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Old 01-13-2014, 07:45 PM
gdpawel gdpawel is offline
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Default The Downside To Clinical Trials

Robert A. Nagourney, M.D.

As the practice of medicine has moved from a profession to an industrial undertaking, this most human of experiences has fallen prey to the dictates of the American business model. Patients are no longer the purchasers of medical care and services, but instead, the consumers of those goods and services that meet the needs of the purveyors. Whether this is a governmental entity, academic institution, or pharmaceutical company, individuals have become cogs in the wheel of the medical-industrial complex.

This has become glaringly apparent in the field of cancer research. Cancer patients were once, for better or worse, in charge of their own destinies. They could choose their surgeon, oncologist, and institution, even to some degree the treatments that they wished to undergo. As the HMO model came into play, patients were increasingly told what doctor, what treatment, and what hospital. The capacity of individuals to make decisions was eliminated in favor of standardized care, cost guidelines and treatment protocols. While much of the academic community described this as progress with adherence to standardized protocols, these protocols have not provided superior outcomes in most settings. Instead, they offer hospital administrators the opportunity to anticipate costs, allocate resources, codify drug administration and regulate care delivery.

Recent experience has brought several disturbing examples to the fore. Working in the laboratory, we have been able to select candidates for new combinations, sometimes years before these regimens became broadly available. We then identify centers with access to these drugs under protocol. Many of the drugs have well-established safety records from prior phase 1 and 2 clinical trials, but have not achieved full FDA approval. When several of our patients with lung cancer revealed sensitivity to a regimen that we had identified years earlier (Kollin, C et al Abs 2170, Proc AACR, 2005) we immediately explored sites offering this combination of an oral agent with an IV antibody. The closest we could find was in Colorado. The injection, a widely established monoclonal antibody, FDA approved for gastrointestinal cancer, was not yet approved for lung cancer while the pill had been administered safely in hundreds of patients. Indeed, the combination had also been safely administered to dozens of patients by the time we inquired. Nonetheless, to participate in this potentially life-saving treatment my patients were forced to commute from LA to Colorado every other week.

It would have been quite easy, once the patients were formally accrued, for them to return to California and receive the same drugs under our care. After all, we were the ones who identified them as candidates in the first place and we were very familiar with the trial. Despite this, the rigidity of the protocol forced these lung cancer patients to become frequent fliers. The good news was that the treatments worked.

More recently a patient, who had failed experimental therapy for advanced uterine carcinoma at a large academic center in Texas, returned to LA five years ago to seek my assistance. A lymph node biopsy at the time revealed exquisite sensitivity to a drug combination developed and published by our group and she achieved a prompt complete remission. She has since relapsed and required additional chemotherapy. My concern for her long-term bone marrow tolerance, with repeated exposure to cytotoxic drugs, led me to seek alternatives. Her EVA-PCD functional profile had revealed excellent activity for PARP inhibitors. Here, I thought, would be the solution to her problem. After all, the PARP inhibitors had been in development for years. Several had revealed compelling activity in clinical trials and they are well tolerated. Despite this, no PARP inhibitor has been FDA approved.

When we pursued opportunities to accrue the patient to one of the PARP inhibitor trials, however, she did not qualify. Having received low dose Carboplatin several months earlier she ran afoul of an exclusion criterion in the protocol that dictated no platinum exposure for six months. “Six months?” I exclaimed. Few cancer patients can wait six months to start treatment and virtually no cancer patients can wait six months once they have relapsed. I was flabbergasted.

What exactly were the protocol designers thinking when they demanded a six-month wash out, fully four, five or six times longer than any protocol I’d ever encountered? The absurdity of this demand virtually eliminated patients-in-need from consideration. As I considered the dilemma it became increasingly clear. When one examines the thinking behind clinical protocols it becomes evident that they are not designed to help patients or cure cancer. Instead, they are created to answer specific questions. In so doing they further the careers of investigators, expand medical center market share, standardize treatments and simplify the activities of clinical research organizations. Patient outcomes, well-being and convenience are far down the ladder of expectations.

As I pondered the inconvenience, hardship and lost opportunities associated with clinical trial participation for many patients around the United States, I began to wonder whether patients should throw off the yoke of this oppressive system. After all, it is not the academic centers that own the process, it is the patients. It is those brave individuals willing to participate in these studies. It is the patients whose tax dollars support these institutions. It is the patients who purchase either directly or indirectly the drugs they receive and it is the patients that are necessary for the process to succeed.

