Is That Plastic Shrink Wrap In Your Merck Vaccine?
As if Merck does not have enough problems with vaccine production, the drugmaker apparently distributed charred bits of plastic shrink wrap in vials of various vaccines – including Gardasil for preventing HPV infection, Varivax for chicken pox, Pneumovax for pneumococcal disease, Zostavax for shingles and MMR II for measles, mumps and rubella, according to Dow Jones.
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In 2008, the FDA issued a warning letter about manufacturing problems at Merck’s West Point, Pa., plant . Since then, FDA inspection reports have cited more problems: the presence of metal particles in certain products, cracks in vaccine vials and delays in Merck’s reporting adverse event from products made at the plant to the FDA, Dow Jones writes.
The drugmaker maintains most problems have been resolved, but there were no subsequent health problems and the FDA has not issued another warning letter. Dow Jones, by the way, obtained the inspection reports, known as Form 483s, from the FDA under the Freedom of Information Act. “We do have a complex operation,” James Robinson, vp of vaccines product and technical operations, tells Dow Jones. “What we are seeing is that the severity and criticality of observations (by the FDA) are declining. What we’ve seen in the last few inspections tells us we’re on the right track.”
The problems are crucial to Merck, which is struggling to replenish its pharma product portfolio and jumpstart the vaccine business. Through the first half of the year, vaccine sales accounted for nearly 7 percent of $23.7 billion in revenue (look here). But vaccine production has been troubled for some time.
Over the past couple of years, Merck has struggled to maintain supplies of Vaqta for hepatitis A, ProQuad for MMR, Zostavax for shingles and Recombivax for hepatitis B (see here for the latest). And a year ago, Merck was finally able to restore production of all pediatric vaccines for the first time since 2007 .
But how did pieces of protective shrink wrap find their way into incoming glass vials? The shrink wrap was not removed during washing and was subsequently charred during a heat-based sterilization process, according to an FDA inspection report in April, Dow Jones writes, adding that some vials made their to customers.
Since November 2009, Merck has submitted to the FDA at least 12 reports of charred shrink wrap found in vaccines, according to the FDA report. Eight arose from consumer complaints, and four stemmed from internal sample testing. Merck responded by switching from shrink-wrap to plastic or cardboard trays for incoming vials for a majority of its products, Robinson tells Dow Jones.
But in its April inspection report, the FDA said shrink wrap was still being used for some incoming vials, which the agency said made Merck’s initial response inadequate (see the report). Robinson said Merck expected to abandon shrink wrap on all incoming vials by year’s end. The FDA report also said patient safety risks associated with the charred shrink wrap couldn’t be ruled out. Robinson denied there have reports of adverse events associated with the shrink wrap, Dow Jones writes.
Source: Pharmalot
Category : News
FDA issues Eisai with ‘refuse to file’ letter for epilepsy drug
Eisai has suffered a setback with the news that regulators in the USA have turned down the Japanese drugmaker’s submission for its new antiepileptic perampanel.
The US Food and Drug Administration has issued a ‘refusal to file’ letter in response to the company’s New Drug Application for perampanel. The drug, which is also known as E2007, is a first-in-class highly selective non-competitive AMPA-type glutamate receptor antagonist and has been developed for the treatment of partial-onset seizures associated with epilepsy.
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The FDA has requested “reformatting and reanalyses of some datasets in the dossier to assist with a substantive review”, Eisai noted, adding that it believes that “no new non-clinical or clinical studies are required to support this filing”.
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Eisai files epilepsy treatment perampanel Success for Eisai s antiepileptic Zonegran as monotherapy
The Tokyo-based firm went on to note that the FDA’s letter does not comment on the approvability of the drug, “and no determination has been made with regard to the efficacy or safety of perampanel”. Eisai concluded by saying that it will work closely with the agency to “provide the information requested for resubmission of this application as quickly as possible”.
