Question

Please summarize the below two articles in you own words 150 words each article

 

Article 1

HIPAA Privacy Rule Thwarts Clinical Research Recruitment

Feb. 15, 2005 — Since the federal government's sweeping medical privacy rule went into effect two years ago, the additional paperwork required of academic institutions to obtain patients' consent to participate in clinical research trials has caused enrollment to plummet by as much as 50% at one institution and confusion among many others, a new editorial concludes.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) included a major provision that required covered entities (hospitals, physicians, health plans, and other entities that handle patient information) to obtain confidentiality documentation from researchers before disclosing health data. This section of the law, which took effect as part of the overall medical privacy law in April 2003, was intended to ensure that patients' protected health information (PHI) would not be inappropriately disclosed or used during the course of a research trial.

But a lack of guidance by the U.S. Department of Health and Human Services (HHS) about how to interpret this provision and the resulting variability in approaches by research institutions "could not have been what was intended by the law and is not optimal for balancing the need for confidentiality and research progress," said Roberta B. Ness, MD, MPH, chairman of the Department of Epidemiology at the University of Pittsburgh Medical Center in Pennsylvania. "To put out the rules without guidance has resulted in a lack of clarity," she told Medscape in an interview.

Writing in the February issue of the Annals of Epidemiology, Dr. Ness describes the before-and-after effect of HIPAA's rules governing medical research as it applied to patient recruitment in a single-institution, prospective study to determine the cause of preeclampsia.

In the pre-HIPAA phase of the study, called the Pregnancy Exposures and Preeclampsia Program Project (PEPP I), 2,892 women were recruited in 55 months, for an average of 12.4 women per week. The study was renewed in early 2002, but recruitment was shut down for four months while the maternity hospital at which the study was conducted decided how to comply with upcoming medical privacy laws.

Between April and September 2003, recruitment into the study took place under new rules that disallowed all waivers of HIPAA medical record review, according to Dr. Ness. (Waivers allowing an institution to use or disclose PHI for research purposes can be granted if specific conditions are met, according to the privacy rule).

Under that restriction, "the only medical records PEPP II staff could review to determine potential eligibility were for women who had enrolled into a research registry," Dr. Ness writes. "Only about 10% of women enrolled into the registry, presumably because only a clinical staff was authorized to initiate registry enrollment."

Shortly afterward, the hospital's institutional review board allowed applications for a waiver so that researchers could review medical records and flag those that represented potentially eligible subjects, as had been done before HIPAA. Recruitment was further hindered because health provider consent was required before the clinical research staff could approach potential research subjects, and when the maternity hospital merged with the University of Pittsburgh in June 2004.

After HIPAA took effect, the average recruitment rate for participation in PEPP II was 2.5 women per week without a waiver, 5.7 women per week with a waiver, and 3.3 women per week since retraction of the HIPAA waiver, according to Dr. Ness.

"[R]ecruitment with a HIPAA waiver, as compared to pre-HIPAA, decreased by half; and recruitment without a HIPAA waiver fell by half again as compared to with a waiver," Dr. Ness writes. "We cannot identify other systematic explanations for these trends other than the obvious: local interpretation of the HIPAA regulations had a negative effect on the pace of our research."

The slowdown in Pittsburgh's ability to recruit additional subjects into the preeclampsia study has put the program "way behind where we should be," said Dr. Ness. "I have a long career of running prospective studies, and we have never been this far behind on a study at this juncture."

Many research institutions report being in a similar situation, Dr. Ness notes in the editorial. Nearly three quarters (72%) of the 331 U.S. investigators polled by the Association of American Medical Colleges reported that HIPAA was having an adverse effect on clinical research during the first six months after its implementation. Negative effects on patient recruitment, data access, and data acquisition were cited by more than 68% of the respondents.

An HHS advisory committee has proposed modifications to HIPAA that would better coordinate the rule's requirements with those of the Common Rule, a federal law that protects human research subjects, Dr. Ness writes. "We can only hope that the new Secretary for Health and Human Services will adopt these modifications," she concludes.

Article 2

Established by FDA to Expedite Patient Access to Medications

Approximately 10-15 years elapse between the discovery of a new drug in the laboratory and its therapeutic use in the clinical setting.^[1] One factor influencing the duration of drug development is the Food and Drug Administration's (FDA's) review of an agent's efficacy and safety data. In 2001, FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 31 new molecular entities.^[2-4] The average time from sponsor submission of a new drug application (NDA) or biologics license application (BLA) to FDA approval of these compounds was 18.6 months, an increase from 17.2 months in 2000, 12.9 months in 1999, and 12.5 months in 1998.

FDA has implemented several programs intended to reduce the review time of a new pharmaceutical and accelerate patient access to medications for the treatment of serious or life-threatening diseases. This review article provides an overview of these initiatives, with a focus on fast-track designation, priority review, accelerated approval, and orphan drug status. Imatinib mesylate (Gleevec, Novartis), which was approved for three phases (chronic, accelerated, and blast crisis) of chronic myelogenous leukemia (CML) in May 2001 and gastrointestinal stromal tumors (GIST) in February 2002, serves as an example of drug development focused on expedited patient access. The information on the clinical development and approval of imatinib was available through the Freedom of Information Act. Imatinib will be discussed throughout this review to illustrate the highlights and opportunities of each FDA program. Finally, the clinical implications of the programs will be described.

Regulatory Overview

There are multiple regulatory documents that outline the responsibilities of FDA and the industry sponsor throughout the drug development process, including the Prescription Drug User Fee Act (PDUFA) of 1992, the five-year renewal of PDUFA (PDUFA II), the recently approved PDUFA III, and the Food and Drug Modernization Act of 1997 (FDAMA). In addition, supporting regulatory documents (i.e., guidance documents) have been established that specifically relate to fast-track designation, accelerated approval, priority review, and orphan drug status. Although these four programs share features, each is a distinct initiative with different requirements. Fast-track designation relates to the interactions between the sponsor and FDA during the drug development process. Accelerated approval refers specifically to the design of studies performed by the sponsor, and priority review sets the time frame for FDA review of a submitted BLA or NDA. Finally, allowing drug manufacturers to seek orphan drug status encourages the development of drugs to treat rare diseases.

Answer 1

ARTICLE 1

HIPAA privacy rule has a decremental effect on pace of research. HIPAA rule make obligation for consent of patient to obtain his medical records for research purposes and whether the patient willing or not willing it requires proper paper work for proof and that is surely gonna decrease the pace of any prospective study based research. To prove HIPAA is decreasing the pace of research , we review the research study on preeclampsia study on pregnant women before HIPAA and that stopped due to HIPAA and when continued there were several factors affecting the participation of patient in the research. Surely HIPAA is good for privacy of an individual medical records but is detrimental for the pace of prospective research study.

ARTICLE 2

It take huge time period between the discovery of new drug and its theurepeutic uses, so to decrease these period FDA is trying many new approaches towards drug development and availability process to make it fast. This review article provides an overview of these initiatives, with a focus on fast-track designation, priority review, accelerated approval, and orphan drug status. all these approach are having different role in process of drug development.  Fast-track designation relates to the interactions between the sponsor and FDA during the drug development process. Accelerated approval refers specifically to the design of studies performed by the sponsor, and priority review sets the time frame for FDA review . Finally, allowing drug manufacturers to seek orphan drug status encourages the development of drugs to treat rare diseases. Example of it is imatinib mesylate drug used in CML . These FDA interference to fasten drug development was necessary because according to survey time taken for drug development compare to early time is high and showing a increasing time perod. So it was necessary step.