According to the law of 2007, researchers are required to report on the findings of their study within a year on medical website that was created way back in 2000 under the congress authority. However, a New England Journal of Medicine has revealed that is not the case with many researchers since only one out of every clinical trials met federal requirements that would necessitate the reporting. The most surprising thing was that even the simple reporting was not being done timely besides that nobody was doing it.
“The reporting regulation gives researchers and sponsors of clinical trials an ethical obligation into which the will show respect to human trial participants”. This is according to Dr. Monique L. Anderson of the Duke Clinical Research Institute. He also added that; “It also develops in them fidelity to show commitment towards contributing to generalizable knowledge”.
After all, failure to report on time was described to be a risk to patients since they would not access valuable information which would be deemed necessary to treat serious and life – threatening ailments.
The enacting of the law resulted from numerous public concerns which indicated that sponsors and investigators werepublishing only the trials that favored their interests and which were reflecting positive findings only.
Dr. Anderson who is the lead author of this research stresses the fact that all any sponsor of a clinical trial is obligated to disclose their findings for public interest.The law’s enactment has yielded positive results in that many more pharmaceutical companies are developing disclosure in their policies. Besides, they are actively pursuing enlarged public disclosure of data. The only risk in this is that there may not be enough resources to push for timely reporting of this data.
All said and done, penalties have been introduced to those who fail to comply with the reporting. The fines range up to $10,000 a day as well as freezing of NIH. However, Dr. Anderson was fast to point out that enforcement of these penalties has not occurred due to technical reasons.