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Clinical Trial News

Time and Motion Studies Emerge as Critical Tool for Healthcare Efficiency Assessment

• Time and motion studies provide valuable real-world evidence by quantifying the impact of medical interventions on healthcare facility dynamics and resource utilization through direct observational data collection.
• These studies help facility administrators optimize staffing needs and resource allocation while supporting regulatory requirements for new medical products with real-world effectiveness data.
• Success in time and motion studies requires careful study design, well-trained observers, standardized data collection processes, and sophisticated analytical approaches to generate meaningful efficiency metrics.

Wales Launches £100 Million Life Sciences Hub to Boost Innovation and Investment

• Wales establishes a major life sciences initiative with a £100 million investment fund, representing the largest sector-specific investment in the country's history.
• Life Sciences Hub Wales secures Johnson & Johnson Innovation and GE Healthcare as anchor tenants, creating a collaborative ecosystem for academia, business, and healthcare sectors.
• The initiative has already invested £20 million in strategic projects, including Simbec Research's expansion and ReNeuron's relocation of cell manufacturing operations to Wales.

FDA Approves HPV DNA Test as Primary Cervical Cancer Screening Alternative to Pap Smear

• The FDA has approved Roche's cobas HPV DNA test as the first alternative primary screening method for cervical cancer, potentially shifting decades of clinical practice centered around Pap testing.
• The HPV test detects the human papillomavirus DNA in cervical samples, targeting the virus responsible for nearly all cervical cancer cases, while traditional Pap tests examine cells microscopically for abnormalities.
• Despite unanimous endorsement from FDA advisory committee members, a coalition of 17 women's health organizations has opposed the approval, citing concerns about inadequate testing, potential overtreatment, and increased healthcare costs.

Innovative Strategies for Patient Recruitment in Rare Disease Trials: Lessons from the Alkaptonuria Experience

  • The National Alkaptonuria Centre (NAC) and DevelopAKUre clinical trials face significant recruitment challenges, needing to identify patients from a limited global pool of only 1,000 known cases.
  • Novel recruitment strategies include GP fax campaigns, professional medical network outreach, and dedicated microsites, though initial physician response rates remain low at 6%.
  • Patient retention proves more challenging than recruitment, requiring dedicated support staff and comprehensive benefits communication to maintain participation in long-term trials.

Strategic Clinical Trial Design: Bridging the Gap Between Regulatory Approval and Market Access

• Clinical trial data now serves dual purposes: regulatory approval and reimbursement decisions, requiring pharmaceutical companies to rethink their trial design strategies.
• Analysis of Multiple Sclerosis trials revealed significant misalignment between clinical trial outcomes and Health Technology Assessment (HTA) priorities, highlighting the need for better trial planning.
• Effective trial design must incorporate both clinical efficacy measures and economic modeling parameters to successfully navigate regulatory approval and secure market access.

Oasis Diagnostics Receives Michael J. Fox Foundation Grant for Saliva-Based Parkinson's Test

Neurology
  • Oasis Diagnostics has been awarded a research grant from The Michael J. Fox Foundation to validate their non-invasive, saliva-based rapid test for Parkinson's disease detection and diagnosis.
  • The company will collaborate with Dr. Charles Adler's team at Mayo Clinic in Scottsdale to study proprietary salivary biomarkers, with research suggesting that just three of 50 identified biomarkers can provide accurate diagnosis.
  • The VerOFy® Rapid Test Platform could potentially transform Parkinson's diagnosis, offering a non-invasive alternative to current expensive and invasive diagnostic methods while potentially accelerating clinical trials of disease-modifying treatments.

Advancements in Natural Killer Cell Cancer Immunotherapy

Recent studies highlight the potential of Natural Killer (NK) cells in cancer immunotherapy, focusing on enhancing their anti-tumor responses through adoptive transfer, cytokine activation, and blocking inhibitory signals. Clinical trials have shown promising results, especially in treating hematologic malignancies, by improving NK cell targeting, functional competence, and expansion in patients.

