CRO/ Sponsorship and Future of Clinical Trials

With the increasing challenges associated with bringing a medical product to market, and skyrocketing R&D costs, there has been a shift in biopharmaceutical commercialization and clinical trial strategies in order to minimize risk and maximize success.  It is estimated that bringing medical products to market costs $1.3 billion and 1 out of every 5000 experimental compounds achieve FDA approval. Moreover, market saturation in many disease modalities is also forcing biopharmaceutical enterprises to focus their efforts on accessing patients with orphan/rare diseases.
 
The future of clinical trials illustrated as follows. Access and engage the patient online – Attract patients to the trial – Consent patients & convert to subjects – Remotely manage subjects & collect data. The sponsor plans to engage the patient through social media, such as Facebook, and regular e-mail updates in order to attract the patient to the trial, and once the patient agrees to learn more about the trial, the sponsor mails the patient a package containing mobile health devices, which collect medical diagnostic data and sends that data to the sponsor.  The patient turns on the tablet, which contains an electronic consent and a video of a physician explaining the clinical trial in detail. Humanization in digital media is believed to be an effective tool that is used to communicate with patients. During the clinical trial, the subject is able to access live physicians either virtually or through nearby medical community centers. Remote nurses visit the subject at their homes to collect samples.  In addition, the patient uses the mobile health device to automatically upload study data directly to the sponsor's EDC database.
 

Based on our research, we forecast that the global clinical trial service market will likely reach more than $64 B by 2020, up from $38.4 B at present, representing a CAGR of 9% between 2015 and 2020. By 2020 the average clinical trial outsourcing penetration will likely reach around 72%. In other words, by then close to three fourths of clinical trials will likely be performed by professional CROs.

 

Traditional clinical trials center on one or more sites where study staff see patients directly for recruitment, follow-up and data collection. Currently available remote technologies are mobile health delivery systems, telemedicine, and remote sensor devices, may increase the efficiency of clinical trials. Mobile technologies hold the prospect of reducing or eliminating visits of trial participants to study sites and may result in more efficient and reliable data collection. The program aims to determine how mobile technologies can be used to improve clinical trials in areas of remote monitoring/engagement and new novel data collections methods to enhance knowledge of disease trajectory and treatment efficacy.

  • Basis for a successful sponsor-CRO partnership
  • The past, present and future of clinical research
  • Clinical development of the future
  • Clinical trial site of the future
  • Clinical assessments of the future
  • Outsourcing of technologies
  • Mobile technology
  • Business development tactics for clinical research sites

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