Columns | View from Washington

The need to revise the design, performance and interpretation of clinical research to reflect changing methods and standards is drawing increased attention.

FDA's breakthrough drug initiative has proven successful to date, but challenges remain in addressing the expectations and patient concerns surrounding candidates in this program.

FDA's new commissioner advocates for a "learning healthcare system" and less-complex clinical trial models that tap efficiencies in study design and enrollment.

Agency is asking sponsors to propose demonstration projects that test the use of electronic health records and standards-based technology solutions. Ensuring trials assess new drugs in diverse patient populations is also a priority focus for FDA.

These three areas will be at center of drug development discussions in the year ahead.

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The "Cures" bill and PDUFA IV are the latest measures pushing for more systematic inclusion of patient views into drug development.

Agency concerned about how proposals in "Cures" bill will be crafted and implemented.

The productivity of the U.S. biomedical research enterprise is undergoing a broad re-examination.

Agency proposes new standards in hopes of capitalizing on 2014 surge in new drug approvals.

The promise is that customized delivery of injectible drugs and biologics will reduce toxicity, enhance individual response, facilitate the delivery of multiple drugs, minimize waste, and encourage patient adherence to prescribed treatment.

There's a mounting campaign to encourage biopharmaceutical companies to develop new therapies to treat drug-resistant infections.

The rush is on to develop new therapies and vaccines to combat the lethal outbreak.

The mounting outrage over exorbitant prices for new medicines increases the importance of reducing the cost of biomedical product development.

Congressional leaders have launched a major initiative to revise laws and regulatory policies to speed new cures to patients.

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval.

Despite guidances and rules advising sponsors to include all demographic groups in clinical trials, many subgroups remain underrepresented.

Pharmaceutical companies are jumping on the clinical trial transparency bandwagon, while also seeking to protect confidential information.

The decline in important new medicines reaching market in 2013 has produced multiple proposals for making clinical trials more effective and efficient.

The shift to personalized medicine has begun to account for a greater portion of new therapies in pharmaceutical pipelines, and the biomedical research community is watching to see if this trend continues in the coming months.

Ease of use, and clear directions and labeling can improve patient satisfaction with participating in a study and enhance compliance, says new ISPE survey.

Policies to widen access to patient level data from clinical trials are gaining traction, despite strong opposition from research sponsors that such initiatives will undermine patient privacy and incentives for new drug development.

Multiple proposals for streamlining research emerge in legislation, expert reports.

Expanding access to nonprescription drugs and facilitating comparative effectiveness research.

Demand for more information on study results and investigator payments create challenges.

Congress, industry map out goals and concerns for revising FDA policies linked to user fee legislation.

FDA wants sponsors to build quality into protocols, adopt risk-based strategies to streamline trials.

Pressure to approve new user fees will affect policies for foreign studies and research methods.

A comprehensive listing of US departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

Alternative approaches aim to tackle drug shortages, spur orphan drug development.