Clinical News Roundup: FDA Releases Draft Guidance On EHR Data

By Ed Miseta, Chief Editor, Clinical Leader

The Regulatory Affairs Professionals Society (RAPS) reports the FDA has released draft guidance to assist clinical trial sponsors, investigators, CROs, and institutional review boards (IRBs) using electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance is meant to promote the interoperability of EHRs and systems supporting such trials.

The 12-page guidance was prepared by the Office of Medical Policy and the Office of Translational Sciences in the FDA Center for Drug Evaluation and Research (CDER) in coordination with three other centers. The guidance offers recommendations on:

1. Deciding whether or not to use EHRs as a source of data in clinical trials
2. Use of interoperable EHRs that produce electronic records and support clinical investigations
3. Ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical trials
4. Ensuring that the EHR data used as electronic source data meets FDA’s inspection, record keeping, and record retention requirements.  

“With the widespread use of EHRs, there are opportunities to improve patient safety, data accuracy, and clinical trial efficiency when data from these systems are used in clinical investigations,” says the FDA. “EHRs may enable clinical investigators and study personnel to more easily combine, aggregate, and analyze data from many different sources (e.g. clinical notes; physician orders; radiology, laboratory, and pharmacy records).”

FDA Promises Expedited Compassionate Use For Investigational Drugs
RAPS is also reporting the fight over patients gaining access to investigational drugs via the compassionate use process is about to get easier. Compassionate use, also known as expanded access, allows physicians to request the FDA allow the use of an investigational drug outside of a clinical trial for a patient with a terminal illness or no other treatment options. However, the process can only be initiated if the company developing the drug and the physician treating the patient agree to move forward and make the FDA request.

Speaking at the Expanded Access Navigator Public Workshop, Richard Moscicki, M.D., deputy center director for science operations at FDA’s Center for Drug Evaluation and Research (CDER), said the agency will soon finalize a plan that could reduce the time it takes physicians to fill out the paperwork for expanded access requests to 45 minutes. This would be a significant change from the previous form, which could take more than 100 hours to complete.

The agency also expects to release three guidance documents linked to compassionate use and expanded access soon. The announcement comes just as the FDA’s nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better.

Minority Participation In Clinical Trials: Why It Matters
According to the FDA, African Americans comprise 14 percent of the U.S. population, but represent only 5 percent of clinical trial participants. African Americans also account for a disproportionately high number of cases of cardiovascular disease and hypertension. At the same time, Hispanic/Latinos comprise 17 percent of the U.S. population, but less than 1 percent of clinical trial participants. We also know diseases such as obesity and Type 2 diabetes disproportionately affect members of Hispanic populations. This only begins to illustrate the importance of minority participation in clinical trials.

With 2016 being declared the year of diversity in clinical trials, Continuum Clinical, a healthcare research and communications company that works with pharmaceutical companies to market and recruit patients for clinical trials, together with leading multicultural marketing expert Sheila Thorne, president and CEO of Multicultural Healthcare Marketing Group, have created a new infographic that they hope will help to illustrate further the importance of increasing diversity in clinical trials.

“At a time where it is becoming increasingly difficult for pharmaceutical companies to achieve their patient recruitment goals, we have found that connecting with and engaging patients from diverse ethnic groups is a key element of a successful communications plan,” said Ken Shore, executive VP of Continuum Clinical. “Each patient population requires its own strategy and appropriate tactics for it to be successful, however.”

A news release on Business Wire notes that in 2014, the FDA released a report that called for, among other things, “identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation,” that was specifically aimed at underrepresented ethnic populations and women. The FDA reported its progress earlier last year, including “education/training for reviewers about demographic inclusion, analysis, and communication of clinical data.” However, the industry has continued to face challenges in adjusting to the FDA recommendations to encourage wider participation among minority populations.

PRA Health Sciences Named International Clinical Research Company Of The Year
For the third year in a row, PRA Health Sciences has been recognized as the Clinical Research Company of the Year. PRA received the award at the PharmaTimes International Clinical Researcher of the Year ceremony in London, and comes on the heels of the company’s recognition as Clinical Research Company of the Year in the PharmaTimes Americas competition.

PRA also swept the Clinical Trial Administrator category, winning the gold, silver, and bronze awards. The company won individual gold awards for clinical trial administrator, project manager, and strategic partnership team (partners PRA and Bayer).

“PRA is honored to receive this prestigious recognition,” said Sean Leech, executive VP, product registration for PRA. “This award speaks to the passion and professionalism PRA employees bring to their clinical development work. We are extremely proud of this accomplishment.”   

Clinical Trial Reports Positive Results For Mushrooms In Treating Depression
The Guardian is reporting that magic mushrooms have lifted severe depression in a dozen volunteers in a clinical trial, raising scientists’ hopes that the psychedelic experiences beloved of the Aztecs and the hippy counterculture of the 1970s could one day become mainstream medicine.

The trial, which required several years to complete due to stringent regulatory restrictions imposed on the Class 1 drug, found that 2 doses of psilocybin, the active substance in the mushrooms, lifted depression in all 12 volunteers for 3 weeks. In five of the participants, it also kept the depression away for an additional nine weeks.

The research, funded by the Medical Research Council (MRC), is proof of principle only. In addition to the small patient size, no placebo was used in the study. Scientists from Imperial College London hope the results will spur additional funding from MRC and other funders for a full trial. In a clear case of stating the obvious, The Guardian notes use of a placebo would be difficult since it would be unmistakable who was having a psychedelic experience.

Researchers are urging people not to try the magic mushrooms themselves. The lead author, Dr. Robin Carhart-Harris, notes the drugs have potent psychological effects and are only given in  trials with appropriate safeguards are in place, such as careful screening and professional therapeutic support. Individuals attempting to treat themselves are taking a risk.

AstraZeneca Respiratory Drug Passes Final Clinical Trials
Benralizumab, an AstraZeneca drug for patients suffering from severe asthma which current drugs cannot control, has made it through final clinical trials. The milestone is important for AstraZeneca as Benralizumab is a significant drug in its pipeline and is one of four respiratory medications the company hopes to launch between now and 2020. It is also AstraZeneca’s first asthma drug that is biological, meaning it treats the underlying cause of the illness, rather than the symptoms.

“This medication is unique and will make a real difference,” said Tom Keith-Roach, VP for respiratory, inflammation and autoimmunity therapy at AstraZeneca. “The science is at a very exciting point as we are starting to understand the underlying causes of the disease and are bringing forward biologic therapies that target specific patient groups.”