Mary Beth Stepanek
Founder and President
Accelerated Clinical Research

Speed and Feasibility, Two Key Aspects of Clinical Trials

Wed, 09/05/2018 - 14:36

In an industry looking for speed, sometimes it is better to bet on certainty, says Mary Beth Stepanek, Founder and President of Accelerated Clinical Research (ACR), a US consulting company that performs clinical trial monitoring, regulatory consulting, reimbursement and health outcomes services for Mexican and foreign companies.

“When a company wants to perform a clinical study the first thing they ask is, ‘How long will it take to begin the study?’ I answer: ‘Do you want to begin the study or do you want to finish it?’” In some clinical studies, patient recruitment and patient voluntary continuation until the end of the trial are critical issues for data acceptability. Regulatory authorities are reluctant to accept data if patients drop out before the conclusion of the follow-up period. If there is a high dropout rate, authorities could not be sure if patients did not return because of dissatisfaction or if the company decided not to disclose the data. “For example, the FDA does not accept clinical trial data if more than 20 percent of the volunteers dropped out of the study.”

Stepanek believes, however, that when talking about recruitment and retention, the odds are in Mexico’s favor because of its unique doctor-patient relationship. Mexican physicians have good relations with their patients, she says, so they return for the necessary follow-ups. Stepanek experienced this situation first-hand in 1998 while working with Intuitive Surgical, the manufacturer of the Da Vinci Surgical System. “Our analysis concluded that any other location in which we performed these trials would take between 18 and 27 months to complete enrollment.” However, the company completed its enrollment in just three months, which convinced Stepanek about the opportunities Mexico had for clinical research.

ACR works with medical device manufacturers that have their own Clinical Operations Department or outsource Clinical Operations services. ACR acts as sponsor legal representative and helps companies to comply with the requirements of the Mexican regulatory processes. The company also helps clients to select qualified medical physician researchers and investigational sites to submit paperwork to Institutional Review Boards (ethics, investigative, and biosecurity and committees as applicable) throughout Mexico and Latin America. “We are focused on clinical research and are prepared to provide clients with anything they need to safely and successfully complete their goals.”

Clinical studies, explains Stepanek, require well-trained researchers with significant experience in their field. “With an investigational medical device, the development starts with a prototype that is expected to be safe based on extensive pre-clinical testing. Then, the developer/sponsor initiates clinical studies to prove safety and improve the device along the way using the medical doctor’s/ researchers input on device features.” She adds that for medical devices some studies take six months, while others can take up to 10 years. Slower approval processes in Mexico have already hindered the clinical research industry. “Six years ago, COFEPRIS took only one month to approve a trial. Because of that, multiple sponsors wanted to perform studies in Mexico, creating an abundance of protocols to review. COFEPRIS could not catch up, so the council extended its timeline to 90 days. As a result, Mexico is receiving fewer device studies due to the lengthy time it takes to approve them.”

Stepanek sees significant potential in Mexico. “Latin America hosts around 8 percent of the world’s population and 3 percent of the world’s clinical trials. In Mexico, the proportion is similar. The US has 4 percent of the world’s population and 40 percent of the clinical trials, while Canada has 0.5 percent of the world’s population and 16 percent of the clinical trials.”

As Mexico continues growing its interest in clinical research as a means of delivering extra medical attention and resources to the population, Stepanek believes the country will attract more and more clinical trials. It must, however, address its slow approval times. “We are not the right place when you are in a hurry to get your study started. We are the right place if you want to acquire large volumes of quality, relevant data.”