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Anticipating the Need

16th October 2019

Does fast site activation give us a jump-start in patient recruitment? In the words of Gergely Kokas:

Site activation is a continuous effort

History and common sense tell us that those who plan ahead give themselves the best possible opportunity to stay ahead. Today at Optimising Clinical Trials in Berlin, Gergely Kokas gave us his insight into Amgen’s forward thinking.

Does effective site activation help give us a jump-start in patient recruitment? In Gergely’s own words:

“Site activation is a continuous effort”.

Patients benefit from smart use of reliable data, not from quick site activation for its own sake. With so much data available to us, there’s no reason why we should ever have to go into an activation process “blind”. Add to this the rigour of optimized protocol development and feasibility assessment and we have the beginnings of a strategy that should pay dividends.

It’s not pleasant to have to admit to past mistakes, but admitting to them means learning from them. That can only add value to protocol development, trial planning and execution. Learning lessons from the successful practices of our peers, making the best use of relevant data and ensuring seamless communication between sites, CROs and sponsors all help us build the platform we need to build and get on with the key job in hand: putting the patient first.

Amgen’s track record of innovation in human therapeutics gives immediate credibility to their arguments. The development of their West Greenwich biomanufacturing plant, the first of its kind in the United States, has given a shot in the arm to the Rhode Island job market while also delivering a smaller manufacturing footprint, reduced consumption of water and energy and lower carbon emissions. Equipment is portable – some of it is disposable – enabling efficiency, agility and eco-friendliness. Amgen are thinking ahead, in trial site selection and in manufacturing planning, and they stand to reap the benefits.

When we give in to impatience and attach too much importance to site activation at the expense of forward planning and the implementation of a workable critical path, we risk undoing good work and jeopardising positive outcomes. It was a pleasure to hear Gergely Kokas make the case for forward planning in Berlin today..


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