Globalized Clinical Trial Solutions

The discussion here is that 'Is it positive to have more globalised clinical trial locations’?

Clinical trial locations are no longer restricted to a handful of key scientific bases in the UK, US and Europe. In the first of our occasional series, we look at how this movement has impacted global skills needs. 

The horrific incident at Northwick Park Hospital in 2006 that left clinical trial lists critically ill not only shocked the British public, it coincided with a shift change in the type of subjects happy to take part in certain kinds of drug trials and, more pertinently, where those trials are now held. 

Emerging markets in Japan, Korea, India, Mexico and various Eastern European countries have radically changed what clinical trials are happening where, with whom and why. 

Local regulations are increasingly stringent and the sheer cost of running a clinical trial in the UK, France or the US is making it harder to justify and secure funding. 

Moving East is one way of getting round this. Foreign clinical trials create job opportunities for researchers, scientists and medical personnel. They can also lead to new therapies being available. 

Some locations make better sense for particular drug tests because of the prevalence of certain conditions and illnesses in those regions. 

And, of course, there can be financial advantages for companies dealing with budget restrictions. According to one study, the cost of conducting biomedical research in China is only around 20% of the cost for similar trials in the West.                                             (Source:http://www.pharmafocusasia.com/clinical_trials/biotech_trials_asia.htm) 

Is this a good thing? We know there are real concerns about how different populations affected by poverty, prevalent diseases etc. may metabolise drugs differently. How does that affect the skills needed to apply these study results to medicines on sale elsewhere around the world? 

Then there are the regulatory hitches and differences in local legislations. So do you feel it is positive to have more globalised clinical trial locations? Are pharma companies exploiting a less aware set of subjects and are the results always transferrable and reliable?

Importance of Regulatory Science

When someone uses the word “science,” we might think of chemistry, biology, or physics, to name just a few fields.

We probably wouldn’t think “regulatory science.”

But it’s a field that has a big impact on the daily life of the average consumer. The breadth and scope of FDA’s regulatory oversight is extraordinary, touching the lives of every individual, through the food we eat, the medicines we take, and the medical devices we use.

That oversight is based on the sound science, called regulatory science, that is the foundation of FDA’s day-to-day decisions. Scientists throughout the agency research the development of new ways to evaluate FDA-regulated products.

As new discoveries yield increasingly complex products, the agency must be able to make science-based decisions that result in sound regulatory policy.

And there’s a need for speed.

There’s a gap between research and discovery—which is ongoing and very vibrant—and the actual delivery of products to the market and to those who use them. So this is an area that we think is critical for making that link between discovery and the actual product on the market.

Focus Areas within Regulatory Science

In August 2011, FDA released its “Strategic Plan for Regulatory Science,” an initiative that identifies eight priority areas essential to the continued success of FDA’s public health and regulatory mission. The plan is wide-ranging, with its target areas including personalized medicine, food safety and medical countermeasures to protect against threats to U.S. health and security.

• Personalized medicine involves the development of treatments that are tailored to an individual patient or a group that shares certain genetic characteristics.
  
  
  Medical science is now capable of creating treatments that are guided by the patient’s unique genetic information, In June 2011, FDA approved a novel genetic test to determine if breast cancer patients are candidates for Herceptin drug treatment. 
  
  
  These treatments can be specifically tailored to provide individuals with maximum health benefits while posing the minimum of risks. We’re approaching an era when ‘one size fits all’ medications will no longer be the doctor’s only option.
   
• FDA’s long-range goal for food safety is to prevent food safety problems from happening in the first place. But the agency also needs the tools to contain problems if they do occur and to understand how they occur so they can be prevented in the future.
  
  
  Food safety can be affected at many points along the farm-to-table chain, and our goal is to establish preventive controls at each step to minimize hazards. But success requires the most advanced science and technology to know what preventive controls are needed, to detect problems when they happen and to minimize illnesses when outbreaks occur.
  
  
  The need for state-of-the-art know-how was shown in 2010, when an oil rig explosion dumped more than 200 million gallons of crude oil into the heavily fished waters of the Gulf of Mexico. When the crisis began, the chemical test to confirm that seafood was free from harmful oil residues took about a week to run—too long for the large number of samples that had to be analyzed.
  
  
  To solve this problem FDA scientists, working with state partners, developed a new testing procedure that could detect oil-based contaminants in seafood in just 24 hours. The time saved by using the new test enabled FDA and state authorities to safely reopen the Gulf for fishing weeks sooner than would have been possible using the existing test. This meant seafood harvesters could go back to work sooner and consumers could again safely enjoy seafood from the Gulf.
   
• Infectious diseases—including those that could occur from hostile attempts to harm Americans—can take many forms and present FDA with serious challenges. FDA’s Center for Biologics Evaluation and Research has been studying potential hazards that range from smallpox and influenza epidemics to anthrax attacks and radiation poisoning. 
  
  
  FDA is tackling these threats through research and collaboration focused on medical countermeasures. For example, the agency has worked with the Centers for Disease Control and Prevention and industry to help manufacturers develop tests to prevent transfusions of blood and transplantation of organs infected by the West Nile virus. FDA’s work was critical in facilitating rapid development and deployment of these tests. Other major objectives of FDA’s regulatory science research include:
  
  
  1. The development of technologies to accelerate the large-scale manufacture of new influenza vaccines.
  2. Creation and evaluation of rapid testing methods for the detection of infectious microorganisms in such biological products as blood and tissue.
  3. Finding new methods to improve the shelf-life and stability of products that have to be warehoused for use in an emergency.
  4. Formulating new ways, such as needle-free systems, for more rapid use and self-administration of drugs.

Other priority areas include improving the design of clinical trials and manufacturing processes.

Advances in these areas will bring more innovative medical products to the market to help people with chronic and life-threatening diseases. I think that’s where the consumer would really appreciate or feel the investments that are made in this area.

Tecfidera approved for Multiple Sclerosis

About Multiple Sclerosis:

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline in function and increased disability. MS patients often experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of MS between the ages of 20 and 40.

 

Treatment:

No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients, said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.

 

Tecfidera:

Results from two clinical trials showed that those taking Tecfidera had fewer MS relapses compared to people taking an inactive pill (placebo). One of the trials showed that those taking Tecfidera experienced a worsening of disability less often than patients taking a placebo.  

Tecfidera may decrease a person’s white blood cell count (lymphocytes). Lymphocytes help protect the body from infection and low counts can raise the risk of infection, although no significant increase in infections was seen in patients taking Tecfidera in clinical trials. Before starting treatment, and annually thereafter, the FDA recommends that the patient’s white blood cell count be assessed by their health care provider.

 

Flushing (warmth and redness) and stomach problems (nausea, vomiting, and diarrhea) were the most common adverse reactions reported by patients receiving Tecfidera in clinical trials, especially at the start of therapy. These side effects may decrease over time.

Manufacturer:

 

Tecfidera is made by Biogen Idec, Weston, Mass.

Reference:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345528.htm