Patients should demand more user-friendly, convenient, patient-centric therapy programs. Perhaps patients should simply refuse to participate. A ground swell of patient advocacy could re-orient the discussion away from the convenience and ease of the treating physicians and toward the good outcome and ease of the treated patient. While we applaud the investigators for their brilliance and prowess, we forget that no clinical investigator would receive accolades were it not for the hundreds or thousands of patients who martyr themselves at the altar of clinical research. Patients, not their doctors, are the heroes. Perhaps it is time for cancer patients to stand up to cancer research.
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Last edited by gdpawel : 01-14-2014 at 01:42 AM. Reason: Post full article on forum board
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Old 01-14-2014, 01:42 AM
gdpawel gdpawel is offline
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Default Randomized Clinical Trial Paradigm

Cancer clinical trials can exclude those patients most likely to benefit from certain treatments. And institutions usually offer treatments based only on standard protocols. Has cancer medicine become just another industry?

Read about the Randomized Clinical Trial Paradigm: [url]http://cancerfocus.org/forum/showthread.php?t=3692

World renowned Oncologists are challenging the cancer industry to recognize a Chemo-Screening test (CSRA) that takes the "guesswork" out of drug selection. One of the reasons medical oncologists don’t like in vitro chemosensitivity tests is that it may be in direct competition with the randomized controlled clinical trial paradigm.

[url]http://vimeo.com/72389724
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Last edited by gdpawel : 02-26-2014 at 12:34 AM. Reason: additional info
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Old 01-24-2014, 09:35 PM
gdpawel gdpawel is offline
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Default Further Information on The Downside To Clinical Trials

Robert A. Nagourney, M.D.

The recent blog “The Downside To Clinical Trials” described some of the pitfalls of modern cancer research and the clinical trial process. It has engendered an active discussion. It may be helpful to address some of issues raised. For those of you who did not have the opportunity to read that blog, it defined the difficulty that many patients encounter when they seek experimental treatments. Clinical trials are often only available at select centers, sometimes at great distances from patient’s homes. There can be rigid inclusionary and exclusionary criteria, and the pre-entry evaluations e.g. re-biopsy, CT/PET, etc. can be daunting, time consuming and inconvenient. Travel and accommodations may come at great personal expense.

I penned the blog, in part, to remind patients that they are ultimately in control of the process. One patient asked how can “we stand up to the system” describing herself a consumer while “they’ve got the goods.” This is the frustration many people feel. It should be remembered, however, that a substantial portion of research support comes from tax dollars and charitable donations. These are your dollars. If the system is not working, then those responsible must be held accountable. The American public has the power of the vote. Patient advocates can approach and lobby their representatives and demand improvements in the clinical trial process. To wit, the level of scrutiny and restriction upon access to new drugs must be re-examined. There is an army of well-trained clinical oncologists capable of delivering experimental drugs today. Not just the fully vetted, just-about-ready-for-prime-time agents currently found in phase III trials, but the really new exciting drugs. Once a drug has passed Phase I and found to be safe in patients, open up the accrual process. “Compassionate use” has virtually disappeared from the lexicon of cancer research. Twenty years ago I made a discovery in the laboratory. Working with the pharmaceutical company and the FDA, we were almost immediately granted access to a yet-to-be approved agent. The combination proved so effective that today it is one of the most widely used regimens in the world. That would not happen today. We simply cannot get access to the best drugs for our patients.

With the industrialization of medical care, growth of mega-medical systems and the increasing role of government, medicine must be viewed through a different lens. Changes in cancer research will require changes in cancer policy, and policy comes from political power. Cancer patients will need to identify legitimate spokespeople to take their concerns forward to their elected officials. While the current clinical trial process slowly grinds out new development, even the smartest, fastest trials take years to change practice. Every day, more than 1,500 cancer patients die in the United States alone. Cancer patients do not have time for clever doctors to pose interesting questions while they suffer the slings and arrows of ignoble, ineffective therapy. It is time for a change in cancer research, and patients must be the instrument for that change.

[url]http://robertanagourney.wordpress.com/2014/01/13/stand-up-to-cancer-research-the-downside-to-clinical-trials/

The bottom line is to encourage cancer patients to be proactive not only in their own cancer treatment but also in changing the tax supported clinical trial system.

If the system isn't working for you or your loved ones, let's fix it!

