Breaking News
December 18, 2018 - California Farm Implicated in Outbreak of E. coli Tied to Romaine Lettuce
December 18, 2018 - Mobile health has power to transform HIV/AIDS nursing
December 18, 2018 - Celiac Vaccine in Clinical Trials at Columbia
December 18, 2018 - Research into mental health first aid prompts practical guidance and resources for workplace
December 18, 2018 - Researcher conducts study to investigate peripheral blood markers of Alzheimer’s disease
December 18, 2018 - Researchers identify link between mucus in the small airways and pulmonary fibrosis
December 18, 2018 - EU Commission’s Health Policy Platform to host EKHA program on transplantation
December 18, 2018 - Survivors of childhood Hodgkin lymphoma have high risk of developing solid tumors
December 18, 2018 - Small changes to cafeteria design can get kids to eat healthier, new assessment tool finds
December 18, 2018 - From Machines to Cyclic Compounds
December 18, 2018 - New study reveals best assessment tools to establish delirium severity
December 18, 2018 - Rice University scientists develop synthetic protein switches to control electron flow
December 18, 2018 - Home-based pulmonary function monitoring for teens with Duchenne muscular dystrophy
December 18, 2018 - Researchers identify potential target for new breast cancer treatments
December 18, 2018 - National Biofilms Innovation Centre award grant to Neem Biotech for novel anti-biofilm drug development
December 18, 2018 - Artificial intelligence and the future of medicine
December 18, 2018 - Montana State doctoral student receives grant for her work to improve neuroscience tool
December 18, 2018 - Early postpartum initiation of opioids associated with persistent use
December 18, 2018 - Russian scientists identify molecular ‘switch’ that could be target for treatment of allergic asthma
December 18, 2018 - Surgeons make more mistakes in the operating room during stressful moments, shows study
December 18, 2018 - Immune cells explode themselves to inform about the danger of invading bacteria
December 18, 2018 - Malnutrition in children with Crohn’s disease linked with increased risk of surgical complications
December 18, 2018 - FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)
December 18, 2018 - The long and short of CDK12
December 18, 2018 - Hologic’s Cynosure division introduces TempSure Surgical RF technology in North America
December 18, 2018 - CMR Surgical partners with Nicholson Center to launch U.S.-based training program for Versius
December 18, 2018 - Findings reinforce guidelines for cautious use of antipsychotics in younger populations
December 18, 2018 - Study finds new strains of hepatitis C virus in sub-Saharan Africa
December 18, 2018 - New battery-free, implantable device aids weight loss
December 18, 2018 - Parental alcohol use disorder associated with offspring marital outcomes
December 18, 2018 - Novel Breast Imaging Technique Might Cut Unnecessary Biopsies
December 18, 2018 - What can a snowflake teach us about how cancer spreads in the body?
December 18, 2018 - Management of nausea and vomiting in pregnancy costs the NHS more than previously thought
December 18, 2018 - Green leafy vegetables may reduce risk of developing liver steatosis
December 18, 2018 - Veganism linked to nutrient deficiencies and malnutrition if not planned correctly
December 18, 2018 - Coming Soon: A Tiny Robot You Swallow to Help You Stay Healthy
December 18, 2018 - Modified malaria drug proven effective at inhibiting Ebola
December 18, 2018 - Study finds epigenetic differences in the brains of individuals with schizophrenia
December 18, 2018 - Fitness instructors’ motivational comments influence women’s body satisfaction
December 18, 2018 - Study focuses on modification of lipid nanoparticles for successful brain cell targeting
December 18, 2018 - New gut bacteria may be effective against obesity, metabolic and mental disorders
December 18, 2018 - New two-in-one powder aerosol to upgrade fight against deadly superbugs in lungs
December 18, 2018 - Biofilms feed with swirling flows
December 17, 2018 - Study identifies specific neurological changes related to traumatic brain injury
December 17, 2018 - New study confirms geographic bias in lung allocation for transplant
December 17, 2018 - Research focuses on optimization of solid lipid nanoparticle that encapsulates Vinorelbine bitartrate
December 17, 2018 - Carpal tunnel syndrome – Genetics Home Reference
December 17, 2018 - A novel insulin accelerant
December 17, 2018 - Tips for caring for patients with disabilities, from a mother and physician
December 17, 2018 - Menopause-related sexual, urinary problems tied to worse quality of life
December 17, 2018 - In-school nutrition programs among students limit increases in BMI, finds study
December 17, 2018 - Risk for Hospitalization for Heart Failure Greater With Diabetes
December 17, 2018 - Food assistance may help older adults adhere to diabetes meds
December 17, 2018 - Supporting a family’s goals during a difficult pregnancy
December 17, 2018 - Neurons with Good Housekeeping Are Protected from Alzheimer’s
December 17, 2018 - New approach to tumor analysis could improve prognosis for bowel cancer patients
December 17, 2018 - New ‘epigenetics-based’ cervical cancer test outperforms Pap smear and HPV tests
December 17, 2018 - Ten year follow-up after negative colonoscopy related to reduced risk of colorectal cancer
December 17, 2018 - CTF along with NTAP and Sage announce first-ever open data portal for neurofibromatosis
December 17, 2018 - Intimacy: The Elusive Fountain of Youth?
December 17, 2018 - Will saliva translate to a real diagnostic tool?
December 17, 2018 - DFG establishes nine new Research Units and one new Clinical Research Unit
December 17, 2018 - Assisted living’s breakneck growth leaves patient safety behind
December 17, 2018 - America’s teens report dramatic increase in their use of vaping devices in just one year
December 17, 2018 - Enlarged heart linked to a higher risk of dementia
December 17, 2018 - Prostate cancer detection using MRI now first-line investigation tool
December 17, 2018 - Loughborough academics part of new project investigating effectiveness of personalized breast cancer screening
December 17, 2018 - Adolescents who use cognitive reappraisal had better metabolic measures, shows study
December 17, 2018 - Probiotics may offer therapeutic benefits for biopolar patients
December 17, 2018 - Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Dry Age-Related Macular Degeneration with Geographic Atrophy
December 17, 2018 - Studies reveal role of red meat in gut bacteria, heart disease development
December 17, 2018 - Eisai enters into agreement with Eurofarma for its anti-obesity agent lorcaserin
December 17, 2018 - Researchers use brain connectome to reassess neuroimaging findings of Alzheimer’s disease
December 17, 2018 - “Miracle” baby survives Ebola in Congo and rapid a new Ebola detection device
December 17, 2018 - Mechanisms behind neonatal diabetes uncovered
December 17, 2018 - AHF urges the WHO to expedite approval process for vaccine effective against Ebola
December 17, 2018 - Study finds misuse of benzodiazepines to be highest among young adults
December 17, 2018 - TGen receives PayPal grant to underwrite costs of genetic tests for children with rare disorders
December 17, 2018 - New research highlights why HIV-infected patients suffer higher rates of cancer
December 17, 2018 - Antibiotic-resistant bacteria could soon be targeted with Alzheimer’s drug
Clinical trial investigators found non-compliant with requirement to report results on EU register

