Merck director discusses company's strategies for clinical research success

Working with investigators is key

[Editor's note: Ernesto Aycardi, MD, senior director of worldwide research operations for Merck & Co., is responsible for the Global Medical Organization, clinical research operations. Clinical Trials Administrator asked Aycardi by e-mail how the company has achieved its success as a fast drug developer in this question & answer story.]

CTA: The Tufts Center for the Study of Drug Development has identified Merck as one of the five fastest drug developers for the most recent time period studied (2000-2005). As such, the Tufts analysis says that your company has more than a year time advantage over the majority of your peers. What are some of the benefits to a pharmaceutical company when a year or more can be shaved off the drug development process?

Aycardi: The drug development process is a very complex process that has a lot of variables and interdependencies. Probably one of the most important issues in this process is to be able to be consistent. Reducing the time of the drug development process has significant benefits. First, we are able to bring new medications to patients faster, helping them to solve and/or alleviate significant health problems. It also gives us a great opportunity to focus our drug development efforts and facilitate investment decisions that bring significant value to our shareholders.

CTA: The Tufts Center says that one of the ways top-performing companies, such as Merck, have achieved success is through improving their sponsor-investigator relationship quality and collaborative effectiveness. Please discuss a few of the measures Merck has taken to improve its site selection process with regard to better study quality and faster product development?

Aycardi: Merck understands that the relationships we build with investigators, regulatory agencies, medical societies, etc., are critical to the drug development process. This is not just about individual efforts—we have to collaborate and work as real teams to be successful.

Selecting sites for clinical research is one of the most important decisions. As in any other process, the success requires having a simple, lean process with objective metrics, built on a well-structured control plan. Site selection decisions should be based on investigator qualifications and patient availability. We keep our focus on selecting investigators with high scientific qualifications and the appropriate training and background required by the protocol. The availability of patients is another critical factor to measure in order to facilitate our planning and anticipate potential difficulties. Understanding that all our processes should be primarily focused on quality is the key factor.

At Merck, we also always try to work closely with investigators in a collaborative way to achieve successful outcomes (i.e., full patient recruitment, within established timelines). For example, getting input from investigators in early phases of protocol design, engaging them in estimation of enrollment potential, and being responsive to their needs in how we run our clinical trials are some of the strategies that help us build this collaborative environment.

CTA: Some clinical trial experts say that pharmaceutical companies too often select sites that have low performance records, including returning to opinion leader investigators who often do not enroll patients in trials. Has Merck done anything to change this trend in hopes of improving site performance?

Aycardi: At Merck, site selection is a decision that is basically driven by the medical and scientific qualifications of the investigator and by placing a significant effort on estimating patient availability to predict enrollment success.

CTA: What are some other ways that Merck has improved collaboration with clinical trial sites?

Aycardi: Clinical research is not an individual effort. We have to build a collaborative environment that facilitates all the processes. Collaboration is based on two-way thinking. The expectations of all parties need to be clear up-front, and both parties must be totally transparent about capabilities and what they can offer to each other. It is not a matter of promises, it is a matter of responsibility and commitment. With this mindset, we develop our processes to facilitate this dialogue and have the appropriate discussion at the appropriate time, facilitating our decision-making processes.