NORTON SCIENTIFIC SCAM-Detection and Prevention of Clinical Research Fraud and Misconduct A Norton M

Scheduled as Needed based on Student Demand. Email us at onlinetrain@nortonaudits.com if you are interested in this course.

Description - This is an advanced-level class that takes an in-depth examination of severe noncompliance, clinical data fabrication and falsification, scientific misconduct and fraud cases. The course focus is on developing skills for preventing fraud and misconduct and preparing clinical research professionals to better handle severe noncompliance.

Class Agenda/Modules - Instructors Make a Difference

Defining Clinical Research Fraud and Misconduct

Evaluation of Case History

R.E.S.E.A.R.C.H. TM Skills Program

Advanced Auditing and Monitoring Skills for Prevention

Case Development

Typical Class Attendee -

Sponsor Auditors

Contract Research Organization Auditors

Clinical Research Associates and Monitors

Institutional Review Board Internal Auditors

Food and Drug Administration Investigators

Independent Consultant Auditors

Compliance Auditors

Experience Level - Advanced; CRC, CRA or Auditor position for two years, preferably with a four year medical or science degree

Class Price - $1500 (10% Southeast Regional Discount and 10% multiple persons from the same organization discounts are available)

Norton: Donald Roberts, "Scientific Fraud", and DDT

In this piece Roger Bate, Donald Roberts and Richard Tren accuse the UN of "Scientific Fraud against DDT". Their Accusation is based on an Opinion paper byRoberts and Tren published in Research and Reports in Tropical Medicine. So let's look at their paper and see where the "Scientific Fraud" is.

Roberts and Tren's key argument is that reductions in malaria in the Americas were not the result of Global Environmental Facility interventions but were caused by increased use of antimalarial drugs. In their own words:

"However, their successes were not a result of the interventions we describe as components of the GEF project. Their successes were mostly a result of wide distributions of antimalarial drugs to suppress malaria (see Table 1). Data in the Table reveal trends of increased numbers of antimalarial pills distributed per diagnosed case and decreased numbers of cases. Equally obvious is the decreased numbers of pills distributed per diagnosed case, and increased numbers of cases in two countries (Costa Rica and Panama)."

So their argument rests on table 1. Here's table 1.

Country pills/case pills/case % change in % change in 1990 in 2004 pills/case in cases Mexico 235 2566 1092 -1307 Belize 21 82 390 -287 Costa Rica 653 100 -653 112 El Salvador 34 22802 67064 -8276 Guatemala 38 54 142 -144 Honduras 30 51 170 -338 Nicaragua 279 1319 473 -519 Panama 202 140 -144 1337

The first thing that leaps out at you is that the table shows reductions of more than 100%, which is impossible. Panama cannot have experienced a decrease of 144% in pills/case. According to the two previous columns in the table there was a decrease from 202 to 140, which is a 31% reduction, not 144%. 202/140 is 144%, but it is not the case that the column contains the ratio of pill/case in 1990 divided by pills/case in 2004 (ie, is just labelled wrongly), because then the number for Guatemala would be 70%, not the 142% shown in the table. The column appears to show the bigger number divided by the smaller. That is, all the percent changes in that column are calculated incorrectly and the increases and decrease were calculated differently.

DRG sees what develops

UK distributor DRG is hoping to meet demand for long-running drama by developing original content. Michael Pickard reports.

Anke Stoll

When executives from DRG arrive in Cannes next week for the start of MipTV, their sales catalogue won’t be the only thing occupying their time.

For the first time, DRG is moving into developing original content, specifically drama, in a move that it hopes will create new opportunities to sell longform series to buyers who demand more bang for their buck.

“There are fewer commissions and, particularly in the UK, much shorter runs get ordered, like 3x60’ or 4x60’, which don’t sell internationally or are difficult sells,” says Anke Stoll, head of acquisitions, coproductions and development at DRG.

She also explains that series from the US are an expensive proposition for distributors, while the lack of second-season orders for some of DRG’s Australian shows, such as Canal Road (13x60′), contributed also led to its decision to join series on the ground floor, rather than step in when a show is already in the can.

That’s not to say DRG hasn’t had notable success with its scripted portfolio. The sales outfit found multiple homes for titles from the UK and Australia, in particular comedy drama Doc Martin, crime series Underbelly, Shameless and both the UK and US versions of The Inbetweeners. Doc Martin alone has been sold into more than 200 countries.

“We’re doing this mainly to have more titles for the international market,” says Stoll. “We’re trying to find titles that are truly international and we’re looking for partners around the world who can produce, showrun, write and commission them.

“We are not going into production; we don’t own a production company. We will just facilitate new development and bring the best partners together. There are some treatments and scripts we’ve paid for. Some have writers attached, some have producers and commissioners. But we have to package it and bring the finance together.”

Though its move into development is just several months old, DRG has already built up an extensive slate of forthcoming projects.

First up are three series commissioned by Italian broadcaster Rai. The first is Pirates of the East (6x90’), an adaptation of the book by Emilo Salgari set in 1840s Malaysia at the height of the British Empire.

Doc Martin

Italian production company PayPerMoon is also onboard the swashbuckling adventure, which has been conceived as a long-running series beyond its initial six-episode order. A German partner is also being sought.

PayPerMoon is also working on a retelling of the story of Helen of Troy (3x120’), while So You Think You Can Dance creator Nigel Lythgoe will coproduce Nureyev, a biographical miniseries about Russian ballet dancer Rudolph Nureyev.

Scottish broadcaster STV has commissioned Wallace, to be produced by STV Productions, in association with DRG, Los Angeles-based Creative Media and Nine/8 Entertainment. The drama is set to echo period series such as Game of Thrones and Spartacus as it charts medieval hero William Wallace’s life, from childhood to his attempt to unify Scotland.

Other DRG projects include Saigon, based on the book by Anthony Grey, with Australian producer Greg Coote; and Pitcairn: Paradise Lost, a telemovie based on the true story of the 2004 child abuse scandal, with Quail TV for TV3 New Zealand and Foxtel in Australia.

Meanwhile, DRG has partnered with Future Films, a film production and financing company, on three additional projects. Together they have secured rights to Russian author Boris Akunin’s The Adventures of Erast Fandorin series, about the eponymous 19th century detective.

“It’s a mix of Sherlock Holmes and James Bond,” says Stoll. “We hope to have UK broadcasters interested and I pitched it to some German partners recently and they are really keen.”

The second project, another book deal, is for Jeffrey Archer’s Short Stories, with an aspiration to adapt them into docudramas with a US copro partner. The takes cover subjects including scams, cons and fraud.

Shameless

DRG is also working with Future Films and author Jeff Norton on Cortex, a futuristic procedural drama about a team of scientists and investigators who solve crimes by inserting themselves into the memories of witnesses, criminals and each other.

Each project will be filmed in English and is likely to begin production this year for delivery in 2013.

“We had to do something because drama buyers from around the world come to us expecting us to have big drama and there’s not much coming up,” says Stoll. “Linking with international partners, we feel we have a possibility here to make things happen.”

With DRG’s motives laid bare, its move into drama development is about finding a way to supply what international broadcasters are demanding.

“This is the right time,” adds Stoll. “Broadcasters have opened up their schedules to some foreign drama but because of money and budget issues, you still want to produce really good drama. But that’s expensive and this is the only way to do it.”