Although many boutique consulting firms and the majority of contract research organizations (CROs) have been offering trial design and regulatory consulting for years, demand has been surfacing as of late in phase I.
“All sponsors have the same problem and that is to get to decisions quicker and we have noticed this.And as sponsors in the past gave you a protocol and just expected you to conduct the study, now they are looking for thought leadership,” said Michelle Middle, vice president and worldwide head of Parexel’s clinical pharmacology business.
Parexel has begun to incorporate this approach in its early phase services division (Parexel Clinpharm), a stage of drug development that sponsors have been concentrating on to improve their R&D timelines. They want faster, richer data to make strategic decisions right out of the gate.
“Traditionally, Parexel’s phase I work focused on healthy volunteers, but we are moving more towards early drug development, which includes proof-of-concept work.We are seeing, across the board, that sponsors are seeking patient volunteers [intent-to-treat subjects] as soon as possible in phase I. We review every potential protocol we receive from a scientific point of view and suggest to sponsors, if it is necessary, different study designs,” said Middle.
Middle stated that having the ability and expertise to manage a successful phase I trial in healthy volunteers does not mean CROs can easily add efficacy components with intent-to-treat subjects. Phase I units have continual recruitment initiatives to bring in healthy volunteers. In proof-of-concept studies, recruitment is more difficult and you need medical expertise to run the study.
“So we can help sponsors with adaptive clinical trial design and that is exactly where the more difficult studies come in.We are heavily involved in bridging studies, where you have both healthy and patient volunteers in one protocol. It is critical not to extend set timelines.You have to have a very effective system,” said Middle.
One way Parexel is helping sponsors make strategic decisions early in development is with its newly launched central nervous system (CNS) modeling techniques. The tools were developed with the help of Matthias Grossmann,M.D., Ph.D., the company’s vice president and principal clinical pharmacology consultant.
Grossman stated that research models for cognitive disorder and chronic pain are two areas it will be focusing on. He stated that he joined Parexel to improve CNS drug development using the complex research models he helped develop.
“We are introducing these models, so we can get an idea of whether or not a compound is going to be both efficacious and successful. I don’t think the current side effects in the CNS area today will be acceptable in the future, especially if it leads to cognitive dysfunction, which is a disease itself. So we are looking at educating our sponsors that we need more complex methodologies and relevant biomarkers,” said Grossman.