[url]http://robertanagourney.wordpress.com/2014/01/24/rallying-the-troops-to-confront-cancer/

Dr. Nagourney has also stated on his blog that while marginally effective therapies are promoted by many academic centers, simple, comparatively easy techniques are available that can empower patients in treatment selection. Cancer patients must demand access to treatment options and explore every lead.

The Internet has offered an entirely new platform for cancer patients to communicate their experiences, recommend physicians, educate friends and family members and change referral patterns. The power to change the way cancer is treated in America today is within the grasp of the patients themselves. Patients enlightened about better ways to treat cancer need to communicate and take charge of their disease.
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Last edited by gdpawel : 01-30-2014 at 11:36 PM. Reason: additional info
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Old 01-24-2014, 09:45 PM
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Default JAMA papers raise questions about FDA drug and device approval

Gary Schwitzer

HealthNewsReview.org

An important series of papers was published in the Journal of the American Medical Association this week.

“Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” by Dr. Joseph Ross and colleagues, concluded that the quality of clinical trial evidence used by the FDA as the basis of approving new drugs varies widely. A couple of interesting data points:

- in the seven-year period of analysis, 37% of drugs were approved on the basis of a single pivotal trial.

- trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 45% of drugs approved.

[url]http://jama.jamanetwork.com/article.aspx?articleid=1817794

In an opinion piece, “Opening the FDA Black Box,” Drs. Steven Goodman and Rita Redberg said the study:

“…raises a host of questions needing further exploration. Despite the FDA requirement for evidence from a minimum of 2 randomized clinical trials supporting an effect on health outcomes, 37% of product approvals were based on only 1 trial, 53% of cancer trials were nonrandomized, and an active comparator was used in only 27% of non–infectious disease trials. Surrogate end points were used in almost all approvals via the accelerated approval process and in 44% of nonaccelerated approvals. Trials were comparatively short, with most lasting less than 6 months, even those assessing chronic treatments for chronic diseases. Cancer drugs, perhaps predictably, were more often approved via the accelerated process and with weaker designs.”

[url]http://jama.jamanetwork.com/article.aspx?articleid=1817770

Another paper looked at the reasons that FDA marketing approval for new drugs was delayed or denied.

[url]http://jama.jamanetwork.com/article.aspx?articleid=1817795

And a fourth paper looked at FDA regulation of medical devices, “a process that has received relatively little attention,” according to Goodman and Redberg, who continued:

“There are 2 different pathways of devices to market. The most rigorous is the premarket approval (PMA) route, which requires some evidence of clinical effectiveness and safety data, although only 14% of high-risk devices have been assessed in even 1 randomized controlled trial, usually unblinded. As a result of the 2004 Medical Devices User Fee Act, which requires the FDA to require the “least burdensome route” to approval, less than 1% of medical devices are approved through this most rigorous pathway.For moderate- and low-risk devices, the other route is the 510(k) pathway, which allows devices to be marketed if they show “substantial equivalence” to existing devices.A 2010 Institute of Medicine committee strongly recommended elimination of this path.

(That paper also describes) an underexamined third way for a device to reach the market via the “supplement” process, used for modifications of devices originally approved through a PMA. Focusing on cardiac implantable electronic devices in the period from 1979-2012, Rome et al found that there were 5825 supplemental PMA applications for 77 original devices—a median of 50 supplements per device, of which about half were for design changes. It is not surprising that many of the devices are, according to the authors, “much different from the original.”

Rome et al report that supplemental PMA applications are commonly approved without clinical testing, based on reviewer judgments, suggesting that “in some cases, preclinical testing may be superior to clinical testing in assessing changes.” The main role of preclinical testing is to identify devices that demonstrate problems in the laboratory setting and thus avoid clinical testing of that device change. However, the absence of problems in the laboratory setting might not reliably predict the long-term fate of the device in the human body, where environmental and physiologic forces impossible to replicate in the laboratory setting work in combination. The malfunction of implantable cardioverter-defibrillator leads, which resulted in a widespread recall,and the hazards posed by particles shed from metal-on-metal hip replacements were not predictable based on engineering insights or in vitro studies. More empirical work is needed to assess the validity of reviewer judgments about whether clinical data are needed prior to certain types of device approval. Moreover, if the approval process depends on subsequent clinical trials, a less obvious consequence of constant design modification is that it could be difficult to know what device versions were used in the trials and whether results are generalizable to other versions of the device.”

