Posts tagged oncology

The Days Of Blockbuster Drugs Are Gone; Niche Clinical Trials To Thrive

Mar 06, 2013 Leave a Comment ~ Written by Dan Sfera

Partially due to the Affordable Care Act which I have discussed numerous times on this blog, especially as it pertains to the world of clinical research, drug companies have been scrambling to get their drugs approved by the FDA and added to insurance company formularies before the legislation officially goes into action. Basically, drugs that do not show any significant differences or improvements from previous drugs that target the same medical conditions will NOT gain formulary approval by insurance companies. The FDA is also looking at these “me too” drugs and will make drug approval much more difficult for drugs that do not show any improvements from their predecessors.

Under the situation described above, at first glance, the situation for clinical trials going forward may seem dire. Fortunately for those of us working in this sector, I believe we are entering into a new era for not only clinical research, but for the pharmaceutical industry in general. This new era will usher in a new business model for drugmakers, CRO’s and research clinics alike, and we have already started seeing the beginning of niche studies, otherwise known as studies for drugs that target smaller populations and attack the biological pathways for the disease or disorder rather than focus on the symptoms. According to Novartis CEO Joseph Jimenez who was recently quoted in a Fortune magazine article regarding his company’s strategy going forward in terms of drug development, “The company plans to do that by attacking disease pathways, the biological processes. That way, you get a drug that, while designed for kidney cancer, is also helpful to patients with certain lung or breast cancers.” Novartis has already done this with several of it’s cancer drugs, essentially creating “mini blockbusters” by attacking the biological pathway of a disease rather than merely looking to subdue symptoms.

What does all this mean for clinical trial sites and CRO’s? Perhaps a new study participant recruitment model is in order combined with strategic partnerships and alliances in the industry which we have already begun to see with certain CRO’s and SMO’s lately. perhaps new business development tactics for getting the contracts for these studies at your organization? No matter how you may look at the situation and attempt a business strategy going forward, the industry is undergoing a paradigm shift and, as in all industries that eventually go through changes such as these, some will fail while others will succeed enormously.

Posted in Featured, Research Professionals, Study Participants - Tagged blockbuster, cancer, cro's, fda, insurance, niche, novartis, recruitment, smo's

Inpatient Clinical Trial Requirements

Feb 11, 2013 Leave a Comment ~ Written by Dan Sfera

I’ve been getting asked a lot of questions lately regarding my experiences with inpatient clinical trials. For those who may not know, inpatient studies are studies that require the study participants to stay in a secured facility for either a certain portion of the study or the entire study altogether. Participation is of course, voluntary, and the study participants may withdraw from the study at any given time. The requirements for the inpatient facilities that are to be utilized for these studies vary widely from protocol to protocol, and I have had experiences with actual hospital units, nursing homes, assisted living facilities, and privately-owned research clinics that specialize in these types of studies. In this video I get into some of the different types of facilities as well as requirements for the different types of inpatient studies.

Posted in Featured, Research Professionals, Study Participants - Tagged cancer, cns, inpatient, phase 1, psychiatry, voluntary

23andMe Gathering Massive Database of Thousands Of Potential Clinical Trial Participants By Using DNA Samples

Dec 02, 2012 Leave a Comment ~ Written by Dan Sfera

The genetic company that allows anyone to get their genotype analyzed for $299 from their home by sending in a saliva sample, is forming strategic partnerships with Pharmaceutical companies such as Genentech and others to not only perhaps recruit more participants into clinical trials, but also serve as the genomic testing arm for the various clinical trials that they partner with. According to 23andMe’s blog post from August of this year, they are partnering with Genentech for a cancer trial testing the investigational product Avastin. According to the blog post, not only will 23andMe help with recruitment efforts by sifting through it’s massive database, but their genomic technologies will also serve as one of the clinical trial study procedures that Genentech is incorporating into its protocol. Another example of 23andMe’s partnership with clinical trials is the relationship they have with the National Parkinson Foundation. Under this partnership, from what I understand, individuals with Parkinson’s who are not 23andMe members, will get free access to 23andMe’s services which include ancestry research, genotype analysis and potential notifications about future research studies. 23andMe is a venture backed firm that has investors from Google Ventures amongst other venture capitalists. I see this as merely the beginning of genomics playing a larger role in clinical trials going forward. In fact, I covered this topic a few months ago here regarding Quitniles and their predictions for the direction in which clinical trials are headed. Stay tuned for more info on this as I have put out an interview request with 23andMe CEO Anne Wojcicki to discuss the company further. If you are interested in learning more about 23andMe’s genomic services as I personally am for myself, check out their website.

