Who’s in and who’s out? ACRO talks Inclusion-Exclusion Criteria

ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers

Clinical trials have an enormous number of inter-related, moving parts and large, global clinical research organizations (CROs) mirror that complexity. When we examine questions of trial participation – criteria for inclusion and exclusion – CROs approach the issue from a variety of perspectives. There are considerations around regulatory intelligence and study startup, feasibility, design, patient recruitment, site management and the sphere of global operations surrounding modern trials.

Called for by the 21st Century Cures Act, on April 16 the FDA and the Margolis Center for Health Policy at Duke University convened a public workshop “Evaluating Inclusion and Exclusion Criteria in Clinical Trials. Joined by stakeholders from the NIH, FDA, patient groups, pharmaceutical and biotech companies, academics and public health practitioners,  ACRO’s Executive Director,  Doug Peddicord,  shared the unique perspectives of the CRO industry. This public event saw discussion on a variety of topics related to eligibility criteria in clinical trials, their potential impact on patient access to investigational drugs, and how they might facilitate the enrollment of a diverse patient population.

The central issue is designing and executing a clinical trial that accurately differentiates the signal from noise – assessing a candidate drug’s effect – and finds a balance among the variables. Finding that signal also means accounting for probability, effect size, power and sample size. All these have to be considered without breaking the bank.

Increasingly, sponsors and CROs aim to model complex trial variables and their interaction. With a growing use of technology and data sources like electronic health records and real-world evidence, data analytics can be used to predict issues like “how recruitable” a trial will be, and the applicability of the results. A foundational issue is the criteria used to determine trial participation, and meeting participants agreed that trial protocols need to be less complex and impose fewer burdens on investigators and patients alike.

Expanding participation will require thinking outside of traditional clinical research models. Successful trials will incorporate patient  preferences during the study design phase, gather patient experience data and use virtual trials to help patients participate within their normal clinical care.

As the  stakeholder meeting demonstrated, there is no shortage of complexity in clinical research. CROs will be at the forefront of innovation to help ideas become medicines. To get more details about the topics, presentations and watch a recording of the entire meeting, visit the Margolis Center.

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