[url]http://jama.jamanetwork.com/article.aspx?articleid=1817796

In USA Today, Liz Szabo wrote a good summary of the JAMA papers under the headline, “Not all FDA-approved drugs get same level of testing: Evidence behind FDA-approved drugs and devices often has major limitations.”

[url]http://www.usatoday.com/story/news/nation/2014/01/21/fda-drug-testing/4713621/
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Old 03-01-2014, 12:39 AM
gdpawel gdpawel is offline
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Default Personalized Cancer Care: N-of-1

Robert A. Nagourney, M.D.

The New York Yankees catcher Yogi Berra famous quote, “Déjà vu all over again,” reminds me of the growing focus on the concept of “N- of-1.” For those of you unfamiliar with the catchphrase, it refers to a clinical trial of one subject.

In clinical research, studies are deemed reportable when they achieve statistical significance. The so-called power analysis is the purview of the biostatistician who examines the desired outcome and explores the number of patients (subjects) required to achieve significance. The term “N” is this number. The most famous clinical trials are those large, cooperative group studies that, when successful, are considered practice-changing. That is, a new paradigm for a disease is described. To achieve this level of significance it is generally necessary to accrue hundreds, even thousands of patients. This is the “N” that satisfies the power analysis and fulfills the investigators expectations.

So what about an N-of-1? This disrupts every tenet of cancer research, upends every power analysis, and completely rewrites the book of developmental therapeutics. Every patient is his or her own control. Their good outcome reflects the success or failure of “the trial.” There is no power analysis. It is an “N” of 1.

This “breakthrough” concept however, has been the underpinning of the work of investigators like Drs. Larry Weisenthal, Andrew Bosanquet, Ian Cree, myself and all the other dedicated researchers who pioneered the concept of advancing cancer outcomes one patient at a time. These intrepid scientists described the use of each patient’s tissue to guide therapy selection. They wrote papers, conducted trials and reported their successful results in the peer-reviewed literature. These results I might add have provided statistically significant improvements in clinical responses, times to progression, even survival. By incorporating the contribution of the cellular milieu into clinical response prediction, these functional platforms have consistently outperformed their genomic counterparts in therapy selection So why, one might ask, have the efforts of these dedicated investigators fallen on deaf ears?

I think that the explanation lies in the fact that we live in a technocracy. In this environment, science has replaced religion and medical doctors have abdicated control of clinical development to the basic scientists and basic scientists love genomics. It is no longer enough to have good results; you have to get the results the right way. And so, meaningful advances in therapeutics based on functional platforms have been passed over in favor of marginal advances based on genomic platforms.

There is nothing new about N-of-1. It has been the subject of these investigators compelling observations for more than two decades. Though functional platforms (such as our EVA-PCD) are not perfect, they provide a 2.04 (1.62 to 2.57, P < 0.001) fold improvement in clinical response for virtually all forms of cancer – as we will be reporting (Apfel C, et al Proc ASCO, 2013).

It seems that in the field of cancer therapeutics “perfect is the enemy of good.” By this reasoning, good tests should not be used until perfect tests are available. Unfortunately, for the thousands of Americans who confront cancer each day there are no perfect tests. Perhaps we should be more willing to use good ones while we await the arrival of perfect ones. After all, it was Yogi Berra who said, “If the world was perfect, it wouldn’t be.”
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Last edited by gdpawel : 07-10-2014 at 12:57 AM. Reason: spelling error
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Old 03-01-2014, 07:16 PM
gdpawel gdpawel is offline
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Default Personalized Chemotherapy: Understanding Clinical Trials - the Kaplan Meier Graph

In this video of Personalized Cancer Chemotherapy, Dr. Larry M. Weisenthal explains the Kaplan-Meier graph. The graph is often used in clinical trials to compare survival times among patients with the same type of cancer who received different chemotherapy treatments. Understanding the graph is easy and also very useful as it will enable you to cut through the clutter in published clinical trial manuscripts and see at glance if any chemotherapy regimen provided a superior survival benefit.

[url]http://www.youtube.com/watch?v=1Fz6kBXmAt0

Big Data Meets Cancer: Neil Hunt at TEDxBeaconStreet

[url]https://www.youtube.com/watch?v=IWu6XWzbPBs

The consistent and specific cure or control of cancer will require multiple drugs administered in combination targeted to abnormal patterns of normal cellular machinery that effect or reflect malignant behavior, according to Dr. Arnold Glazier, former Oncology Fellow at Johns Hopkins. It is finding the patterns of malignant cells and developing a set of 5 to 10 drugs in order to cure or control cancer that classical clinical trials are not going to solve.

