Checking all the boxes: compliance in patient studies

Navigating through compliance issues and regulatory mazes when designing a patient study is undoubtedly difficult, but success can be achieved through a well-conceived, high-quality approach.
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Dr. Jessica Santos
Dr. Jessica

Senior Director, Global Compliance and Quality, UK

Ensuring that Regulatory and Ethical Requirements are Met in Patient Research

Gathering and analyzing patient insights while adhering to regulatory and compliance demands can be very challenging, especially since patient studies can move in many directions. Regulations, ethics, compliance and privacy, as well as study types such as Market Intelligence (MI), Real World Research (RWR), Non-Interventional Study (NIS), Health Economics and Outcomes Research (HEOR) and even clinical trials, are all key factors that must be considered when designing a study. Decisions are critical – as they influence cost, the timeline, correct conduct, and the final output of the study.

Key Questions

The first question to ask is how the study results will be used. Will the results be used to satisfy regulatory bodies, such as the U.S. FDA or the European Medicines Agency? Or, will they be used as part of a submission dossier, released externally in a scientific publication, produced for internal business use, or to evaluate a patient support program? From there, we'll want to determine study type, where the objectives will let us know whether we need an opinion-based study or one that’s grounded in real-world evidence.

At Kantar, we determine the operational study type based on the scientific and regulatory aspects of the study design and other sources, including study protocol/outline and questions and answers submitted with the RFP. We then decide how the project will be categorized by assigning an operational research area. This can be Market Research (MR), Clinical Research (CR), Health Research (HR) or Pharmacoepidemiology (PE), depending on the study type and purpose.

Once a study type is confirmed, we determine the correct conduct of the study. This includes the quality standards to follow and industry codes of conduct to observe. For example, if patients are recruited through investigational sites there are specific guidelines to follow that are different from the guidelines that apply to patients recruited from traditional market research panels. We always apply standards specific to the four key operational research areas. These standards include ISO, GEP, GPP and GCP. Next, it's critical to have a solid understanding of the required quality standards and SOPs in the countries of interest. This will ensure full compliance with legal and ethical requirements, as well as positively impact study costs, timing, the ability to achieve objectives, and validity of results.

An increasingly common question in healthcare research involving patients is whether or not to obtain IRB/EC approval. This needs to be carefully considered, as the purpose of IRB/EC review is to make sure that appropriate steps are taken to protect the rights and welfare of people participating as research subjects. Finally, we must always keep in mind that research involving patient intervention has higher risks than observational studies or studies using secondary patient data alone.

A Highly Skilled Partner

As demand for healthcare research involving patients continues to increase, the patient’s voice, patient-based evidence and published findings will remain front and center. Navigating through compliance issues and regulatory mazes when designing a patient study is undoubtedly difficult, but success can be more easily achieved through a well-conceived, high-quality approach. Partnering with a highly-skilled research partner enables companies to better navigate this complex environment and instill confidence that all regulatory and ethical requirements are identified, disclosed, discussed and addressed.

Kantar's HERO Framework™, short for Healthcare Ecosystem and Real-world Outcomes, provides the most holistic view of patients and their behaviors and motivations. The HERO Framework™ combines Kantar Health's ability to listen to the healthcare consumer, apply our unmatched healthcare consumer-based evidence, and leverage our vast heritage and expertise to create an action-ready blueprint for achieving commercial success.

I encourage you to take a look at our latest white paper: Navigating the Regulatory and Compliance Landscape of Patient Centric Research.


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