MALVERN, Pennsylvania, March 29, 2017 /PRNewswire/ --
Center Point Clinical Services, creator of the world's first Siteless CRO platform, announced today study results presented in two separate posters at the Academy of Managed Care Pharmacy, #AMCP2017, Managed Care and Specialty Pharmacy annual meeting in Denver, Colorado. Data in both posters demonstrated that pharmacist-led patient interventions during clinical studies enhance patient medication compliance and protocol adherence. These factors are crucial to generating the robust and high quality study data required for the regulatory approval process.
Joe Martinez, CEO of Center Point Clinical Services and the lead author of both posters, said, "The average drug requires $2. 86 billion in R&D costs to receive FDA approval and only one out of ten drugs that reach phase 1 are ultimately approved. In order for a drug sponsor company to succeed, the clinical trial data must be robust and trustworthy. This can only happen if the patients in the sponsor's clinical trial are willing to follow the protocol 100%. Unfortunately, mean short- and long- term medication adherence rates often don't make the grade, at 78% and 59% respectively."
Mr. Martinez continued, "The data presented at AMCP show that when study patients are supported by calls from pharmacists who educate, develop patient relationships as the trusted healthcare professional and reinforce study protocol, adherence and compliance impressively improve, as does the reliability of the data and the potential of the drug meeting regulatory thresholds. The improvement resulting from pharmacist-intervention also helps to save study sponsors time and money in the long-term development of the drug."
The first poster, Evaluating frequency and cost impact of pharmacist interventions in phase 3 clinical trials for patients with sub optimally controlled diabetes, explores the impact of pharmacist interventions on medication adherence and adverse events in clinical trials focusing on diabetes. Pharmacists called study participants at speciﬁc time-points during the trials. The pharmacist call was in addition to the normal monitoring provided by the clinical trial site staff. During each call, the number and types of interventions were documented. Descriptive statistics (frequencies) and stratiﬁcation by cost impact were performed to determine the number and type of interventions by call and by patient across 2 NiGLM Drug A and Drug B studies.
A total of 25, 829 calls were made. Of these calls, 11,765 calls had at least one intervention involving 3,573 patients (92.3%). The most frequent interventions were regarding adverse events, protocol violations for medication usage, concurrent medications, etc. The greatest number of interventions pertained to high cost, serious, adverse events that could have had a negative impact on the trial's outcomes data.
The second poster, Evaluating the impact of pharmacist support for medication adherence and patient compliance in clinical trials for two NIGLMs in sub optimally controlled patients with diabetes, details the results of an initiative whereby pharmacists called study participants at speciﬁc time points during 11 clinical trials of two non-insulin glucose lowering medications (NIGLM) according to protocol. These calls were in addition to regular site monitoring interactions provided by the clinical trial site staff.
The number and amount of interventions were documented during each call. Retrospective and descriptive analysis (frequency and type) were performed. A total of 3212 patients received a total of 9302 pharmacist calls. Patients were called five times by pharmacists, and more if required. There were 444 interventions during the first call, 374 during the second, 184 during the third, 36 during the fourth, and 93 during the fifth call. During these calls the pharmacists' identiﬁed and addressed patient compliance and adherence issues that would, if gone unchecked, would have negatively impacted the trial primary endpoints and outcomes.
The data confirmed that pharmacists were able to successfully intervene regarding multiple types of medication management issues, including those related to concurrent medication use, adverse events, and other medication-related issues. These interventions resulted in better patient outcomes and ultimately, more robust and reliable study results for review by regulatory agencies.
To receive a copy of the Center Point posters presented at AMCP, please contact Marjie Hadad at firstname.lastname@example.org.
About Center Point Clinical Services
Center Point Clinical Services LLC. is a specialty, site-less, 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 Site-less 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