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Clinical trials Phase 1 trials, Research blog of Veeda Group > Categories
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8/25/2010
Dr. Joel Ross, the founder and chief executive of the Memory Enhancement Centers of New Jersey, makes his living enrolling subjects in drug company clinical trials that are testing drugs for Alzheimer’s disease, among others.
When Eli Lilly announced last week that its promising Alzheimer’s drug was making patients worse and that it was halting two large clinical trials, it seemed likely that Dr. Ross would hear from family members of his patients. Are other experimental Alzheimer’s drugs safe? they might ask. Should they get their family members out of those Alzheimer’s studies?
Not a single family member called. And Dr. Ross, is not sure why.
If a study of an experimental breast cancer drug was ended because it made the cancer grow and spread, women in other breast cancer studies of similar drugs would be calling their doctors and asking what to do.
But Alzheimer’s is different. “It may reflect the incredible desperation surrounding Alzheimer’s disease,” said Baruch Brody, director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
There is no treatment and no way to prevent Alzheimer’s. It is a leading cause of death, ravaging patients and their families. “Possibly, the overworked caregiver has precious little time to listen to news or read a paper,” Dr. Ross said. Whatever the reason, the silence of Alzheimer’s family members gives rise to an ethical question. Do families now need extra protection or warnings about the Lilly experience when they sign up Alzheimer’s patients for studies? There are no easy answers, ethicists and drug companies say, in part because it is not known what went wrong with the Lilly drug.
When patients enter studies or, in the case of patients with Alzheimer’s, when caregivers sign them up for studies, they or their caregivers sign an informed consent document. The forms are reviewed by ethics panels known as institutional review boards.
When the federal government conducts studies, it makes the consent forms public. Drug companies, though, generally insist that their forms be confidential. Investigators conducting studies for companies and institutional review boards must agree not to distribute the forms.
But every form contains a statement that warns patients that a drug might not help, said Angela Bowen of the Western Institutional Review Board, a private group which does ethical reviews of research on human subjects, including studies of Alzheimer drugs. The forms say a clinical trial is aimed at helping future patients. It is not a treatment for a disease. The forms also say “there may be side effects that are not known at this time” and “your condition may not get better or may get worse during this study.”
Sourced from the NY times-
http://www.nytimes.com
Identifying, Developing and Investing in " wonder drug" is not so easy anymore for any Global Pharma company. When the options are are less it becomes a challenge for the companies to take the molecule to its final stages. One of the companies today is Pfizer which has been trying to develop a " wonder drug", Sutent.
By my count, Pfizer's cancer drug Sutent has failed in as many cancer types as it has shown a meaningful effect in. The drug works against kidney cancer, gastrointestinal stromal cancer, and pancreatic neuroendocrine tumors, but has failed to show an effect in liver, breast, and now lung cancer.
The drugmaker said yesterday that Sutent failed to improve survival in lung cancer patients when combined with Roche and OSI Pharmaceuticals' Tarceva compared to Tarceva alone. The combination product did extend the time before the tumor started to grow again, but it's survival that patients -- and the Food and Drug Administration -- care about.
Batting 500 isn't so bad for baseball players or cancer therapies. The problem is that the lung and breast cancer markets are large markets. Gastrointestinal stromal cancer? Not so much. 8/2/2010
Figures for all Phases are up, which is encouraging given the economic circumstances. The rise at Phase II is not insignificant, at 7.9%. However, two points should be made which might temper our enthusiasm at this point. Firstly, as has been the case every year in the past decade, the increases seen at Phase I and Phase II have not fed through to a significant increase at Phase III. While one would expect considerable attrition between Phase II and Phase III, the fact is that an extra 22 compounds at Phase III, compared to an extra 134 at Phase II, is frankly disappointing. This is better than in some years though, when the Phase III figure remained resolutely flat.
Trends in preclinical drug development are always more difficult to divine. The annual figure is more volatile, and subject to both changes in reporting practices by the industry and the data source in consideration. 6/24/2010
Big Pharma like Pfizer is facing rising pressure from the easing generic competition, patent cliffs and investor pressures has made them conduct clinical studies for more than one indication. However clinical setbacks are increasingly becoming part of various company programs despite efforts to ensure that the relevant and suitable clinical endpoints are achieved.
One of the major concerns for various drug majors today is safety. A recent example of this is as follows: -Pfizer has suffered a clinical setback with the news that a late-stage trial of its oncology blockbuster Sutent as a potential treatment for liver cancer has been halted over safety concerns. The New York-based giant has discontinued the SUN 1170 Phase III study of Sutent (sunitinib) in advanced hepatocellular carcinoma following a review by an independent data monitoring committee. It has been halted because of a higher incidence of serious adverse events in the sunitinib arm of the trial compared to Bayer/Onyx' Nexavar (sorafenib).
Furthermore, Sutent "did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer.
Drug and biotech companies now fund more than 80 percent of clinical trials in USA.
