Pharmaceutical industry has fat to trim — How will that impact CT sites?

Lean/Six Sigma may be next industry trend

In the future, clinical trial sites might have to prove their success in recruiting participants and meeting deadlines before they're offered new research contracts. At least that's what will happen if the latest trend in the pharmaceutical research business world takes hold.

Called Lean/Six Sigma, the process combines a Toyota production system with a Motorola technique designed to reduce manufacturing defects.

"After World War II, Edward Deming trained Toyota in new techniques or product development and manufacturing, which they perfected as they moved plants into the United States," explains Douglas E. May, MS, a solution partner in life sciences practices for BusinessEdge Solutions of East Brunswick, NJ.

"Two years ago, a book called 'Lean Thinking' [by James P. Womack and Daniel T. Jones] came out," May adds. "It was about how elements of lean manufacturing can be applied to any product development or manufacturing process."

Six Sigma refers to a process that tries to improve process quality, and combined, the Lean/Six Sigma model is a powerful technique for taking a look at the end-to-end clinical product development process, May says.

"It eliminates waste and puts in mechanisms for continuous improvement," he adds.

This model is ideal for pharmaceutical companies and the research process, especially as the industry's profitability has reached its apex and as sponsors increase their focus on outsourcing for clinical research, says David T. Asher, MBA, MBB, a pharmaceutical consultant with Asher Consultancy of Double Oak, TX.

Some of the largest pharmaceutical companies across the globe closed some facilities last year, Asher notes.

"They had workforce reductions, and this is a leading indicator that they're not as profitable as they once were," he says.

With the need to trim fat and become more efficient, many people in the clinical research industry are saying that the industry can't afford the same 40-50-year-old model anymore, Asher says.

Lean/Six Sigma is not about laying off workers, but it is about restructuring work to be more efficient, Asher explains.

"All pharmaceutical companies have open job postings," he says. "If we do a better job at what we're doing, then we can take people from within and repost them."

This requires rethinking the old business model and beginning major changes.

"A lot of time and money is spent in clinical trial work," Asher says. "We're trying to better manage our costs as a business."

The old model and business practices no longer work, Asher notes.

For example, clinical trial statistics show that 30 percent of clinical trial sites never enroll one participant. Yet, pharmaceutical sponsors return again and again to these non-producing sites out of habit and the belief that the physician investigators are thought leaders in their fields, Asher says.

"This is an enabling process," Asher says. "How do we select our clinical trial sites using good data, or is it a purely emotional process?"

The Lean/Six Sigma process requires sponsors to look at this objectively and decide whether the current method of site selection has more or less benefits than risks.

These are the questions both sponsors and sites will need to ask, Asher suggests:

  • How do you get patient materials to sites faster?
  • How do you collect information from sites faster?
  • How long will it take to schedule the first participant visit?
  • How is the organization performing on each of its core functions, including subject enrollment?
  • How can the organization sustain the delivery of its strategy?
  • How can the organization manage patients, document research, and close the site while delivering value to its clients?

There are societal pressures that make the current time for most research trials unacceptable, Asher notes.

The public wants safe and effective drugs as quickly as possible, and sponsors are finding that the current process is too expensive, as their investors express frustration over the length of time it takes to get a drug through the pipeline, Asher explains.

"We want to make these processes better," Asher says. "We can no longer take 10 years to get a drug to market."

For sponsors, the patent for a potential new drug is filed before clinical trials begin, which means that if the drug takes five to 10 years to make it to market, then the pharmaceutical company has lost that amount of time on its patent, Asher adds.

Also, the faster a drug makes it to market, the sooner patients can benefit from its use, he says.

"If we can get a drug to market three years earlier, you can imagine the impact that would have on patients — especially for cancer drugs," Asher says.

In the current clinical research model, the business processes create delays through oversight, inefficiencies, and breakdowns, he says.

"If we can fix these processes, then we wouldn't have to do the same thing over again," Asher says.

There typically are two types of waste in a process, May says.

The first type involves activities that add no value to the final outcome, and these can be eliminated by redesigning the process, May says.

"In other words, these are things we do for no good reason," May explains.

The second type of waste is one that adds activity but doesn't add value, he says.

"You have to do it because you're missing tools or other things," May says.

For example, in clinical research there are case report forms that need to be completed after patient visits. Often these forms are accumulated in a batch and then shipped back to the sponsor company for data entry and data cleaning, May says.

"The time spent accumulating the batch is a time where there's no value being added to the process, so the waiting time is a waste," May says.

The way to eliminate this waste would be to make the process electronic, perhaps through using a fax input system in which the case report forms could be continuously faxed and used at the receiver end, May says.

An even better solution would be to have an electronic data transfer in which the information from the patient chart is put directly into a tool where it is cleaned up by the tool and distributed in real time, May adds.

By switching to an electronic process, sites and sponsors would save time and money and have clean data to review on a continuous basis.

In the example of site selection, sponsors could improve the process by making the process entirely objective, using past data about sites' performance when making decisions about new sites to use.

Sponsors might object, saying they need to keep their thought leaders in the equation, but there are other ways to handle this, Asher says.

"Maybe we need to rethink where to apply the thought leader," Asher suggests. "Maybe the thought leaders shouldn't do clinical trials, but could serve as a consultant for how to structure the trial."

By finding a different way to use the thought leader, sponsors would change the cultural tradition and paradigms, but preserve their goals.

Another example of how the research industry can improve its process involves the handling of clinical supplies, May says.

"If you have a clinical supply chain that is not efficient then you could have patients visiting with now kit ready at the site," May says. "Or if you ship a lot of kits to a site, then you have inventory sitting there, and maybe nothing is being done with it."

A lean/Six Sigma intervention would have sites reduce the time spent in the distribution of the kits.

Other ways to improve the process might be to get investigators involved in the protocol process early on to make certain the protocol is suitable, May says.

"Sometimes the protocols have all kinds of exclusions/inclusions, and investigators say, 'I can't do this — you've made the criteria so stringent that I now have no patients in this population,'" May explains.

Sponsors could avoid this problem by setting up a secure Internet portal where investigators could review the proposed protocol and make comments. It would be done electronically and quickly, and would eliminate some problems during the start-up of a trial, May suggests.

"On average, the study start-up for a big trial takes about 26 weeks, and in the best cases, it may take 13 weeks," May says. "I know of one company where their average start-up took 39 weeks, so there's tremendous variability across the industry."

"Six Sigma says variability is your enemy," May says.

So when efficiency experts look at the clinical research industry and see tremendous variability, they know the process is messed up, May says.

For instance, clinical research organizations are known to develop drugs 30 percent faster than other companies, and this is because they operate on a different economic model where rapid cycles and efficiency are critical, May says.

"Sponsor companies have traditionally been insulated from the reality of the economics," May adds.