From The Editor | May 11, 2016

Merck Changes The Paradigm On Clinical Trials

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

Merck Changes The Paradigm On Clinical Trials

Patient centricity remains a hot topic in the clinical space, and generated a significant amount of discussion at the CROWN Congress in Philadelphia earlier this year. Few would argue this will be a critical factor in turning around patient perceptions of the pharma industry, and hopefully solve the patient recruitment and retention issues that have long plagued the industry. But taking all of the hoopla and discussions you hear at conferences, running it through the internal channels within your company, and generating changes that have a real impact on patients is not an easy endeavor.

Years ago, before he started working for Merck, Mark Travers, global head of monitoring excellence and interim head of North America clinical operations, conducted an experiment where he asked a group of diabetes patients about their trial experience. The responses he heard were a real eye-opener.

“It was a learning experience for people at all levels including the physicians, data managers, and our folks who put the clinical supplies together,” he says. “Things that we took for granted, such as the storage of the drugs, the assessments we were going to use, and the frequency of visits to the hospital were all challenged by the patients, and rightly so. When you begin to look at a trial from the patient’s perspective and consider the complexity of the trial and what we are asking them to do, is it any wonder that so many patients are refusing to participate? And is it any wonder why so many patients choose to withdraw from a clinical trial?”

For Travers, the experience left him feeling that something absolutely needed to be done. To meet the needs of patients, pharma would have to start looking at everything it did from the perspective of the trial participant. At a minimum, he felt it was necessary to explain to patients why they were being asked to do certain things, to make sure they understood the terminology being used, and for trial personnel to take a hard look at the “doability” of the trial.

“This is not the same as feasibility,” he states. “We might know that the patients and the investigators needed for the trial actually exist. But you need to take a close look at how doable the trial will be for the patients we enroll in it.”

When looking at a trial from that perspective, a lot of questions should arise. For example, do we need all of these assessments, and do we need all of these biopsies? More importantly, what is it like for a patient to have to arrive at a hospital or clinic at 9:00 a.m., spend half a day moving from one station to the next, and then have to come back and do it all again a month later? In his opinion, if a researcher is not willing to do it themselves, they probably shouldn’t be asking a patient to do it.  

“You hear a lot of talk about patient centricity, and I do believe that is the way forward for clinical trials,” Travers says. “Patients have a voice, and that voice is very important. It needs to be embraced and not just as an industry buzzword.  It will be a very valuable contribution to how we run clinical trials in the future.”

The Mindset Is Shifting

While the thinking on patients is changing within the sponsor companies, Travers notes there has been a change in mindset within the patient community as well. Patients are the central focus in any clinical trial. Patients are aware of their importance, and the industry needs to better recognize this as well. This change in mindset should start with thanking patients, physicians, and clinicians for their participation in a study. It should also involve making data from the trial available to them much sooner.

“As a company that brings new medicines to market, we must feel privileged to be part of that process,” he says. “We cannot take any of the participants for granted, and we must respect the participation of all those putting forth an effort to make these studies more successful.”

Of course, bringing change and innovation into a Fortune 500 company is never an easy effort. Innovation at any level requires changes to be made, and Merck is trying to change to keep up with what is expected by patients, sites, and investigators.

“Merck has recently undergone some changes and is likely not the Merck that many of you have worked with before,” Travers says. “Our new focus, in terms of global clinical trial operations, is to be the sponsor of choice for both internal and external partners. External partners are both vendors and sites, with the sites comprised of both patients and investigators. The overall goal is to make it easier for all of our partners to work with Merck.”

To make that happen, a number of changes have been made. First, the company looked at what could be done to make it easier for partners to be a part of Merck’s clinical trials. Several avenues are being examined, including less complicated documentation, quicker startups, and fewer handoffs.

“At startup, we found there were multiple contacts with sites, which made the process complicated and inefficient,” says Travers. “We want that experience to be easier and more enjoyable for our partners. We started this process by identifying processes and procedures that are too complex, and we are now beginning to retire many of them. One obvious starting point was SOPs. We often find ourselves with too many SOPs in places where we don’t actually need them. We also looked at our monitoring visit report template and felt it needed to be simplified.”

Give Your Partners Some Credit

Merck has a functional service provider clinical outsourcing model in place, which Travers says requires the company to have good relationships in place with all of its vendors, including the clinical research associates (CRAs) working at the clinical sites. He also believes the job of CRAs and investigators has become much more difficult than in the past. This further reinforces the importance of retaining trained and qualified individuals for as long as possible.  

“I believe our new model is much more open, transparent, and communicative than it has been in the past,” says Travers. “We are bringing our vendors together and having many more discussions than we have in the past. We no longer meet with vendors one at a time. We will bring together three or four or 10 vendors at one time to hear our goals and objectives and to be part of the organization and share in our mission, vision, and objectives. This makes for more informed partners, and makes them feel they are an integral part of our clinical trial process -- which they are. We are also much more open to listening to feedback. To us, feedback is a gift that we need to embrace with open arms.”    

Travers believes transparency will continue to be an issue moving forward, noting pharma will have to become much more transparent. He believes the industry will need to come together and create a consensus on how to be more transparent with data. “When we do, that will be a major disruption,” he says. “It will make the lives of regulators easier and make us seem less secretive to the public and the patients taking part in our studies.”

Finally, new technologies will continue to impact trials and the patient experience. Travers believes pharma will need to embrace these new platforms in order to become more patient centric. One of these is the expanded use of a system allowing patients to interact with physicians via remote connections on their computers. He is currently aware of two companies developing that technology and in the process of piloting it. A more efficient method of delivering medication to patients is also vital, so as to reduce the need for patients to have to travel to a clinic to pick up medicines.

Point-of-care diagnostics (i.e., where a patient would not have to visit a hospital to have blood drawn) is showing a lot of potential. Merck is also looking into wearable devices for trials and is piloting a system using a sensor, tablet, and Wi-Fi. When a patient takes a medication, information is sent to a wearable device, such as a patch, which is then sent to a central database, indicating when the patient took the medication. Finally, the company is looking into the use of eConsent, or using iPads to provide information to the patient in a multimedia approach, using text, pictures, or cartoons.

“Any of these technologies would do wonders to improve the patient experience,” adds Travers. “That is what is exciting for me. Anything that will help the patient experience, and can be piloted in small numbers, is definitely a big plus.”