EMA to look at Zonegran as monotherapy
In better news for Eisai, the European Medicines Agency has accepted for review their application to extend the use of Zonegran (zonisamide) as monotherapy for newly-diagnosed epilepsy patients with partial seizures, with and without second generalisation. It is currently approved in the European Union as an adjunctive therapy in the treatment of partial seizures.
Bettina Bauer, head of the EU Epilepsy Business Unit at Eisai Europe, said that “as a research-based pharmaceutical company with a particular focus on epilepsy, we are not only committed to bringing innovative new therapies to market, but also ensuring that we maximise the clinical benefits of our currently-licensed products”. She added that “if approved as monotherapy zonisamide will offer newly diagnosed epilepsy patients a new option to help improve their seizure control”.
Category : News
Pfizer Hacking & Pharma Ineptness: Meyer Explains
Last week, the Pfizer Facebook page was hacked by ScriptKiddies, setting off a flurry of chatter about not just hacking, but the extent to which this episode would affect the way drugmakers view the virtues of Facebook and, beyond that, social media (back story). This happened just as Facebook changes it rules so that drugmakers will no longer be allowed to disable comments, prompting some to consider walking away from Facebook (see this and this). We spoke with Rich Meyer, a former Eli Lilly marketer who worked on the Prozac and Cialis brand teams, and now runs Online Strategic Solutions and the World of DTC Marketing blog, for his thoughts on the implications…
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Pharmalot: How bad was the hacking incident?
Meyer: For consumers and patients, I don’t think it was that bad. They know hacking occurs. Sony was hacked. Banks and credit card companies have been hacked. So was the Defense Department. For pharma, though, it’s really bad, because I think it’ll give them another reason to say they shouldn’t move into social media. It will give them an excuse to say there’s another obstacle, instead of saying what can we learn and move forward. So now, they may not. Ironically, when pharma employees check their email, there’s a portable ID to change the log in every five or 10 minutes to gain access. There are layers of security to get email. Yet this same level of security wasn’t put on their Facebook page. It tells me a couple of things – they don’t really understand social media, which was evident by having a pr agency doing it, and it also tells me they don’t understand social media marketing itself.
Pharmalot: Having a PR agency doing a Facebook page signifies what? Why does it matter?
Meyer: Social media only works when it’s effective and genuine. I conducted some research earlier this year when we wanted to talk to patients and consumers about biopharma companies. We heard concerns about who they’d be talking to? What surprised me was they said they didn’t want to talk to pr people or third party people. They want a genuine person. So pharma needs to put someone there who is authentic. ..People want a genuine conversation with the brand – that’s the way you build trust and establish a genuine persona for the brand.
facebook-question1Pharmalot: And what exactly does pharm not understand about social media marketing?
Meyer: There’s a misperception that social media is setting up Twitter, Facebook and YouTube. But it’s a lot more than setting up a page. It’s a way of thinking. In my opinion, pharma has not shifted from outbound marketing to conversational marketing. At one client, a senior legal vp person said this to me: ‘ I’m not going to allow any in-bound marketing (which is allowing people to come to you and ask question) at this company.’ When I asked why, he said there’s too much risk. For every item of risk he named, I was able to say we could manage it doing this and doing this. And he responded by saying when there’s human interaction there’s always a possibility of falling outside of DDMAC guidelines and getting a letter, and I don’t want any letter. So long as you have that mentality, pharma just doesn’t get what social media marketing is. It’s not just a tactic or strategy, it’s a way of thinking about marketing in today’s environment.
Pharmalot: And what should Pharma do about the upcoming Facebook changes?
Meyer: A couple of things. One digital agency launched a pharma wall- an addition to a Facebook page that would allow pharma companies to moderate anybody who posted something on their Facebook page. This tool would allow pharma to approve something before it goes on a wall. The second thing is most biopahrma companies are not set up for legal, regulatory and medical reviews in real time. When I launched Sarafem for pmdd, we launched a message board for women because our research told us women wanted to share information about their views on this condition.
