The World on Trial

By Matt Buttell, Deputy Editor

Johnson & Johnson's Janet Flisak talks to NGP's Matt Buttell about completing clinical trials on an international landscape, discussing the difficulties associated with patient recruitment.

“I think a lot of companies are facing these issues and it's a general industry-wide issue. If anybody has some magic cure, I'd sure be happy to hear about it”
-Janet Flisak, Johnson & Johnson

Johnson & Johnson (J&J) are no strangers to the challenges of the pharmaceutical industry. They are also no strangers to the pages of this magazine. Having been founded more than 120 years ago, they are today dedicated to advancing the health and wellbeing of people around the world, and have presence in approximately 50 different countries worldwide.

Like many of today's global industries - manufacturing, retail, financial - pharmaceuticals has found that it too is not wholly immune to the affects of the economic crisis and has had to learn to operate in an ever-changing and faster-paced environment.

Along with this comes an inevitable degree of change, and one area of the industry that has seen great change in recent years is its clinical trials. Today these have become increasingly global operations, which means they are becoming both more and more complex and that patient groups are getting larger: all this brings a series of challenges to those involved in this process, and for J&J's Janet Flisak, this is no exception. 

"What we're doing with J&J is that we have an organizational model where we're tapping into our resources at a local level in different companies," she explains when we speak with her in Pennsylvania. "One of our missions is to look to Eastern countries and we have more trials starting up in Eastern Europe and in Asia Pacific where we are using our experts in those local areas."

While Flisak does acknowledge that there are some issues related to the GCP in those countries, and that the general standard of care may not always be the same as what we have come to expect from the Western world, she highlights how J&J are currently in the process of trying to standardize their trials and support sites to maintain a unified standard. In addition to this she points out several advantages in looking to Eastern countries for trials: "Firstly it costs less," she says, " and that's because those countries who have not been at the forefront of clinical trials are considerably more motivated and enthusiastic in trying to prove that they can do just as well as traditionally chosen Western countries." She also says that the Eastern countries often offer more patients, are more cost effective and provide more quality data.

This is very important as, in essence, a clinical trial is strictly all about data: conducted to allow for safety and efficacy information to be accumulated for new drugs or devices. Subsequently, both of these factors are very prominent within J&J's efforts. "For the safety component we have a global safety unit located in Germany and everything we do floats through that unit.

"As far as reporting safety events go, that is all centralized," she continues. "I guess that is easy because it enables us to report things easily and makes it attainable for reporting that information to the different health authorities and, also, it makes it easier having one central point of contact for all of sites."

Flisak goes on to say that though there are different processes internally, that every compound holds quarterly safety meetings: "I think that's a policy of J&J to do that," she qualifies. "We look at the ADR's across compounds and although we start developing the safety profile as well as the efficacy, it is ultimately the safety that is the primary concern."

The challenge of design

Another thing that J&J are trying to do is adaptive design so they can shorten the time for trials to get to registration, and this remains something of a hot topic within the industry in general. Elsewhere for J&J, notably in terms of recruiting patients for clinical trials, Flisak points out several difficulties that are raised when conducing trials on the global stage. "Recruitment is different in the different countries," she says first of all. "In the US and Western Europe, it's really a case of getting the KOL's on board as promoters of the compound and understanding the mechanism of action and then publishing it as quickly as possible.

"But what we have found is that if we move East, like I suggested earlier, that there's better performance and we get more patients from Eastern sites. They're eager to prove that they can do as well as the West and you find that it's not as difficult to recruit patients for trial out there.

"What's really important is having the data on the compound, and then presenting that data so that these sites can be comfortable with the investigational product and comfortable in using it with their patients."

A lot of what Johnson & Johnson are investigating at the moment is related to the generalized standard of care for patients and how, though with the Western formularies there's a lot of process and regulations surrounding clinical trials, there's not the same for the patients in Eastern countries. "The recruitment techniques are basically the same," suggests Flisak, "but today the patient populations have been saturated. It's difficult to get naive patients in some therapeutic areas, and that's something that needs to be addressed."

Sadly, Flisak isn't wrong. She illustrates her point by telling us about an instance in the US where J&J were looking for patients for a prostate cancer trail. According the Flisak, the trial went to 230 different sites but only ended up with five patients. "Obviously it took an enormous amount of effort to evaluate all of those sites and to go up to them with questionnaires, to go through the necessary protocol and talk to them individually about the trial." Yet despite all this, return on the trial was still minimal. As a result, Flisak suggests that one of the biggest challenges facing the industry right now lies in getting to place where there's a better return on effort.

"I think this is something that a lot of companies are facing right now," she concludes. "I'd like to hear what other companies are saying and what they're looking at. I think a lot of companies are facing these issues and it's a general industry-wide issue. If anybody has some magic cure, I'd sure be happy to hear about it."

Johnson & Johnson: a quick history

1886 Founders Robert Wood Johnson, James Wood Johnson and Edward Mead Johnson started a small medical products company in New Jersey.
1926 - 1946: J&J expanded into Mexico, South Africa, Australia, France, Belgium, Ireland, Switzerland, Argentina, and Brazil.
1946 - 1966: Expansion continued in Zimbabwe, Austria, Sweden, the Philippines, Colombia, Puerto Rico, the Netherlands, India, Scotland, Pakistan, Zambia, Venezuela, Italy, Malaysia and Portugal.
1966 - 1986: J&J's operating companies pioneered several important medical advances and in 1985 expansion continued to China.
1986 - 2009: Continued growth through acquisitions and internally developed businesses that have given the firm leadership positions in a number of areas.

Janet Flisak is Clinical Program Leader, Oncology at Johnson and Johnson, within the Global Clinical Operations (GCO) group. She has over 14 years experience in the clinical development field. She has an international team made up of experienced global trial managers who oversee the day-to-day activities of trial execution, reporting directly to her.