Clinical trial investigators found non-compliant with requirement to report results on EU register

image_pdfDownload PDFimage_print

According to EU legislation, clinical trials must be prospectively registered in the European Union Clinical Trials Register (EUCTR) and the main results must be reported there one year after completion of the trial. This information is thus publicly available. But in fact, results are only reported for half of drug trials (49.5%). According to an analysis recently published in the British Medical Journal (BMJ), with a rate of 68.1%, pharmaceutical companies were relatively compliant, but with a rate of 11.0%, the result was very poor for non-commercial research organizations.

Jürgen Windeler, the Director of the German Institute for Quality and Efficiency in Health Care (IQWiG) notes: “The fact that tax-funded universities are not fulfilling their legal obligations is particularly regrettable. But the BMJ article does not surprise us: On several previous occasions, the Institute experienced that clinical trial investigators at universities withheld data.”

Transparency is relatively high for drug trials

In general, data transparency is higher for drug trials than for trials of non-drug interventions, in which medical devices are often used. This is because the EU regulation mentioned above has been effective for drugs since 2012. A comparable regulation for medical devices was only concluded in 2017 and will be effective from 2020 onwards.

Moreover, since 2011 in Germany, according to the Act on the Reform of the Market for Medicinal Products (AMNOG), pharmaceutical companies must provide all relevant data on new drugs, which as a rule can be published. After initial resistance, the companies now accept these transparency requirements. This corresponds to the BMJ finding that 11 large commercial sponsors of trials reported all results in EUCTR within the one-year deadline.

University research groups withhold data

According to the BMJ, compliance is particularly lacking at universities conducting drug trials. These also include German universities such as Berlin (Charité), Heidelberg and Cologne (0%). In contrast, a British university, Dundee, reached the highest rate of registry entries (82%).

IQWiG’s negative experiences with university research groups primarily refer to medical device trials. At the end of August 2018, in its preliminary report on negative pressure wound therapy the Institute found that not only the device manufacturer, but also clinical trial investigators at universities answered the Institute’s requests only incompletely or not at all.

This was not an exceptional case: The Institute could not draw a conclusion on the benefit or harm of stem cell transplantation for multiple myeloma because even more than 10 years after their completion, three large trials had still not been fully published. Two of these trials were under German supervision (universities of Heidelberg and Würzburg). An Australian research group has shown that things can be handled differently: They provided all individual patient data from a trial to IQWiG. This enabled IQWiG to perform additional analyses that ultimately led to a positive conclusion in the benefit assessment (corneal collagen cross-linking in patients with keratoconus).

Increase pressure on clinical trial investigators

Jürgen Windeler notes: “There are substantial deficits in investigator-initiated trials (IITs) with regard to data transparency – and sanctions are seemingly required to quickly change this.” One option could be that research funders impose specific requirements. They should check whether an applicant has completely reported its previously funded project in the EU Register and, if applicable, refuse further funding.

As trials are also conducted without public funding, in addition, ethics committees should also monitor whether legal regulations such as inclusion of a trial in the EU Register are being followed, because these committees know all trials conducted in a certain region or university.

Lack of transparency impairs health care

The fact that clinical trials are not registered and their results are not reported is not a trivial offence. Rather, ethical and scientific standards are being violated, because the benefit and harm of medical interventions can only be correctly assessed on the basis of complete data. Only then can physicians and patients decide on the best-possible alternative.

Source:

https://www.iqwig.de/en/press/press-releases/clinical-trial-investigators-violate-eu-regulations-entries-in-eu-register-are-incomplete.10189.html

Tagged with:

About author

Related Articles