Clinical Trials: A Winning Step Toward Medical Breakthroughs

By Habib N’Konou, Senior Director of Operations for Clinical Trials, UPS

Let’s take a step back in time. First stop is 1955, when Dr. Jonas Salk announced a major medical breakthrough — the fight against polio was won.

Now, let’s take a step further back. Physician James Lind in the mid-1700s conducted the first controlled clinical trial of the modern era. Essentially, his work found that the digestion of oranges and lemons were highly effective in combatting scurvy, a disease caused by Vitamin C deficiency.

In those two landmark discoveries, research pushed what was possible.

Throughout history, there have been nasty outbreaks and afflictions that created medical nightmares, threatened quality of lives, and even decimated populations.

You need only step back to the14th century and recall the devastating effects of the plague on Europe (this “Black Death” is reported to have killed off as much as 60 percent of the population) to recognize that understanding, controlling, treating and preventing diseases, viruses, epidemics, pandemics and superbugs must remain priority No. 1 for clinical investigators globally.

There is a direct correlation between innovations in modern medicine and clinical trials. Researchers and their sponsors continue to push what is possible with new forms of life-saving therapies enabled through cutting-edge science and good, old-fashioned trial and error.

Yet drug and vaccine research comes at a hefty price. While clinical trials in the 1970s averaged $179 million for a single drug, today a study can cost close to $3 billion, according to Pharmaceutical Research Manufacturers of America (PHRMA). For the few breakthroughs that make it onto the market, or even experimental therapies not yet approved for wide distribution, the important work of pharmaceutical and biopharma research taking place behind the scenes continues to pave the way for countless medical miracles that are turning former death sentences into manageable patient care.

• Experimental cancer therapies: At age 58, Nancy Justice had only months to live after being diagnosed with recurrent brain cancer. When traditional treatment failed to stop the cancer, her only hope was a breakthrough clinical trial being conducted at Duke University using the same polio virus that researchers desperately tried to wipe out in the 1950s.

Orphan drugs, novel medicines as well as experimental therapies still in trials are becoming bolder, more personalized and moving closer to the rule rather than the exception. Oncology has a crowded field of drug research, so pharmaceutical companies are working more collaboratively with federal agencies than ever before to expedite breakthroughs in immunotherapies, chemotherapy, genomic testing and more.

• HIV/AIDS drugs: New, sophisticated anti-retroviral drugs are enabling HIV patients to live longer and enjoy a better quality of life than 25 years ago. Ongoing R&D is showing outstanding promise of drugs that more effectively suppress viral loads, and providing immense data to understand the virus’s tricky and evasive behaviors.

New innovations in HIV vaccine trials involve gene modification intended to “restructure” test subjects’ cells and make them resistant to HIV infection. Also, a gene therapy being researched involves preventing the virus from getting through cell membranes.

You need only look to breakthrough drugs like PrEP (pre-exposure prophylactic), which has been shown to effectively prevent HIV infection, and a new vaccine now being tested in South Africa to see that clinical investigators are on the cusp of something extraordinary in the fight to end the HIV pandemic.

• Diabetes treatment: According to the American Diabetes Association, one in three adults in the U.S. will develop diabetes by 2050 if current trends continue. In Europe, the prevalence of diabetes is steadily increasing among all ages. Clinical investigators are rigorously engaged in research to develop new drugs and monitoring devices, with the hope of eventually finding a cure.

One of many areas of research involve diabetic retinopathy, a leading cause of blindness among diabetics. High blood glucose causes retinopathy, which leads to abnormal tiny blood vessels developing in the eye. Researchers are demonstrating that intensive glycemic control reduces the development and progression of diabetic retinopathy.

These and a great number of other biopharmaceutical studies taking place globally are critical links to improved public health, advanced medicines, and better patient outcomes.

Think about it, without clinical trials there likely would be no (or much less effective) over-the-counter pills to fight back pain, or antibiotics to kill bacterial infections. Forget about biologics to treat rheumatoid arthritis, or antimalarial drugs to help prevent the mosquito-borne disease.

Forget about progress being made in the fight against the Ebola and Zika viruses. Modern medicines improve quality of lives. Clinical trials improve the quality of modern medicines.

It’s worth noting that clinical studies in all their stages are not without their risks, challenges and dizzying complexities. The majority yield little promise (though learning what doesn’t work often is just as important as learning what does), regulatory oversight is intense, and costs exorbitant. Critics decry limited patient access once some high-price medicines and therapies are approved and enter the market.

But the benefits far outweigh the challenges. Ethical and safe clinical trials have a clear place in the world for the well-being and safety, even survival, of the world’s populations.

Sure, the human body has extraordinary natural defenses, but it can only do so much.

That’s when smart biomedical science has to show its strength again and again, and third party logistics providers (3PLs) with a global footprint are doing their part supporting the healthcare and life science industry with enhanced clinical trial logistics capabilities. Partnering with 3PLs that leverage their assets and expertise to connect critical specimens and patients enrolled in trial programs with innovative laboratories around the world will enable researchers to focus on the science and technology behind these life-saving applications.

We understand that in order for medical breakthroughs to happen, smart logistics has to show its strength again and again too.