RALEIGH, N.C. -- Triangle pharmaceutical manufacturers and hospitals have a lot at stake in the drug development business. But no more than the patients who stake their lives on the hundreds of clinical trials going on at any given time in our area. 

 

Clinical trials are the final step in the approval process for new medications that must meet Food and Drug Administration approval before being put on the market. For cancer patients like Rich Csarny, new drugs can mean renewed hope.

 

“I wanted more and I considered that my life was not finished. I was not going to give in to this, and I saw that there was hope in trials being offered and that there was success,” Csarny said. “I also saw that cancer was being treated more and more as if it was a chronic disease and not a death sentence.”

 

After surgery and almost two years of radiation and chemotherapy for pancreatic cancer, and with his own oncologist’s encouragement, Csarny enrolled in a clinical trial at Duke University Medical Center.   

 

Dr. Herb Hurwitz, co-director of the Gastrointestinal Oncology Program at Duke, cautions patients not to jump into a clinical trial without considering what it will involve, including the time commitment and possible side effects.

 

“Fundamentally, participating in a clinical trial is at its best an extension of the regular doctor-patient relationship,” Hurwitz said. “A clinical trial represents simply another option to offer the patient.”

 

For Csarny and his wife Janet, it was the best option. Standard treatments weren’t working for him and the drugs being tested weren’t available to his own doctor. Best of all, he was able to receive care close to home.

 

“There are people here, even in our support group, who come from miles around, even out of state, to get treatment here,” he said. “And for us, it’s within 30 minutes. It’s a blessing.”

 

Many patients do come to Duke from outside the Triangle, but Hurwitz says the education process is the same, even when time is of the essence.   

 

“It takes a long time to teach a patient and to be sure they understand what it means to have cancer, to get treatment and then to sort out which of these different options make a good fit for them,” he said. 

 

Rich’s wife, Janet, spent a career as a nurse. But she says being involved in clinical trials has been a learning experience for both of them. She admits it was scary at first, but the benefits of participating in the trial have made it worth the risk. 

 

“The trials have given us a new lease on life,” she said. “He has gotten two extra quality years out of his cancer journey which we never even dreamed of three years ago.”

 

New evidence of cancer growth forced Rich to drop out of the first trial in December, but he has already enrolled in a second at Duke. Just one more step in his journey.

 

If you’d like to know more about clinical trials in the Triangle, visit

 

 

 

 

For an illustration of the drug development process, visit Merck & Co.’s website at www.msd.com.hk/health_info/drug_education/e_ddp_introduction.html