A successful tie-up with a contract research organisation (CRO) can be a major boon during product development and clinical trials. Eugene McCarthy reports.
Clinical Research Organisations (CROs) can take the pain out of product development for pharmaceutical and biopharmaceutical companies by reducing both direct and indirect costs, boosting efficiency and speeding up the time to market of new products (Fig. 1).
Design of clinical trials is an important aspect of this work and here Pharmaceutical Product Development (PPD) has acquired RCT Logic’s exclusive license from Massachusetts General Hospital (MGH) for the portfolio of patents related to its sequential parallel comparison design (SPCD).
SPCD is an alternative method for conducting well-controlled clinical trials that substantially decreases the impact on trial outcomes of any placebo effect and will enable PPD’s clients to significantly reduce the time and cost of conducting their clinical trials.
This methodology, which PPD is branding as Trimentum, has been particularly effective in studying major depressive disorder (MDD), but is applicable to clinical trials in many disease areas where outcomes can be impacted by placebo effects. A total of 22 SPCD trials are completed, ongoing or planned. These include Phase II and III trials by corporate sponsors that are licensees of RCT Logic, as well as trials with funding from the US National Institutes of Health (NIH) and charitable organisations.
The SPCD method greatly lessens the impact of the placebo effect in trials by incorporating two sequential placebo-controlled stages into the process, the second of which includes a re-randomisation of placebo non-responders from the first.
Trials in psychiatric indications are particularly vulnerable to placebo effects due to the subjective nature of the assessments because some of the responses may relate to actual improvement in the patient’s condition while others may relate to expectancy, trial design or implementation flaws.
Due to its basic structure, SPCD reduces the number of patients required for a given trial by 20-40%. This not only decreases the cost and time it takes to conduct a trial, but also eliminates some of the factors that make results more difficult to interpret.
For Quintiles, the focus is on the clinical development needs and goals of emerging biopharmaceutical companies.
To this end it has launched the Quintiles Emerging Biopharma Solution to improve both service delivery and the probability of product success for the sector.
“This new offering focuses squarely on those challenges – combining an operational model designed to meet these customers’ needs with access to Quintiles’ global infrastructure, integrated technology and therapeutic expertise,” noted Paula Brown Stafford, president of clinical development at Quintiles.
Real time data access
The idea is that this new operating model leverages Quintiles’ integrated technology platforms to provide customers with real-time data access as well as a transparent view of project performance.
In addition to providing a dedicated leader with emerging biopharmaceutical operations expertise, the offering includes senior-level sponsorship for each customer.
“This level of support provides easy access to the unique expertise and nimble operational support required by these companies,” says the company.
The new offering covers all therapeutic areas and, says the company, adds to the proven oncology expertise of Novella Clinical – Quintiles’ oncology service provider for emerging biopharmaceutical customers.
The company is recognised as a leader in Phase I and Phase II/III research among small biopharmaceutical customers and has worked with 240 of them since 2009. Its activity in this sector has more than doubled in the last year.
In collaboration news, Covance has signed a research deal with Frenova Renal Research that will seek more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).
This collaboration enables Covance to use its powerful analytics capabilities to conduct research on behalf of its biopharmaceutical clients using Frenova’s database, the world’s largest renal database with longitudinal data on more than 393,000 CKD patients and 980,000 ESRD patients.
The goal is to improve the lives of kidney patients by looking at which treatments are most effective.
The data will be used to better understand the burden of illness, treatment patterns, medication adherence, and comparative safety and efficacy of medical treatments in the real world.
The collaboration will also help new drug sponsors assess protocol feasibility, select study sites, conduct targeted patient recruitment and determine optimal sample size.
The two companies believe that this new collaboration has significant potential to support all key stakeholders, but especially dialysis patients who undergo intensive treatment three days a week and whose average life expectancy after diagnosis is five years.
The ultimate goal is for the analyses to provide insights into ways of slowing the progression of chronic kidney disease and preventing the need for dialysis for some patients altogether.
Finally, in news from Ireland, Icon has announced that Pfizer and Roche have joined the ADDPLAN DF consortium. The consortium was founded in 2013 by Novartis Pharma, Janssen Pharmaceuticals, Eli Lilly, and Aptiv Solutions – the latter an Icon company leading the design and implementation of adaptive trials. The goal of the consortium is to develop methodologies and execution technologies that improve dose-selection, which remains a major barrier to resolving high failure rates in Phase III trials.
ADDPLAN DF is statistical software for the design, simulation and analysis of adaptive dose-finding trials.
The graphical user interface supports the design process, allowing the development team to model flexible dose-response shapes and multiple design and analysis options.
Icon notes that both Pfizer’s and Roche’s decision to join the consortium comes as more companies recognise the value of adaptive design in improving decision making in exploratory development.
Parexel acquires ClinIntel
Parexel has bought UK-based ClinIntel, a specialist provider of clinical randomisation and trial supply management (RTSM) services. ClinIntel’s offerings now will be combined into Parexel’s ClinPhone RTSM suite, technology that is designed to make patient randomisation and clinical supply chain solutions more efficient.
Together, the advanced RTSM technologies will offer improved planning, forecasting and supply chain eLogistics. They will also be aimed at accelerating study start-up timelines. The entire ClinPhone RTSM suite will be available through the Perceptive MyTrials platform and as a standalone solution, and both solutions will be available through Parexel’s Perceptive Partner Programme.
Perceptive MyTrials is one of the industry’s leading suites of applications for managing clinical trials. Its flexible, open architecture allows partners to integrate targeted, specialised solutions within the platform. This gives their sponsor customers efficient access to clinical data and applications from a single source, allowing them to more efficiently and effectively manage critical trial activities.
The idea of the Perceptive Partner Programme is to allow CROs, technology, consulting, reseller and training companies to enhance and broaden their services to biopharmaceutical customers by leveraging the Perceptive MyTrials eClinical platform along with clinical and technical support services.
Josef von Rickenbach, chairman and CEO of Parexel, believes that by combining the ClinIntel and ClinPhone solutions his company will be have an opportunity to further advance its position as a clinical technology leader and grow market share by bringing enhanced speed, efficiency, and simplicity to its existing RTSM offering.
In a separate development, Parexel has announced that clinical technology companies CRF Health and Clinical Ink have joined the Perceptive Partner Programme.