FDA approves new Transparency Life Sciences clinical drug trial

The Federal Drug Administration (FDA) has approved a proposal by drug development company Transperency Life Sciences (TLS) to carry out a phase II study of the effects of lisinopril on multiple sclerosis patients.

This work was designed with feedback from an online crowdsourcing system, representing the first time that such technology has been used in a clinical drug trial.

Marc Foster, co-founder and chief operating officer of TLS, said the organisation is aiming to get physicians involved with the design of these trials "more systematically".

Mr Foster explained that the firm wants to offer a broader set of ideas with regard to the design of clinical trials, and is opening up the process via an online system, enabling physicians and patients to submit ideas.

Telemonitoring will also be utilised in the work in order to collect patient data, as opposed to asking participants to see clinical trial personnel.

As well as reducing the number of in-person visits, the technology will lower the cost of the research to $1.5 million (£930,000) in comparison to the $5 million to $10 million which such work usually costs.

"When we speak with patients, and when patients are involved in conversations about clinical trials, time and time again they talk about the inconvenience of having to take off chunks of the day to go in and have data collected in a hospital or clinic setting," Mr Foster stated.

He went on to say that telemonitoring will help people to put a lot of data collection into patients' homes, providing an incentive for more patients to take part in clinical trials.

News of this latest approval comes after Avaxia Biologics announced that the FDA cleared its Investigational New Drug Application for AVX-470.

The drug is an anti-TNF (tumour necrosis factor) polyclonal antibody and is the first clinical contender to emerge from its oral antibody platform.

TNF is a pro-inflammatory protein that has been used as a treatment for inflammatory bowel disease.

Posted by Ben Evans