Q&A: Improving clinical trial design for gonorrhea treatment

Edward Hook
Edward W. Hook III

The clinical trial design for testing new urogenital gonorrhea treatments needs to be re-evaluated, researchers said.

Writing in Clinical Infectious Diseases, Edward W. Hook III, MD, endowed professor of infectious disease translational research in the departments of medicine, epidemiology and microbiology at the University of Alabama at Birmingham, and colleagues summarized the current state of clinical trials for gonorrhea therapies, as well as methods that may improve efficacy and increase the number of treatments under evaluation.

Infectious Disease News spoke with Hook about the importance of trial design, its impact on new antimicrobials entering the market and the path future trials evaluating gonorrhea treatment should take. – by Marley Ghizzone

Q: What prompted this paper?

A: The long and the short of it is that we are in a period of crisis regarding sexually transmitted infections. Gonorrhea rates have gone up steadily for the past decade and the rate at which they are going up is actually accelerating. It’s been over 25 years since there was a thoughtful evaluation of the overall approach to studying new therapies for gonorrhea and in that 25-year period, much has changed: the people who get it, the sites of infection, the methods of diagnosis, etc. Given that, and given the fact that there are few drugs in development for gonorrhea, that the time course for the evaluation of a new drug for gonorrhea really takes quite a long time, and the cost of doing clinical trials is so expensive, we thought it was a useful time to provide an overview of methods for evaluating new treatments for gonorrhea.

Q: Why is trial design so important?

A: Trial design has a number of determinates. First of all, it determines how drugs are approved and it determines what drugs are referred for. I’d like to point out that when new drugs are approved for gonorrhea, they are approved for gonorrhea occurring in the genital tract of men and women. Yet, emerging data show that more and more gonorrhea infections occur at the rectum and throat in men and women. Furthermore, both the time and the cost of conducting a trial to evaluate a new drug for gonorrhea represents a disincentive or relative barrier to development of new drugs and we would love to see more and more new drugs.

Q: What is wrong with how potential new treatments for gonorrhea are currently evaluated?

A: I wouldn’t say that it’s wrong. I think there are a number of challenges, and the results may not be totally applicable to the patients we see who have this infection.

Q: How should future trials investigating new treatment for gonorrhea be designed?

A: This paper does not come down with specific recommendations. It makes a number of suggestions and points out a number of points and challenges related to gonorrhea treatment evaluations. I think one of the things we can do, however, is modify trial design to allow progression from evaluation of a new drug in a phase 2 trial to shift more quickly into pivotal phase 3 trials. That would speed the time required to develop new therapies. Furthermore, by changing our criteria and our outlook and methods, we might be able to carry out these trials less expensively, reducing at least one relative barrier to development of new drugs.

Q: What is the take-home message for practicing ID clinicians?

A: One of the challenges in evaluation of new drugs for gonorrhea is that less and less gonorrhea is being seen in specialty clinics. There is an opportunity for practicing ID clinicians to participate in these clinical trials and help shape the future of antibiotic therapy.

Reference:

Hook III EW, et al. Clin Infect Dis. 2019;doi:10.1093/cid/ciz899.

Disclosures: Hook reports receiving grants from GlaxoSmithKline, Hologic and Roche Molecular, all outside the submitted work. Please see the study for all other authors relevant financial disclosures.

Edward Hook
Edward W. Hook III

The clinical trial design for testing new urogenital gonorrhea treatments needs to be re-evaluated, researchers said.

Writing in Clinical Infectious Diseases, Edward W. Hook III, MD, endowed professor of infectious disease translational research in the departments of medicine, epidemiology and microbiology at the University of Alabama at Birmingham, and colleagues summarized the current state of clinical trials for gonorrhea therapies, as well as methods that may improve efficacy and increase the number of treatments under evaluation.

Infectious Disease News spoke with Hook about the importance of trial design, its impact on new antimicrobials entering the market and the path future trials evaluating gonorrhea treatment should take. – by Marley Ghizzone

Q: What prompted this paper?

A: The long and the short of it is that we are in a period of crisis regarding sexually transmitted infections. Gonorrhea rates have gone up steadily for the past decade and the rate at which they are going up is actually accelerating. It’s been over 25 years since there was a thoughtful evaluation of the overall approach to studying new therapies for gonorrhea and in that 25-year period, much has changed: the people who get it, the sites of infection, the methods of diagnosis, etc. Given that, and given the fact that there are few drugs in development for gonorrhea, that the time course for the evaluation of a new drug for gonorrhea really takes quite a long time, and the cost of doing clinical trials is so expensive, we thought it was a useful time to provide an overview of methods for evaluating new treatments for gonorrhea.

Q: Why is trial design so important?

A: Trial design has a number of determinates. First of all, it determines how drugs are approved and it determines what drugs are referred for. I’d like to point out that when new drugs are approved for gonorrhea, they are approved for gonorrhea occurring in the genital tract of men and women. Yet, emerging data show that more and more gonorrhea infections occur at the rectum and throat in men and women. Furthermore, both the time and the cost of conducting a trial to evaluate a new drug for gonorrhea represents a disincentive or relative barrier to development of new drugs and we would love to see more and more new drugs.

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Q: What is wrong with how potential new treatments for gonorrhea are currently evaluated?

A: I wouldn’t say that it’s wrong. I think there are a number of challenges, and the results may not be totally applicable to the patients we see who have this infection.

Q: How should future trials investigating new treatment for gonorrhea be designed?

A: This paper does not come down with specific recommendations. It makes a number of suggestions and points out a number of points and challenges related to gonorrhea treatment evaluations. I think one of the things we can do, however, is modify trial design to allow progression from evaluation of a new drug in a phase 2 trial to shift more quickly into pivotal phase 3 trials. That would speed the time required to develop new therapies. Furthermore, by changing our criteria and our outlook and methods, we might be able to carry out these trials less expensively, reducing at least one relative barrier to development of new drugs.

Q: What is the take-home message for practicing ID clinicians?

A: One of the challenges in evaluation of new drugs for gonorrhea is that less and less gonorrhea is being seen in specialty clinics. There is an opportunity for practicing ID clinicians to participate in these clinical trials and help shape the future of antibiotic therapy.

Reference:

Hook III EW, et al. Clin Infect Dis. 2019;doi:10.1093/cid/ciz899.

Disclosures: Hook reports receiving grants from GlaxoSmithKline, Hologic and Roche Molecular, all outside the submitted work. Please see the study for all other authors relevant financial disclosures.