Tuesday, June 21, 2016

Patient-led design is finally coming of age

What patients think does matter. The pharmaceutical industry has made great strides in accepting that. They have even gone as far as understanding how patient views can be taken into account in drug development.

Delegates at the recent industry event in London heard that what doctors think is NOT the same as what patients think. Five years ago, this conference would not have happened. The industry was sure that what doctors think was interchangeable with what patients think: “Why would we want to speak to patients?” was the common refrain.

It’s hard to think of another industry where the views of the user have so recently been ignored. It is partly because the pharmaceutical industry employs a lot of doctors, and doctors have typically held the patrician view that doctor knows best. It’s also because drug development is complicated: designing, planning and implementing complex clinical trials in multiple countries means it can take 10 years to get a drug to market. You have to be sure that doctors want it and that regulators are likely to accept the results when the dossier of evidence is submitted. So it is understandable that drug developers have been averse to adding another variable into the mix by asking the users – that’s the patients – what they want.

It is early days but there are signs of change in pharma land. Like most change, a cultural change has to come first. Helping to drive that change is the quietly-spoken but not to be under-estimated Iris Loew-Friedrich, Chief Medical Officer of UCB. When faced with internal objections from legal or compliance that they can’t produce a straightforward, patient-friendly, informed consent form, she simply says: “I won’t take no for an answer. Show me the path and find a way!” A 20-page, dense legal dossier simply won’t do.

Novartis is taking a top-down approach in tackling what it sees as an industry at breaking point due to inefficiencies. The dream of Novartis CMO and Global Head of Drug Development, Vasant Narasimhan is an entirely paperless study. Overcoming internal resistance to change is key: “Usually you get six to twelve months of complaining. Then people move on to something new to complain about.”

• Amgen is trying more tests at home or with a GP rather than at a trial site

• Pfizer is involving the patient’s GP during the referral process, paying for their time in consulting a patient’s medical records to check if suitable for a particular trial

• Merck has improved trial design thanks to patient advisory boards; the company is also advising patients of trial progress along the way eg how many enrolled so far

• Lilly, a leader in the area of trial education, expects to have lay summaries of trial results by Q1 2017; it also runs CoLabs where a trial simulation is held to see if it works in the real world ahead of a protocol being approved.


There was general consensus at the conference that the industry is very good at being negative about the next two years and terrible at envisaging the next 10 years. 2016 could see a step change.


About the author:

Julie Walters, Raremark, the Founder, is a contributing writer for the Partnerships in Clinical Trials conference who has over 20 years of experience in the digital healthcare sector, including time spent as a news reporter and news editor at Sky News, Reuters TV and Good Morning.




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