Thursday, September 22, 2016

7 Predictions for the Future of Clinical Trials


Over the past six months we’ve spoken to dozens of industry leaders and asked for their predictions for the future of the clinical trials industry over the next 2-3 years. We’ve gathered 7 of the most common answers below…


1) Partnerships will develop

“The industry will be leaner. We will still need to work at building good outsourcing partnerships.” Mireille Zerola , Risk Based Monitoring Implementation Project Lead, Boehringer Ingelheim

“Today’s fledgling strategic partnerships will have matured, allowing sponsors and CROs to better realize their potentials.” David Shalhevet, Associate Director, Senior Clinical Trial Manager, Teva Pharmaceutical

“I hope we will be really seeing the benefit coming out of the industry consortia, such as TransCelerate, where different companies work together for the benefit of the patient.” Diane Driver, Head Outsourcing Contracts & Strategic Partnerships, UCB

2) Remote monitoring through wearables

“Technology with wearables will be the biggest disruptor in clinical trials, as well as how this will be implemented consistently in studies.” Scott Sawicki, Director of Clinical Procurement Management, Novartis

“Where the data is collected in the background with no additional effort, there is the possibility of not only more, but better quality data.” Matthew Simmons, Head of the Drug Development Unit, Sarah Cannon Research Institute

“Relationships with sites will evolve to include remote monitoring aspects.” Zerola

“There will be an improvement of dropout rates by outsourcing of ancillary services to patients' homes.” Wenke Schult, MD, emovis home care visits GmbH


3) Regulations will continue to be a challenge

“Regulators and legislators will remain a challenge because of the number of new directives they generate each year. Five years means another 400 new rules and regulations to contend with; the unknown.” Mike Sitton, Consultant & former CEO, Haoma Medica

“New regulations tend to increase complexity.” Dimitri Stamatiadis, Founder and CEO, MAIA Consulting


4) Patient-centricty

“We will move toward a more patient-centric rather than the present research-centric approach to conducting clinical trials. Emerging ePRO (electronic Patient Reported Outcomes) and COA (Clinical Outcome Assessment) data collection and reporting tools in the hands of patients and clinicians will help researchers.” Jack Whelan, Research Advocate at Cancer Survivor Warrior

“The ‘new’ patient-centric approach being made by pharma should help open up ways to improve patient recruitment.” Sitton


5) Risk Based Monitoring

“Risked Based Monitoring [is the biggest trend], and the outcomes of this and data review – what are companies are doing now that some studies have followed RBM, is there a best practice?” Sawicki

“Risk Based Monitoring will become the norm. With CROs perhaps sharing fully in the risk associated with success.” Sitton


6) Data management and sharing 

“Companies who will embrace a culture of sharing of non- or pre-competitive information will succeed the others may find themselves in dire waters.” Beat Widler, Managing Partner, Widler & Schiemann AG

“The biggest challenge and opportunity in my current role is to reimagine what clinical data management really is” Gary Thompson, Senior Director of Data Sciences, Eli Lilly & Co


7) Standardized processes for sites

“I hope that standardized processes will be implemented for sites (e.g. with the help of ACRES initiatives) and sites will have fewer challenges in their practical clinical work. The site accreditation process could help to identify the right sites for the right study and overcome the recruitment and quality issues.” Helena Sigal, Founder, SIGAL SMS




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