I set up a web site where people could put something on the message board but it would not go live until legal regulatory and medical people signed off. That is something else they could physically do. It doesn’t have to be around the brand, it can be around the health condition. A lot of pharma people are not finding out why consumers are searching for information. Nothing we do in DTC marketing is without risk. The conversations consumers are having is around products and disease states, and they’re going online to do this. What pharma has to ask is ‘Do we want to be part of that conversation or a train stop on the road as consumers go online to learn about health?’
Pharmalot: Recently, Steve Woodruff wrote that maybe it’s time to concede that pharma and social media don’t mix (read here). What do you think?
Meyer: I don’t believe that. If you’ve got magnetic content that draws people in – if you give me a reason to talk to you on an elevator full of people, I’m going to continue talking. Pharma needs to get in the minds of their consumers and ask what’s important , what do you want to hear from us and what do you want to know. But there’s no emphasis to provide magnetic content in a way that’s conversational instead of a brochure you’d pick up at a doctor’s office. Read the Pradaxa DTC web site and it’s like reading a medical journal. I don’t see how anyone would read that and say they’ll go to their doctor and ask for Pradaxa. There’s only going to be more interactivity online – they have to get away from push, push and push and learn to listen, listen, listen.
Source: Pharmalot
Category : News
Kindler Undone: The Dysfunctional Pfizer Culture
For those curious as to what went down before Jeff Kindler unexpectedly resigned last December as the Pfizer ceo, a new treatise in Fortune magazine offers a behind-the-scenes look at the political infighting, overblown aspirations and inept calculations that contributed to his demise, as well as a decade of disappointment and a few spectacular failures at the big drugmaker.
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For Kindler, the end came in a plain vanilla Florida airport conference room where he was confronted by three board members, who – after probing a steady stream of confidential reports that his managerial style was overbearing, his behavior was increasingly erratic and his judgment was questionable – decided he must go. Essentially, he was given an ultimatum – with a lot of money.
The moment capped a tumultuous few years in which Kindler tried, but failed to recalibrate a withering strategic direction, but lacked the necessary experience to stick with decisions and rely on the right people – whether he inherited them or, sometimes, those he chose himself. He even upbraided a board member, losing his temper in the process, in front of other directors. In short, Kindler came undone, but not before alienating countless executives and alarming his own board.
“A decision is made, then reconsidered and changed. Decisions, even minor…are picked apart and often directed to be undone. Then re-studied. Then the decision-making group expands. Paranoia results. Autonomy is sapped,” an unnamed exec tells Fortune. Known to vacuum information, his reactions were feared. “Jeff heard something or read something,” a former HR exec says, “and there would be a barrage of e-mails in the middle of the night.”
Then there was George Evans, who was general counsel for the pharma division and worked at Pfizer for 26 years, but had been a candidate for the top legal job when Kindler was hired. After reading this boss was promoted to ceo, he resigned. “At the end of the day, you have to have some level of respect for the person you are working for,” Evans tells Fortune. “Having watched Jeff in action over a number of years, I just couldn’t work for a company that had him as its ceo.”
Kindler may have had good intentions, but he needlessly berated lieutenants, micro-managed decisions and demonstrated a blind spot toward those who undermined the enterprise. A key example was his willingness to bend over backwards to give former HR chief Mary McLeod huge compensation, including helicopter trips for commuting through an extended agreement (see this).
To Pfizer pfans, the central characters are familiar – Bill Steere, who presided over the board and maneuvered Kindler and his predecessor, Hank McKinnell, in and out of the corner office; Ian Read, the Pfizer lifer who is now ceo, but threatened to leave last year after deciding he also had seen enough of Kindler; Karen Katen and David Shedlarz, former Pfizer execs who vyed for the top job; and Amy Schulman, who apparently regretted going to work for Kindler as general counsel. And of course, there are a few board members, too.
Source: Pharmalot
Category : News
Kindler Undone: The Dysfunctional Pfizer Culture
For those curious as to what went down before Jeff Kindler unexpectedly resigned last December as the Pfizer ceo, a new treatise in Fortune magazine offers a behind-the-scenes look at the political infighting, overblown aspirations and inept calculations that contributed to his demise, as well as a decade of disappointment and a few spectacular failures at the big drugmaker.
