Apple ResearchKit attracted a lot of attention from researchers after its announcement on 9th of March 2015. One of the most discussed topics is clinical trials recruitment and consent option and all possible ethical challenges associated with open access database. 

Although there are some valid points for concern this is a great opportunity for researchers to be able to adopt electronic recruitment and consent. Currently there are companies that offer web-based recruitment and consent options for clinical trials. However, these options are not cost effective and therefor not widely adopted. This is why Apple ResearchKit for clinical trials is an important step in the process of adoption of electronic consent process, which could improve significantly patients’ participation in clinical trials.

However, the main challenge remains and it is not related to electronic consent process and ResearchKit ethical concerns but to clinical trials design. Majority of the clinical trials require participants to attend clinic and have assessments. Therefor, clinical trials participation cannot be limited only to online data collection. 

Case study

A very good example of this challenge is a recent phase 1 paid study with healthy volunteers, which was using web-based electronic consent and recruitment. In this particular study participants were able to complete eligibility assessment online and sign electronically initial agreement to participate in the trial. Then they had to book an appointment with clinical trials team to attend their first visit and have a full consent. There was a great interest in the study and lots of people registered in the web-site, however then the real challenge emerged. 

  • Participants provided wrong contact details
  • Changed their mind and decided not to participate
  • Not answering their phones and e-mails
  • Participants not attending their appointments 
  • Withdrawing from the study after the first appointment 
  • Providing wrong information about their medical history, not meeting eligibility criteria, etc.

The result was that clinical trial team was frustrated with lack of contact with participants and constant challenges. The online assessment and consent system, which was supposed to streamline the process, has become time- and resource-consuming burden. 

In clinical trials the real challenge begins after the online assessment and consent. Can we trust the data provided? Do the participants understand the requirements of the clinical trial? Are they serious about participating? 

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 11 Mar 2015