We require a firm consensus from all the stakeholders on best way

We require a firm consensus from all the stakeholders on best way to respond to such access demands. The Legislation and guidelines are inconsistent, ambiguous or silent Sorafenib Tosylate CAS about many of these aspects. The post-trial access is one of the issues which is still not been precisely analyzed and several aspect of it remain inconclusive. This article tries discussing the ethical issues, regulatory guidelines and perspective of major stakeholders on post trial access of the trial drug. The discourse on PTA begins with the evaluation of group entitled to claim the trial drug, the ones receiving trial drug, trial participants or the patient population. The trial subjects are a miniscule of the whole patient population from where they are derived and exposed to trial medicine.

Providing PTA to those exposed to trial drug and denying others create disparity among patients. This is especially true in life threatening conditions where the trial drug is proven effective, as it seems to be inhumane depriving non-trial patients of the same benefit. Imatinib was approved by FDA in March 2003, although the drug was safe and highly efficacious in the trial patients, its post trial access was denied to 3,600 patients who died waiting for the wonder drug to cure them. Lapatinib also describes the similar story, where 28,000 women who were positive for the marker against which the drug works when other drugs fail, died waiting for the drug. They would, have each lived an average of eight months longer. Long enough, perhaps, to see a child graduate from college or get married, or to meet a new grandchild.

[1] According to Declaration of Helsinki ??At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.??[2] The claim for post trial access is defended to extend benefit to the trial participants, in such a case the participants of early phase II clinical trial are unarmed where the benefit of the trial drug is still at stake. The benefit is a relative term in many of the clinical trials and it is often difficult to quantify the benefit of the trial medicine compared to the standard treatment which forms the basis to advocate it during the post trial period.

[3] The phase I to III AV-951 clinical trials provide preliminary evidence rather than proof of safety http://www.selleckchem.com/products/CAL-101.html of the drug. Many a times, it is observed that after the drug is introduced in large general patient population, that the rare adverse effects are revealed. This explains the intense ADR reporting and long term pharmacovigilance studies conducted post approval of drug.[4] The withdrawal of cox-2 inhibitors after its approval and wide use exemplifies the situation.

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