In clinical research, studies are deemed reportable when they achieve statistical significance. The so-called power analysis is the purview of the biostatistician who examines the desired outcome and explores the number of patients (subjects) required to achieve significance. The term “N” is this number. The most famous clinical trials are those large, cooperative group studies that, when successful, are considered practice-changing. That is, a new paradigm for a disease is described. To achieve this level of significance it is generally necessary to accrue hundreds, even thousands of patients. This is the “N” that satisfies the power analysis and fulfills the investigators expectations.

So what about Trials of N=1? This disrupts every tenet of cancer research, upends every power analysis and completely rewrites the book of developmental therapeutics, according to Laboratory Oncologist Dr. Robert A. Nagourney. Every patient is his or her own control. Their good outcome reflects the success or failure of "the trial." There is no power analysis. It is an "N" of 1.

This “breakthrough” concept however, has been the underpinning of the work of investigators like Drs. Larry Weisenthal, Andrew Bosanquet, Ian Cree, Robert Nagourney and all the other dedicated researchers who pioneered the concept of advancing cancer outcomes one patient at a time. These intrepid scientists described the use of each patient’s tissue to guide therapy selection.

They wrote papers, conducted trials and reported their successful results in the peer-reviewed literature. These results have provided statistically significant improvements in clinical responses, times to progression, even survival. By incorporating the contribution of the cellular milieu into clinical response prediction, these functional platforms have consistently outperformed their genomic counterparts in therapy selection.

With Cancer, Don’t Ask the Experts

[url]http://robertanagourney.wordpress.com/2014/07/09/with-cancer-dont-ask-the-experts/
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Last edited by gdpawel : 07-10-2014 at 12:53 AM. Reason: Additional info
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Old 03-12-2014, 11:31 PM
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Default Published Studies Often Conflict With Results Reported to ClinicalTrials.gov

Joseph S. Ross, M.D., MHS.
Yale University School of Medicine

Study results published in major medical journals often conflict with the data its authors have submitted to ClinicalTrials.gov, according to an analysis published in JAMA March 11, 2014.

The ClinicalTrials.gov registry, maintained by the National Library of Medicine, was created to help improve transparency in the medical literature by ensuring that all results of clinical trials, whether published or not, are archived in a single repository. A 2007 law mandated that researchers post results of studies on all products regulated by the US Food and Drug Administration (FDA) within 12 months. Many journals have also pledged to require their authors to report their findings in the registry. But numerous problems with the registry have been documented since its creation, including a failure of many researchers to report their results and sloppy data entry by investigators.

A new analysis by Joseph S. Ross, MD, MHS, an assistant professor of medicine at Yale University School of Medicine, and his colleagues raise questions about the accuracy of what is reported in the registry and in the medical literature. The team compared the results of 96 trials published in top-tier medical journals, including JAMA, the New England Journal of Medicine, and the Lancet, with the results of those trials reported in ClinicalTrials.gov. They found at least 1 discrepency in the results reported for 93 of the trials. Results matched in both the registry and journal article in only about half the cases.

Ross discussed the findings with news@JAMA.

news@JAMA: Why did you choose to do this study?

Dr Ross: Our research group is interested in thinking of ways to improve the quality of clinical research. When the Food and Drug Administration amendments were passed requiring results reporting [to the ClinicalTrials.gov registry], we were interested in how that would play out. There have been studies about how compliant researchers are with this requirement. We wanted to look at how accurate the reported findings are. By comparing the reported results to published trials, we wanted to see how well it was working. What we found was a surprise.

news@JAMA: Why were the results surprising?

Dr Ross: We found important discrepancies between the results reported in ClinicalTrials.gov and the published results. We don’t know which is right. There were lots of end points reported in 1 source that weren’t reported in the other.

news@JAMA: Can you give an example?

Dr Ross: We started by looking at the primary end points published in high-impact journals and what end points were reported in ClinicalTrials.gov. Of 90-some-odd trials, there were 150 to 160 primary end points; 85% were described in both sources, 9% only in ClinicalTrials.gov and 6% only in the publications.

