Greater use of risk-based monitoring (RBM) in clinical trials is needed to modernise the drug development process, says industry consortium TransCelerate BioPharma.
In a newly-published position paper, TransCelerate lays out a toolkit to help clinical researchers apply RBM in trials in order to enhance patient safety, boost the quality of clinical data, and drive up efficiencies.
TransCelerate is a non-profit organisation set up last September by 10 leading pharma companies to develop ways to overcome inefficiencies undermining R&D in the sector and driving up the costs of developing new medicines.
With another six companies getting on board last month, the consortium has now delivered the first major milestone among its five core clinical trial initiatives, which also include the development of a shared investigator portal, improved practices for site qualification and training, data standards development and new models for comparator drug distribution.
Companies spend an enormous amount of time and resources collating and reviewing data generated during clinical trials, but "there isn't much evidence to indicate that this level of review is effective at identifying systemic errors or substantially improving the quality of data gathered," according to TransCelerate's chief executive Dalvir Gill, who took over the helm of the organisation last December.
Over the last decade, the complexity and cost of clinical trials has increased dramatically but operational practices used in clinical trials are expensive and do not guarantee data quality, says the consortium.
In the 33-page position paper (available on its website) TransCelerate details a standard framework and approach for RBM, including common tools and triggers to identify risk and categorisation criteria for low, medium and high risk trials.
Current approaches to trial monitoring are typically based on a technique known as source data verification (SDV) that is reactive, expensive and limited in its ability to quickly identify issues and prevent them from recurring, notes the paper.
Instead of relying heavily on this type of on-site monitoring, TransCelerate's recommendations are driven by centralised and off-site monitoring techniques, as well as adaptive on-site monitoring.
At the heart of the new scheme is a risk assessment categorisation tool (RACT) and an integrated quality and risk management plan (IQRMP) tailored to each trial, which tie in with draft guidance issued recently by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Both agencies have reviewed the RBM methodology paper.
"TransCelerate's RBM methodology provides the framework and tools to manage clinical trial risks through identification, categorisation and appropriate mitigation," commented Bristol-Myers Squibb's Rehbar Tayyabkhan, RBM project lead for TransCelerate.
TransCelerate's founding companies were Johnson & Johnson, Eli Lilly AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, Roche and Sanofi. In April their ranks were swelled by the addition of Astellas Pharma, Biogen Idec, Braeburn Pharmaceuticals, EMD Serono, Forest Laboratories and Onyx Pharmaceuticals.