One Center’s Oversized Impact on Drug Development and…

by

Mary-Russell Roberson

August 25, 2026

When pharmaceutical companies want to make their clinical trials faster and more efficient, they look at data compiled by the Tufts Center for the Study of Drug Development (CSDD). When the U.S. Food and Drug Administration (FDA) wants to know how the regulatory process affects drug development and approval times, they do the same. The U.S. Congress invites members of CSDD to testify. Clinical researchers consult publications from CSDD when designing and executing clinical trials. And when a layperson reads an article in the press about how much it costs to bring a new drug to market, it is CSDD that most likely provided the figure.

Since it was founded in 1976, CSDD has conducted scholarly analyses and published thousands of research articles that have helped pharmaceutical companies, regulatory agencies, and other research professionals in their ongoing efforts to improve the drug development process.

“We do large-scale empirical studies that we share as widely as possible with the drug development community,” said Kenneth Getz, research professor in the Public Health and Community Medicine Department at Tufts University School of Medicine and executive director of the center. “Our work helps the scientific and clinical research communities develop new treatments that address unmet and underserved medical needs faster and more efficiently.”

“The center has been a very reliable source of information about the trends in clinical research and how things are evolving,” said Robert Califf, a cardiologist at the Duke University School of Medicine who twice served as the commissioner of the FDA. “The information they produced was enormously helpful as the FDA thought about policy.”

Early Impacts

CSDD’s first impactful study, in the 1970s, documented that drugs were being approved in other major markets 3-7 years before the United States. At that time, for example, no beta blockers were available in the U.S. despite their widespread use in the United Kingdom for hypertension and other cardiovascular applications.

A photo of Ken Kaitin from the CSDD seated at a table with three other people

“The FDA was seen as conservative and risk averse, and that study showed that U.S. citizens were paying a price: Important and sometimes life-saving therapeutic drugs were not reaching the market in a timely manner,” said Kenneth Kaitin, a professor at the School of Medicine who joined CSDD in 1986 and was director from 1997-2020. Kaitin said that “drug lag” study added fuel to the demands for regulatory reform of the FDA and led to congressional hearings.

When the FDA announced in the early 1990s that the drug lag had finally disappeared, the agency cited data from CSDD. According to Kaitin, that highlighted the philosophy of the center’s founder Louis Lasagna, that scholarly research and analyses can and should play an important role in informing public debate on drug development and policy.

Louis Lasagna, a renowned physician and pioneer in the field of clinical pharmacology, founded CSDD in 1976 at the University of Rochester with the goal of documenting information relating to the development and regulation of new medicines “to raise the intellectual level of debate on questions of public policy.” Lasagna brought the center with him when he joined Tufts University as the first dean of the Graduate School of Biomedical Sciences in 1984.

Another impactful study came in 1979, when the center showed that the cost to bring a drug to market was $54 million. Since then, the center has periodically updated this study, with the next report due out in the fall of 2026.

In 1983, the center showed that, due to lack of commercial incentives, the pharmaceutical industry tended to focus on the development of drugs for broad indications, leaving patients with rare diseases few options and little hope. That led to the passage of the Orphan Drug Act, which provides regulatory and commercial incentives for companies to develop drugs for rare diseases.

Physician Louis Lasagna, founder of the Center for the Study of Drug Development.

The center also began a longitudinal study analyzing the success rate of drugs in clinical trials. Then, as now, the overwhelming majority of drugs and biologics fail to gain regulatory approval. “We’ve done a great deal of research helping to explain why drugs and biologics fail overall and by individual phases,” Getz said. “Many failed to demonstrate efficacy or had a poor safety profile. Others failed to enroll enough of the right patients or raised questions about clinical trial design and execution.”

“Our work helps the scientific and clinical research communities develop new treatments that address unmet and underserved medical needs faster and more efficiently.”

Kenneth Getz, research professor at Tufts University School of Medicine and executive director of CSDD

Digging Deeper

Since its founding, the center focused on documenting what Getz calls macro-level issues, such as development costs and timelines. About 20 years ago, the center added a series of studies to get a clearer picture of underlying factors behind some of those big trends. “Protocol design and execution is one of the largest, if not the largest, drivers of rising costs and increasing levels of inefficiencies and longer timelines,” Getz said.

Every five years, Getz leads a study to analyze clinical trial protocols, which includes, among other things, quantifying the type and number of endpoints, procedures supporting them, and the number of data points generated. He has found that protocols are becoming ever more scientifically and operationally complex with highly customized designs requiring more elaborate and demanding logistics to administer.

“Complexity is running away from us,” he said. “In 2012, [the average protocol collected] under a million data points and today it’s more than 6 million as pharmaceutical and biotechnology companies focus on more challenging diseases, target more narrowly defined patient communities, and execute more global and more expansive clinical trial activity.”

