The EMEA has republished points to consider on the clinical investigation of medicinal products used in the treatment of osteoarthritis, this was originally published in July 1998 however the EMEA has recently re-posted it on their website. The publication has not been altered since 1998. This concept paper presents guidance for clinical studies addressing pharmaceutical treatment of osteoarthritis only systemic products are addressd, topical remedies in particular and not dealt with in this paper and other rheumatic diseases are also not considered.

The concept paper starts by outlining the classification of anti-osteoarthritis therapies, these are medications that affect the symptoms and/or modify structures within the disease. The nomenclature currently proposed recognises 3 types of drugs acting on osteoarthritis: fast acting drugs that induce symptomatic relief, slow acting drugs that induce symptomatic relief and disease modifying drugs.

Due to the pathophysiological differences of osteoarthritis in different body parts the EMEA treats different body parts sa different indications for the purposes of results interpretation and product registration.

The paper also goes on to describe the primary and secondary efficacy endpoints for the different types of drug: symptom modifying drugs, largely rely on pain and function as primary endpoints. Structure modifying drugs rely on long-term outcomes such as necessity for joint replacement time to need surgery and long-term clinical performance (pain and disability).

The paper also includes guidance on clinical trial design for dose finding and therapeutic comparative trials: study population is given particular attention, as is concomitant interventions. The use of placebo and the choice of comparators is also addressed in the document as are safety considerations.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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