martes, 10 de noviembre de 2015

Investigación Clínica: Competitive trial management (CTM) / Stan Bernard*


Originally, pharmaceutical clinical trials had two fundamental, interdependent roles: regulatory and clinical. In the US, the 1962 Kefauver-Harris Amendment, or “Drug Efficacy Amendment” to the 1938 Federal Food, Drug, and Cosmetic Act, required that drugs demonstrate efficacy and safety to be approved for patient use. In 1966, the Fair Packaging and Labeling Act required that all drugs have specific labeling to assist doctors and patients in the clinical use of these products. Four years later, the FDA required the first patient package insert (for oral contraceptives), which contained information for patients about specific risks and benefits. 

Soon thereafter, pharma companies began to leverage clinical trials for promotional purposes by seeking to highlight product details or differentiation from other products, which the FDA and other agencies over time progressively regulated. Over the past few decades, companies have been compelled or inclined to use clinical trials for reimbursement or payer purposes, as product cost-effectiveness and value have become increasingly important worldwide. Complete with their own unique and memorable brand names, clinical trials have progressed to embody battles in the larger brand wars and are now increasingly being used for competitive purposes in what can be termed “competitive trial management,” or CTM

Competitive trial management examples (CTM)

Pharma companies have leveraged CTM in a variety of ways to gain competitive advantages and steal market share: 

  • Better: The most direct form of CTM is competitors’ head-to-head clinical trials against market leaders, almost unheard of 15 years ago. For example, over the last three years, Janssen has conducted several head-to-head studies with its SGLT-2 agent Invokana, demonstrating advantages in glucose-lowering, weight loss, and cost-effectiveness versus the market-leading ral T2D agent Januvia. Similarly, Amgen recently announced interim results demonstrating that Kyprolis helped patients with orelapsed multiple myeloma live twice as long before their blood cancer worsened compared to a regimen containing rival drug Velcade.  

  • Counter: In a 2007 head-to-head study published in The New England Journal of Medicine, the experimental anticlotting drug Effient from Daiichi Sankyo and Lilly reduced heart attacks in patients with heart disease by 24% compared with market leader Plavix from Sanofi and Bristol-Myers Squibb. However, BMS planned ahead and leveraged CTM techniques to counter a head-to-head trial. Months prior to the announcement of the trial results, BMS conducted a systematic campaign among key US market stakeholders to highlight the significantly higher bleeding risks associated with Effient, ultimately undermining the study’s and the product’s benefits.  

  • Faster: For its new PD-1 cancer agent, Keytruda, Merck & Co. streamlined its clinical trial package and transformed a first-in-human study into a registrational study in order to beat BMS’s rival Opdivo to the US melanoma market. According to Merck’s VP of early oncology clinical research, Eric Rubin, Keytruda’s rapid development required “less than four years from the first patient that we enrolled to approval.”  

  • Broader and higher: Not to be outdone, BMS worked collaboratively with the FDA to obtain expedited approval for Opdivo and beat Keytruda to the larger US lung cancer market months ahead of schedule. Moreover, despite its initial submission for the third-line setting in squamous-type non-small cell lung cancer, BMS leveraged two studies to obtain labeling in both second- and third-line use, a much broader competitive opportunity, and an overall survival benefit.  

  • Bolder: At the 2014 American Society of Hematology Conference, Janssen took out a full-page advertisement showing several different studies the company was planning to conduct with its investigational multiple myeloma agent daratumumab—not the ones that the company had completed. Janssen took this step to try to create the impression that its CD38-targeting monoclonal antibody could potentially be used across different patient segments and lines of therapy.  

  • Newer: For its investigational submental fat treatment Kybella, Kythera Biopharmaceuticals worked extensively with the FDA to create a new patient-reported outcomes assessment tool called the “Patient-Reported Submental Fat Impact Scale.” As a result of the patient survey results, the company achieved novel product labeling that includes improvements in overall patient-reported satisfaction and self-perceived visual attributes. (Más)

(*) Stan Bernard MD, MBA is President of Bernard Associates, LLC, a leading global pharmaceutical industry competition consulting firm. He is also a member of Pharm Exec’s EAB Board. He can be reached at SBernardMD @BernardAssociatesLL C.com
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