MALVERN, Pennsylvania, April 19, 2017 /PRNewswire/ --
Center Point Clinical Services, creator of the world's first Siteless CRO platform, announced today new consensus guidelines drafted by Key Opinion Leader (KOL) industry leaders for modern clinical trials, including in-home and siteless clinical trials. The guidelines were announced today at a webinar hosted and sponsored by Center Point Clinical Services in cooperation with FierceMarkets. They are also detailed in an article published by the peer-reviewed Clinical Therapeutics journal. Click here to access the article titled "Incorporating Site-Less Clinical Trials into Drug Development: A Framework for Action Clinical Therapeutics". The article will be printed in the May edition of the journal.
Contributors include: Irl B. Hirsch MD from the University Of Washington School Of Medicine, Zan Fleming, MD, CEO and President of Kinexum Metabolics, Inc., Daniel Kaufer, MD, Division Chief, of Cognitive Neurology and Memory Disorders at the University Of North Carolina Chapel Hill School Of Medicine, Spyros Papapetropoulos, MD, PhD, VP, Global Head Clinical Development Movement Disorders & Neurodegenerative Diseases, Teva Pharmaceuticals, Boston, MA, Philip Home, Professor of Diabetes Medicine at Newcastle University, UK and Joe Martinez, RPh, PDE, PPC, CEO of Center Point Clinical Services, which launched the first siteless, technology CRO in December 2016.
Irl Hirsch, M.D. told webinar participants, "Mobile health technologies are moving forward at warp speed and clinical trials and new drug development are treading water with the growing number of patient recruitment and retention uncertainties. An estimated 11% percent of sites in any multi-center, global clinical trial fail to enroll a patient, while almost 40% fail to meet initial recruitment targets and 49% percent of all enrolled participants drop out before study completion. The numbers with the current trial model are not promising, especially considering that site monitoring alone accounts for between 9% and 14% of overall expenditures."
Dr. Hirsch continued, "There are four major reasons why patient recruitment and retention are so challenging: 1) Potential participants lack proximity to academic medical centers; 2) participants don't always want to or are not able to commit to follow-up visits; 3) inefficient trial management; and also, 4) the need for larger and more diverse sample sizes over wider geographic areas, to answer the question of whether the drug, device or medical procedure is safe and efficacious across appropriate age groups and ethnicities. The way to reverse these trends is to modernize the clinical trial process, where appropriate, is to consider the siteless CRO model, and to adopt a set of industry accepted guidelines to regulate the process. We took our first steps in this direction in December 2016 by participating in a KOL roundtable. Today, we are pleased to announce our recommendations, which are intended as a starting point."
The following are the best practices recommendations of the KOL Roundtable:
- Enroll a more diverse trial participant population
- Measure patient-centric clinical outcomes
- Capitalize on existing digital sources of information to generate higher quality data more quickly and at lower cost
- Encourage collaboration among public and private sectors to focus on standards, applied science, and technology that advances the field of clinical trial research for all stakeholders
How? Near term action items include:
- Align siteless CRO processes with stakeholder needs
- Enhance operational efficiencies of drug development
- Use technology to improve data quality and documentation
- Advance innovative R&D paradigms using siteless CRO methods
- Reinforce credibility of results using siteless CRO methods
- Remote e-consenting and eSource data collection
- Real-time notification of adverse events
- Direct-to-patient clinical supply shipments
- Consortia for global, harmonized standards to establish site-less CRO best practices
Mr. Martinez, said, "In-home, siteless CRO clinical trials are the cornerstones of the modern clinical trial. Though clearly the way forward, until today, an important and extremely relevant question had remained unanswered: how to regulate the process? To begin the process of answering this question, last December, Center Point organized and hosted a round table that included KOL stakeholders from each part of the clinical trial industry-investigators, regulators, pharma industry, ancillary services and academicians. Following two days of deliberation, participants reached a consensus agreement on what the preliminary minimum best practice guidelines should be. We are proud to have rallied our colleagues to contribute to the worthy cause of putting the future of the clinical trial back on course for the benefit of patients everywhere."
About Center Point Clinical Services
Center Point Clinical Services LLC. is a specialty, siteless, technology contract research organization (CRO) that helps pharmaceutical, biotech, and medical device companies successfully reach their regulatory and commercialization goals in less time and at a lower cost than competitors. The company's evolutionary Siteless CRO model helps to recruit patients faster, identify and address patient issues in real-time and complete trials within time and cost projections. The company offers two premier signature services. The first is the Clinical Trial Research Pharmacist (CTRP®) program, which uses only licensed, specially trained pharmacists to communicate with patients. Center Point is the only CRO to offer such a unique and effective service. CTRP has repeatedly demonstrated improved patient retention, medication compliance and overall outcomes in clinical trials. The second service includes a series of practical signature study solutions intended to support regulatory and commercialization goals. These include: real world evidence (RWE) analysis and publications, health economic outcomes and research (HEOR), market access and reimbursement support, industry standard quality metrics data, and scientific publications. For more information please visit http://www.centerpointclinicalservices.com
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SOURCE Center Point Clinical Services