Blog posts

Meet patients where they are with consent information

The cornerstone of access to any clinical research project is the informed consent process–the decision of a participant to join a study based upon full and complete sharing of information about what the study will require, the risks of participation, and the voluntary nature of that participation.

This isn’t simply the participant’s signature on a paper or electronic form. According to governmental organizations like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), that signature is only part of the process. Of perhaps even greater importance is the provision of information to the patient accompanied by a discussion of the study and a chance to have questions answered, so that the decision can truly be considered “informed.”

Webinars

Improve trial enrollment using patient perspectives and technology

In this webinar, Nisha Trivedi, Patient Advocate, and Jena Daniels, VP of Patient Success showcase how adding technology in clinical trials enables greater diversity and an increase in study enrollment upfront and maintains patient engagement over the course of the study.

Webinar Highlights:

  • Establishing internal relationships with end-users (patients, caregivers, and sites) will increase technology adoption
  • Using technology to increase participant access, engagement, retention, and education
  • Navigating uncertainties in technology and approach while balancing the needs of participants providing them with a positive and differentiated experience
  • Ensuring patients, caregivers, and sites are engaged in the study design and implementation process

Blog posts

Podcast: How do you ensure clinical trial access for all?

Medable CEO Michelle Longmire joins Beyond the Molecule Podcast to discuss how the industry can expand clinical trial access to all populations.

Blog posts

Where does patient recruitment end and patient engagement begin?

It’s widely understood that patient recruitment is one of the most critical and yet most challenging aspects to a successful clinical trial. In fact, many trials fail to reach recruitment goals, with far-ranging implications for investigators, sponsors, study participants, and the population affected by the disease or condition under study.

A man completes eConsent on his smartphone
Blog posts

Informed Consent Forms (ICFs) for Clinical Trials: Write with plain language please

Informed consent is a critical element of any clinical trial, as it starts the process that leads to a patient's participation in a trial. An informed consent form (ICF) is written by sponsors and delivered to patients to provide them with all the information they need about the study to make an informed decision around their participation. Traditionally done with paper-and-pen, an effective ICF is clear, concise, and straightforward, while covering all of the required elements defined by regulatory bodies, such as Good Clinical Practice (GCP) as defined in ICH E6(R2). Unfortunately, many ICFs are not well-written, use overly scientific language, and are overly complex, which can confuse and potentially alienate a potential participant. This blog examines ways to improve this important communication process using clear language and the latest technology.

See how Medable can make your trials more efficient.