Dangerous Documents: How to Avoid Land Mines in Your FDA Documents and Emails
Totally Original, Interactive, 6-Hour IN PERSON Event featuring former DOJ Prosecutor Nancy Singer
For Kindler, the end came in a plain vanilla Florida airport conference room where he was confronted by three board members, who – after probing a steady stream of confidential reports that his managerial style was overbearing, his behavior was increasingly erratic and his judgment was questionable – decided he must go. Essentially, he was given an ultimatum – with a lot of money.
The moment capped a tumultuous few years in which Kindler tried, but failed to recalibrate a withering strategic direction, but lacked the necessary experience to stick with decisions and rely on the right people – whether he inherited them or, sometimes, those he chose himself. He even upbraided a board member, losing his temper in the process, in front of other directors. In short, Kindler came undone, but not before alienating countless executives and alarming his own board.
“A decision is made, then reconsidered and changed. Decisions, even minor…are picked apart and often directed to be undone. Then re-studied. Then the decision-making group expands. Paranoia results. Autonomy is sapped,” an unnamed exec tells Fortune. Known to vacuum information, his reactions were feared. “Jeff heard something or read something,” a former HR exec says, “and there would be a barrage of e-mails in the middle of the night.”
Then there was George Evans, who was general counsel for the pharma division and worked at Pfizer for 26 years, but had been a candidate for the top legal job when Kindler was hired. After reading this boss was promoted to ceo, he resigned. “At the end of the day, you have to have some level of respect for the person you are working for,” Evans tells Fortune. “Having watched Jeff in action over a number of years, I just couldn’t work for a company that had him as its ceo.”
Kindler may have had good intentions, but he needlessly berated lieutenants, micro-managed decisions and demonstrated a blind spot toward those who undermined the enterprise. A key example was his willingness to bend over backwards to give former HR chief Mary McLeod huge compensation, including helicopter trips for commuting through an extended agreement (see this).
To Pfizer pfans, the central characters are familiar – Bill Steere, who presided over the board and maneuvered Kindler and his predecessor, Hank McKinnell, in and out of the corner office; Ian Read, the Pfizer lifer who is now ceo, but threatened to leave last year after deciding he also had seen enough of Kindler; Karen Katen and David Shedlarz, former Pfizer execs who vyed for the top job; and Amy Schulman, who apparently regretted going to work for Kindler as general counsel. And of course, there are a few board members, too.
Source: Pharmalot
Category : News
Is AstraZeneca Overcharging For Its Bloodthinner?
File this under a not-so Brilinta move? Now, that the FDA has finally approved Brilinta, a bloodthinner developed by AstraZeneca that had to overcome a curious hurdle, the drugmaker has set its pricing. But one Wall Street analyst questions whether AstraZeneca may have priced itself out of the market.
To wit, Brilinta will cost about 19 percent higher, on a wholesale acquisition basis, than Plavix, the leading bloodthinner, which faces generic competition next May. Moreover, the Brilinta labeling suffers from a Black Box warning that may give physicians a reason to use Plavix, according to Sanford Bernstein analyst Tim Anderson. An AstraZeneca spokesman confirmed that daily WAC pricing is $7.24 which, by the way, will be about 25 percent higher than Eli Lilly’s Effient.
“This price seems high to us given the competitive dynamics in the antiplatelet category,” Anderson writes in an investor note. What are those dynamics? The Black Box says docs should use only low doses of aspirin with Brilinta. Other bloodthinners do not carry this edict, which results from the findings of a clinical trial that yielded an unexpected adverse finding only in US patients (see here).
The drugmaker explained this by claiming results from US patients were confounded by the use of high-dose aspirin. And so the FDA approved Brilinta last week, but recommended that patients use only low-dose aspirin (read this). Anderson points out, though, that this is “a potential problem, given that most US physicians prefer high dose aspirin.”
