Queen's University

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Wendy Parulekar

Asking Questions and Improving Outcomes: Making a Difference through Clinical Trials

[Wendy Parulekar]
Photo: Bernard Clark

When Wendy Parulekar was first starting out as a physician and researcher, she remembers feeling uneasy about admitting that there were things she didn’t know.

“It was an uncomfortable space for me when I first started my career,” she recalls. “But honesty and transparency are so important in our interactions with patients, that if we want to find cures, we have to articulate what we don’t know and what we want to improve.”

Indeed, Parulekar says it is those questions inspired by the unknown that are at the heart of the work she does as a Senior Investigator with the Canadian Cancer Trials Group (CCTG), a research group at Queen’s that brings together more than 2,000 Canadian and international investigators overseeing as many as 30 to 40 trials at any given time.

“Any clinical trial that is conducted represents efforts on the part of a lot of people,” she says. “That’s why we do our best to design what we think are the best clinical trials answering the most important questions.”

[CCTG logo]

For Parulekar, who first arrived at Queen’s in 1999, being a part of the CCTG team has allowed her to be part of an organization that has defined practice standards in many cancers, including breast, brain, colon, lung, and prostate. Her commitment to clinical trials is reflected in her status as a Fellow and Past President of the Society for Clinical Trials.

“My role is to be engaged, really, at the forefront of clinical research within Canada and internationally,” Parulekar explains, “whether we’re testing new therapies or new drugs, or evaluating established therapies in innovative ways.”

She also works as a clinician, meeting with breast cancer patients on a weekly basis at Kingston General Hospital, a practice that allows her to see firsthand where the gaps are in terms of knowledge and care – gaps that can, in turn, inform future clinical trials.

“The excellent care that every cancer centre promotes ‒ care that I think is the right of every Canadian to expect ‒ is based on the results of clinical trials,” she says. “The decisions and treatment recommendations we make are based on data – data we have accumulated with the assistance of patients who participated in studies.”

According to Parulekar, many clinical trials are designed to resemble standard medical practice, with a goal of minimizing additional inconvenience to patients. Participating in trials gives patients the ability to assist in the evaluation of new treatment strategies, while allowing them to be part of research that can make a real difference in tackling various cancers for current and future generations.

One such trial, looking at the impact of extending hormone therapy in post-menopausal women with a common type of early breast cancer, was included on the Canadian Cancer Society’s list of the top 10 research impact stories for 2016. The MA.17R trial, which was led by the CCTG in collaboration with the National Clinical Trials Network in the United States, examined what would happen if the length of time women were treated with an aromatase inhibitor was extended from five years to ten.

“We know that women who have this kind of breast cancer are at risk of the cancer coming back, even years after the surgery to remove the tumour,” says Parulekar. “That’s an example of an unmet need. We needed to help these patients further.”

The trial enlisted the participation of almost 1,900 women across North America between October 2004 and May 2009. Half of the participants were given a drug, while the other half received a matched placebo. The results, which were available nearly six and a half years later, confirmed a 34 per cent reduction in the risk of the cancer coming back for those who took the hormone for an additional five years.

“We did this trial because the data told us that this would be an important question to study,” she says, explaining the trial also allowed researchers to collect information on significant side effects associated with hormone therapy, like hot flushes, vaginal dryness and bone thinning.

“The drug is currently available. It’s cheap, and it’s available in many countries. So these are the types of results that can have an immediate impact on patients lives,” she says of the results that will enable post-menopausal women and their doctors to make more informed decisions about breast cancer treatment.

Clinical trials should be viewed as part of our commitment to each other, and our commitment to improving the health of our nations.

Parulekar looks forward to a day when clinical trials aren’t viewed as a luxury, but as part of a robust and forward-looking medical system.

“Most, if not all, of the recommendations I make to patients are based on data that were generated thanks to the generosity and hard work of researchers and patients through clinical trials,” she says. “It’s not just a theoretical discussion. Clinical trials should be viewed as part of our commitment to each other, and our commitment to improving the health of our nations.”

Parulekar is deeply grateful to be a member of the CCTG team.

“I would not have had the kind of impact I do now if I were working as an individual physician,” she says. “Ideally, advances in disease outcomes have no geographical boundaries.”

Meredith Dault
(e)AFFECT Issue 11 Spring/Summer 2017