Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Study shows Phase I cancer findings under-reported

23.08.2005


Increased publishing in peer-reviewed journals could impact patient care, outcome; researchers need commitment, set time devoted to effort

Phase I cancer studies, trials that are conducted to determine the safety and maximum dose of a new agent, are under-reported in peer-reviewed journals - a trend that could ultimately delay scientific progress and negatively affect patient care, say researchers at The University of Texas M. D. Anderson Cancer Center in a new study out on Mon., Aug, 22 online in Cancer.

Over the last decade, greater understanding of cancer at the molecular and cellular levels has resulted in a scientific discovery explosion, translating into the development of numerous potential anticancer agents. An excellent indication of this progress, says Luis Camacho, M.D., assistant professor of medicine in M. D. Anderson’s Phase I Clinical Trials Program, is the 10-fold increase in the number of Investigational New Drug (IND) applications for oncology agents filed with the Food and Drug Administration - from 100 compounds in 1980 to over 1,000 in 1998.



"With all this new knowledge, the need to share information is paramount, now more than ever before," says Camacho, the study’s senior author. "We, as clinicians and researchers, have a tremendous responsibility to not only investigate and discover new agents, but also to disseminate our discoveries - good and bad - to the medical community at large, to ensure the safety and well-being of our patients."

Given this acceleration of discovery, scientific meetings have become inundated with study submissions, reports Camacho. Yet, often these results are preliminary and subject to change after final analysis. Therefore, publishing in peer-reviewed scientific journals remains the "gold-standard" for sharing medical information, he says.

To understand the rate at which Phase I trials were being published, Camacho and his team analyzed the 275 Phase I abstracts accepted by the American Society of Clinical Oncology (ASCO) for presentation at its annual meeting in 1997, and determined whether those findings had been published over the next seven and a half years. Through repeated MEDLINE searches and emailed questionnaires, researchers discovered that by February 2001, two-thirds (67 percent) of the Phase I abstracts had been published in peer-reviewed medical journals.

Researchers found that the Phase I ASCO studies of novel (agents not approved by the FDA) and non-novel (studies including at least one FDA-approved agent) drugs were published at an equal rate. Research that was financially supported by the pharmaceutical industry was published at the same rate of those studies not industry-supported. There was no difference in the rate of oral and poster presentations published; however, oral presentations were published more quickly than those presented as posters.

Publishing positive or negative Phase I trial results is critically important in developing new, or modifying existing cancer therapies, Camacho says.

"Obviously, if a Phase I agent proves too toxic, we need to ensure that information is shared within the cancer medical community, so as to not put patients in harms way," Camacho says. "Of course, if Phase I studies are promising, publishing can encourage further investigation of these potential therapeutic agents."

In unique cases, Camacho says, positive Phase I results can have immediate impact on clinical care.

"Phase I studies are not necessarily first-in-human trials - they also can be combinations of already approved drugs," he adds. "If those combinations prove relatively non-toxic and show some effect, that combination can potentially be moved forward to Phase II and, in selected cases, used to treat patients, almost immediately."

The median time to publication - 3.4 years - also is very concerning, Camacho says. "Releasing data after such a lengthy interval may not allow researchers to build on their scientific experience, thereby significantly delaying further investigation with encouraging agents."

From the questionnaire sent to investigators, Camacho and his team learned that lack of time and investigator relocation were the major obstacles of publication. These reasons were unexpected, as researchers expected to learn that negative results, lack of interest in pursuing projects to completion, or the stringent peer-review process would be among the reasons why investigators had not published.

Given the investigators reasons for not publishing, Camacho says that academic institutions should provide academicians more time to concentrate on publishing efforts. In return, clinicians must be committed to reporting Phase I toxicities in peer-review literature.

Laura Sussman | EurekAlert!
Further information:
http://www.mdanderson.org

More articles from Studies and Analyses:

nachricht New study: How does Europe become a leading player for software and IT services?
03.04.2017 | Fraunhofer-Institut für System- und Innovationsforschung (ISI)

nachricht Reusable carbon nanotubes could be the water filter of the future, says RIT study
30.03.2017 | Rochester Institute of Technology

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Can the immune system be boosted against Staphylococcus aureus by delivery of messenger RNA?

Staphylococcus aureus is a feared pathogen (MRSA, multi-resistant S. aureus) due to frequent resistances against many antibiotics, especially in hospital infections. Researchers at the Paul-Ehrlich-Institut have identified immunological processes that prevent a successful immune response directed against the pathogenic agent. The delivery of bacterial proteins with RNA adjuvant or messenger RNA (mRNA) into immune cells allows the re-direction of the immune response towards an active defense against S. aureus. This could be of significant importance for the development of an effective vaccine. PLOS Pathogens has published these research results online on 25 May 2017.

Staphylococcus aureus (S. aureus) is a bacterium that colonizes by far more than half of the skin and the mucosa of adults, usually without causing infections....

Im Focus: A quantum walk of photons

Physicists from the University of Würzburg are capable of generating identical looking single light particles at the push of a button. Two new studies now demonstrate the potential this method holds.

The quantum computer has fuelled the imagination of scientists for decades: It is based on fundamentally different phenomena than a conventional computer....

Im Focus: Turmoil in sluggish electrons’ existence

An international team of physicists has monitored the scattering behaviour of electrons in a non-conducting material in real-time. Their insights could be beneficial for radiotherapy.

We can refer to electrons in non-conducting materials as ‘sluggish’. Typically, they remain fixed in a location, deep inside an atomic composite. It is hence...

Im Focus: Wafer-thin Magnetic Materials Developed for Future Quantum Technologies

Two-dimensional magnetic structures are regarded as a promising material for new types of data storage, since the magnetic properties of individual molecular building blocks can be investigated and modified. For the first time, researchers have now produced a wafer-thin ferrimagnet, in which molecules with different magnetic centers arrange themselves on a gold surface to form a checkerboard pattern. Scientists at the Swiss Nanoscience Institute at the University of Basel and the Paul Scherrer Institute published their findings in the journal Nature Communications.

Ferrimagnets are composed of two centers which are magnetized at different strengths and point in opposing directions. Two-dimensional, quasi-flat ferrimagnets...

Im Focus: World's thinnest hologram paves path to new 3-D world

Nano-hologram paves way for integration of 3-D holography into everyday electronics

An Australian-Chinese research team has created the world's thinnest hologram, paving the way towards the integration of 3D holography into everyday...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Marine Conservation: IASS Contributes to UN Ocean Conference in New York on 5-9 June

24.05.2017 | Event News

AWK Aachen Machine Tool Colloquium 2017: Internet of Production for Agile Enterprises

23.05.2017 | Event News

Dortmund MST Conference presents Individualized Healthcare Solutions with micro and nanotechnology

22.05.2017 | Event News

 
Latest News

How herpesviruses win the footrace against the immune system

26.05.2017 | Life Sciences

Water forms 'spine of hydration' around DNA, group finds

26.05.2017 | Life Sciences

First Juno science results supported by University of Leicester's Jupiter 'forecast'

26.05.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>