Validation of patients for non-interventional clinical studies

In November 2018, Global Perspectives™ jointly presented a paper at ISPOR about increasing the level of validation among rare patients who will take part in non-interventional clinical studies. In this blog, I want to briefly summarise the findings to explain how Global Perspectives™ can help tailor the recruitment strategy at the correct level of validation. You can find the full presentation at this link.

When recruiting patients, particularly if they are rare patients, the recruitment strategy should be designed to suit the target audience. Often a large sample size is needed in order to provide confidence in the data. A combination of recruitment techniques is more likely to result in a large sample size. Different recruitment sources have different levels of validation associated with them. The below list is ordered from the most validated to the least validated sources of patients:

  • Clinical sites
  • Physician referrals
  • Patient associations
  • Recruiter networks
  • Patient referrals
  • Social media groups
  • Patient panels
  • Consumer panels
  • Open survey links

Validation of patients is allied to patient knowledge, engagement and honesty. If the eligibility criteria is too technical then patients may not know whether they fit the validation criteria. If patients are not engaged, for example, during a long and repetitive survey then they might not be giving their full attention, and there is a risk of a dishonest respondent completing the study if proper checks and not put in place during the recruitment stage.

The following methods can increase the validation of patients for non-interventional clinical studies:

  • Careful selection of recruitment techniques
  • Confirmation of diagnosis by Dr’s notes, CRFs, photos of medication or copies of healthcare records
  • Using experienced human recruiters to check validation of patients and to ensure that patients are engaged. Patients with rare diseases are usually very engaged to share their experiences for a clinical study so it is important that the recruiter can explain the study objectives in a clear way to patients
  • Using a good hidden screener that has been tested on patients to be understandable
  • Checking and removing bad data. For example, respondents who have completed the survey too quickly without fully considering their answers

Global Perspectives™ can help design the right recruitment and validation strategy for your project. Please get in touch with Joe Waby for more information.