PRA: Kent Thoelke, Executive Vice President of Scientific and Medical Affairs

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Clinical trial accrual in the United States runs around 3 percent and often takes a “keep your fingers crossed” approach. Up to the point of beginning clinical trials, drug development follows detailed research and design processes steeped in scientific methodology.

One contract research organization (CRO) is working to change the landscape of clinical-trial design and accrual. PRA draws on data from numerous databases in the United States and around the world to create a more targeted approach.

“At PRA, we are at the forefront of leveraging data for decision-making in the clinical trial industry,” said Kent Thoelke, executive vice president of scientific and medical affairs. “We think an evidence-based approach to trial development is the best way to go.”

Using data to design clinical trials

When a protocol comes in from a sponsor company, PRA uses a team of specialists around the world to evaluate the feasibility of a clinical trial. Thoelke said PRA has resources in countries around the world consisting of regulatory specialists, physicians, PhDs, and others who help inform the company of the current standard of care, customary care, socioeconomic issues, taxation issues, import issues, and the regulatory landscape in that region. For example, the group looks at the practicality of following patients for 10 years in India or remote areas of China.

PRA also has a team of data specialists who compile claims data, payer data, Centers for Medicare and Medicaid data, and World Health Organization data to design clinical trials for optimum accrual and efficacy.

“We have been working to understand why patient recruitment in the United States is so poor,” Thoelke said. “Most estimates cite 3 to 6 percent of patients will participate. But projections say that if we could raise accrual to even 10 percent, we could decrease clinical trial time from three to five years down to one to two years, which could save millions of dollars in the drug-development process.”

An expanding operation

PRA is a mid-size CRO operating in more than 40 countries and conducting trials in up to 80 countries across all phases of pharmaceutical, biotech, and biosimilar drug development. The company provides services through all phases of clinical development. Therapeutic areas of focus include cardiometabolic disease, neuroscience and central nervous system, oncology and hematology, rare disease, respiratory/allergy, scientific affairs, and infectious diseases.

PRA conducts Phase I–IIa studies via its U.S. and European clinics with support from its two bioanalytical laboratories nearby. Always forward-thinking, PRA offers a Fast Track development program for these early-phase studies that can reach proof of concept six to 12 months faster than traditional models.

PRA also executes complex, global Phase II-III studies across a variety of indications and its Late Phase Services group specializes in Phase IIIb, IV, and registry studies.

The company is also expanding operations in emerging markets, including Asia, Latin America, and India, recently having opened a second office in China to facilitate the growing demand for studies in the Asia Pacific region.

Growing within a highly competitive industry is difficult, but Thoelke said PRA has seen significant growth within the past few years. Its size still allows the company to offer clients a more personal relationship.

Educating and integrating patients

In addition to giving clients personal attention, Thoelke said a key part of PRA’s business is patient access and recruitment.

“We encourage everyone to educate patients about participation and really integrate them into the process, rather than using them as a plug-and-play model,” he said. “At the end of everything we do, every protocol, there’s a person on the other side of that report. It’s easy to get caught up in charts and data and forget that we’re actually saving patients’ lives.”

As part of the clinical-trial process, Clinical Research Associates (CRAs) perform most of the monitoring of hospital and investigator data to reflect safety, efficacy, and drug use.

“We remind [the CRAs] that these are people with life-threatening diseases, and we are asking them to participate in a trial, to do extra work they would not otherwise have to do,” Thoelke said. “We need to make the experience as positive as possible and become a partner with them.”

Overall, PRA’s goal is to reform the clinical-trial development landscape — using all the data available to develop an evidence-based approach to trial design and patient accrual and to enhance the patient experience.

“We can no longer sustain the model that costs millions or even a billion dollars, requires thousands of sites and lasts five years,” Thoelke said. “With the technology available we can do what we’ve always done, but more efficiently and quickly, producing the same high-quality results. But it takes time to become comfortable using that methodology.”

-by Patricia Chaney

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