Urelumab (CD137 mAb) With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients

NCT02420938WithdrawnPhase 2
M.D. Anderson Cancer Center
Posted 7/1/2015

Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation

NCT01853358CompletedPhase 1
Institut Paoli-Calmettes
Posted 4/1/2013

Phase I/II Carfilzomib Plus Lenalidomide and Rituximab in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

NCT01729104TerminatedPhase 1
M.D. Anderson Cancer Center
Posted 4/25/2013

Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies

NCT01823198CompletedPhase 1
M.D. Anderson Cancer Center
Posted 6/11/2013

Expanded Natural Killer (NK) Cells for Multiple Myeloma Study

NCT01040026CompletedPhase 1
University Hospital, Basel, Switzerland
Posted 10/1/2012

QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab

NCT02384954TerminatedPhase 1
Altor BioScience
Posted 4/17/2015

Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

NCT01904136CompletedPhase 1
M.D. Anderson Cancer Center
Posted 4/22/2014

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

NCT01898793TerminatedPhase 1
Washington University School of Medicine
Posted 8/11/2014

NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases

NCT01370213CompletedPhase 2
Masonic Cancer Center, University of Minnesota
Posted 9/1/2011

Efficacy of Lenalidomide With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma

NCT01956695CompletedPhase 2
Institut Curie
Posted 9/18/2013

QUILT-3.018: Neukoplast™ (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia

NCT00900809CompletedPhase 1
ImmunityBio, Inc.
Posted 5/12/2014

IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT

NCT01885897CompletedPhase 1
Masonic Cancer Center, University of Minnesota
Posted 11/11/2013

QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma

NCT02099539Unknown StatusPhase 1
Altor BioScience
Posted 10/1/2014

A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias

NCT01287104CompletedPhase 1
National Cancer Institute (NCI)
Posted 1/29/2011

NK Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer

NCT02030561Unknown StatusPhase 1
National University Hospital, Singapore
Posted 1/1/2014

NK Cells in Cord Blood Transplantation

NCT01619761Unknown StatusPhase 1
M.D. Anderson Cancer Center
Posted 5/3/2013

Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer

NCT00789776CompletedPhase 1
Fred Hutchinson Cancer Center
Posted 10/13/2008

Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma

NCT02280525CompletedPhase 1
M.D. Anderson Cancer Center
Posted 3/5/2015

Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)

NCT02185781CompletedPhase 1
Gruppo Italiano Malattie EMatologiche dell'Adulto
Posted 1/28/2015

Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)

NCT01385423CompletedPhase 1
Masonic Cancer Center, University of Minnesota
Posted 9/1/2011

Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT01787474CompletedPhase 1
M.D. Anderson Cancer Center
Posted 5/19/2014

Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy

NCT01807611CompletedPhase 2
St. Jude Children's Research Hospital
Posted 5/16/2013

CNDO-109-AANK for AML in First Complete Remission (CR1)

NCT01520558Unknown StatusPhase 1
Coronado Biosciences, Inc.
Posted 12/1/2012

Niraparib Maintenance Therapy Demonstrates Sustained Benefit in Recurrent Ovarian Cancer

  • Niraparib maintenance therapy significantly improves progression-free survival (PFS) in patients with recurrent, platinum-sensitive ovarian cancer, regardless of BRCA mutation status.
  • The NOVA trial, a phase 3 study, demonstrated a statistically significant and clinically meaningful benefit with niraparib compared to placebo in prolonging time to disease progression.
  • Niraparib showed efficacy in both patients with and without germline BRCA mutations, highlighting its potential as a broad maintenance therapy option.
  • The safety profile of niraparib was manageable, supporting its use as a maintenance strategy to extend remission in recurrent ovarian cancer.

Contraceptive Implant on Day of Mifepristone Administration Shows High Satisfaction

  • A pilot study evaluated the acceptability of initiating the etonogestrel implant at the time of mifepristone administration for medical abortion.
  • The study found that 87.5% of participants were satisfied with the timing of implant insertion.
  • At one year, 87.5% of participants with available follow-up data continued using the implant.
  • These findings suggest that initiating the contraceptive implant on the first day of medical abortion is a well-received approach.

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