“With a less-than-ideal label, and given the short window AstraZeneca has to get Brilinta established given the pending launch of generic launch of Plavix in the US, coming out with a premium price seems like it will give payers one more reason to push Plavix ahead of Brilinta. In less than a year from now, generic versions of Plavix will be available for pennies on the dollar, creating a substantial price differential between generics and Brilinta.”
An AstraZeneca spokesman disagrees. “Brilinta will be priced to reflect the label and its value in treating patients with ACS (acute coronary syndromes). AstraZeneca believes Brilinta should be priced at a premium because of its label and the safety and efficacy versus clopidogrel,” he writes us. “The cost to an individual patient will differ depending on an individual patient’s insurance status.”
As for the claim about the label that is used to justify the higher price, he points to this wording: “Brilinta has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke compared to clopidogrel,” or Plavix. Will this be sufficient to convince payers? Perhaps the AstraZeneca team should take two aspirin and call the formulary gatekeepers in the morning.
Source: Pharmalot
Category : News
Clinical Trial Costs Are Rising Rapidly
As drugmakers scramble to replenish their pipelines, they are encountering all sorts of difficulties, including rising costs for clinical trials. And this is happening across all phases. Why? There is increasing competition for trial sites and clinical research organizations that can yield reliable, high quality data, according to a recent survey.
And so, 32 percent of those surveyed pointed to higher costs for enrolling patients and 25 percent cited vendor fees. Expenses for recruiting trial sites was named by 14 percent, followed by 12 percent who fingered technology costs, according to Cutting Edge Information, which surveyed 21 drugmakers, 12 biotechs, nine device makers and 23 contract research organizations.
Meanwhile, staffing for drug development is rising. For instance, Phase IV staffing increased by 85 percent from 2008 to 2011, while Phase IIIa doubled. Phase IIIb staffing rose 57 percent, Phase II staffing jumped 106 percent and Phase I staffing spiked 108 percent. One big reason – more clinical research associates. In 2008, the average Phase II trial employed 3.6 clinical research associates, but that rose 9 in 2011. The average ratio of CRAs per site was 10 in Phase IIIb and 6.3 in Phase IIIa.
As for the average per-patient trial costs across all therapeutic areas, in Phase I, costs rose from $15,023 in 2008 to $21,883 in 2011. In Phase II, the cost rose from $21,009 to $36,070. In Phase IIIa, the cost increased from $25,280 to $47,523 and in Phase IIIb, cost jumped from $25,707 to $47,095. Finally, Phase IV expenses rose from $13,011 to $17.042.
“Everybody is working hard to control those costs. The biggest thing on the horizon is trying to get a handle on earlier go-no-go decisions,” Cutting Edge chief operating officer Adam Bianchi tells us. “The competition for quality sites is creating a lot of headaches. You have a greater number of sites worldwide than ever before, but not all are yielding quality data that companies want.
Consequently, more clinical trial work is being outsourced all the time. For Phase I trials, 58 percent is now outsourced compared with 35 percent in 2008. In Phase II, the figure is 63 percent, up from 36 percent. In Phase IIIb, 54 percent is outsourced versus 46 percent, and in Phase IV, 51 percent is now outsourced, compared with 43 percent three years ago.
A few other nuggets: The recent average cost per patient for a cardiovascular trial in Phase IIIa was $21,750 and $6,830 in Phase IIIb. The cost for Phase II was $33,700. In oncology, the average per patient trial cost for Phase IIIa was $57,207 and $65,900 for Phase IIIb. For Phase II, the average cost was $73,303. For drug to treat central nervous system disorders, Phase IIIb costs were $41,824 and Phase IIIa costs were $33,768, on average per patient. Phase II was $28,197. And for diabetes, Phase IIIb costs were $10,700, Phase IIIa costs were $12,667 and Phase II costs were $8,854.
Source: Pharmalot
Category : News
A Valeant Pharma Unit Has Problems Making Drugs
Valeant Pharmaceuticals has been on an acquisition spree, but perhaps the Canadian drugmaker may want to conduct a bit more due diligence before its next purchase. One of its recent deals was for Sanitas, which is based in Lithuania and controls Jelfa, another drugmaker based in Poland and that actually produces much of the Sanitas portfolio . Valeant is paying about $455 million in cash .
