News — Arlington Heights, Ill., April 27, 2023 -- The Society for Clinical Trials (SCT) is pleased to announce that the prestigious David Sackett Trial of the Year Award will be presented to The Chronic Hypertension and Pregnancy (CHAP) Trial.
The award will be presented on May 24, 2023, as part of SCT’s 44th Annual Meeting, “Championing High-quality Evidence to Optimize Human Health,” May 21 - 24 at the Baltimore Marriott Waterfront Hotel. Accepting the award and presenting the trial will be Dr. Alan T. Tita, Senior Vice Chair for Research and Innovation, Department of Obstetrics and Gynecology, Center for Women’s Reproductive Health, Marnix E. Heersink School of Medicine, University of Alabama at Birmingham.
Since 2008, SCT has awarded the David Sackett Trial of the Year Award to a randomized, controlled trial published in the previous calendar year that best fulfills the following standards:
- Improves the lot of humankind.
- Provides the basis for a substantial, beneficial change in health care.
- Reflects expertise in subject matter, excellence in methodology, and concern for study participants.
- Overcame obstacles in implementation.
- The presentation of its design, execution, and results is a model of clarity and intellectual soundness.
- The peer reviewed trial publication date (be that on paper or electronic) must be within the 2022 calendar year.
- The trial must be tied to a single publication (or a set of papers published simultaneously in a single journal).
- Consistent with the overall aims of the Society, we support the goals of equity, diversity, and inclusion. We welcome all nominations regardless of trial setting, investigator, or patient group.
The Chronic Hypertension and Pregnancy (CHAP) trial evaluated the effects of prescribing blood pressure medication to pregnant people with mild chronic hypertension. With over 2,408 randomized participants at 61 US sites, CHAP is the largest and most diverse study of its kind.
According to the nomination submitted by Dr. Tita, chronic hypertension is a common medical disorder that causes life-threatening complications for pregnant people and their babies. At least 70% of pregnant women with chronic hypertension fall into the ‘mild’ category where there was not a medical consensus on whether to treat with medications as recommended in non-pregnant patients. This uncertainty stemmed primarily from concerns that treatment would affect the baby’s growth in the absence of proven benefits.
The research reported there was a 20% decrease in pregnancy complications, including severe preeclampsia and preterm birth before 35 weeks, for women treated with medication compared to no treatment. There were no differences in new-born size or other outcomes. CHAP led to a change in national guidelines.
“This year, the SCT David Sackett Trial of the Year Committee was honored to review numerous global nominations of clinical trials spanning a wide variety of medical settings including COVID-19, oncology, cardiology, obesity, diabetes, orthopedics, and pregnancy,” said Suzanne Dahlberg, PhD, Chair of the SCT David Sackett Trial of the Year Committee. “We are eager for Dr. Tita to present the details of his trial of treatment for mild chronic hypertension during pregnancy, a trial most deserving of this competitive award, and look forward to a lively discussion afterwards.”
Nominations for the David Sackett Trial of the Year are submitted by Society members, investigators, and interested scholars from around the world. The 2022 David Sackett Trial of the Year Committee included: Drs. Andrew Cook (co-chair), Karla Ballman, Jonathan Cook, Manohara Basoor Halasiddappa, Sonia Jain, Yan Lin, Theodore Lystig, Jessica Overbey, and Sameer Parpia. Dr. David L. Sackett was a dedicated long-time SCT member and a pioneer in evidence-based medicine and champion of clinical trials.
The SCT will issue a call for 2023 David Sackett Trial of the Year nominations later this year. Additional information and a list of past David Sackett Trial of the Year recipients on .
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About the Society for Clinical Trials: The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct, analyses, and reporting of government and industry-sponsored clinical trials and related health care research methodologies. Visit www.sctweb.org.
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