For the more than 2000 secondary end points, 20% were reported only in ClinicalTrials.gov and 50% only in publications. Only 30% were described in both sources.

You see that only part of the information is available in 1 source. We need to make the sources as complete as possible. The publications need to link back to ClinicalTrials.gov because they often don’t include all the end points.

news@JAMA:Why might there be such a difference?

Dr Ross: There are a lot of potential explanations.

More end points were reported in the published papers than in ClinicalTrials.gov. This suggests authors are reporting end points in the paper that make the results look better that weren’t predetermined. That can skew the literature.

news@JAMA: Could edits made by the journals, such as requests for more information or new analyses, or typographical errors account for some discrepancies?

Dr Ross: It could be editing. An authorship team submits the results and these are publications that have strong editorial staffs. There could be slightly different approaches in analysis submitted to the 2 sources.

Some are typographical errors. For example, 1 study reported a hazard ratio of 4 in ClinicalTrials.gov instead of the hazard ratio of 2 in the study [the hazard ratio and standard deviation were transposed]. That perverts the study result.

news@JAMA: What can be done to improve the accuracy results in reporting?

Dr Ross: These results are increasingly being used by researchers and in meta-analyses; we want them to be accurate. The journals pay a large staff of full-time editors to make sure these studies don’t have errors, but ClinicalTrials.gov has a relatively small staff. We may need a larger endeavor than what the National Library of Medicine originally envisioned.

A third of the discordant results led to a different interpretation of the trial. This a problem we need to be attending to. We studied the highest-tier journals, so this is likely the best-case scenario. These are likely the highest-achieving researchers. Who knows what’s happening with lower-tier journals?

[url]http://newsatjama.jama.com/2014/03/11/author-insights-published-studies-often-conflict-with-results-reported-to-clinicaltrials-gov/

Note: Different results from the same study reported in different publications. This is sort of mind boggling. It shows that a whole lot of the time medical research authors are massaging and/or cherry picking their own data and they can't even keep their own stories straight!
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Old 09-07-2014, 11:06 PM
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Default FDA Inspections of Clinical Investigators

Cary Presant, M.D.

Most oncologists want to participate in clinical trials. To help sustain our practices, participation as an investigator in trials gives our patients access to new therapies, gives the physician a sense of helping to advance oncology (a commitment often made during fellowship training), and affords the practice a more admirable position for patient referral and contract procurement.

But a recent report in Clinical Cancer Research 2014; 20: 3364 by S. Morgan-Linell and coauthors gives us a current view of one aspect of clinical trial investigator activities: FDA inspection.

An important aspect of FDA oversight of clinical trials is to review clinical investigators to verify that the investigator is protecting the rights of the patients enrolled on trials, verify the accuracy of data collected, and respond to concerns or complaints. The report reviews these inspections of clinical trial investigators from 1977 to 2009.

Administrative FDA inspections have become more common, while at the same time the clinical trials themselves have become much more complex with consent processes, inclusion/exclusion criteria, testing requirements, evaluation performance, and documentation performance all placing more responsibilities in the hands of the physician. Meeting these responsibilities is not optional, rather it is required by law and regulation.

The inspection results were surprising. Although each investigator seeks to have no deficiencies during participation in the trial, only 11.2% of inspections found no deficiency when data audits were performed. In 31% of inspections, although deficiencies were found, no action was indicated based on the review. FDA action resulted in 3.9%, and voluntary investigator action resulted from the inspections.

Deficiencies that were most commonly found were inadequate records (27%), inadequate informed consent documentation (28%), and failure to follow the investigational protocol plan in 34%. If you find out you have been deficient and action is indicated, this can be time consuming and challenging to your practice. It can shake your confidence in your practice.

Compliance is often not just a function of your commitment. Preventing deficiencies can be dependent on performance of clinical trial monitors, administrators, nurses, medical assistants, insurance company authorizations, and even the patients themselves. It is not therefore unexpected that only 11.2% of inspections showed no deficiencies.

Where do we go from here with this new data? Do we continue to participate, or just focus on standard treatment? These results challenge us to make a better commitment to clinical trial performance, or to refocus our goals in areas where we can achieve higher compliance and satisfaction. Regardless of the decision we make, we can do so with a greater understanding of this aspect of clinical trials participation.

Citation: FDA Inspections of Clinical Investigators: Do You Want To Do Clinical Research? Medscape. Sep 07, 2014.
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