A recent article in the Huffington Post featured Dr Rachel Gawley as part of a series on female entrepreneurs. A self-confessed tech geek, Dr Gawley has been heralded one of Innovate UK’s Women in Innovation for her pioneering healthcare app AppAttic.
Evolution of the clinical trials design process
AppAttic was developed out of frustration with traditionally-designed and implemented randomised controlled clinical trial services. Designed by a small group of researchers and conducted according to a protocol set solely from a ‘top down’ perspective with little initial patient input or consultation, randomised controlled trials (RCTs) can become a bureaucratic nightmare. Recruitment and retention of patients can be disastrous and funding can be scarce. Resources are stretched and, as a result, it can take much longer than necessary to get effective new treatments to market.
Crowdsourcing has developed as a result of the failure of the traditional system of clinical trials designed to advance new treatments in a timely and efficient manner. Patients are now better informed and more engaged with their own care than ever before and members of the public are keen to be involved in the development of new treatments and protocols.
Too many cooks?
It is sometimes suggested that too many voices contributing to a project can create confusion and lack of direction; however, companies involved in the Patient Recruitment Services, such as richmond pharmacology, are at the forefront of the new inclusive approach to trials design, with expertise in this area sourced from many diverse sectors of employment experience. People come to work on clinical trials from many different backgrounds, not always restricted to the medical sector.
Trials researchers now recognise the benefit of integrating the patient voice right from the inception of a clinical trial. Companies such as Transparency Life Sciences have developed toolkits such as their Protocol Builder, which solicits opinions from members of the public about all aspects of their prototype trials during the development stage.
Far from causing confusion, it is thought that this integrative approach will tap into the day-to-day concerns of patients that ultimately interfere with the implementation of traditionally-designed trials. Anticipating problems such as this makes trials more thorough and realistic in their scope; in addition, utilising patient expertise right from the beginning often forestalls problems developing at a later stage.