Kenneth Getz in a suit speaking at a podium at a conference

While each clinical trial protocol is unique, Getz said it’s possible to identify common areas for improvement. “We devised a methodology to characterize certain design decisions,” he said, “and found there are a lot of areas that could be simplified.” One such area is the proliferation of patient procedures that don’t directly inform the primary endpoint the trial is measuring.

Including too many procedures not only takes more time and money, it can also deter potential participants. Indeed, the center is finding that recruitment and retention are increasing challenges.

Mary Jo Lamberti, research associate professor at the School of Medicine and director of sponsored research at CSDD, hopes her work might help change that. “The more patients who can participate in trials, the more chances we have of getting treatments for some of the more difficult-to-treat diseases like Alzheimer’s disease or certain forms of cancer or rare diseases,” she said. “That’s how I became interested in this work. We identify areas of inefficiency and gather valuable benchmark data and generate insights.”

Lamberti gathers and publishes data related to recruitment and retention trends. She is seeing companies broaden their reach to include more sites and screen more potential study participants for a trial.

She also collects data on new tactics companies are using to reach and recruit patients, such as using artificial intelligence to seek potential participants through electronic health records and using chatbots to engage with participants.

The Center for the Study of Drug Development (CSDD) team portrait

Reducing Complexity and Burden

Zak Smith, assistant director of data science and analytics at CSDD, evaluates strategies intended to streamline complex protocols, such as decentralized clinical trials (DCT). DCT refers to a collection of techniques and technologies to reduce visits to the research site, including telehealth visits, wearable data-collecting devices, mobile clinics, and allowing participants to complete procedures close to home.

“One of the things we’ve seen that can have the biggest impact on trial performance is to allow patients to get procedures or lab tests done with their primary care physician or at a local lab rather than visiting the clinical trial site,” he said. “That’s one of the easier and more straightforward ways to ease the burden on the participant’s side.”

He has also looked to see whether DCT strategies improve proportional representation in trials – that is, making sure the demographics of participants matches that of the intended population. “We saw that some DCT solutions may help improve diversity and others are associated with less,” he said. “Allowing the use of local labs was associated with increased diversity within the clinical trials.”

Smith has also developed a way to quantify how burdensome it is to participate in clinical trials. He analyzed thousands of patient surveys about the perceived burden of procedures and other common requirements of clinical trials. He uses the results to assess draft protocols that companies submit.

“We break it down into individual procedures, calculate a burden score and say, ‘Your burden is higher or lower than our benchmark,’” he said. “It always sparks some great conversations between the companies and us.”

“The more patients who can participate in trials, the more chances we have of getting treatments for some of the more difficult-to-treat diseases like Alzheimer’s disease or certain forms of cancer or rare diseases.”

Mary Jo Lamberti, research associate professor and director of sponsored research at CSDD

Supporting Change

Moving forward, Getz wants the center to focus even more on data that could help organizations manage change in this era when everything seems to be moving at lightning speed, most notably AI.

To that end, he brought on Jennifer Kim, research associate professor at the School of Medicine, who is the first member of CSDD with a Ph.D. in behavioral science. “I came on board to look at drug development using a people-centered approach,” she said. “I’ve always been interested in understanding ways to tie the study of human behavior and organizational performance optimization, and in this case, we’re looking at optimizing drug development through human behavior.”

Kim is investigating the readiness of both organizations and individuals to respond to the changes that are happening in drug development. “We are looking at organizational changes, including how people are responding to AI being incorporated into their workflow, the resistance to that, and ways to address that resistance,” she said.

A black-and-white photograph of a group of people including CSDD founder Louis Lasagna

On the participant side, she’s studied how participants’ interactions with research staff influence their satisfaction with the experience and their willingness to complete the clinical trial and participate in future research. She found that those interactions carry a lot of weight. That’s significant, she said, because improving those interactions could be an easy-to-implement strategy to increase retention and even grow the population of future participants.

“We want patients of all backgrounds to have a good experience and to be able to go into their community and tell family and friends that participating in clinical trials is safe and can be life-enhancing,” she said.

While Kim’s work represents a new direction for the center, Getz said the longitudinal studies documenting cost, timelines, and success rates will continue. “Organizations follow these longitudinal studies to monitor how practices and use of solutions are impacting drug development performance,” he said. “There is no shortage of work to do there. At the same time, CSDD is moving into new domains. The drug development community started demanding more actionable and practical ways to react to insights we were offering, so we are evolving.”

No matter what the future brings, Getz remains committed to the mission. “I’m passionate about collecting hard data and evidence to inform insights,” he said. “We have amazing people at CSDD who share that same passion, and we love to watch the impact our research has on drug development strategies, practices, and performance. It’s meaningful and consequential work.”