BY ADELLE LARMOUR
Date Published | April 20, 2007

From molecule to marketed product, Barbara Ward knows the satisfaction of seeing investigational medicine in clinical trials evolve into a potentially life-saving treatment.
As director of Sudbury-based Medicor Research Inc., Ward has overseen a myriad of clinical trials. She has even received acknowledgement in the publication of the DREAM study, which evaluated the impact of ramipril and rosiglitazone in reducing the onset of type-2 diabetes in people with impaired glucose tolerance and/or impaired fasting glucose.

“It was the first clinical trial ever done looking at the prevention of a disease using medication,” Ward said. “How exciting to be part of that!”

Originally, Ward pursued studies in business on the advice of her father, but her passion for medicine led her to nursing, where she began her career at MDS Laboratories in Sudbury.

“The lab job was such an asset because I learned so much about diagnostics.”
With five years experience, she moved on to a busy GP’s office as a primary care nurse manager in 1994. It was there that Ward launched Medicor when one of the doctors for whom she was working approached her about a research study. After 10 years of juggling her own business and daily nursing duties, she decided to focus her energy on developing Medicor on a full-time basis.

Ward’s timing couldn’t have been better. Shortly after leaving the doctors’ practice in 2005, a local research firm folded, creating a huge demand for her services. Business mushroomed.

“I had reached the five-year goal in my business plan in a matter of two months,” she said.

Ward currently has a staff of seven and recently moved to a larger office space. She is actively recruiting patients for 16 of the 20 to 30 studies performed annually. Some of the studies are national, but most are international, with the greatest number coming from the United States, followed by Europe, then Canada.

Medicor performs community-based industry-sponsored trials, hospital-based industry-sponsored trials and academic research.

The company is currently conducting its first research study with the Northern Ontario School of Medicine. It is a cohort study called Maternal-Infants Research on Environmental Chemicals, and led by scientists from Montreal’s Sainte Justine Hospital and the University of Montreal.

Trace metals
“We’re looking at how the environment is affecting the health of children,” Ward said.

“Their concerns are that if a mother is exposed to trace metals, how does that translate to the baby?”

Sponsored by Health Canada, it is a two-year study involving 2,000 patients across Canada living in highly industrialized communities. This translates to 200 patients at 10 sites. Sudbury was selected due to its large mining industry.

When conducting clinical trials, Medicor is primarily involved in phases two and three of the four-phase process. Currently, Ward works with about 27 physicians in Sudbury in most of the therapeutic areas, excluding cancer, HIV and psychiatry.
After phase one, which tests the effects of an investigational product on a healthy person, Medicor seeks out studies that will match protocols to physicians’ interests and patient population.

Medicor responds to a feasibility questionnaire and participates in a sponsor-directed interview. The pharmaceutical company reviews a written report based on the interview and decides whether the test site will meet the needs of the study.

Depending on what stage the study has reached, Medicor will recruit for either phase two testing of 100 to 200 people with a specific condition (and no co-morbidity conditions) for which the product was designed; or phase three, studying the pharmacokinetics of the drug on several thousand people anywhere in the world who have a specific disease and a co-morbid condition.

For the patients, all trials are voluntary and performed with signed consent. A strict protocol is followed when conducting clinical trials.

All studies must follow Good Clinical Practice (GCP) guidelines, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

“We use two different types of ethics boards: a local ethics committee in Sudbury at the Sudbury Regional Hospital…and a central ethics board, one of 12 ethics companies in Canada,” Ward said.

Additionally, the pharmaceutical companies send out clinical research associates (CRAs) to monitor the trials, ensuring protocol is followed for quality uniformity.

“Everything in research is designed for patient safety,” Ward said. “That comes first.”
Any adverse effects to clients are monitored and recorded throughout the course of the trial, whether related to the study or not.

“We have someone on call, live, 24 hours a day, seven days a week,” Ward said. “I want all patients to be able to talk to a person.”

Adverse effects
Serious adverse events requiring hospitalization are reported to the ethics committees and sponsor within 24 hours.

At the study’s completion, the patients are taken off the investigational product and return to their previous medication, or are referred back to their family doctor for treatment. All data is submitted, the ethics committees are notified, and the study is closed and archived for 25 years.

Phase four involves the marketing and licensing of the product, undertaken by the pharmaceutical company. The entire process from molecule to market can take up to 15 years.

Although all studies are spearheaded by a doctor, Medicor acts as the site management organization for the study. Essentially, Ward and her team manage the study, performing tasks to make it easier for the doctor.

“A lot of doctors who haven’t done research with me think it is very time consuming and burdensome, but it is not, because we take care of the non-medical and some medical (issues) and they take care of the medicine.”

Ward said the number one reason doctors do research is that it is interesting work, and the number one reason people participate is for the greater cause. Other benefits are free medication, and careful monitoring and diagnostics not normally received as a standard of care.

www.medicorresearch.com