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Pharma companies in the U.S. are working with the FDA to add mobile health tools to clinical trials, but it’s a complex path forward. In Europe, companies have to navigate not one market but several, which means working with several different regulatory bodies and cultures.
The European Medicines Agency is FDA’s equivalent in Europe, but unlike the FDA, regulations can differ slightly as they filter down to EMA’s member countries. Pharma companies in Europe need to be able to navigate between the subtle differences between nations. So what happens when companies want to introduce new technologies and methods into their clinical trial design?
Laboratoires Pierre Fabre, a French pharmaceutical company that focuses its research and development efforts in oncology, dermatology, central nervous system disease and consumer healthcare, has had a front row seat to witness Europe’s clinical development transformation.
Pierre Fabre announced in November 2015 it would use implantable chips as biosensors to monitor patients in clinical trials. The chips, developed by the Swiss Federal Institute of Technology, monitor temperature, pH and blood glucose levels, and can be used to measure the concentration of a drug within the body, which can help determine in near real-time a drug’s therapeutic effect and a patient’s tolerability for the drug.
The company hopes this technology will allow it to make quick decisions whether to continue a study, and once a drug is marketed, would make it easier to monitor treatment progress. The collaboration between EPFL and Pierre Fabre Medicament will begin with a feasibility study on the use of biosensor chips for a molecule currently in development for the treatment of schizophrenia.
“There is an energy to move towards new technology to include patients more into drug development….to try to fit the requirements of the the health authorities and the payers,” International Clinical Operations Director Thierry Escudier said.
Big data, and more specifically extracting insight from big data, is one of the most enticing areas for pharma companies looking to transform the way they conduct clinical trials. Pharma companies have no shortage of data, but new tools are allowing companies “to extract the spirit of the data,” Escudier said.
Escudier also points to “decentralized clinical trials” as an area he is excited to see evolve. Mobile health (mHealth) tools now allow pharma companies to collect patient data remotely, which allows patients to avoid excessive clinic visits and allows trial sponsors and investigators to run clinical trials that are less focused on site visits and more focused on active monitoring of patient data.
In Europe, as in the U.S., momentum towards new technology in the clinical trial space is often stymied by company perception.
“The obstacles to adopt new technologies in fact are very often due to the thought, ‘We cannot do it,’” Escudier said, adding “In this environment there is more belief than truth.”
On the contrary to any industry perception that transforming trials is impossible, the FDA in the U.S. has over and over again encouraged pharma companies to submit mHealth-enabled clinical trials to FDA for review. Europe is also moving at a high speed, according to Escudier.
“Sometimes the access to new technology might be very different depending on the country [in Europe]..the ethical standpoint, the social culture might be different.”
In general, pharma companies can only be concerned about so many areas at one time. Adopting new technology can require investments in time and money, and Escudier says companies need to work in tandem with tech partners as new innovations becomes more complex, because pharma companies cannot do everything themselves.
Likewise, as technology evolves and clinical trials begin to spread beyond the confines of clinical sites, pharma companies will need to reassess their relationships with trial investigators and patients.
If trials are to become decentralized in a region like Europe, it’s vital to maintain data homogeneity. Wherever the data is collected – regardless of hospital, patient or country of origin – drug approval authorities will require uniform data collection. Technology can help here; new statistical tools can alert sponsors of any irregularities in the data. But standardized data collection also requires buy-in from all stakeholders.
“In this new way of doing things, we fall back to the trust we put in the investigator doing the trial and with the patient’s trust in the investigator to do the trial. That’s why collaboration between all bodies so so important,” Escudier said.
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