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

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.

Pfizer Virtual Clinical Trial Success Or Failure, My Follow Up Interview With Director Craig Lipset


A few weeks ago I reported on Pfizer’s Virtual Clinical Trial, also known as the “trial in a box”. While this study by many critics was considered to be a failure due to recruitment issues, many others viewed it as a refreshing innovation in a clinical trial industry which is desperately in need of greater efficiency. In today’s much-anticipated follow up interview, I sit down with Craig Lipset, Director of Clinical Innovation at Pfizer, and discuss some of the things that worked in this virtual trial, as well as some of the things which did not work, and whether these types of clinical trials are here to stay or whether this was a failed experiment at best. We realy covered a lot in this interview but what I found interesting was the emergence of the new physician role that will be part investigator, part referral source. Guys, this trial may not have been a success in terms of recruiting the number of participants needed, but this is just the tip of the iceberg and in my opinion, elements of this trial are here to stay.

Your Rights As A Clinical Trial Study Participant

If you are ever considering joining a clinical trial, there are a few major things you will need to know that are study-specific. These are risks and benefits of the trial, possible side effects, and nature of the study and procedures involved. However, no matter what study you may end up participating in, you need to know that you have many rights that protect you as a study volunteer. If you feel that any of these rights have been violated or not followed appropriately, you should contact the IRB (Institutional Review Board). They are the committee whose sole responsibility is to ensure the safety of trial participants, and their number will be on the Informed Consent that you have to sign before or on your first study visit. (More on Informed Consents later).

Here are your rights:
-You must be FULLY informed of the risks of the trial
-You must give FULLY informed consent
-You can stop participating at any time for any (or no) reason
-You can refuse any research procedure done to you
These are your basic rights in any study. It is in your best interest to be as informed as possible about all of the details of the study, but these are the big things you need to keep in mind. Just keep in mind that the research clinic also has the right to withdraw you from the study at any given time even if you still want to continue. These decisions are usually made by the Doctor in charge of the study, and believe it or not, happen often enough for me to mention here. Also, the research site does not have to pay you for incomplete visits, although they should pay you for the amount of total studies that you did complete. Issues regarding payment are also found in the Informed Consent, and it is your responsibility to ensure that you are being compensated accordingly. Throughout the study you should speak up about concerns and any questions you may have. Any reputable research clinic will make sure you have sufficient time to have your questions answered.

Every state has their own variation of a Bill of Rights for people who participate in clinical trials. I happen to live and work in California, so I have posted the CA Bill of Rights for you to view below. No matter what state you live in, research clinics must follow Good Clinical Practice (GCP) which the FDA (Food and Drug Administration) enforces. Good Clinical Practice guidelines pretty much have these Bill of Rights covered as well.

Here are the Bill of Rights:
Experimental Research Subject’s Bill of Rights
California law, under Health & Safety Code Section 24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the following list of rights written in a language in which the person is fluent. This list includes the right to:

1. Be informed of the nature and purpose of the experiment.

2. Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.

3. Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.

4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.

5. Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.

6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.

7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved.

8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.

9. Be given a copy of the signed and dated written consent form.

10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.

My Interview With DrugDev.Org Founder: Get Your Research Clinic Signed Up, It’s Urgent!


Today I got a chance to interview Melissa Easy, one of the founders from DrugDev.Org, an online database where research clinics can enter their information in order to get contacted by pharmaceutical companies and CRO’s for clinical trials that may match their areas of expertise. I wrote a few posts these past weeks on the fact that some drug companies are collaborating in order to improve their study start up times and perhaps streamline some of the study start up activities. I also reported on the Transcelerate collaboration in Europe and the US pharma companies Eli Lilly, Johnson&Johnson and Merck collaborating on the same type of activities. In this interview with Melissa, we got into some of the reasons why DrugDev.org was founded, and her thoughts on the future of study start up activities and Pharma collaborations when it comes to clinical trial studies being initiated. I apologize for some audio issues in the middle of the interview, but for the most part you can make out what Melissa is talking about, and we will definitely do a follow up interview in a few months. In the meantime, if you are a research clinic, you need to register your company on DrugDev.org as it is free and pharma companies will be utilizing this database more often as they begin to look for research clinics to conduct their clinical trials in the future.

Clinical Trial Collaborations and How You Can Benefit As A Research Clinic


So I’ve been doing a lot of writing lately about the recent collaborations between Pharma companies looking to get their clinical trials started faster, cheaper and more efficiently. I especially focused on the Transcelerate project which has 10 European Pharma companies collaborating and sharing all sorts of information amongst each other such as Research Site information, training documentation for their Investigators, therapeutic specialties of their sites, etc. I even blogged about the US partnerships/collaborations occurring in the US. This video I did today is a follow up to the already classic interview I did with Melissa Easy from DrugDev.org. Basically, things are changing for the better in this industry and they are changing fast. While we may see more consolidation in the industry from the CRO and Research Site levels somewhere in the future, what is occurring now are these Big Pharma collaborative efforts where study start up and cost saving measures are being put into high gear in order to allow clinical trials to get started faster. We will see how this plays out, but things are definitely shaping out to make for an interesting 2013.

Beware Of Therapeutic Misconception In Clinical Trials

What’s therapeutic misconception? Therapeutic misconception is a term for making a clinical trial seem like it was designed to be a treatment for the study participant as opposed to calling a clinical trial what it really is, a means of collecting data, you know, actual research!

Let’s get one thing crystal clear. Clinical trials are designed to collect data so that eventually, better and better drugs can be developed. As a clinical trials professional, I would love to tell you that clinical trials will also provide you with excellent medical treatment and care. I would be lying to you.

Unless you are using clinical trials as an alternative of last resorts (life threatening conditions that have not responded well to available treatments), you should not go in to a study expecting any type of treatment. After all, you may very well get placebo. However, this does not mean that your participation will be nightmarish, or that your condition will get worse. It simply means that you should be aware of the context of your participation in the study in the greater scheme of things. The drug companies want their drugs to perform well in these studies. Therefore, they are expecting that the individuals on placebo should not do well in the study relative to their non-placebo taking counterparts. In fact, if a drug does not show separation from placebo, there is very little use for the drug.

If the drug companies don’t have unrealistic expectations for everyone who joins a study, neither should you. Some people will do very well, others will stay the same, and some will get worse. So while participating in a trial does not guarantee a treatment, it also does not mean that you shouldn’t participate. The medical attention (not treatment) that EVERY participant receives in a clinical trial is second to none. Every function of your body will be analyzed and you may end up learning something new about your health that otherwise went unnoticed (this has happened in our studies many times). This is simply not economically possible anywhere outside of a research setting where the medical bill is paid for by the sponsors.

Therefore, if you have been frustrated by a lack of medical attention to your health, clinical trials may be a viable option. Finally, if you really are not doing well in the trial, you have the right to withdraw at any time for any reason, and will be given appropriate after trial care. To learn more about placebos check this post I did here.