Clinical Trial Impact of Superstorm Sandy Lingers
By Marie Powers
Four weeks after Hurricane Sandy slammed into the Eastern U.S., the full scope of the superstorm's impact on one of the busiest clinical trials centers in the world remains unknown. The discovery of thousands of drowned lab mice in the bowels of New York University's (NYU) Smilow Research Building following Sandy's storm surge the night of Oct. 29 suggested the region's medical infrastructure would be damaged beyond bricks and mortar. A month later, it's clear some hospitals and university medical centers across the hard-hit Northeast U.S. are still in recovery mode.
Reports of disruptions to human clinical trials prompted the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) to issue informal guidance last week regarding accommodations to institutional review board (IRB) policies – most notably, but not limited to, institutions in New Jersey, New York, Delaware and Connecticut.
Those four states, combined, account for 42 percent of nearly 60,000 U.S. studies currently listed on ClinicalTrials.gov, including more than 16,500 actively recruiting. A BioWorld Today analysis of the 1,198 studies listed in Delaware – the smallest universe among the four states in the OHRP memo – revealed 316, or about 25 percent, active or currently recruiting studies focused on drug interventions. Extrapolating those data across the four states suggesed some 6,000 drug trials are currently active or recruiting in the four states cited by OHRP. Each study represents several dozen to thousands of participants.
Calculating the extent of the human impact is even more difficult than estimating the numbers affected. Most pharmas and biotechs did not respond to BioWorld Today's inquiries about the effect of Hurricane Sandy on active trials in the storm zone. Several indicated the storm caused little or no delay to ongoing studies, based on feedback from their trial sites and investigators.
The FDA's Office of Good Clinical Practice received one hurricane-related inquiry from New York involving the loss of IRB records and study-related documents, according to an FDA spokeswoman. And the OHRP memo acknowledged that human subjects protections programs at some institutions in affected areas "are unable to function and may be unable to do so for some time."
An HHS spokeswoman said the agency decided to communicate with all institutions in the region after receiving anecdotal reports of clinical trials disruptions. "Any discussion of specific institutions by our staff could not portray a full – or even authoritative – picture of storm devastation," she added.
But the National Institutes of Health (NIH), which sent a team to New York last week, offered a bleak assessment of the situation on the ground.
"Research institutions affected by Hurricane Sandy are still assessing the impact of the storm, and we know some buildings and facilities have not yet reopened," a spokeswoman told BioWorld Today. "NIH will address any issues that come up on a case-by-case basis, and will assess damage to NIH-supported research, but it is still too soon to say which and how many institutions were impacted by the storm."
Total Impact 'May Never Be Completely Known'
BioWorld Today asked three New York institutions that participate in thousands of clinical trials about obstacles they encountered in recruiting or maintaining trial protocols in the wake of Sandy. Of these, Columbia University Medical Center referred its request to New York-Presbyterian Hospital, which, through a spokesman, declined to respond.
A spokeswoman for Memorial Sloan-Kettering Cancer Center said only that the center "had continuous power throughout the storm and remained open and fully functional for all of our inpatients; however, due to the intensity and duration of the storm and difficult travel conditions, outpatient appointments were cancelled, except for pediatric day hospital patients, at all our locations on Tuesday, Oct. 30."
NYU Langone provided a written statement on the progress of its recovery, noting that "significant work to restore damaged areas is already under way. The medical center's priority is to become fully operational as soon as is safe and feasible, and we expect to announce the reopening date for Tisch Hospital in the near future."
Last week, NYU Langone reopened its Skirball building – home to hundreds of clinical investigators – re-starting the treatment of patients on its main campus. The university's Hospital for Joint Diseases, Center for Musculoskeletal Care, Clinical Cancer Center and other off-site buildings are open. The School of Medicine's medical education programs have resumed, "thanks to the generous support and facilitation of many institutions and affiliate hospitals in the greater New York area," according to the statement.
The Sackler Institute of Biomedical Sciences, home to doctoral studies in biomedicine, reopened Nov. 12.
However, physician offices in the Schwartz Health Care Center remain closed, as do the Rusk Institute building and the NYU Langone emergency department.
"NYU Langone has been in close communication with Federal Emergency Management Association and the National Institutes of Health, who have made commitments to assist research programs during the upcoming months," according to the statement.
Although clinical trials at New York institutions may have borne the brunt of the hurricane's wrath, a ripple effect was felt throughout the region. A spokesman at BioNJ said many of its members have yet to calculate the storm's impact on their clinical investigations.
In short, individuals, institutions, companies and agencies in Sandy's path are still too busy picking up the pieces of their lives and routines to quantify how many recruitment efforts were suspended, active drug regimens were interrupted, evaluations were delayed or data were lost to the storm.
In a research note issued Oct. 30, Wells Fargo Securities LLC analyst Brian Abrahams predicted as much, noting "the precise impact on each [clinical trials] program may never be completely known."
Biotech Operations Largely Unscathed
The direct hit to biotech operations appeared minimal. A critical data readout for BioMarin Pharmaceuticals Inc.'s GALNS (N-acetylgalactosamine-6 sulfatase), which enrolled patients with the rare lysosomal storage disorder mucopolysaccharidosis Type IVA at multiple sites in the storm zone, was unaffected. Earlier this month, the company reported stellar Phase III results. (See BioWorld Today, Nov. 6, 2012.)
Other companies with ongoing trial sites in the region – including Gilead Sciences Inc., Celgene Corp., InterMune Inc., Rigel Pharmaceuticals Inc. and Biogen Idec Inc. – reported little disruption.
Insmed Inc., of Monmouth Junction, N.J., had no clinical trials impact, since its pivotal Phase III studies are under way in Europe, said Will Lewis, the company's president and CEO. Nevertheless, the hurricane served as "quite a dramatic case study of why it makes sense to do disaster planning," Lewis told BioWorld Today.
"The good news is that our disaster plan worked," added Lewis, who had reviewed the plan when he joined Insmed in September and conducted daily meetings with staff during the week prior to the hurricane's arrival. "The reality is that you can't afford slip-ups in this industry."
OHRP directed institutions facing challenges in IRB research oversight to refer reviews to another IRB unaffected by the storm, wherever possible, and to continue research determined to be in the best interest of participants even in the wake of IRB expiration.
The agency said it will use "available flexibility in any decision-making" in the event storm-affected institutions fail to suspend or refer research to another IRB.
In June, the FDA also issued draft guidance (www.fda.gov/RegulatoryInformation/Guidances/ucm307757.htm) for IRBs, clinical investigators and sponsors encountering situations where research or IRB oversight of research must be transferred to another site.
The guidance discusses possible actions the original and receiving IRBs should consider before, during and after such a transfer, either on a temporary or permanent basis. The FDA also encouraged affected sponsors, investigators and IRBs to contact the appropriate FDA reviewing center with questions or concerns about handling study issues related to the hurricane.
OHRP indicated participants who are unable to receive research interventions at their usual clinical trial site may temporarily receive the stated care at other facilities, which are not required to secure IRB review and approval.
But OHRP may have sealed the fate on conclusive data collection of hurricane-related study disruptions with its final comment.
"In general, disruptions of human subjects protections programs by this storm do not constitute unanticipated problems involving risks to subjects or others, serious or continuing noncompliance or suspension or termination of IRB approval," according to the memo. "Therefore, these events need not be reported to OHRP as such."
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