an investigator meeting is to educate participants on the protocol and procedures, to provide a platform for discussion about the protocol, as well as to motivate all site staff present to commit to the trial at hand, the common format is commonly all but educational and certainly not motivational.

The average investigator meeting is a parade of presentations, one-way communications, where a conference room is often darkened to allow for better visual presentations and better naps. The organisation of an investigator meeting is often assigened to members of the clinical team who are already working overtime to start up the trial They get the organisation of the meeting as an added bonus. Presenters are often the subject matter experts (SMEs), who are, with all due respect, often not the best presenters. This does not do justice to the meeting, nor does it demonstrate respect for the time investment made the participants.

A True IM (Investigator Meeting) is set up with in mind the audience. It covers the topics knowing that the target audience is site staff and thus approaches it from their perspective, actively demonstrating how this is important for them. How the information applies to their job and answering the imagined questions the audience could have, before giving them the floor to come with further questions. It should not contain information the sponsor wants to share, but information the audience needs to know. The SMEs don't have to do the presenting, if they're not captivating presenters. As long as they're present for the best answers to challenging questions, a good presenter will be able to draw those questions by getting the audience interested.

Yes, investigators should come well prepared and ready to ask good questions, just as much as the sponsor should run the meeting well prepared, inviting, if not challenging the audience to come with good questions.

So, in the spirit of Dr. Ross' column about the "True PI", some points for a "True IM".

A True IM is interesting
A True IM is interactive
A True IM has two-way communication
A True IM has practical sessions
A True IM captivates the audience
A True IM involves the audience
A True IM is a platform for discsussion
A True IM has the lights on all day (in the room and in the eyes)
A True IM has proper follow up, including a Q&A from the meeting
A True IM respects all attending

Most of all:
A True IM is educational
A True IM is motivational wow gold