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Clinical Trial News

FDA Issues Guidance for Cardiovascular Risk Assessment of Novel Antidiabetic Agents

The FDA has released final guidance for assessing cardiovascular risks in new type 2 diabetes treatments, emphasizing the importance of clinical trials to ensure these therapies do not increase cardiovascular event risks. The guidance mandates detailed safety information from Phase II and III trials, including the establishment of a cardiovascular end-point committee and the inclusion of high-risk individuals. A meta-analysis of trial data is required post-trial to evaluate drug safety comprehensively.

WuXi PharmaTech Strengthens Board with Strategic Appointments of Industry Veterans

• WuXi PharmaTech has appointed several key executives to its Board of Directors, including Ying Han, Stewart Hen, and co-founder Ning Zhao, bringing valuable financial and pharmaceutical expertise to the company.
• The strategic board appointments aim to enhance WuXi's business operations and financial systems as the company continues to expand its pharmaceutical R&D outsourcing services in China and the United States.
• Co-founder Tao Lin has stepped down from his position on the board and as Vice President of Internal Operations, marking a significant leadership transition for the growing pharmaceutical services organization.

New Cancer Treatment Successes Identified in Phase 3 Trials

A comprehensive evaluation of phase 3 randomized controlled trials (RCTs) conducted by the NCI-funded COG program from 1955 to 2000 reveals that new cancer treatments were statistically superior in 24% of comparisons, with a 5% relative reduction in the death rate. The study highlights the importance of the ethical principle of equipoise in clinical research and suggests that the current system of RCTs in cancer is efficient within certain limits, with a consistent pattern of treatment successes over time.

KU Team Announces Breakthrough in Leishmaniasis Treatment

Scientists at Karachi University's H.E.J. Research Institute of Chemistry have developed a herbal ointment for treating cutaneous leishmaniasis, showing high success rates in clinical trials without side effects. The disease, a significant public health concern in Pakistan, has seen a 90% treatment success rate in trials.

Study on Adherence to Glaucoma Medication Regimens

A study utilizing electronic monitoring to objectively measure adherence to glaucoma medication regimens found good adherence rates among patients using once-daily prostaglandin analogs, whether as sole therapy or with an adjunctive medicine.

Mifepristone Shows Promise as Weekly Contraceptive in Clinical Trial

  • A clinical trial in China evaluated weekly doses of 25mg and 50mg of mifepristone for contraception, demonstrating no pregnancies across 456 women-months of use.
  • The 50mg mifepristone group experienced significantly fewer bleeding days and more bleeding-free days compared to the 25mg group in later study cycles.
  • Side effects like nausea and breast distension were uncommon and mild in both mifepristone dosage groups, suggesting good tolerability.
  • These findings suggest weekly mifepristone could be a potential contraceptive option, warranting further investigation into its efficacy and safety.

Progress and Challenges in Developing Blood-Stage Malaria Vaccines

Recent trials of the MSP/RESA (Combination B) vaccine, targeting the blood-stage of malaria, show promise in reducing parasite density but not in preventing clinical malaria episodes. The vaccine's efficacy is variant-specific, highlighting the need for further development and inclusion of all significant allelic types.

Lyme Disease Treatment Trials: Generalizability Concerns Highlighted

  • A review questions the broad applicability of chronic Lyme disease treatment trials due to patient selection criteria.
  • The original study's population had long-term illness and multiple prior treatments, unlike many typical Lyme patients.
  • Exclusion of patients with early-stage chronic Lyme or those never treated limits the trial's generalizability.
  • The analysis suggests caution in applying trial results to all chronic Lyme disease patients, especially regarding antibiotic treatment.

FDA Approves First Fully Implantable Artificial Heart for End-Stage Patients

  • The FDA has approved the AbioCor Implantable Replacement Heart, the first completely implantable artificial heart, for patients with severe heart failure who are ineligible for a heart transplant.
  • The device is intended for individuals with acute heart failure who are not candidates for heart transplantation and have a life expectancy of less than a month.
  • Clinical trials demonstrated that the AbioCor extended survival by an average of 4.5 months, providing patients with valuable time with family and friends.
  • Abiomed Inc. developed the artificial heart, which replaces the patient's own heart and includes a power transfer coil, internal battery, and controller.
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