by Belen Diego at Eyeforpharma Barcelona
BARCELONA, March 17, 2017 (APM) - Janssen's head of global commercial strategy organisation supports moves to involve patients as early as possible in the drug development process as a strategy to obtain more precise measurements of outcomes and improve access.
Speaking to APM on the sidelines of the Eyeforpharma meeting in Barcelona on Wednesday, Steve Wooding said designing trials in a manner which is "manageable" for patients, incorporating their needs and preferences, can contribute to facilitating market access.
According to Wooding, trial design needs to take into account the way medicines are "really" used. If measurement of a particular outcome is burdensome, a different, patient-oriented strategy would help get better results more rapidly.
At the time of patient recruitment for trials, before they are actually engaged, initiatives can be adopted to facilitate their participation. He noted that clinical trial websites such as ClinicalTrials.gov can be difficult to read, hence Janssen's own website, which offers information about the company's trials. It was designed to be easily understood by the non-specialised reader.
Real-world evidence has a particular advantage when patients' perspectives are incorporated at early development stages, he noted. A collaborative approach would also be vital to obtain information of statistical relevance.
Where patients and regulators meet
Wooding said regulators, health authorities and payers are increasingly interested in patients' views on medicines' performance. This is due to a number of factors, including the increase in risk-sharing agreements where conventional outcomes such as 'tumour shrinkage' can be accompanied by patient quality of life scores.
Additional, patient-centered variables add up to evidence about a drug's efficacy and can give an idea of its value. Its benefit to both patients and society, including its potential to reduce other costs, as well as the improvement it represents, must be taken into account.
"It is a matter of combining endpoints where patients' needs are key, because they give the idea of value and have important consequences in compliance, for one thing," he added.
EU's harmonised HTA too complex
Wooding said that before the European Medicines Agency existed, seeking approval in 27 different countries was certainly more arduous. In theory, the idea of harmonised HTA therefore seems logical and appealing.
He said Janssen cooperates with the European Network for Health Technology Assessment (EUnetHTA) on a regular basis. In his opinion, there are a number of interesting opportunities in harmonised HTA, "but it is not easy to find a way to align national or regional differences" (APMHE 51719).
How science is transforming organisations
Wooding thinks innovation must be transformat ional, not only for patients but also within companies.
For instance, immunother apies are showing how a particular target can be shared by different kinds of cancer, which offers the possibility of using the same therapy in a number of diseases.
This has made Janssen use a combined strategy when it comes to its teams. While some members are highly specialised, others have the ability to 'step back' and look at the bigger picture. The identification of shared elements in initially separate projects can lead to new opportunities. Janssen's staff look for such synergies in what Wooding called a sort of "deep internal peer review".
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