NCI Expands Oncologists’ Participation in Phase III Trials

BETHESDA, Md—Less than 3% of adult cancer patients take part in clinical trials. In an effort to increase patient enrollment in phase III studies, the National Cancer Institute (NCI) launched a pilot program last year—called the Expanded Participation Project (EPP)—to allow greater physician participation in its cooperative research groups.

Qualified oncologists who become EPP “partners” can enter patients into selected cooperative group studies and receive the same compensation to cover their research costs as do cooperative group members.

In this interview with Patrick Young, ONI Washington Bureau Chief, Scott Saxman, MD, a senior investigator in NCI’s Clinical Investigations Branch, discusses the role of the EPP and the benefits it offers oncologists who are not members of cooperative groups.

ONI: How many cancer patients take part in cooperative group phase III trials?

Dr. Saxman: The cooperative groups enroll about 20,000 patients each year in NCI-supported multi-institutional clinical trials.

ONI: What is the basic concept and strategy of the EPP?

Dr. Saxman: Overall, it is to enhance physician participation in phase III trials, thereby increasing the number of patients who go on study and, in the long term, allowing more rapid completion of phase III trials.

The National Cancer Institute recognized that, for one reason or another, a significant body of physicians did not participate in the cooperative groups. We identified several major barriers that community-based physicians encountered. We wanted to lower those barriers.

ONI: Obviously, the next question is, what are those barriers?

Dr. Saxman: One complaint that investigators had is the amount of paper work that it takes to participate. For community oncologists, that’s a significant problem. They don’t always have data managers or research nurses.

So the Expanded Participation Project is exclusively Internet based. All the forms, the on-study data, everything is entered via computer. There is not a lot of paper flying back and forth.

Physicians also wanted access to a larger body of protocols. As you know, when you’re an ECOG member, you get ECOG protocols, but if there is a CALGB trial that very much interests you, you can’t participate in it. The EPP has opened up the phase III trials from all of the cooperative groups to the investigators represented in the EPP.

Reimbursement was another major issue. A lot of people in the community have had relationships with the cooperative groups indirectly through universities. One problem that we heard from oncolo-gists is that reimbursements for the costs of doing studies were not getting passed down to them in full. They were getting less money than they would have if they had been group members, and the reimbursements were much less than what they needed to support their research.

The EPP reimburses physicians directly for participation in a study on a per-patient basis. There is no pass through where multiple hands take a piece out of it. The EPP physicians get $1,725 per patient, the same amount that the cooperative groups reimburse their members.

ONI: What other major issues has the EPP addressed?

Dr. Saxman: Physicians who do participate in multiple groups complained about having to deal with two or three operations offices. For instance, a community-based investigator with patients in RTOG, ECOG, and GOG trials would have to interact with each group’s office. That means different paperwork, different phone numbers, and different individuals to contact.

With the EPP, there is one central operations office called a CTMU, or clinical trials management unit. Even through EPP partners are participating in multiple trials with multiple groups, they don’t interact with the groups directly. All the data flow to the CTMU over the Internet. The CTMU then distributes the data to the appropriate groups.

ONI: Are there concerns about the purpose of the EPP?

Dr. Saxman: I think there is a fear out there that we are trying to supplant or replace the cooperative groups, and that clearly is not true. The EPP is intended to enhance participation by physicians and patients. It is not intended to deliberately include physicians who are actively involved with the cooperative groups or to shift resources from one to another.

ONI: Does the EPP program represent a radical change in direction?

Dr. Saxman: It is different in some ways, but it is different in a direction that we are also heading with the cooperative groups. These are parallel tracks. As you may be aware, we’ve recently put into place a clinical trials support unit, or CTSU, for the cooperative groups. So, as of early July, cooperative group members can actually participate in randomized phase III trials from other cooperative groups through the CTSU.

The intention is that in approximately 2 years, the EPP will roll over into the CTSU. The CTSU will then allow participation in multiple cooperative group trials, not only for group members but for nongroup oncologists as well.

ONI: Would you explain the concept of the physician partners further?

Dr. Saxman: Physician partners are just that. They are physicians, individuals, and groups who, for one reason or another, have not participated significantly in the cooperative group structure, which doesn’t mean they haven’t participated at all. Basically, they become members of the EPP, and through their partner memberships, they have access to cooperative group phase III trials. They can accrue and put patients on studies. The same institutional review board [IRB] rules apply to them.

ONI: And so a joint practice or a solo oncologist could participate as a partner.

Dr. Saxman: That is correct. We have tried to target different types of practice models. We have solo practitioners, group practices, several community-based cancer centers, a couple of VA hospitals, and a couple of universities.

ONI: What has been the response of oncologists?

Dr. Saxman: As the word has gotten out about the EPP, we have had more and more interest. The project was slow to start up. We found that some things made it difficult for the community-based members to begin. Many of our partners don’t have a research nurse waiting to immediately accrue patients. Some had to put an IRB into place or get federal approval for their IRB.

It has been a real educational process, not only for us but also for our partners. Many of them are starting from ground zero. And so we have had to help them as they put things into place.

We have had to educate some of our partners about IRBs and what the IRB means. We have helped their offices learn what informed consent is all about and how to obtain it. And we have a course in which we teach them how to use the Web-based Internet system, and our partners have helped us significantly to debug that system and to tell us what works about it and what doesn’t. So it really has been a partnership.

ONI: How many phase III trials are now open to EPP partners and for what cancers?

Dr. Saxman: There are four diseases that we’ve chosen to include in the EPP—breast, colorectal, prostate, and lung cancer. We chose them for the obvious reason that they are the most common malignancies that practicing oncologists see. Currently, there are 16 studies that are open in the EPP in those four diseases, with four more studies to open soon.

ONI: Are there plans to expand the program to other diseases?

Dr. Saxman: We have not decided whether we are going to add more disease sites to the EPP. We are still discussing that. Again, the EPP will roll over into the CTSU in a couple of years, and that unit will include more diseases, such as genitourinary cancer, leukemia, and gastrointestinal cancer. The long-term goal is to expand the number of diseases in the CTSU to allow for broader access across multiple disease sites.