While I am sure the vast majority of this CRO's employees seek only to place the best patient candidates -- in a completely neutral and above-board fashion -- into these myriad FDA-required clinical trials, this drive for "innovation", coupled to a tightly controlled, marketing department driven study design -- will almost inexorably lead to more of these all-too preventable tragedies. [Additional earlier background here.]
In any event, another honcho at Old Merck has landed softly, per the PR NewsWires site-feed:
. . . .Kendle, a leading, global full-service clinical research organization, today announced the appointment of Jeffrey M. Zucker as Senior Director and Global Head, Patient Recruitment. Zucker will provide global leadership for the development and implementation of innovative strategies to accelerate patient recruitment, improve retention and support the timely and efficient delivery of Phase I-IV clinical development programs for the Company's biopharmaceutical customers. . . .
Zucker brings extensive experience from across the biopharmaceutical industry, including management positions focused on site selection and patient recruitment. In his most recent position, he led global trial optimization efforts for Merck & Co. He also has served as Director of Inpatient Operations at CRI Worldwide and as founder and President of Applied Research Trials, a biopharmaceutical consulting firm focused on improving clinical research trials and processes. Zucker has held leadership positions for Eli Lilly, Princeton Biomedical Research and multiple clinical investigative sites. . . .
. . .Innovative patient recruitment strategies in support of investigative sites have earned Kendle consistent recognition as a CRO of choice. . . .
[From Kendle brochures:]
For a Phase III trial across 26 countries Kendle created a proactive optimization strategy to boost recruitment at slow or non-enrolling sites. Kendle’s extensive experience made rapid implementation possible, leading to a 50 percent increase in patient randomizations within one month. . . .
[And this. . .]
Kendle’s global medical writing team has extensive expertise in producing high-quality protocols, Informed Consent Forms, clinical study reports, regulatory submissions with supporting Integrated Summaries of Safety and Efficacy (ISS/ISE), medical manuscripts, abstracts and patient narratives. . . .
I truly believe clinical trials should be about science, not marketing pitches. I hope the FDA (still) agrees.
3 comments:
think you need to dig some further; patient narratives are written to describe a.o. adverse events that did occur in more detail. Narratives aid the evaluation of trial data by describing events more completely and by putting events into perspective in most if not all trials.
Right.
I am aware of that. I highlighted the mention fo the patient narratives, because -- as Salmon will no doubt shortly swim by, and inform us -- there is an "art" to the science of writing the adverse event narrative, in a way that is truthful, yet does not unduly harm the chances of the drug candidate putatively under study.
That sometimes dark art is exactly the sort of thing that more than occassionally leads to the FDA's approval of some dubious drugs.
Do stop back -- I do appreciate varying perspectives, here. I think you presume drug companies motivations are generally benign; I presume that the companies are generally motivated by the promise of a blockbuster -- even if they have to create it through a manufactured "sizzle", rather than just letting the steak's taste sell it, by word of mouth.
Namaste
Working in the industry I can only say that the usual intentions are to create good drugs that sell good.
Companies working on projects of this magnitude have to operate in the financial system of today where 'shareholder value' is #1.
However, should healthcare depend on academia alone the trickle of new drugs would dwindle down ultra fast. Pharma as we know it is about to melt down IMHO. In the cycle of life the industry will have to redesign itself rapidly.
Adverse events and their incidence rates can not be evaluated in the proper perspective of all circumstances which might skew the risk-benefit evaluation, narratives help by painting the fuller picture-not necessarily a brighter picture.
Narratives do not ever replace the cold safety data that is evaluated by regulators, but they can put the right perspective on matters by describing the relevant circumstances under which the events occurred.
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