However, a July 14 warning letter issued by the FDA to Jelfa notes that the Polish drugmaker has some basic problems with quality control. During an October 2010 inspection, the FDA found Jelfa did not thoroughly investigate the failure of a batch or any of its components to meet specifications, which the agency called an unacceptable practice. The FDA then offered a tutorial after Jelfa failed to investigate its manufacturing process and facility controls to identify the cause of a sterility failure.
“This information from the failure investigation also helps determine how many additional other batches may be affected,” the agency wrote Jelfa president Marek Wojcikowski in summarizing its October 2010 inspection, during which various violations of good manufacturing practice were cited. “Please note that when microbial growth is observed, a lot should be considered nonsterile and an investigation conducted.”
In case Wojcikowski missed the point, the FDA was specific: “For information on sterility testing, see Section XI of the FDA’s Guidance on Sterile Drug Products Produced by Aseptic Processing.”
There were other problems. Employees were seen following poor aseptic techniques; tubing ends used to connect solution tanks to a filling line were not protected prior to sterilization to reduce the potential of contamination, and disinfectant efficacy studies were not completed for a few disinfectants used to sanitize surfaces in the sterility testing suite and production aseptic core filling line. One more problem: inadequate vendor qualification of active pharmaceutical ingredient, or API, suppliers.
“Repeat citations from prior inspections indicate that your quality control unit is not exercising its responsibilities, and may not have the appropriate authority to carry out its responsibilities. Due to continuing CGMP issues at your firm, we recommend you engage a third party consultant having appropriate CGMP expertise to assess your firm’s facility, procedures, processes, and systems to ensure that your drug products consistently meet standards for identity, strength, quality, and purity,” the FDA concludes.
This is not the first time that Jelfa reportedly had production problems. In 2006, the Polish government ordered the drugmaker to halt production after mislabeled meds were placed on the market. Jelfa reportedly distributed vials labeled for a drug used to treat allergies and inflammation, but actually contained a drug for treating muscle paralysis during emergency surgery . This occurred just a few months before Sanitas bought Jelfa.
We asked Valeant for a reply and will update you accordingly. UPDATE: A Valeant spokeswoman wrote us this: “We do not yet own Sanitas as the deal has not yet closed, so cannot really comment on their business at this time. As part of the due diligence process, we did verify that Sanitas does have appropriate certifications in Poland and any US exposure is extremely small, if anything.”
Source: Pharmalot
Category : News
FDA Says CRO Studies Should Be Reevaluated
This is every drugmaker’s nightmare. The pharmaceutical industry has been put on alert by the FDA that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. There were “significant instances” of misconduct, the FDA says.
“This misconduct appears to be significant enough to cast doubt on the data generated…If the foundation of the laboratory is corrupt, then the data generated will be also,” according to the auditor. The FDA adds that Cetero also failed to conduct an adequate internal investigation to determine the extent and impact of the violations, and failed to take sufficient measures to assure data integrity within those five years.
The agency is asking drugmakers to check their databases for trials that were used to support New Drug Applications and Abbreviated New Drug Applications during those years – and to be prepared to repeat or confirm the results. Drugmakers will need to determine whether retesting is required. And those with pending applications will have to repeat bioequivalence testing or retest samples using a different lab . Cetero performed bioequivalence and pharmacokinetic testing.
The FDA has asked Cetero for each study, drug name, study number, and the name of drug sponsors. For the moment, the FDA says it is “unlikely” these “data integrity” failures will affect the safety and efficacy of drugs on the market and there is no evidence of any problems. But the agency adds that its request that drugmakers review testing is a precautionary measure. This is due to a “pattern of misconduct” over that five-year period.
According to a July 26 letter to Cetero, the FDA is taking this action for three reasons – widespread falsification of dates and times in lab records for subject sample extractions, apparent manipulation of equilibration or ‘prep’ run samples to meet pre-determined acceptance criteria, and a lack of documentation regarding ‘prep’ runs that prevented (Cetero) from conducting an adequate internal investigation to determine the extent and impact of these violations.”
