Research from the Tufts Center for the Study of Drug Development indicates that 18 per cent of a typical clinical trial budget, or $1m, is spent on direct costs to administer procedures for supplementary secondary, tertiary and exploratory endpoints.
The authors – whose work was published in the latest edition of the Tufts CSDD Impact Report – suggest the average trial protocol has 13 endpoints and that the number of less essential endpoints - those not related to the efficacy or safety of a candidate drug - has nearly doubled compared with procedures conducted a decade ago.
Specifically, they believe that 22.3 per cent of all procedures carried out during clinical trials are non-core with 18 per cent of those done at Phase II and nearly one quarter of those conducted at Phase III being extraneous.
Part of the problem is that drug firms are unsure as to what data they will be asked for by regulators according to Ken Getz, assistant professor at Tufts CSDD, who said: "The impetus to collect these data is strong, and until now there has been no systematic assessment of this practice."
"We believe our findings offer a framework that pharmaceutical and biotechnology companies can use to streamline protocol designs, improve clinical research performance, and reduce development costs."
The research findings and Getz’ comments fit with research carried out by Tufts and CRO Medidata earlier this year, which examined eight months’ worth of data about 115 clinical trial protocols from 15 companies, including big international players like Lilly, Sanofi and GSK (GlaxoSmithKline).
At the time Michelle Marlborough, director of product management at Medidata Solutions told Outsourcing-Pharma.com that: “There seems to be a fear in organisations of not having data if it is requested by the regulators, and so that drives a culture of collecting data 'just in case."
Publication
In addition to the financial benefits, the elimination of procedures that generate non-core data may also help drug makers if regulator's ongoing efforts to ensure that all data from clinical trials is made publicly available.
One of the arguments put forward by sponsors is that clinical trials generate large amounts of data and that disclosing all of this information is a very complex and time consuming task.
A joint position statement issued by the EFPIA, IFPMA, PhRMA and JPMA last week hinted that the value of data should be considered when choosing what should be published.
"The primary publication for the study should provide an accurate report of the clinical trial findings, including adverse events. This should include primary efficacy analyses, safety results with relevance for patient care and, when informative (and within the space constraints for abstracts), secondary and exploratory analyses."
Ceasing to collect unnecessary data will therefore make publication a straightforward task, at least that is assuming the sponsor in question can be sure the 'non-core' data from procedures that are dropped will not be asked for by regulators at a later date.