Applied Clinical Trials
Interviews with Editorial Advisory Board Members Maarten Beekman, MD, Vice President, Medical & Regulatory Affairs; Stewart Geary, MD, Vice President & Global Safety Office, Eisai; as well as Applied Clinical Trials columnist Ken Getz, Chairman of CISCRP and Senior Research Fellow for the Tufts Center for Drug Development were used in our video [link to anniversary page] celebrating our 20th anniversary this month.
Stewart, Maarten and Ken offered many more insights on the changing drug development industry, as well as coming trends that we could offer on video.
Here is just a sample of what these experts had to share:
What has not changed in the past 20 years…is the amount of documentation that is still needed—logical because we are talking about the development of drugs–but the time to get a new drug into the market has not really improved and is actually contrary to the new technologies you would expect that to improve a lot. But at the same time, the demands that have been set by regulatory agencies due to the safety issues it has seen, the demands have increased so much that it has become more expensive and takes longer to get new drugs on the market.”
Differences working in drug development in the United States and in Europe ….The US is one country, Europe is 27 countries. The big difference is it is so much more diverse in Europe, which is important. Multi-country CRO projects need to understand the culture of the other country to avoid misunderstandings and miscommunications. One positive aspect in the United States is that there are many commercial research sites where you can really predict your recruitment of patients because they deliver. In Europe, that does not exist, so their research is still on top of the daily patient care.
Change in the past 20 years….There are more parties involved …CROs other contract providers, technologies to capture data and metrics on performance or on cost, and new approaches to managing clinical research. At same time, the industry has become more competitively intense and heavily regulated. And public perception of the clinical research enterprise has gotten worse, the public trust has declined.
What do you hope will occur in the next five years….What I would like to see in the next five years, downstream areas in clinical research that have been largely ignored.
Investigator site community move from being viewed and treated as a commodity service provider to more of a partner in the clinical research process. CROs and sponsors are starting to realize this and reconsidering their relationships with sites.
Patients and patient advocacy groups play a much more active role in the research process as well. Patients are really helping to shape the research agenda and actually funding research or becoming a primary funding source and participating in all aspects of the clinical research process.
What hasn’t changed in the industry? …..parts of the industry haven’t changed that we can feel proud of.
The pharma industry is excellent at the forefront of knowledge, in medicine and genomics, and has learned a lot of whole new information in the past 10, 15, 20 years, that we haven’t really assimilated that will have effects in personalized medicine. We work in a very innovative field and very demanding field but really for the benefits of patients that I think we can all take pride in.
Biggest trends in drug safety ….the biggest trend in drug safety is we see the expectations for what is a safe drug is changing every year. We put our drugs through more test and more specific tests to prove they are safe, but that has made it more difficult to bring these drugs to market than it used to.
This is have driven the use of earlier tests to mitigate the drug risks for certain populations that can then be used safely if the patients don’t have the right markers or don’t have the risk factors to use these drugs.