FDA rules on adaptive trials would help sector, says PI
As the name suggests adaptive trials can be adjusted while they are in progress to improve the efficiency of the development process, target responsive subjects and reduce the number of patients exposed to candidates that prove to be ineffective.
A PI survey of 500 biopharma developers and contract research professionals ranked concerns about regulatory acceptance of data as the major stumbling block preventing greater use of adaptive trials.
Second and third on the list of worries about adaptive studies were: a lack of understanding of the techniques needed to carry out such trials, cited by 33 per cent of respondents; and confusion over access to clinical endpoint data, which was mentioned by 28 per cent of those who took part.
Other barriers to implementing adaptive trial designs included understanding and implementing complex statistical methodologies as well as difficulties in medication supplies estimation and supply chain management.
PI’s senior director Bill Byrom said that: "Formal FDA guidance on adaptive trials implementation is expected later this year and should help to alleviate regulatory acceptance concerns.
“As biopharmaceutical companies focus on making reliable decisions as early as possible in drug development, a growing area for adaptive trials is the ability to include more dose levels in Phase II dose-finding studies without significantly increasing the number of study participants or timeline required.”
The US Food and Drug Administration (FDA) has been developing its rules on adaptive trials since 2004 but is yet to issue any formal guidance.
PI, which is the eClinical arm of US contract research organisation (CRO) Parexel, provides a range of adaptive trial design services to the pharmaceutical industry with a particular focus on electronic data capture (EDC).