I am a 57-year-old white American male infected with Hepatitis C. I am involved in a controlled medical research study by Roche Pharmaceuticals of an experimental Polymerase Inhibitor (RO5024048 also known as RG7128) drug therapy for the virus. This document is the story of my illness and the experience of treatment. My lovely and pretty damn wonderful wife will be contributing her take on the experience as well.

Friday, May 28, 2010

Research Leverage – Use It or Lose It

In the previous post, I discussed at some length the reasons Research Drug Trials are often harder on the patient than Standard of Care (SOC) treatment through you doctor. I also talked about the advantages of being in a research trial not the least of which is the access to new drugs that can increase the chances for successful treatment. There is another aspect of being in a research trial that you can use to help you mitigate the side effects and stress of being in a drug trial, it is the leverage you have regarding the data they are collecting from you body.

Once they move beyond the Phase 1 trials to determine basic efficacy and safety, research trials increase in size and length. The reason is that to determine the effectiveness and side effects of the drugs under study, they need a large enough sample to give them statistical significance. Therefore they recruit hundreds of subjects for the trials. There is another reason for recruiting larger numbers of subjects. The researchers know that a certain number of the patients entering their trial will not finish it. Some will fail to abide by the parameters of the study. Others will consistently miss taking doses of their drugs and be dropped from the study. Still others will have such severe reactions to the drugs that they will not be allowed to continue. There are those who will leave the area and not be moving to a location that has the necessary facilities to allow them to continue and some will just not be able to stay the course for the necessary time to complete the study. So they need to recruit enough people to collect enough data even after the inevitable attrition of subjects.

This is where your leverage comes in. The researchers want your data, they need your data and they need you to complete the trial for that data to become a useful part of their records, reports and papers. Therefore they will go to some lengths to keep you in the study. If you move, they will try to find a lab or medical facility near you that can continue the testing they need for the trial. They will work hard to educate you about what you have to do as far as dosing and record keeping and keep at you to do it correctly. They will also prescribe remedies for some of the side effects to make it possible for you to stay in the trial.

That is why it is important to report side effects to the researchers as they happen. It is also important to tell them how severe they are. If they are interfering with your ability to function effectively tell the researchers that as well. For some of the side effects, they will adjust you research drug dose to attempt to mitigate the situation, for others they will prescribe medications to ease the side effects. It is not necessary to exaggerate any of the information you are giving them. Be factual, but above all be timely. If you report accurately and quickly when you have side effects and when those side effects are becoming a real detriment to your life, they will do what they can to help because they want your data. To get your data, they need you in the study. That is your leverage and if you don’t use it, you lose the advantages it can bring.

To use my case as an example, if I had reported the muscle pain in my sides that the interferon causes as soon as it happened, they would have prescribed Tramadol sooner. I would have been more comfortable and probably better rested earlier in the study than I was simply by reporting the severity of the situation as soon as it was happening. Likewise with the insomnia that is a common side effect. I was sleeping badly for a few weeks before the truly enormous bags and dark circles under my eyes made it plain that I was not getting enough sleep. When it became obvious they moved quickly to prescribe the Trazadone to help me sleep. The same was true with the depression caused by the interferon. If I had been reporting my mental state more accurately, it would have been apparently several weeks earlier that I need help for my mental state. As soon as it was plain that I did, they started on the search for the correct antidepressant.

So even though, they want to watch the progression and severity of the effects and side effects of the drugs and they want to control the variables of drug interactions by keeping what you are taking to a minimum, they also want you to complete the study and get your data. Use that leverage to help make your own treatment as bearable as possible.

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