Category Archives: drug company

Risk-based clinical trial monitoring

Increasing efficiency in clinical trials

While it sounds intimidating, risk based management is simply applying common sense in a systematic way.  Defining, evaluating, and managing risk is easily accomplished by using a documented approach to evaluate the risks.  Which needs closer monitoring:  a simple clinical trial in the United States at a reputable site previously used with much success or a complex trial in Zimbabwe at a location never utilized before?

Obviously, the trial with the greater unknowns is higher risk.

risk management for the FDA clinical trial

Evaluating risk to monitor clinical trials

Recently, the FDA came out with guidelines on risk-based management for clinical trials.  “The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.”

What this means is merely commonsense in monitoring of clinical trials based on which ones have a higher risk of problems. 

 Another factor to consider beyond experience with a site and the complexity of the trial are the patient outcomes.  Will your trial involve life and death situations? 

Quantifying this can be done using a matrix of categories such as geographical location of the study, Good Clinical Practice compliance (GCP), and the relationship of the sponsor with the investigator.

 Understanding these concepts is crucial to increase efficiency and decrease costs of clinical trials.  As with any change in a regulatory environment, the industry is grappling with how to implement it. Pilot programs explore the implementation and thousands are waiting anxiously for “the answer”. The challenge is that the answer—as with everything within clinical research—is that it depends.

 Laurie Halloran’s presentation on this and other topics in clinical trials made them easy to grasp.  She presented at the San Diego Clinical Research Network meeting last week Tuesday at the Sheppard Mullin law firm.

DeeAnn Visk, Ph.D., is a freelance science writer, editor, and blogger. Her passions include cell culture, molecular biology, genetics, and microscopy. DeeAnn lives in the San Diego, California area with her husband, two kids, and two spoiled hens. You are welcome to contact her at deeann.v@cox.net

Drug Companies Embroiled in Chinese Bribery Scandal

Glaxo-Smith-Kline and Novartis among those accused of bribery

The Chinese government is cracking down on large pharmaceutical companies accused of bribing Chinese doctors.  Unfortunately, doing business in China routinely involves bribery.  With doctors in metropolitan areas making only a few hundred dollars a month, the fact that they accept bribes is understandable.

On September 18, reports surfaced of monies being channeled from a fake clinical trial to bribes in the Alcon division of Novartis.  Allegedly, Alcon out sourced the trial to a third party who then paid doctors with “research payments”.  In addition to this misappropriation of funds, more cash earmarked for patient experience surveys was instead used to bribe doctors at more than 200 hospitals.

Alcon denies the allegations, stating that a 2012 internal audit found no wrong doings.

Besides Alcon, several other firms are accused of corruption in China.  A story on GlaxoSmithKline  broke in July according to the 21st Century Business Herald.  In August, a former Novartis employee claimed that she was encouraged to offer kickbacks to doctors who used the cancer drug Sandostatin LAR.

bribery common in China

Bribery is common in China, especially for underpaid doctors.

Another method of passing along the bribes was through the overbilling, or fictitious billing, for travel and conference services. Not just doctors, but hospital and government officials were also implicated.

Guilt by association:  other large pharma companies like Sanofi, Roche, and Novartis have also used Shanehai Linjiang, one of the travel agencies accused of being an intermediary.  Chinese authorizes have also visited Eli Lilly and Bayer.

Hence sales of pharmaceuticals in China have rapidly tapered off.  Companies under investigation in China dare not promote their products.  Other drug companies are also affected since Chinese doctors refuse to even meet with them.  Elsewhere, reports state that Glaxo is considering removing itself completely from the Chinese market; four Glaxo executives have been detained and its financial director banned from traveling.  While Glaxo has lowered drug prices to compensate for the alleged bribes, it is still facing an estimated decrease in Chinese profits of 30%.

Why crack down now on bribery?

Chinese regulators have been flexing their muscles beyond the drug industry.  Earlier this year they made tough conditions for a mining conglomerate to take over a national company.  Companies making liquid crystal display panels (LCD), including Samsung were hit by $57M in fines for price fixing.  Nestle and Apple are two more large names that have recently tangled with the Chinese government’s crackdown on corruption.

Secondly, there is a new focus on domestic consumption in China.  Consumers in country are more important than ever.   If one country needs more consumer protection, China is certainly it after a baby formula adulteration killed several infants.

To bring cost-effective healthcare to over a billion people, China needs to encourage the use of non-branded generic drugs.  China is a huge market, behind only the US and Japan on the total spent on medication.  Thus, large pharmaceutical companies need to learn how to adapt and grow in a different cultural environment.

DeeAnn Visk, Ph.D., is a freelance science writer, editor, and blogger. Her passions include cell culture, molecular biology, genetics, and microscopy. DeeAnn lives in the San Diego, California area with her husband, two kids, and two spoiled hens. You are welcome to contact her at deeann.v@cox.net