Advocacy > Clinical Trial Design and Participation

Informed Patient Perspectives

Last update: 05/29/2008

Overview | Details

Timely participation in clinical trials is vital – delays are costly to sponsors and to patients.

If patients fail to sign on in adequate numbers ... the assessment of the therapy will not be made
no matter how well the study is designed from the point of view of regulators and scientists.

Indeed, the urgency of our situation requires that the evaluation system
becomes as efficient as it can be.

Resulting in efficiency and faster accrual

We prepare continuously by reviewing reputable materials on drug development 
and assessment, and by seeking guidance from our scientific advisors. 
 
Importantly, to minimize bias, our policy is to accept no funding from 
commercial entities that market drugs or health supplements.

We are committed to: 

• Sharing patient's perspectives on clinical trial design with the FDA, drug sponsors, 
  the NCI, independent scientists, and community physicians.
   
• Making informed and practical suggestions when consulting on clinical trial design.  
  Note that we will not accept gifts or fees for this service, and that we will honor 
  confidentially agreements.
   
• Vigorously representing patient interests in matters of concern.
   
• Identifying opportunities and obstacles to the progress of clinical research.

We believe that the following goals must not be considered mutually exclusive:

• Applying the best possible evidence-based standards to ensure that patients 
  have reliable information about the risks and benefits of marketed treatments, 
  and increasing incentives for companies to develop new therapies to meet our needs.
   

• Providing cancer patients with every reasonable chance to improve their quality of life 
  and survival.

Patient Perspectives: the details 

• Guidance on clinical trial design for drug sponsors and the FDA  Patient perspectives

• Itemizing opportunities and challenges in FDA evaluations of new drugs  Patient perspectives

• For patients

  • Background on treatment: goals | types | outcomes | interventions

  • Evaluating medical claims and data  What we have learned about the importance of objectivity

  • Would a clinical trial be appropriate for me? Questions for your doctor 
    A printable brochure prepared by Patients Against Lymphoma  PDF | PDF-Help

• Harmonizing Research and Treatment Goals - Patients Against Lymphoma Presentation
  Cancer Vaccine Conference in Boston - April 2003

  • Harmonizing Research and Treatment Goals (web version)
    Color PDF or B&W PDF  |  PDF-Help

• Letter to Mark McClellan, MD, PhD Commissioner, Food and Drug Administration 
  Commentary on Abigail Petition - Compassionate Use Proposal

• Overcoming obstacles to participation in clinical trials Patient perspectives
  A checklist that will help all parties to overcome known obstacles.