Source: Pharmalot
Category : News
HHS To Boost Protections In Clinical Trials
After two decades during which complaints have mounted over various aspects of clinical trials, the US Department of Health & Human Services has issued a proposal that would, presumably, better protect clinical trial subjects. There are various suggestions, but include improving consent forms for participants and mandating the use of a single institutional review board for multi-study sites.
“The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site,” the HHS states in its proposal, which indicates comments can be submitted for 60 days as of July 25 – which is today – according to an HHS spokeswoman.
“Although the regulations have been amended over the years, they have not kept pace with…the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics.”
A portion of the proposal is also devoted to suggested changes that would involve boosting data protections to lessen the risk that patient info is used improperly or goes unprotected; revising or eliminating certain criteria used to determine when trials should be expedited; boosting consent protections for reusing or running additional analyses of existing data and biospecimens, and shifting away from studies that are exempt from IRB review to a new category called excused.
The sections that may generate some of the most significant discussion, though, involve strengthening consent forms and requiring a single IRB review. As the HHS notes, consent forms frequently fail to include “some of the most important pieces of information that a person would need in order to make an ‘enlightened decision’ (to quote the Nuremberg Code) to enroll in a research study…but instead of presenting the information in a way that is most helpful to prospective subjects – such as explaining why someone might want to choose not to enroll – the forms often function as sales documents, instead of as genuine aids to good decision-making.”
The agency acknowledges that regs have changed little since 1974, but the average length of consent forms has increased and become “excessively long and legalistic,” even for routine and low-risk research. “It is not uncommon for documents to stretch to 15 or even 30 pages…Moreover, studies have shown that the reading level of many of these documents is above the desired 8th grade level.” That means many participants may avoid reading forms or are unable to understand them.
And so the HHS proposes requiring “appropriate content” with “greater specificity” than is currently mandated; restricting content that would be inappropriate to include in consent forms; limiting the acceptable length of various sections of the forms; mandating how info should be presented, such as infor that should be included in the beginning of a form or types of info that should be included in appendices and not in the main body of a form; reducing institutional “boilerplate” language, and making available standardized consent form templates.
As for multiple IRBs, the HHS notes that the Common Rule requires each institution engaged in a multi-site research study obtain IRB approval for the study, but does not require a separate local IRB at each institution conduct a review. Just the same, this does happen, resulting in hundreds of reviews for one study. And so when any of these IRBs requires changes to a research protocol that are adopted for the entire study, study investigators must re-submit the revised protocol to all reviewing IRBs, which can significantly delay research. Another problem – the HHS cites reports that there can be “widely differing outcomes” among reviews from IRB to IRB, “even for identical studies.”
So the HHS suggests mandating that all domestic sites in a multi-site study rely upon a single IRB as their IRB of record for that study. And this would apply regardless of whether the study underwent convened review or expedited review. The proposal would only affect the IRB designated as the IRB of record for institutional compliance with review requirements, and would not relieve any site of its other obligations under regulations to protect human subjects.
As for data security, the HHS suggests calibrating protection standards to match what is required by the HIPAA Privacy Rule. As a result, an IRB would no longer be responsible for assessing the adequacy of a study’s procedures for protecting against informational risks.
And three changes are being considered for research that will receive expedited review – revising criteria that make research studies eligible for expedited review, eliminating the requirement of routine annual continuing review of expedited studies and streamlining submission requirements. To sort this out, the HHS may change the list of research activities that qualify a study for expedited review, and also determine that a study involves no more than minimal risk and meets requirements of a section of federal law known as 45 CFR 46.111.
This states that before an IRB may approve a research study, including research that is
being reviewed under an expedited procedure, the IRB must find that risks to subjects are minimized and are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. Selection of subjects must also be equitable and informed consent will be sought from each prospective subject or a legally authorized representative. And finally, informed consent will be appropriately documented.
Source: Pharmalot
Category : News
