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Enforcing Report Findings for Clinical Trial Results of Importance to Industry and Patients

March 10, 2016

Stages-Clinical-Trials2

Yale University published their findings that 1/3rd of United States clinical trials results go unreported. 4347 trials between October 2007 and September 2010 were monitored throughout 51 medical centers. 2892 (66%) trials released their results, through journal publications or clinical trial registries, but the remaining 33% remained unaccounted for.

In 2000, the U.S. created ClinicalTrials.Gov, an online registry that mandated that every trial since 2007 with drugs subject to FDA regulation be submitted online. Only 26.8% have complied since then, with 12.6% resulting from just two years.

Key to Reporting: Enforcement

Publication rates ranged between 35-67.2% in individual institutions, while reporting to ClinicalTrials.Gov ranged between 4.1-55.4%. Those clinical trials that did have released results did not always do so completely: 21.9% of the entire study took more than 2+ years to publish to individual institutions, with 14.4% taking longer than 2+ years to publish results at ClinicalTrials.Gov.

Nihar Desai, a Yale assistant professor who worked on the study, said, “While there are statutory requirements to disseminate clinical-trial results, there aren’t any enforcement mechanisms. Investigators know that the requirements are requirements in name only. If instead, funders announced that previous performance on results dissemination would be incorporated into funding decisions, or journals would incorporate this into the adjudication of manuscripts, or leaders of academic institutions incorporated it into the promotions process, I suspect it would lead to a sense of urgency to ensure timely dissemination.”

Dr. Desai called for members of the International Committee of Medical Journal Editors to demand that trial investigators submit data with a 6 month process and for clinical trial patients themselves to have an active voice by asking for data as a part of the registration process.

Existing EMA Database

The European Medicines Agency (EMA) launched its own clinical trials results forum EudraCT, in January, where this information will be made public on the EU Clinical Trials Register. Trials with youths must be posted within 6 months, those with adults within 1 year. Each participating member state is responsible for penalizing non-compliant trial holders, a guideline with which the European pharmaceutical industry has so far been cooperative.

Servicing Patient Recruitment in Clinical Trials

James Cockerill, co-founder of AllTrials, said, “Missing results are a disservice to medical science, and a disservice to the thousands of clinical-trial participants who take part in trials.”

The more access all scientists and researchers have to each other’s published data, the more beneficial it is to biopharma development. The public can also gain a deeper knowledge of what it is exactly they are volunteering for – and the act of providing knowledge is comforting in itself. Clinical trials are unarguably of great value in advancements in biotechnological and pharmaceutical fields, but without patients such advancements would not be possible. Continuing with the targeted patient-centric approach, your clinical trial should focus on the needs of the patient in your recruitment process, a feature that we provide. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

 

 

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