Posted in Featured, Research Professionals, Study Participants - Tagged 23andme, cancer, dna, genomics, parkinson's, recruitment, social media

Clinical Trials Being Analyzed In Real Time and Even Predicted Prior To The Study Starting: Adaptive Clinical Trials

Nov 23, 2012 1 Comment ~ Written by Dan Sfera

In recent news, CRO giant Pharmaceutical Product Development (PPD) has begun to utilize adaptive clinical trial software known as FACTS, that will not only analyze trial results in real time as data is entered into the Electronic Data Capture (EDC) Systems, but also run clinical trial simulations prior to the trials actually starting. Furthermore, once data begins to be gathered on either the study drug, regular treatment, or even placebo arms, the trial can be “adapted” so that more people would be randomized into the study drug arm, or vice-versa. This article from last summer’s Los Angeles Times explains the concept pretty well. The benefit for trial participants is that if a study drug proves effective, the randomization ratios can be altered so more trial participants in the future will be assigned to the study drug. Check out my explanation of randomization here. In any case, adaptive clinical trials have been running for the past few years, but as technology gets better and data can get analyzed faster, adaptive clinical trials would be able to truly “adapt” in real time, and in theory at least, clinical trial participants may see greater benefits by being assigned a study drug at a higher ratio if the drug proves to be beneficial. This would be especially helpful in clinical trials for life-threatening conditions. For research clinics however, adaptive clinical trials may mean that studies may terminate earlier than we would like if the drugs being studies are shown to not be as effective as the sponsor would like. I have had this happen to me with my research clinics several times over the last few years and it has reinforced the fact that your study pipeline should be pretty busy at all times as more studies are being halted prematurely. In the long run I do believe that adaptive clinical trials will allow for better treatments reaching the market faster and the potential for clinical trial participants outweighs any inconveniences this may cause research clinics. Let me know your thoughts on this.

Posted in Featured, Research Professionals, Study Participants - Tagged adaptive clinical trials, adaptive trials, business development, cancer, cro's, life threatening, placebo, randomization, randomized, research clinics

New Study Reveals Black Patients Offered Clinical Trials Less Often Than Whites

Oct 30, 2012 Leave a Comment ~ Written by Dan Sfera

In a presentation at the Science of Cancer Health Disparities Conference these past few days, researchers highlighted results from a recent study which videotaped the way oncologists discuss clinical trial options with their patients. In this particular study, 22 video recordings in which a clinical trial was offered were analyzed of oncologists discussing clinical trials with their patients, 11 of whom were white and 11 of whom were black. Not surprisingly, as studies were done on this in the past (however this is the first study that utilizes real time data), African Americans were spoken to overall less than their white counterparts. African Americans were also offered clinical trials less than Whites in this analysis. Informed Consent of the study was also explained less to blacks than whites. The study also shows, and previous studies confirmed, that black patients also ask their physicians fewer questions and overall speak less than the white patients which were analyzed.
One of the researchers, Susan Eggly, PhD, commented, “Minority patients tend to receive less information, which could, in part, explain under-enrollment by minorities in clinical cancer trials, these disparities could also lead to minority patients being enrolled in trials without fully understanding the purpose of the trial and the potential risks of participation.”
The reason for the lack of minority, specifically African American, participation in clinical trials has been looked at and discussed before. In fact, I did an interview here with someone from John Hopkins University on the reason African American lack trust when it comes to clinical trials. The key seems to stem from an adequate lack of communication between physician (usually white) and minority patients. Whether this can be changed by better educating physicians on how to include minorities into these conversations, or simply encouraging more minority youth to pursue a career in medicine, the current result is that there is an obvious problem here that needs to be repaired. For more information on the study I am writing about, please check it out here. As always, let me know your thoughts.

Posted in Interviews, Research Professionals, Study Participants - Tagged african americans, cancer, ethics, informed consent, minorities, recruitment

FDA Considering Faster Clinical Trial Pathway For Drugs With Societal Benefit

Oct 24, 2012 Leave a Comment ~ Written by Dan Sfera

In a story that broke today, FDA commisioner Margaret Hamburg made it known that the FDA is playing around with the idea of having a different clinical trial pathway that would involve “smaller and faster” clinical trials for obesity drugs, life-saving antibiotics and any other drugs which may provide “societal benefit” although she did not elaborate any further. I will report on this more as further details emerge, and I would like to know how this would be different than the FDA’s current “compassionate use” program that I discussed a few days ago. It is interesting to note that cancer treatments were not explicitly mentioned by Mrs Hamburg. This may prove to be exciting news for researchers none the less and may end up benefiting individuals who are in need of these treatments. As for Pharma companies looking for shortcuts in their clinical trials, it was made clear that these expedited pathways would be used only for people who would actually need the medications and risk-benefit situation would be analyzed. “A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good,” said Pew Health Group’s Allan Coukell, deputy director of medical programs. As always, please stay tuned for more info.