DURHAM, N.C., May 13, 2016 — A potent mix of benefits, risks, and ethical questions confronts researchers conducting novel adaptive design clinical trials. Dr. Thomas Laage, Senior Medical Director, Premier Research, explored this complex challenge in a webinar with members of the DIA Adaptive Design Scientific Working Group.
Dr. Laage, with several co-authors of the paper on which the presentation is based, led industry peers in a wide-ranging discussion that examined published and unpublished adaptive design trials in presenting Ethical Considerations in Novel Adaptive Design Clinical Trials.
The ethical challenges inherent in clinical research multiply in adaptive design trials. Though widely embraced as an advance in trial methodology, adaptive design gives rise to new ethical questions. How, for example, should investigators balance the potential to shorten drug studies — abandoning futile treatments and possibly saving lives — with the desire to protect their scientific validity?
- Confirmatory trials for treatments widely accepted on the basis of uncontrolled case series or open-label trials.
- Withholding information necessary to make a considered judgment versus compromising a trial’s scientific basis.
- Adaptations involving sample-size reassessment or dose adjustments by dropping or adding treatment arms, deeming smaller samples as statistically significant, and adjusting dosages in the interest of beneficence.
- Seeking more efficient allocation of societal resources for research in the public and commercial realms.
About Premier Research
Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.