With only a third of studies still being done in academic medical centers and universities, institutions are under heavy pressure to accept the drug companies' requirements for clinical studies. Those terms, according to a 2001 joint statement by leading medical journals, threaten the objectivity of research.
Medical scientists working on corporate-sponsored research, the journals warned, may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation.
Of course, that isn't true of NIH-sponsored trials. The basic research funded by NIH appears to be fairly free of taint. But the industry-sponsored clinical trials that flow from some of that research are a different story. Sponsored studies are about four times as likely as trials without commercial funding to favor the drug under study.
The NIH also proposed that academic institutions, rather than individual investigators, be held responsible for conflicts of interest. That means that the universities themselves would have to investigate potential conflicts and report them to the NIH.
Consistent Drug demise in Clinical Development
Ignoring generics and medicines of the 1990's are "ignored' by drug companies for treatment. It is indeed important to note that the drug companies are unable to "invent "any drugs since the last 4 years. The last drug that came in as a blockbuster drug was Merck's Januvia which came in the year 2006 and now has annual sales of $1.9 billion. (The other contender would be Merck's Gardasil vaccine, also launched in 2006.).
After the year 2006, there has been a lacuna in new drug launches. The Drug development has on the other seen a consistent demise of their most potential and favorable products in the pipeline since the last 4 years.
This has made companies revise their strategies on an ongoing basis as most of the MNC's like Pfizer, Astra, , Roche, SAV, etc have faced major pipeline failures in the late stages.
It's no secret that the pharmaceutical industry's problem is that it can't invent enough drugs. There was a flood of big selling medicines launched by pharmaceutical companies, and since then, despite a collective research budget that eclipses the annual spend of the National Institutes of Health, new medicines are approved at comparative trickle.
The late 1990s were an anomaly, when lots of drugs were launched thanks to a perfect storm of regulation and science. The average number of drugs approved each year seems to hover around 25 a year. And we're about at that level now. Last year doesn't look that different from 1995 or, for that matter, 1975.
What has changed is that it's costing a lot more to get a medicine approved, and all the technical efforts at changing that, from combinatorial chemistry to genomics, haven't really had an impact. Also, new drugs are generating less revenue. And one thing you can't see from the graph is that in recent years, many more products are biotech protein medicines, which are far more expensive. But the picture above raises the possibility that Pfizer, Merck, GlaxoSmithKline and Novartis aren't suffering from being in a slump. They're suffering because the normal rate of drug approvals isn't enough to make up for patent expirations and other losses of revenue. That's actually a much scarier thought.
Data source: US FDA website
Pharma is spending far more than ever on R&D. And there's a bunch of people at the FDA who are actually quite interested in helping along innovative new therapies.
Maybe the whole R&D field is just getting harder to work in. The big fat targets in medicine have largely been hit, and now shots on goal at biopharma are pointed not just at new therapies, but something that is demonstrably better than what's already out there.
When you're up against nothing, it's relatively easy to show that you're more effective than the alternative. But when you're up against already-state-of-the-art treatments, you're looking for small improvements. That means you need huge numbers of patients to generate a statistically significant result. And since good treatments already exist, the safety hurdles are also higher-the FDA is less likely to approve a statin that causes internal bleeding than a pancreatic-cancer drug that does the same.
Meanwhile, in the areas where we don't have good drugs, we don't have so many easy targets, either. The great hopes for finding drug prospects by decoding the human genome have largely faltered; so far, reading our DNA seems mostly to have taught us how little we still understand about our own biology. So, researchers are left with complex problems like cancer, which is really not one disease at all, but several thousand different ways that a human cell can go wrong. Or Alzheimer's: after decades, researchers are still trying to decide whether the disease's signature beta-amyloid plaques in the brain are a cause of dementia, or a side effect. 4/22/2010
Everyone here in India is talking of the potential of clinical trials in the Indian geography and there is a wild fire alert saying that India especially Class B cities will the eyed as the destination for setting up the site infrastructure for outsourced clinical trials to India.
However somewhere the forecasters are missing out on the following points:
- Where will the trials come from? (As molecules are failing for big companies i.e. since the last 2 months at least 5-6 major drug failures have taken place in Phase III). Not many investors are willing or convinced to invest in clinical development as it is a high risk business. For clinical development CRO's it is going to a challenge to another dimension.
- Who will "risk" the investment for the infrastructure in Class B cities in India?(which are gradually becoming expensive as well as more educated and the urban masses occupying smaller towns). Class B cities will slowly become urbanized to their gradual rise in expenditures.
As the rising needs of healthcare and expenditures which the governments have to incur followed by the need for more new drugs to cure chronic ailments of the Heart, Nerves and cancer , it is certainly going to be a challenge for the investors when they invest in clinical development . The CRO's will have to bear a "substantial " amount of risk if clinical trials sites are going to be in India especially in Class B cities where urbanization is on the rise. |
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